LEDA at Harvard Law School LEDA at Harvard Law School
When Food is Poison:
the History, Consequences, and Limitations
of the
Food Allergen Labeling and Consumer Protection Act of 2004
Laura E. Derr
Class of 2005, Harvard Law School
ABSTRACT
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) is the first federal law enacted in the United States aimed directly at helping safeguard the health and safety of people with food sensitivities. Although concern for people with food allergies was one impetus behind the mandatory ingredient disclosure requirements of the Federal Food, Drug, and Cosmetic Act of 1938, that act’s purposes and provisions extended much broader than – and fell dangerously short of – adequately addressing the needs of food sensitive individuals.
The FALCPA establishes a comprehensive scheme for food allergen labeling effective January 1, 2006, implementing the most sweeping changes to the food label in America since the Nutrition Labeling and Education Act of 1990. Passage of the FALCPA represents the culmination of significant efforts by consumers, the Food and Drug Administration, Congress, and food manufacturers to deal with the problem of food allergens after decades of inadequate knowledge about food sensitivities and negligible legal or policy action to protect people with food sensitivities.
While the FALCPA is a remarkable achievement for the over 13 million Americans with food sensitivities, it is not ideal. This paper explores the extent to which the FALCPA will benefit people with food sensitivities. After providing an introduction to food allergies and presenting the case for improved food labeling, this paper analyzes the FALCPA’s provisions, summarizes the history of labeling related to food allergens in the U.S., evaluates the FALCPA’s limitations, and presents suggestions for future food sensitivity-related reforms.
TABLE OF CONTENTS
“What is food to one man may be fierce poison to
others.”
– Lucretius (c. 99
B.C.E.–c. 55 B.C.E.),
Roman poet and philosopher
For the over 13 million Americans with a food sensitivity, eating can be a terrifying experience. Phrases like “walking through a mine field,” “playing Russian roulette,” and “being imprisoned” are frequently employed when food allergy sufferers discuss the daily task of eating.[1] For approximately 1 out of every 23 Americans,[2] eating common food staples like wheat, milk, or fish is like eating poison.[3]
People with food sensitivities may experience a wide variety of reactions depending on the specific sensitivity, the amount of unsafe food ingested, and the individual’s particular body chemistry. Harmful reactions to food may induce such symptoms as vomiting, ear and sinus infections, dizziness, hives, eczema, chest pain, migraines, nausea, gastrointestinal distress, drops in blood pressure, swelling of the tongue and throat, arthritis, depression, mental uneasiness, abdominal pain, lethargy, vascular collapse, a weakened immune system, malabsorption of nutrients, increased risk of various cancers, pneumonia, and life-threatening systemic anaphylaxis, asthma, and laryngeal edema.[4] An estimated 150 to 200 Americans, mostly children, die each year of food-induced anaphylactic shock, and thousands more rush to emergency rooms to receive life-saving treatment.[5] Experts have concluded that “fatalities due to ingestion of allergenic foods in susceptible individuals remain a major health problem.”[6]
Millions of people know they risk adverse reactions that range from irritating to debilitating with every bite they take. Countless others, children and adults alike, endure life with an undiagnosed food sensitivity, perplexed and troubled by their mysterious ill health.
For people with food sensitivities, access to accurate, comprehensive information about the contents of food means the difference between a good and a poor quality of life. For many, it literally means the difference between life and death.
Despite the estimated hundreds of people who have died from – and the millions who have struggled with – food sensitivities in the United States since the passage of the first bill to regulate food and drugs nearly a century ago, the Food Allergen Labeling and Consumer Protection Act of 2004[7] (FALCPA), signed into law in August 2004, is the first amendment to the Federal Food, Drug and Cosmetic Act[8] (FFD&CA) to directly address food allergy concerns.[9] By requiring manufacturers to disclose on the food label the presence of any of the eight most prevalent food allergens in plain English, the FALCPA constitutes one of only two successful Congressional initiatives to amend food labeling provisions since the implementation of nutrition labeling in 1990.[10]
The FALCPA received broad and bipartisan Congressional support. Its passage was hailed as a victory by food allergy sufferers and advocacy groups and was endorsed by the food industry. The passage of this legislation is indeed momentous. It represents a national, public recognition of the health, safety, and attendant legal needs of people with food allergies, and it provides a strong foundation to begin to address those needs. The Act’s passage marks the culmination of years of grassroots consumer activism, efforts by the Food and Drug Administration (FDA) to deal with food allergies, and initiatives by the food industry to respond to consumer safety concerns. The FALCPA reflects an increasing awareness of the serious – and growing – problem of food allergies today.
Nevertheless, the FALCPA’s enactment follows decades of Congressional, regulatory, and private sector indifference and ad hoc, chaotic approaches to food allergen management. And as with any legislation, the FALCPA is not without its drawbacks. The benefits of FALCPA are significantly limited in several key respects.
This paper examines the progress that has been made in the United States to help food sensitive consumers. It explores how far the law has come to improve the lives and safety of people with food sensitivities, as well as how far legal reform efforts can – and, I argue, should – continue to go. Part II of this paper provides an introduction to food allergies and presents the case for improved food labeling. Part III summarizes and analyzes the provisions of the FALCPA. Part IV reviews the history of food allergen labeling issues in the United States within context of four different interested groups – the FDA, consumers, the food industry, and Congress. Lastly, in Part V, I evaluate certain limitations of the FALCPA and offer suggestions for future food sensitivity-related legal reforms.
II. LIVING WITH A FOOD SENSITIVITY:
THE PERILS ENDURED AND PROBLEMS ENCOUNTERED
“People with a food allergy typically walk around with a little bit of fear all the time.”
– Robert A. Wood, M.D., Director of the Pediatric Allergy Clinic,
Johns Hopkins Medical Institutions, Baltimore, MD[11]
“When my kids are at school, when I hear the phone ring I sometimes ‘freak’ a little, wondering if this is a call from school about my [peanut-allergic] son. I guess I’m paranoid that someday a reaction will happen at school and I will get that dreaded call. ... Sometimes I’ll take a deep breath before I pick up the phone and look at the caller id.”
– Parent of a peanut-allergic son (Mar. 23, 2005)[12]
To appreciate the significance and drawbacks of the FALCPA, it is instructive to first have a basic understanding of the nature of food sensitivities and to examine the problems faced by food sensitive individuals that motivated the FALCPA’s drafting and passage.
A. An Introduction to Food Sensitivities
This section discusses fundamental background information regarding: types and biological bases of food sensitivities, the prevalence of food sensitivities, typical offending foods, the diagnosis and treatment of food sensitivities, and the impact of a food sensitivity on lifestyle and quality of life.
The blanket term “food sensitivity” encompasses three basic types of ailments associated with adverse responses to foods that are safe for the vast majority of people to ingest – food intolerances (such as lactose intolerance), immediate hypersensitivity reactions (typically known as “food allergies”), and delayed hypersensitivity reactions (the most notable of which for purposes of this paper is celiac disease). The three types of food sensitivities are differentiated by the specific biological mechanisms that lead to adverse reactions when a sensitive individual comes into contact with an offending food. Although exploring the science behind food sensitivities in detail is beyond the scope of this paper, a summary of the principal distinctions between the types of food sensitivities is instructive since the FALCPA and, consequently, this paper, focus on two particular ailments – food allergies and celiac disease.
Food intolerances are characterized by abnormal physiological responses to food or food additives that are non-immunological in nature.[13] Food intolerances are more common than food allergies.[14] The symptoms of food intolerance resemble many of those associated with food allergies, but adverse reactions are not life-threatening and often can be mitigated or prevented by reducing (rather than completely eliminating) consumption of the offending food.[15] In the case of the common intolerance to lactose, the intolerance can be further managed through the use of over-the-counter products[16] that allow an intolerant individual to nonetheless consume dairy products.
Food allergies and celiac disease both involve abnormal immunological responses to proteins in food. When someone is allergic to a food, that person’s immune system mistakenly reacts to certain proteins in the food as if the protein were an invading pathogen; the immune system responds in an exaggerated fashion to counter this perceived invasion. The most common types of food allergies (those mediated by allergen-specific immunoglobulin E, or IgE, antibodies) are known as “immediate hypersensitivity” reactions because symptoms occur within minutes to a few hours after exposure to the allergen.[17] In some cases, exposure to an allergen can induce anaphylaxis that can cause death within minutes.[18]
In contrast with food allergies, celiac disease[19] involves a cell-mediated immune response against gluten (proteins found in wheat,[20] barley, and rye). The onset of symptoms in cell-mediated food reactions, also known as delayed hypersensitivity reactions, begins within 6 to 24 hours after ingestion of the offending food and it can take up to 96 hours for a reaction to subside.[21] Ingestion of gluten is responsible for a wide variety of health dangers, including damage to intestinal lining, malnutrition, nausea, mental distress, migraine headaches, stomach pain, infertility, osteoporosis, neurological conditions, additional autoimmune disorders, and cancer. [22] Thus, although people with celiac disease are not at risk of anaphylactic shock, the consequences of not following a strict gluten-free diet can be “just as grave and deadly.”[23]
The term “food sensitivity” when it is used in the remainder of this paper refers only to food allergies and celiac disease.[24]
2. Prevalence of Food Sensitivities and Severe Adverse Reactions
Until the 1990s, little was known about the prevalence of food allergies,[25] the incidence of severe allergic reactions, which foods were responsible for most allergic reactions, and whether people with food allergies could safely consume an allergenic food below a threshold amount. Understanding about food allergies has substantially increased in the past decade as greater scientific and public attention has focused on the issue of food allergies. Most progress has resulted from private and non-governmental public initiatives.[26] Researchers have partnered with food allergy consumer groups[27] on several occasions to conduct studies that might otherwise have lacked sufficient funding or interest to be pursued.
Despite advances, many facts about food allergies in America remain uncertain, unstudied, uncollected, or unnoticed. Indicative of inattention to food sensitivities within the medical community, food allergies do not appear among the over 330 “diseases and conditions” topics presented on the website of the Centers for Disease Control and Prevention (CDC),[28] nor does the site offer morbidity and mortality statistics related to food sensitivities as it does for nearly a hundred other health conditions.[29] As a Senate Committee Report accompanying an earlier version of the FALCPA notes:
Although several studies have provided estimates, the prevalence of food allergies is uncertain. Currently, the CDC does not sufficiently track data on the prevalence of food allergies, incidence of clinically significant and serious adverse events related to food allergies, and the use of different modes of treatment for and prevention of allergic responses to foods. The CDC should improve the collection of this information to better determine the national significance of food allergies.[30]
The FDA has also opined that “a national assessment of the extent of food allergenicity would be helpful to clarify ... to what extent consumers experience allergic reactions to food.”[31] In recognition of ongoing informational deficiencies in the area of food sensitivities, the FALCPA directs the CDC to collect and publish data related to food allergies[32] and calls for the National Institutes of Health (NIH) to convene a panel of allergy experts to make recommendations for enhancing and coordinating future food allergy-related research.[33]
Although the number of Americans with food allergies is unknown and projections continue to vary, estimates have been improving in recent years. While food allergies were thought to affect 2 to 4 percent of children and as few as 1 percent of adults[34] only five years ago,[35] the projected prevalence of food allergies among both children and adults has more than doubled in the past five years.[36] Results of a 2004 telephone survey indicate that closer to 3.7 percent of Americans are afflicted with food allergies – that is roughly 11 million people, or approximately 1 in every 27 people.[37] Over 6 million people are allergic to fish and shellfish alone.[38] Roughly 3 million people are allergic to peanuts or tree nuts. Food allergies are estimated to be as much as four times more common in children than adults.[39]
Estimates about the prevalence of celiac disease has similarly sky rocketed. According to a 2004 study by the University of Maryland Center for Celiac Research, the most comprehensive study of celiac disease in the United States to date:
Celiac disease affects 1 in 133 healthy, average Americans. That means 2.2 million people are living with celiac disease – 97% of them are undiagnosed. ... The number of people with celiac disease in the U.S. is roughly equal to the number of people living in the state of Nevada. [40]
Celiac disease may be “one of the most common genetic diseases.”[41]
Several factors may account for the recent and substantial increases in prevalence estimates. Research efforts have been intensifying to identify and quantify the existence of food allergies, so estimates are likely becoming more accurate. A growing awareness of food allergies among physicians and patients may be leading to diagnoses of food sensitivities that previously would have gone undiagnosed.
Moreover, evidence suggests that the prevalence is growing. For years scientists have suspected that the prevalence of food sensitivity is expanding.[42] A study published in 2003 in the Journal of Allergy and Clinical Immunology revealed that the prevalence of peanut allergy among children has doubled over the past five years.[43] According to Anne Muñoz-Furlong, founder and CEO of the food allergy advocacy group the Food Allergen and Anaphylaxis Network (FAAN), “this study confirms what we’ve been hearing from growing numbers of families, school administrators and other institutional leaders – food allergy is increasing.”[44] Experts suspect that fatal and near-fatal anaphylactic reactions to food allergens have likewise increased.[45] Researchers expect this trend of increasing prevalence of food allergies to continue.[46]
Thus, current best estimates indicate that as many as 13 to 14 million Americans may be afflicted with food sensitivities. This number is approximately the same as the number of adults afflicted with diabetes.[47] For further comparison, approximately 2.5 million Americans have epilepsy,[48] 4 million suffer from Alzheimer’s Disease,[49] 5 million have had a stroke,[50] 20 million have been diagnosed with cancer at some point during their life,[51] and 23 million have been diagnosed with heart disease.[52]
Although only a subset of people with food allergies are at risk for a life-threatening reaction to food, a large percentage of documented food allergens have been reported to be responsible for severe allergic reactions.[53] It is estimated that 150 to 200 people die of food-induced anaphylaxis each year.[54] Food allergies are responsible for 29,000 emergency room visits annually.[55] Tens of thousands more anaphylactic reactions are experienced each year that do not receive hospital care.[56] Food allergy is believed to be the leading cause of anaphylaxis.[57]
To help put these serious adverse reaction statistics in perspective, another critical food safety hazard, E. coli contamination, is responsible for approximately 61 deaths per year in the United States.[58] Given today’s more effective management of food borne pathogens, food allergens have now been called “arguably the most important chemical hazard posing a threat to processed meat and poultry products.”[59]
Any protein in a food has the potential to trigger an allergic response. Studies have documented the allergenicity of naturally occurring proteins in over 170 foods, ranging from such American food favorites as potatoes, corn, chicken, chocolate, coffee, and strawberries, to spices (like pepper, garlic, and cinnamon) and even nutrients (like Vitamin A).[60] Eight foods, however, have been found to account for about 90 percent of severe allergic reactions worldwide. These foods – milk, eggs, soybeans, wheat, fish,[61] crustacean shellfish,[62] peanuts, and tree nuts[63] – are commonly known as the “Big Eight”.[64]
The most common allergens vary by age. Among American children, the most frequent food allergies are to milk, soy, eggs, peanuts, tree nuts, and wheat,[65] and some children are allergic to more than one food.[66] Among American adults, the most frequent food allergies are to crustacean shellfish, fish, peanuts, and tree nuts.[67]
Children with allergies to milk, soy, eggs, or wheat may outgrow their allergy by age three,[68] whereas adults less frequently lose their allergies.[69] Peanut, tree nut, shellfish, and fish allergies – those allergies most frequently responsible for producing life-threatening reactions[70] – are rarely, if ever, outgrown by children or adults.[71] Celiac disease is also a life-long disorder that currently has no cure.[72]
Several factors contribute to confusion and conflicting information about food sensitivities, including: the difficulty to accurately diagnose them, erroneous self-diagnoses, and professional misdiagnoses.[73] The general public grossly over-estimates the prevalence of food allergies, with as many as 25 percent of people believing they are allergic to a food.[74] This misperception contributes to a faulty belief among some people that, since they are able to occasionally “cheat” and eat foods to which they erroneously believe they are allergic, food sensitivities do not entail serious adverse health consequences. Conversely, some physicians for many years believed that true food sensitivities were exceptionally rare or did not exist at all.[75] Celiac disease did not receive formal recognition by NIH until June 2004.[76] The fact that any specific type of true food sensitivity or particular adverse reaction affects only a relatively small number of individuals and the largely hidden, private nature of food sensitivity have also contributed historically to a general perception that food sensitivities are not a major health concern.[77] The National Institute of Allergy and Infectious Diseases of the National Institutes of Health notes that physicians too often dismiss all forms of allergy, including food allergies, as “nuisance conditions.”[78]
Food sensitivity can develop at any age.[79] People with genuine food sensitivity may take years to receive a professional diagnosis, given the wide variety of symptoms associated with food sensitivity and the commonality of those symptoms with numerous other ailments.[80] Diagnosis can be confounded by the fact that adverse symptoms following exposure to an offending ingredient can occur anywhere from immediately to over two days after exposure, depending on the nature of the food sensitivity. The time between exposure and symptoms, as well as the type of symptoms experienced, can further vary depending on the amount of exposure and the method of exposure (e.g. ingestion, inhalation, dermal contact, and even whether the ingredient is encountered in liquid or solid form). People with celiac disease have on average experienced symptoms of the disorder for 11 years before receiving a diagnosis.[81] Some physicians have told patients that food sensitivities occur only early in life and mistakenly discount the possibility of a person developing a food sensitivity in adulthood.
Even once a food sensitivity is suspected, no single, definitive test is available to diagnose food sensitivities.[82] Diagnosis of a food allergy is based on clinical history and diagnostic studies including skin testing testing with food extracts. Ultimately, diagnosis requires a food challenge test where individuals eliminate a food from their diet and, in consultation with their physicians, evaluate the response.[83] Celiac disease can be conclusively diagnosed only through blood tests and an upper gastrointestinal biopsy in conjunction with improvement following adherence to a gluten-free diet. Still today, substantial disagreement exists within the medical community about the proper way to diagnose food sensitivities.[84]
No cure exists for food sensitivities. The only prophylactic treatment available is strict avoidance of the allergenic food.[85] There is no known safe amount of a food allergen that can be consumed by a sensitive individual.[86]
Food sensitivity experts recognize that food sensitivities can “profoundly alter a person’s life.”[87] As a parent of a teenager with soy allergy explained in his response to the Allergen Labeling Survey, “It is really in today’s culture a horrible burden to have a life-threatening soy allergy.”[88] He further described the maintenance of an allergen-free lifestyle in this way:
I am aware that my tone is one of frustration, but we have been in the game for a long time; and we have little illusion of a workable solution to the constant threat, other than eating at home all the time. As my son gets closer to young adulthood it is unfathomable for any of us to figure out how he will cope when he goes to college, travels, etc. On the one hand we welcome all opportunities to be away from home, travel alone; and then on the other hand there is no safe way; also the people (chaperones, teachers, schools, restaurants, hotels, airlines) are not at all interested in accommodating and supporting the special diet. So, every potential outing/trip/travel is a puzzle as to how to make it somewhat safe and find out what and where to eat, especially at this age when he is escorted on a planned trip and not free to drive and come and go on his own yet. You are with a group and no one else is coping with this minefield of finding out whether there are any safe food choices without soy hidden either in preparation or processing.[89]
The challenging lifestyle of people with celiac disease was discussed on the floor of the House by Representative Bill Shuster of Pennsylvania during Congressional consideration of the FALCPA:
I have had the unfortunate experience to learn more about the trials and tribulations of food allergen sufferers when one of the members of my staff, Christy Farmer, was diagnosed with Celiac Disease earlier this year. ... Having a food allergy, especially something that is found in so many different foods, can add a level of complication to a person’s life that can be difficult to imagine. Christy was required to undergo a total lifestyle change due to her gluten sensitivity. Spontaneously stopping at a restaurant for dinner is no longer possible, traveling not knowing in advance what foods will be available is no longer an option, and giving up your favorite foods is not as easy as it sounds.[90]
Shopping and preparing food for an allergen-free diet can be a time consuming and expensive endeavor, particularly since the most commonly allergenic foods, such as milk, wheat, egg, and soy, are ubiquitous in the American diet. Food sensitive individuals often must prepare food from scratch or purchase expensive specialty products. Eating outside the home poses even greater challenges. Parents must help their children with food sensitivities to learn to negotiate the school cafeteria, field trips, day care, and friends’ birthday parties. Parents have witnessed their young food allergic children be excluded from social events due to the extra care and supervision they require.[91] Food sensitive adults can encounter social restrictions, as well, and face the awkwardness of bringing their own food to client lunches and social events.
The impact of a food allergy extends beyond the dinner table. Travel entails a host of hazards, ranging from the potentially-lethal problem of peanut products served on airplanes[92] to the difficulties associated with unexpected delays and being stranded at airports or train stations, where, after food brought by the individual for the trip is consumed, it may be difficult to find safe food. International travel may prohibit a person from packing certain types of food altogether.
Maintaining daily hyper-vigilance, living with the constant fear of mistakes, managing the frustrations that come from denying oneself tempting foods of uncertain safety, and the feeling of being different can take its toll. Research on children with food allergies has found that the associated food and social restrictions can diminish quality of life. A study conducted in 2003 in the United Kingdom found that children with a peanut allergy reported higher anxiety and an overall poorer quality of life than children with insulin-dependent diabetes.[93] These children reported more fear of an adverse event, felt more threatened by potential hazards within their environment, felt more restricted in their physical activities, and expressed more worry about being away from home.
“Families with food-allergic children must live with constant vigilance and fear,” note the researchers who conducted a 2001 survey of parents of children with food allergies analyzing various quality of life measures.[94] Families of children with food allergies report significantly more negative perceptions of general health, greater distress and worry experienced by parents, and heightened limitations and interruptions to family activities than that experienced by other families.[95] The study attributes these results to the numerous daily challenges faced by food allergic children and their families trying to avoid adverse reactions. “Accidental exposures are common and occur both in the home and in locations such as schools, restaurants, and virtually every location where food is served. Families must diligently read food ingredient labels, a process with numerous pitfalls, and be prepared for treatment of reactions.”[96] Parents must acquaint themselves with their child’s school cafeteria policies regarding food preparation and ensure the school has an emergency response plan if their child has an anaphylactic reaction. Parents diligently carry cell phones, pagers, and watch their caller IDs, dreading phone calls from day care, schools, or hospitals.[97]
One need look no further than the multitude of organizations,[98] discussion boards, and chat groups on the Internet to observe the widespread desire of people dealing with food sensitivities for information sharing and community. Today most cities across America offer support groups for people with food sensitivities. Numerous summer camps have been designed in response to a demand for safe and supportive environments for food sensitive children.
Despite the challenges of living with a food sensitivity, the bottom line is that a person’s quality of life significantly improves following diagnosis and an elimination diet. For most people with food sensitivities, the effort, inconvenience, and annoyance involved in avoiding the consumption of allergens is trivial when compared to the improved health and sense of well-being gained from being allergen-free. The complaint that people with food sensitivities have had, rather, is that despite their very best efforts, avoidance of allergens has been nearly impossible to achieve.
While the precise extent of food sensitivities and severe adverse reactions is unknown, there is little doubt that food sensitivity is sufficiently widespread and its consequences severe enough – particularly since the population with the highest prevalence of food allergies, children, are the most helpless to avoid exposure – to warrant careful consideration of the question of how to provide adequate information to food sensitive consumers who need to make meaningful safety decisions with every bite they take.
The next subsection, which highlights obstacles that people with food sensitivities have encountered while trying to make informed decisions and avoid the consumption of allergens, provides context for understanding the impetus behind the FALCPA and for appreciating the FALCPA’s limitations.
B. When What You Don’t Know Can Hurt You: Problems Related to Allergen Avoidance and the Importance of Food Labels
“When I learned to read five years ago in kindergarten,
I started with Dr. Seuss, Mother Goose, and ingredients labels.”
– Sarah Gitlin, age 10 (allergic to peanuts, tree nuts, and fish)[99]
People unknowingly struggling with a food sensitivity may breathe a sigh of relief when a physician diagnoses the source of their ill health. Although there is no cure for a food sensitivity, the physician explains, the disorder can be effectively treated – the patient must simply avoid consumption of, and in some cases skin contact with, the offending allergenic food. Complete avoidance is especially critical to people susceptible to life-threatening anaphylaxis; as little as one-fifth to one-five-thousandth of a teaspoon of an offending food has been demonstrated to cause death.[100]
What physicians may fail to appreciate,[101] and what people with food sensitivities soon learn, is that following the prescription of avoidance is confounded at every turn.[102] Food sensitive individuals must live with distressing uncertainty. In fact, the FDA has acknowledged the impossibility of obtaining dependable allergen avoidance information given the current state of food labeling and food preparation and has advised people with severe food allergies to be sure to wear medical alert bracelets and carry epinephrine at all times.[103]
Unlike most medical treatments, the treatment of a food sensitivity depends upon the adequate disclosure of information possessed by third parties. The food label is the primary method by which information about product contents is conveyed to consumers.[104] As discussed below, this information is often inadequate. Individuals with food sensitivities have found that the search required to obtain the information upon which their safety and well-being depends can be tremendously time consuming,[105] research intensive, and as likely as not, unsuccessful.
Few people without thorough research would suspect that corn protein is found in iodized salt and orange juice, that bread and products labeled “non-dairy”[106] may include milk protein, that soy protein may be present in tuna, and that turkey[107] and cheese[108] may contain wheat protein. In today’s world of great scientific and technological advances in food production – where most food is processed (rendering ingredients unknown unless communicated to consumers)[109] and even non-processed foods can be contaminated with allergens[110] – virtually any food item has the potential to poison a food sensitive individual.
For food sensitive consumers, navigating the approximately 300,000 food labels[111] in the U.S. marketplace and hundreds of restaurant menus becomes a critical investigation of medical necessity.[112] Consumers must themselves become the sleuths.
The sleuths consult physicians and nutritionists, speak with others with allergies, scour internet resources, and contact manufacturers. They sort through conflicting and false information and continually refine their knowledge, sometimes by unpleasant – and dangerous – trial and error.
This subsection discusses some key obstacles that have impeded allergen-free eating: confusing “usual or common” names of ingredients, hidden ingredients, cross-contamination during processing or preparation, the inability or unwillingness of manufacturers to reveal information about product composition or preparation, mislabeling, and insufficient measures taken by restaurants to prepare and help consumers identify allergen-free foods.[113]
1. Food Labels are Incomprehensible: the Problem of “Usual or Common” Ingredient Names
The FFD&CA requires that all ingredients appearing on the food label be listed according to their “common or usual name.”[114] For many ingredients, the “common or usual” name of a food is hardly common or usual. Consumers in general have long desired more easily comprehensible ingredient terminology.[115] For people with food sensitivities, confusing ingredient terms are not merely an annoyance, but a serious health hazard. Frustrated with what they perceive to be unintelligible technical and scientific jargon, food sensitivity sufferers have opined for labels that state ingredients in “plain English.”[116]
Given the following list of food ingredients – bulgur, couscous, durum, farina, modified food starch, hydrolyzed vegetable protein, kamut, spelt, artificial flavors, semolina, and buckwheat – few people would expect that the only ingredient in this list that is certain to not contain allergenic wheat protein is the one ingredient actually containing the word “wheat”: buckwheat. Terms like albumin, lecithin, livetin, lysozyme, emulsifier, globulin, ovalbumin, and vitellin indicate the presence of egg protein. And what do the words caramel color, casein, caseinate, high protein flavor, lactalbumin, natural flavoring, solids, and whey have in common? These terms can signal the presence of milk protein in a food product.[117]
Even diligent label readers can find this lengthy and varied list of foreign-sounding terms mystifying. Evidence of consumer confusion was manifest in a study published in the American Academy of Allergy, Asthma and Immunology in 2002 that reported that most parents of food sensitive children are unable to identify common allergenic food ingredients.[118] Fully 93 percent of parents of children with a milk allergy and 78 percent of parents of children with a soy allergy could not correctly identify commercial products containing the offending ingredient based on ingredient statements. While the presence of wheat and eggs was correctly identified by most parents, nearly half of parents of children with peanut allergies failed to identify labels containing peanuts. Researchers noted that the study may in fact over-estimate parents’ abilities to discern allergens in food labels since it was performed in a food allergy clinic where half of the participants had a prior consultation and the controlled surroundings of the clinic were more conducive to label reading than “the realities of shopping for and selecting appropriate products in the food market setting.” The study concluded that “these results strongly support the need for improved labeling with plain-English terminology and allergen warnings as well as the need for diligent education of patients about reading labels.”[119] According to Anne Muñoz-Furlong, founder and CEO of FAAN, this study “confirms what we’ve known for quite some time – that ingredient statements are written for scientists and regulators, not for the average consumer.”[120]
Scouring ingredient labels for dozens of terms can be time consuming and tricky for food-allergic adults (especially when the individual has multiple food allergies), increasing the likelihood of mistakes. Nevertheless, the numerous terms can be learned – often with the help of dieticians, nutritionists, and resources like support groups and food allergy consumer organizations – and committed to memory. In the label reading study of parents of food-allergic children, 90 percent of parents who had perfect scores were members of FAAN or had met with a dietician and previously attended an allergy clinic.[121]
Such consumer self-education is not as workable a solution for non-English speakers with food sensitivities. And importantly, relying on self-education is simply not possible when it comes to the population with the highest incidence of food allergies – children. Children are often incapable of deciphering a label themselves.[122] Practicalities prevent parents from being able to approve every item a child consumes while away from home. And educating all those who help care for children – day care providers, teachers, babysitters, relatives, and the parents of friends, to name a few – can be infeasible as well as insufficient, since only one overlooked or forgotten ingredient has the potential to produce serious health repercussions.[123]
As a parent of an allergic child explained at a 2001 Public Meeting concerning the labeling of food allergens held by the FDA:
Plain English in the labeling of food ingredients is critical to empowering individuals to take control of their condition, restoring a certain amount of independence and equally as important is the power and freedom it gives to friends and relatives [and] non-food allergic individuals to make responsible selection of food items to share with or entertain their food allergic friends and relatives.[124]
The prolific and technical names of ingredients also pose significant hurdles to eating out. Even if food service staff is willing to check ingredient labels in the kitchen, it can be nearly impossible to effectively explain to the staff member what ingredients to avoid.
Indicative of the dangers of unintelligible labeling, a 2001 study of 32 people who died of food-induced anaphylactic shock found that 77 percent of fatal allergic reactions occurred outside the home.[125] Nine incidents occurred at school, nine incidents occurred in food service establishments, one child was killed while at camp, one while attending a dance class, and one while in a day care.[126] The researchers concluded that confusing food labels contributed to these deaths: “It is our opinion that only more stringent food-labeling requirements and improved education can bring an end to these tragic fatalities. ... In addition to education of the allergic individual, it is imperative that we improve the knowledge of families, friends, caregivers, schools, restaurants, and the general public.”[127]
Members of FAAN – those individuals most likely to know how to effectively read the food label, according to the 2002 label study – confirm that current labels are grossly inadequate.[128] A survey of 550 attendees at a conference held by FAAN in 2000 revealed that 88 percent of respondents believed food labels currently on the market were not easy to understand and 99 percent of respondents disagreed with the statement that current labels can be understood by a seven-year-old. Additionally, 98 percent believed current labels could not easily be understood by a babysitter, teacher, scout leader, or other individual giving information or food to a child.
2. Food Labels are Incomplete: the Problems of Hidden Ingredients, Cross-Contamination, Advisory Labeling, and Manufacturer Ignorance and Resistance
Even more problematic than the fact that what is on the food label is hard to decipher is the fact that some information crucial to allergen avoidance does not appear on the label at all. Education about terms on ingredient labels cannot ameliorate this problem. As a parent of food-allergic children emphasized, “I already know the words I am looking for (to avoid) on labels. It’s just those questionable listings! What exactly ARE the ingredients for ‘flavorings’? We just usually don’t eat these products (and there are A LOT of them), it’s not worth the risk.”[129]
Food-sensitive individuals have, in the words of a petition drafted by nine state Attorneys General, “often fallen prey to ambiguous or insufficient ingredient labeling.”[130] Of the 550 individuals who participated in the 2000 FAAN survey about food labels, fully 98 percent said the information currently on food labels was not enough to allow them to make effective safety decisions.[131] Four out of five respondents reported calling manufacturers to obtain more product information.[132] According to founder and CEO of FAAN, Anne Muñoz-Furlong, “our members are one of the best educated, highly motivated people in the food allergy community and this country. If they are struggling with these labels, I can only imagine what the general public is going through.”[133] One food-allergic consumer asserts that inadequate information is her “biggest frustration” with her allergies. “There is nothing like having to pass up a food because you just don’t know if it is safe or not.”[134] A parent of a soy-allergic teenager describes the dilemma of insufficient information disclosure on the food label in this way:
We find many processed items not labeled for soy in fact cause a reaction. So we stay away from ‘types’ of processed foods. You develop an instinct, but it is very wrenching to live that way. I compare it to playing a jack in the box. The music goes along and then ‘pop’ goes the unexpected exposure.[135]
What food labels omit are various so-called “hidden ingredients” and information regarding inadvertent allergen contamination of otherwise-safe food. Two methods viewed as supposedly solving this lack of critical information on the label – contacting food manufacturers directly and “advisory” labeling – all too often provide more aggravation than relief.
i. Hidden Ingredients
Not all ingredients are specifically identified on the food label. Allergens are commonly disguised within more general, seemingly innocuous terms.[136] Words like “natural flavors,” “artificial flavors,” and “spices” can conceal the presence of allergens. Federal law has sanctioned two exceptions[137] to general labeling requirements that deprive allergic consumers of information they need to make informed decisions.
First, the FFD&CA has provided since its inception that “spices, flavorings, and colors” may be designated by those generic terms on the food label rather than naming each food source component.[138] Second, FDA regulations have exempted incidental additives, such as processing aids, from ingredient declaration when they are present in a food at “insignificant” levels and do not have a technical or functional effect in the finished product.[139] The FDA has thus recognized that “in some cases food labels may not provide consumers with food allergies with information about all the ingredients that are in the foods that they eat.”[140]
In addition to the spices, flavorings, and colorings and incidental additives exemptions, manufacturers are not mandated to disclose information about the source of certain listed ingredients, nor the process by which the ingredient was formed. For example, “starch” and “modified food starch” can be derived from corn or wheat. “Hydrolyzed vegetable protein” may contain a variety of grains, vegetables, or animal products, many of which contain the proteins of known allergens. Manufacturers may simply list “vinegar” on a label without disclosing whether it was distilled from apples, wheat, or rice, and “caramel color” may be listed without identifying whether the ingredient was produced using sugar or wheat. “Lecithin” and “gelatin” may also contain a variety of allergenic proteins.[141] Whether offending proteins are removed from an allergenic food during the refining and distillation processes involved in producing these various ingredients varies based on the type of process employed in each case.[142] Even where a food’s allergenicity is reduced during processing, remaining protein residues can be enough to trigger adverse reactions in highly sensitive individuals. Unfortunately, some ingredient terms are more expressly deceptive, such as the term “egg substitute,” which is used to describe ingredients that can, nevertheless, contain egg protein.[143]
Incomplete labeling of sources produces numerous consumer headaches and perils. Research-savvy consumers with celiac disease, for instance, discover through research that dextrin may contain gluten, whereas maltodextrin is thought to be safe. Modified food starch in products manufactured in the United States tends to be derived from corn, whereas a product containing modified food starch that was produced overseas is more likely to contain wheat.
Without knowing the source of these ubiquitous ingredients, people with food allergies must either unnecessarily avoid a host of products or attempt to determine product safety through risky trial and error.
ii. Cross-Contamination
Even if a product’s ingredients do not contain a particular allergenic protein, the food label may mislead because the label does not reflect the fact that a product may have become contaminated by allergens during the manufacturing process.[144] “Contamination of food with undeclared allergens is what makes life so fearful for people with severe allergies,” Dr. Michael Jacobson of the consumer watchdog group Center for Science in the Public Interest stated at the 2001 Public Meeting held by the FDA. “They live in terror that a food contains an allergen not listed on the label.”[145] As a petition submitted by nine state Attorneys General observes, FDA regulations establish Good Manufacturing Practices (GMPs) “aimed at preventing the adulteration of food with contaminants such as microorganisms or hazardous chemicals. ... [H]owever, foods that contain even trace amounts of allergenic substances can be as deadly to food-allergic consumers as adulterated food is to ordinary consumers.”[146] At least one state legislature has even proposed a resolution urging the FDA to, inter alia, create guidelines to minimize cross-contact.[147]
Cross-contamination can occur in numerous ways. A product without allergens may be processed on the same line as allergen-containing products, [148] or may be produced utilizing the same utensils and equipment,[149] thereby introducing allergenic proteins into the otherwise allergen-free product. The presence of allergenic products above or near exposed lines for other products can result in cross-contact.[150] Manufacturers may “rework” some unfinished food products or components into other, different food products without identifying the reworked source foods on labels.[151] Peanut, tree nut, soy, and wheat dust generated by one product line may settle on a nearby line. Allergen-containing substances like wheat flour may be used to prevent foods such as candies from sticking to machinery during processing.[152] Sprays containing allergens like wheat proteins may contaminate foods such as rice during the enrichment process. Although a particular flavor itself may not contain a major allergen, it may be delivered onto food using a “spray dry flavor system” that uses a major allergen to “carry the flavor” to the product.[153]
Such practices are widespread in the food industry. Food industry GMPs have not been tailored to address cross-contamination prevention, and FDA factory inspections until recently have not scrutinized allergen management. In 1998 the FDA commissioned a partnership with the departments of agriculture in Minnesota and Wisconsin (“the Partnership”) to study the cross-contamination of undeclared allergen residues in selected Minnesota and Wisconsin firms.[154] The study found that less than 50 percent of firms inspected utilized some procedures to control cross-contamination. Only 4 percent of firms used analytical testing methods to verify that cleaning and sanitation procedures eliminated allergen residues. One in four Minnesota firms employed Sanitation Standard Operating Procedures that were proven effective and were followed. And less than 4 percent of firms inspected employed personnel dedicated to allergen control.
A different study, presented at the 2004 Annual Meeting of the American Academy of Allergy, Asthma & Immunology, found that 15 percent of products with non-wheat ingredients nevertheless contained wheat proteins, likely due to cross-contamination.[155] An Oregon Department of Agriculture study found that 23 percent of chocolate candies studied that were not supposed to contain peanuts, in fact, contained peanut protein. University of Nebraska researchers discovered peanut allergens in 4 out of 19 packaged foods that did not list peanuts as an ingredient.[156]
The Partnership brought together by the FDA identified in 1999 numerous techniques to prevent cross-contamination. These methods include dedicating certain production lines to foods containing a specific type of allergen, scheduling the processing of allergen-containing foods on separate days of the week than products that do not contain allergens, running allergen-containing products on lines after allergen-free products have been run, heightening sanitation processes, verifying sanitation before running non-allergenic products, increasing employee training about allergens, appropriately labeling rework, and making improvements to equipment and system designs.[157]
As the Food Allergen Partnership study indicates, however, few manufacturers have employed such techniques fully and consistently to prevent cross-contamination. Concerns over the inadvertent introduction of allergenic ingredients in foods prompted FDA to name cross-contamination as one of the principal issues to be discussed at the 2001 Public Meeting on the topic of food allergens.[158]
iii. Advisory Labeling
To compensate for uncertainty regarding ingredients and inadequate procedures to control cross-contamination, and in an effort to help shield themselves against liability, some companies have responded by over-labeling products through the use of advisory or precautionary statements on labels. Manufacturers in recent years have increasingly utilized warning statements such as “may contain X allergen,” “processed on shared equipment,” or “this product is produced in a factory that produces products containing X allergen.”
One trouble with such advisory labeling statements is that they may be employed in place of compliance with GMPs or adequate disclosure of source ingredients, thus unnecessarily further limiting accurate consumer information and, hence, choice. For instance, one food allergic consumer discovered that a bag of plain raisins she was about to eat stated on the label that it “may contain peanuts.”[159] Another food sensitive consumer has found that manufacturers erroneously declare the presence of an allergen when it is well known that the ingredient in question does not, in fact, contain allergenic protein.[160] In recent years, the Grocery Manufacturers of America and the National Food Processors Association have urged their members to not use advisory labeling in lieu of following GMPs.[161]
Unwarranted over-use of advisory labeling also perversely causes people to ignore the warnings altogether. “Because of the proliferation of ‘may contain’ statements,” Anne Muñoz-Furlong notes, “the integrity of all precautionary labels [is] being questioned by consumers.”[162] Some physicians have instructed patients to ignore precautionary labeling, which they view as disclaimers employed to protect manufacturers, not consumers.[163]
A food allergy consumer web site that led a zealous grassroots effort to advocate for the passage of the FALCPA summarizes this dilemma of advisory labeling:
“[M]ay contain” labeling [is] used as an “out” to relieve manufacturers of the burden of proper labeling, while protecting them from litigation. Such labeling either places all such foods off limits to those with food allergies (some large manufacturers label virtually all of their foods with this catch-all phrase) or leads to a reverse false sense of security that even if foods are so marked, they are probably safe anyway.[164]
A survey of members of FAAN found that precautionary labeling was their number one labeling concern.[165] FDA emphasized the problems of advisory labeling in its 2001 Public Meeting on food allergen labeling, where one of three panels focused exclusively on the topic.[166]
No industry-wide standards define the meaning of the various precautionary phrases employed by manufacturers, and many manufacturers themselves do not have company policies regarding what the terms signify. Consumers are understandably baffled about how to interpret these statements and gauge the potential risk of products bearing such warnings. Consumers wonder “how can we tell [what a “may contain” warning means]? Is there a code on the package? How does this happen that a manufacturer does not know what is in the product that I’m about to eat?”[167] Precautionary labeling “raises more questions to the consumer than it really answers and it causes again additional frustration,” according to Anne Muñoz-Furlong.[168]
Food industry trade organizations noted at the 2001 Public Meeting that some amount of advisory labeling may be necessary because “the nature of the food supply and our manufacturing processes in some instances make it impossible to avoid.”[169] In such instances, precautionary labeling is indeed a valuable tool. Such labeling serves a legitimate function when it notifies consumers that a manufacturer has taken steps to discover the contents of a food item and, despite a company’s best efforts to eliminate cross-contact and to accurately identify a product’s contents, a given product may contain an allergen.
As the preceding discussion demonstrates, however, manufacturers have too often relied on precautionary labeling in an attempt to protect themselves from lawsuits and to avoid expending resources to determine a product’s actual contents or to prevent cross-contamination. Without industry-wide standards regarding when the various warnings should be used by manufacturers or what those warnings signify, consumers are at a loss to make informed decisions. These factors have caused consumers and physicians alike to discount the labels, undermining the purpose of the warnings outright. The problem is not that manufacturers employ precautionary labeling – it is that precautionary labeling should mean something.
iv. Manufacturer Ignorance and Resistance
For food sensitive individuals, contacting a manufacturer directly may offer their only prospect of obtaining the information they need about a product. Consumers are thus subject, on a manufacturer-by-manufacturer basis, to great variability in terms of procedures to be followed to obtain information and in terms of ultimate information quality. Working to obtain information from manufacturers can be difficult but critical. Recognizing the importance of customer service representatives, one article directed to people with celiac disease advises:
[I]t’s important to be polite, professional, and appreciative when you call manufacturers. Not only will you get much better service, but we need them! We need them to comprehend the gravity of our questions and to understand how important it is to be 100 percent sure that the answers they give us are accurate. We need them to realize that they can’t guess at their answers, and that we very much appreciate that they understand what we’re asking.[170]
Four out of five FAAN members surveyed in 2000 reported calling manufacturers to obtain more information about a product’s contents.[171] Some manufacturers, like Kraft and General Mills, have been food industry leaders with regard to allergens and have for years employed stringent policies regarding food allergens, maintained detailed databases on their products, and been willing to communicate information to consumers who contact their companies. Food sensitive individuals have discovered that many companies, however, cannot – or will not – remedy dangerous information gaps. Often, contacting manufacturers can prove more perplexing than enlightening.
Many product labels do not contain a phone number consumers can call with questions. Once a phone number is located, a customer service representative may not be able to provide the missing information. Typically this is because the manufacturer itself is uncertain of the ingredients. Some customer service personnel know no more about a food’s ingredients than what exists on the food label. Many have not been trained to address questions about allergens, which can cause them to convey incomplete or wholly inaccurate information.[172] As the mother of a peanut-allergic son stated at the 2001 Public Meeting, sometimes she speaks to a customer service representative “who reads from a written policy statement, but won’t send it, and is unable to answer basic questions.”[173] Some manufacturers are unsure of the components of ingredients provided by their suppliers or whether the supplier has an effective allergen control program in place.[174] Because some deviations in product formulation may occur depending on the price or availability of some ingredients, a manufacturer may not know the ingredients contained in any given batch or lot. Few customer service representatives know the reason behind precautionary “may contain” labeling and can advise a consumer about the likelihood a given product was inadvertently contaminated or the method in which it would have been contaminated.
Additionally, it can be difficult to obtain information in a timely fashion. Some manufacturers are slow to return phone calls, or never return them at all.[175] Other manufacturers require written requests for information or a letter or phone call from a physician documenting the food sensitivity before information will be released.[176] The mother of a peanut-allergic son who spoke at the Public Meeting explained that she frequently is unable to receive prompt information from manufacturers that she contacts:
[E]ven after I call the manufacturer, I often do not get accurate information. Sometimes I leave a message on an answering machine that can go unanswered for a period of weeks, and sometimes forever. ... Often I have to make at least three calls before I even talk to an informed person.[177]
Obtaining timely information is important for shoppers debating whether to purchase a product and for people reviewing ingredients before preparing a meal for food sensitive individuals. It is also critical for people who have inadvertently already consumed a product and may need to take action to manage anaphylaxis or other symptoms of an adverse reaction.
A petition submitted to the FDA by nine states Attorneys General for improved allergen labeling summarizes these various problems consumers can encounter when calling manufacturers to obtain allergen information:
[A]ccording to an informal survey recently conducted [in October 1999] by members of the New York Nut Allergy Awareness Group, Inc., numerous food manufacturers do not include a toll-free telephone number on their product labels. Consumers are thus left with the task of ferreting out their appropriate address or telephone number, often expending considerable time and expense in the process. When a consumer manages to track down the manufacturer of a product, there is no guarantee that knowledgeable staff will be available or possess sufficient and accurate information to answer his or her questions. Such was the case when M.A.C., a mother of two food-allergic children, attempted to obtain additional product information concerning Farina Mills@ Enriched Farina Creamy Hot Wheat Cereal. Although M.A.C. made 19 telephone calls, many long-distance, she was not even able to determine who manufactured the product, much less how it was produced. It should not be this difficult to obtain necessary product information from manufacturers.[178]
In some cases, an inability to obtain information from manufacturers may reflect a manufacturer’s insufficient awareness about or sensitivity to the needs of people with food allergies.[179] Some manufacturers refuse to provide requested information out of liability concerns or in an effort to safeguard their proprietary interest in recipe formulas.[180]
If every food sensitive individual calls one manufacturer a week, it is easy to see how the difficulties and inconveniences can quickly multiply for both people with food sensitivities and the untrained or unprepared manufacturers. Insufficient food labeling thus burdens consumers and manufacturers’ customer service personnel alike. It unnecessarily constrains food options available to consumers already limited in choices and contributes to ambiguity – and, hence, fear – about eating.
3. Food Labels are Incorrect: the Problem of Mislabeling
An increasingly common cause of food recalls is the outright mislabeling of food.[181] Mislabeling can occur when companies change product formulas or substitute similar source ingredients without updating labels.[182] Labels may be misprinted, products may be accidentally packaged using the wrong label, or labels on inner and outer packaging may not match.[183] Differences of ingredients present in different package sizes may not be reflected on the label.[184] Formulation mistakes can occur during processing.[185] In some cases, manufacturers simply improperly identify a product’s ingredients.[186]
Studies have revealed an alarming incidence of improperly labeled food. A researcher at the Food Allergy Research and Resource Program at the University of Nebraska in Lincoln found that one in five products studied that claimed to be “wheat-free” or “gluten-free” actually contained significant amounts of wheat protein.[187] The FDA Food Allergen Partnership which surveyed bakeries and ice cream and confectionary manufacturers in Minnesota and Wisconsin in 1999 obtained the following disconcerting results:
These statistics about unreliable labeling shake food sensitive consumers’ confidence in the food supply. Mislabeling is another reason food sensitive individuals know that, despite their vigilant efforts, eating may never be safe.
4. Food Labels are Non-Existent: the Problems of Restaurants
Eating out, which is a pleasurable experience for most Americans, is responsible for much anxiety among food sensitive individuals. A study published in 2001 of 32 fatalities caused by food allergies found that nearly 30 percent of lethal allergen exposures occurred in food establishments.[189] “Dining out feels like Russian roulette,” one parent of a food allergic teen explains. “The wait staff are clueless, [they] try to help from kindness, but cannot because they are not educated.”[190] One study of over 5,000 people registered with the National Peanut and Tree Nut Allergy Registry found that 13.6 percent had experienced at least one allergic reaction while eating at restaurants.[191] Of those who experienced adverse reactions, 38 percent had informed their server in advance about their allergy.[192] Most of the reactions were caused by undisclosed allergens in foods or by cross-contamination during food preparation.
In response to these dangers, some people try to avoid dining out completely.[193] But this option is impractical for most people, since school activities, work events, personal and business travel, and social interaction regularly involve or necessitate eating outside the home.
All the problems of inadequate food labeling discussed above are magnified in the context of eating out. Eating outside the home is threatening because servers and food preparers lack knowledge about dish ingredients, cross-contamination occurs during food preparation, and there is a general absence of restaurant employee training about – and protocols regarding – how to safely serve individuals with food sensitivities.
No mandatory system comparable to packaged food labeling exists for the disclosure of food ingredients to food establishment patrons.[194] Food sensitive consumers must inform servers of their food sensitivity and hope that the person thoroughly investigates whether a dish is safe and conveys the information regarding the sensitivity to those preparing the food. Wait staff not trained to deal with food sensitive customers may rely on their common-sense knowledge of food and falsely assure individuals that a given allergen in not in a food without researching that fact. Even when food establishments take food sensitivity seriously, waiters and food preparers often do not know the ingredients in their foods, either because the original packaging has been discarded or the labels are difficult to decipher due to the absence of plain English labeling.
The possibility for mistakes is high. A wheat-allergic patron who orders fajitas at a Mexican restaurant may talk with the server about a dish, ingredient by ingredient, to determine the food’s safety. He explains his allergy and the common ways wheat may be present in foods. She asks the server about the ingredients and preparation process of the tortillas, the spices in the beef, the type of oil and butter used to prepare the vegetables, and the brand of rice (whether or not enriched). When the food arrives, the patron takes a bite and notices the saltiness of the vegetables, triggering a red flag in his mind. He queries the waiter and discovers that this self-described “authentic Mexican” restaurant has flavored the vegetables with soy sauce. The waiter had earnestly tried to help the customer. But how was the waiter to know that the second most prominent ingredient in most brands of soy sauce is wheat?
Moreover, the sharing of utensils, pans, grills, counter space, cutting boards, and fryers to prepare multiple foods is common practice in food establishments. If restaurants cook pancakes on the same griddles as omelets, both dishes become contaminated with an unexpected allergen – the pancakes with eggs and the omelets with wheat. A restaurant may grill hamburgers on the same grill that they use to grill fish or toast wheat-containing hamburger buns. French fries become contaminated with wheat protein when fried in the oil used to fry battered chicken fingers and onion rings.
Restaurants may be reluctant to disclose food ingredients out of concern that their information may be inaccurate and they may inadvertently harm a consumer. At the same time, restaurants may desire to reduce their exposure to liability by limiting the representations they make about their food.[195] Food establishments also worry about revealing proprietary information.
Some restaurants have designed menus to inform consumers of allergens and have designated an employee trained in allergen management to handle the orders of food sensitive individuals. Unfortunately, these practices remain rare. Although national food chains provide some consistency, attention to the needs of food sensitive consumers in food establishments can vary widely from one restaurant to the next.
5. Problems Related to Allergen Avoidance and the Importance of Food Labels Conclusion
The problem of inadequate labeling has affected millions of Americans – not only people with food sensitivities themselves, but also their families, friends, and caregivers. As the parent of a peanut-allergic child notes, “With the purchase of food for an allergenic individual, there is a ripple effect. For the millions of allergic people, there are tens of millions who are affected. Think of the number of people who are involved in feeding a single child.”[196] Hidden ingredients, cross-contamination, and mislabeling have contributed to a distrust of food and a culture of fear among food sensitive individuals. The difficulties faced by food sensitive individuals trying to follow an avoidance diet were the primary concerns that informed the drafting of and debate surrounding the FALCPA and supported its ultimate passage.
“At present, there is no cure for food allergies,
and a food allergic consumer must avoid the food to which the consumer is allergic.”
– FALCPA § 202(2)(B),(C)
This Part analyzes the FALCPA’s provisions. It first discusses the ways in which the FALCPA amends the FFD&CA’s food labeling requirements to help make the presence of major food allergens “easily visible to consumers”[197] so that food allergic individuals and their caregivers can more effectively avoid inadvertent consumption of hazardous food. This Part then summarizes the Act’s provisions that attempt to improve knowledge about food sensitivities also addresses several safety concerns not remedied by the new labeling requirements.
A. Amendments to the FFD&CA: New Labeling Requirements
Beginning in 2006, packaged food[198] that contains one of eight “major food allergens”[199] will be deemed misbranded unless the ingredients list discloses the presence of that allergen in “plain English.”[200] Section 203(a) of the FALCPA creates a new subsection (w) in 21 U.S.C. § 343 that expands the FFD&CA’s definition of misbranding to include a failure to identify the presence of major food allergens in a product. Explicitly closing the incidental additives and the spices, flavorings, and colorings loopholes, the Act states that “notwithstanding ... any other law, a flavoring, coloring, or incidental additive that is, or that bears or contains, a major food allergen shall be subject to the labeling requirements of this subsection.”[201] Like other labeling requirements of the FFD&CA, these new misbranding provisions have preemptive effect over state and local food labeling laws.[202]
Because the FALCPA’s labeling requirements are self-executing,[203] manufacturer compliance need not be delayed to allow time for the FDA to formulate and issue regulations through notice and comment rulemaking. Manufacturers must be in compliance with the Act by January 1, 2006.[204] The fixed date encourages timely industry action as well as informs consumers when they can expect to begin trusting the accuracy of food labels. This timeframe also helps minimize the burden on industry by corresponding to the deadline for new trans-fat labeling requirements issued by FDA and by giving manufacturers time to exhaust label supplies and develop new labels. Food products labeled before January 1, 2006, and already on the market before this date, however, need not be relabeled.[205]
1. “Major Food Allergens” Defined
Section 203(c) of the FALCPA adds § 321(qq)(1) of Title 21 of the U.S. Code which defines the eight major food allergens as milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, and any protein derived from these foods. Tree nuts, fish, and crustacean shellfish must be labeled by their specific type of nut or species of fish or shellfish (e.g., almonds, pecans, or walnuts; bass, flounder, or cod; crab, lobster, or shrimp, respectively). Identification of tree nuts, fish, and shellfish by their specific name averts the problem of over-generalized labeling that would preclude individuals allergic to only certain types of those foods to partake of numerous products that they could otherwise safely enjoy.
The FALCPA provides three exceptions to the definition of “major food allergen.” First, the FALCPA exempts from its allergen labeling requirements highly refined oils and ingredients derived from highly refined oils.[206] The term “highly refined oils” refers to bleached, deodorized oils,[207] of which the oil that poses the greatest allergenicity concern is peanut oil. Studies have shown that the amount of offending proteins present in highly refined oils is not significant enough to cause an allergic response in most allergic individuals.[208] Highly refined oils, nonetheless, must continue to be labeled by their common or usual name (such as “peanut oil”) under the FFD&CA’s pre-FALCPA labeling standards.[209]
Second, any person can petition the FDA to challenge the “major allergen” designation of ingredients they believe do not produce allergic reactions.[210] The petitioner has the burden to provide scientific evidence that demonstrates that the ingredient when derived using the method described in the petition “does not cause an allergic response that poses a risk to human health.”[211] Thus, a company that is able to remove an allergenic protein from an ingredient, such as through distillation, could petition the Secretary of the U. S. Department of Heath and Human Services (HHS)[212] for an exemption. If the Secretary does not approve the petition within 180 days it is deemed denied.[213]
Lastly, the Act establishes a notification process whereby ingredients derived from the eight major allergens that the manufacturer can demonstrate do not contain allergenic protein or do not cause allergic reactions can be exempt from the Act’s labeling requirements.[214] For example, if it is discovered that the presence of a certain amount of a particular allergen is required to trigger an allergic response, companies could file a notification stating that their products contain less than the established threshold amount of an allergen.[215] It is presumed that the Secretary has approved the exemption unless the Secretary specifically notifies the company of the contrary within 90 days of receipt of the notification.[216] The notification provision also exempts from “major allergen” status ingredients that the Secretary has previously determined or will determine do not cause an allergic response that poses a risk to human health under “a premarket approval or notification program under section 409 of the FFDCA”[217] (the GRAS notification process is not included).[218]
Significantly, the Act confers upon the Secretary the discretion to require by regulation that other food allergens, in addition to the Big Eight, be declared when present in a spice, flavoring, coloring, or incidental additive.[219] The Secretary can determine via regulation the manner in which non-Big Eight allergens shall be disclosed. Section 203 of the FALCPA also states that the Act does not alter FDA’s existing discretionary authority to require the labeling under the FALCPA’s labeling scheme of other food allergens that are not major food allergens.[220]
Manufacturers may choose between two basic options for identifying the presence of a major food allergen. Following or adjacent to the list of ingredients, a manufacturer may print in type size no smaller than the other items in the ingredient list the word “Contains” followed by the plain English name of the food source from which the allergenic ingredient was derived.[221] For example, on a box of cereal a statement such as the following may appear at the end of a list of ingredients: “Contains wheat, milk, and tree nuts.”
Alternatively, the manufacturer may print the plain English name of the allergenic ingredient in parenthesis directly following the item in the ingredients list that contains the allergen.[222] The list of ingredients on the cereal box might thus be printed as follows: durum (wheat), evaporated cane juice, salt, whey (milk), nut flavoring (peanuts, almonds).
In a provision that is unlikely to be applied much in practice, the Act provides that allergen information may appear in a different, third manner in rare circumstances. Allergen information may be placed on another form of labeling other than the ingredients label “if the Secretary finds that such other labeling is sufficient to protect the public health.”[223]
This labeling scheme was designed to alert consumers to the presence of major allergens while limiting label clutter where Congress deemed it feasible. To that end, the Act provides that companies need not declare a major allergen in one of the above ways if the common or usual name of the ingredient already listed incorporates the plain English name of the food source.[224] For example, if “milk casein” is stated in the ingredients list, a manufacturer does not need to additionally indicate the presence of milk in parentheses beside the ingredient or at the end of the ingredient list.[225]
Additionally, if the manufacturer chooses to declare an allergen in parentheses following the ingredient that contains the allergen, the manufacturer need not declare the allergen after any other ingredients in which the allergen may be present.[226] For instance, if “milk casein” or “whey (milk)” appears on the label, the manufacturer is not required to indicate the presence of milk in parentheses after the ingredient “caseinate” or at the end of the ingredient list.[227]
21 U.S.C.A. § 343(w)(5) introduces some flexibility – and consequently, uncertainty – to this labeling scheme. This clause provides that the Secretary may modify the two options for the format of allergen declarations or eliminate either (but not both) options if the Secretary determines that such modification or elimination “is necessary to protect the public health.”[228]
B. Other Provisions: Regulations, Restaurants, Reports, Research, and Resource-Sharing
The Act contains a number of provisions designed to address food allergen safety concerns not met by the labeling requirements and to improve scientific, medical, and public knowledge about food allergies.
Within two years after the FALCPA’s enactment, the Secretary of HHS is directed to issue a proposed rule to define and permit voluntary use of the term “gluten-free” on food labels.[229] Currently there is no standard definition of “gluten-free” in the United States, and studies have found products proclaiming themselves “gluten-free” sometimes contain gluten. The FALCPA calls for the Secretary to consult with experts and stakeholders when drafting the rule. The claim “gluten-free” is not intended to be a claim for special dietary use, a nutrient content claim, or a health claim, with their associated requirements for use.[230] The Senate Committee Report on an earlier version of the FALCPA further explains that “the committee intends that, under the regulation, foods that are ordinarily gluten-free may be appropriately identified as a gluten-free food in food labeling.”[231] A final rule must be issued within four years after the FALCPA’s enactment. The House Committee Report on the FALCPA states that, “[g]iven the devastating nature of celiac disease, the Committee urges the Secretary to move expeditiously in implementing the requirements of this section.”[232]
The Act addresses the problem of cross-contamination on three fronts. First, section 209[233] provides that the Secretary, through the Conference for Food Protection and after consulting with the recommendations of public and private entities, shall “pursue revision” of the Food Code to provide guidelines for preparing allergen-free foods in food establishments. The Act clarifies that the term “food establishments” non-exclusively includes restaurants, grocery store delicatessens and bakeries, and elementary and secondary school cafeterias.[234] This provision appears to be directed at preventing cross-contamination through the use of common grills, common fryers, and common utensils when preparing foods with and without the eight major allergens.[235] Although private guidelines have been instrumental in helping some food establishments better serve food allergic customers, this provision acknowledges the need for explicit revision of the Food Code to “better alert the food establishments to the problem food allergies pose to public health and make distribution of such information more widespread.”[236]
Second, to help manage cross-contamination the Act adds to the FDA’s current inspection duties the responsibility of checking food manufacturing, processing, and packaging facilities for compliance with practices to reduce inadvertent major food allergen contamination with products not otherwise containing allergens.[237] FDA inspectors are also charged with examining food labels to ensure the appropriate declaration of allergen information.
Third, the Act provides that within 18 months of the Act’s enactment the Secretary of HHS shall submit to Congress a report analyzing unintentional contact between non-allergenic and allergenic foods during manufacturing and processing. The report must address an array of issues, including: the prevalence of cross-contact, ways to mitigate the occurrence of cross-contact, how manufacturers use advisory labeling to warn consumers of cross-contact, how consumers would like information about cross-contact to be communicated, and the extent to which the Secretary and the food industry have effectively addressed cross-contact issues.[238]
Section 207[239] of the FALCPA aims to help alleviate the problem of the relative scarcity of and conflicting information about basic food allergy data in the United States.[240] This section calls for the CDC and FDA to collect and publish data on the prevalence of food allergies, the incidence of food allergy-induced serious adverse events, and the use of different techniques to treat and prevent allergic reactions. In this effort, the CDC is expected to analyze existing data, educate healthcare providers about the documentation and publication of this information, increase the precision of surveys of healthcare providers regarding food reactivity, add laboratory tests to the National Health and Nutrition Examination Survey (NHANES), and implement an automated system to help healthcare providers more accurately record food allergy-related deaths.[241] Needless to say, coordinating and expanding information regarding allergic reactions to foods will provide valuable information to people studying food allergies and working to improve diagnosis, treatment, and prevention methods.
The Act further instructs NIH to convene a panel of allergy and immunology experts to review current food allergy-related research efforts and make recommendations for “enhancing and coordinating” research activities.[242] The House Committee Report indicates that Congress intends this panel to also analyze existing data on whether there exist safe consumption levels of the eight major allergens for allergic individuals, which the FDA may find helpful as it reviews scientific data on reaction thresholds as part of the FALCPA’s premarket notification process.[243]
Finally, the Act directs the Secretary of HHS to provide technical assistance regarding the treatment and prevention of food allergic reactions to state and local agencies as part of HHS’s general provision of emergency medical services-related technical assistance pursuant to § 1202(b)(3) of the Public Health Service Act (42 U.S.C. 300d-2(b)(3)).[244] The Senate Committee Report accompanying an earlier version of the FALCPA explains the impetus behind this provision: because “not all states and localities provide emergency medical technicians with adequate training to treat successfully a patient undergoing a food allergic response,” the government should provide assistance “to enhance their preparedness to address emergencies caused by food allergens.”[245] While the preferred treatment for food allergy-induced anaphylaxis currently is injectable epinephrine, the Act does not specify a particular treatment, thereby allowing the Secretary to adapt as new treatments are developed.[246]
C. Estimated Cost to the Government
The Congressional Budget Office (CBO) estimates that the implementation of FALCPA will cost HHS $50 million between 2005 and 2009,[247] with the bulk of the expense spent on developing and operating the system for collecting food allergy data.[248] Although managing the appeals process, preparing the restaurant guidelines, establishing regulations for the term “gluten-free,” and reporting on the cross-contamination problem will require an outlay of an estimated $ 11.5 million over the next five years,[249] these are finite outlays that will be completed within the next few years. CBO estimates that allergen enforcement inspections of food facilities, activities that will continue beyond the five-year financial projection, can be accomplished for no additional cost as part of current inspections.[250] While CBO doubts the Act will generate much revenue through the imposition of penalties on manufacturers of mislabeled food given FDA’s policy of issuing warning letters and seeking injunctions or seizing products in response to noncompliance,[251] it is possible that prosecution of companies that misbrand their products could yield some nominal revenue.
IV. HISTORY OF U.S. FOOD LABELING POLICY
RELATED
TO FOOD
SENSITIVITY
Our thought has been that the purchaser of food products, the one who is going to take those food products into his system, is entitled, as a matter of simple right, to know what he is eating.
– Walter G. Campbell, Chief of the Food and Drug Administration (1934)[252]
The expectation of a safe food supply for all is an American right.
– H. Res. 309, 106th Cong. (1st Sess. 1999), introduced by Rep. Constance Morella
Americans deserve to have confidence in the safety and labeling of the food on their tables.
– H.R. 4704, 107th Cong. §1(8) (2d Sess. 2002), introduced by Rep. Nita Lowey
The statements above, the first articulated by the Commissioner of the FDA who urged the passage of the FFD&CA of 1938 and the latter two found in the preambles of predecessor versions of the FALCPA, in one sense articulate the principles embraced by the original food labeling law enacted in America in 1906 – the spirit of which has endured until today. The statements capture the heart of the U.S. Food and Drug Administration’s mission to “protect[] the public health by assuring the safety, efficacy, and security of ... our nation’s food supply” and to help the public “get the accurate, science-based information they need to use ... foods to improve their health.”[253]
In another sense, however, the quotes above articulate a singularly bold assertion that has never been fully adopted in the United States and is not achieved in the FALCPA. Despite some policy-makers’ rhetoric to the contrary, U.S. food labeling policy has never expressly recognized that Americans have some inherent “right to know” all the ingredients and sources of ingredients in the food they consume, regardless of whether they desire that information for medical, ethical, religious, nutritional, or economic reasons. For consumers with food sensitivities, the absence of a right to know exactly what they are eating represents a serious health hazard.
The idea championed by Rep. Nita Lowey, Sen. Edward Kennedy, and others who supported the FALCPA – expanding notions of “food safety” to include the safety of individuals with food sensitivities – is a radical concept, given that the ingredient disclosure requirements have operated largely unchanged since the passage of the FFD&CA nearly seventy years ago.
As the FDA has stated on numerous occasions, the FFD&CA “does not provide a ‘right to know’ the ingredients of every food.”[254] Nevertheless, beginning in the 1970s, the FDA began a slow return to the roots of the FFD&CA, and began increasingly to recognize the importance of ingredient disclosure for food sensitive individuals. In 1979, the FDA affirmed a “right to know” when it discussed its effort to propose changes to the food label:
The purpose of food labeling is to enable consumers to select and use products that meet their individual needs and preferences. To achieve that purpose, labeling must provide sufficient information to enable the public to identify foods and their characteristics, including their ingredients and nutritional value. ... In their deliberations about recommending specific changes in food labeling requirements to make labels more informative and more easily understood, the [FDA, USDA, and FTC] have followed the following principles: (1). Public Health Importance. ... [A]ccurate and informative labeling about a product’s nutrient content and its other characteristics has even greater public health significance now than in the past. Furthermore, disease or other abnormal physiological conditions such as allergies compel many Americans to follow special diets. These people especially need informative food labeling so they can make informed food choices. (2). The Consumer’s Right-to-Know. Innovations in food processing and packaging have made it increasingly difficult for consumers to judge a product’s actual contents from its appearance, even for traditional foods. The agencies have therefore concluded that law or regulation must strengthen those policies that guard consumers’ right-to-know about the foods they eat. .... (3). Economic protection. ...[255]
More recently, the FDA has noted that, at least in theory, “individuals who are allergic to a specific food need to know when it is present as an ingredient in a food in order to make informed purchase decisions,” and that the “FDA believes that consumers have a right to be able to choose between products on the basis of the ingredients contained in the foods.”[256] Until the 1990s, however, the FDA fell far short of applying or enforcing these ideals.
This Part examines the role of food sensitivities in food labeling policy making in U.S. history. It begins with a short overview of the history of food allergen labeling in the United States and abroad. The second subsection explores in greater detail U.S. policy as it relates to food sensitivities prior to 1996 – a watershed year in which the FDA, in recognition of the serious problems posed by allergens, issued a warning letter to food manufacturers about allergen management and disclosure. The third subsection highlights the rapid development of policy in the area of food sensitivities subsequent to 1996, which resulted ultimately in the passage of the FALCPA.
A. An Overview of the History of Food Allergen Labeling
Until the FALCPA amended the FFD&CA, there were “no labeling standards ... in place for food allergies.”[257] The FALCPA represents the product of intense Congressional, regulatory, consumer, and industry efforts primarily over the past decade. This initiative came in the wake of years of ignorance and apathy: a lack of awareness and concern on the part of industry, ad hoc policymaking and inertia within the FDA, an absence of consumer organization and mobilization, and a general dearth of medical and scientific research about and interest in food sensitivities.
The drafting and passage of the FALCPA was realized because the atmosphere in America surrounding food labeling has dramatically shifted over the past several decades. This altered culture is due to the convergence of numerous factors, including scientific advances in diagnosing food sensitivities and detecting allergens in foods, increased public awareness about food sensitivities, the mobilization of people with food sensitivities, the prioritization of food allergy issues by the FDA, and recognition of the growing market for products to meet special dietary needs.
Since the late 1970s, the FDA has taken seriously the hazards of introducing allergenic proteins into other foods through bioengineering and has devoted efforts to developing and enforcing a policy to maintain the safety of genetically modified foods. The heated public debate concerning the merits of regulating bioengineered foods due to, among other things, the potential that some genetically modified foods might theoretically provoke allergic reactions, is ironic in light of the fact that the problem of hidden major allergens, which have been concealed in common prepackaged foods on a widespread scale and have long been harming food sensitive individuals, remained largely overlooked by the FDA[258] and consumer groups.
Awareness of food sensitivities by the FDA and the public has slowly but steadily increased over the past two decades.[259] Notable advances in scientific understanding of food sensitivities toward the end of the twentieth century led to increased knowledge of food sensitivities among medical and health professionals, prompting more frequent and accurate diagnoses of food sensitivities in individuals and leading to greater understanding about food avoidance treatment. The first studies of food-induced, fatal anaphylaxis emerged in the late 1980s and early 1990s.[260] By the mid 1990s, international scientific consensus developed regarding the foods that tend to be responsible for most allergic reactions. With more scientific information about food sensitivities and the development of technological methods for testing for the presence of allergens in foods, the FDA grew more aware that the needs of people with food sensitivities were not being adequately addressed under the current application and enforcement of the FFD&CA and FDA regulations. As the FDA’s Center for Food Safety and Nutrition noted in 1993:
Another public health issue expected to grow as a result of new knowledge is food sensitivities, namely allergies and intolerances. Modern medicine has long recognized the relationships between foods and physiological reactions. The biomedical sciences have now advanced to the point where links between specific food components and food sensitivities can be described with increasing accuracy. Therefore, it can be expected that as the scientific evidence of these links advances, the FDA will respond by providing consumers with new information of importance for their health.[261]
In 1990, Congress overhauled the food label after 50 years of relative stasis when it called for heightened nutrition labeling on prepackaged foods. The enactment of the Nutrition Labeling and Education Act responded to concerns about the American diet and recognized the desires of consumers for more product information.[262] It reflected greater national focus on nutrition; it invigorated an emphasis on consumer choice through disclosure of information on product labels;[263] and it initiated regulations by the FDA to “reestablish the credibility of the food label.”[264] The NLEA acknowledged that the FFD&CA’s original labeling model, based on disclosing on labels only deviations from food standards of identity set by FDA regulations, was outmoded. The legislation addressed the changing nature of the food supply – the modern processing of foods with hidden ingredients, chemicals, and additives, and the concomitant increasing prevalence of scientific ingredient names in and uncertain nutritional quality of products that once employed relatively standard ingredients. Explicit identification of major allergens on the food label, however, was still not required.
The surge in knowledge about and diagnosis of food sensitivities piggy-backed on the birth of and major strides in the disability rights movement in the 1980s, which reconceptualized disability and illness as civil rights issues and demanded equality through integration and accommodation. The growing number of people concerned about food sensitivities rapidly developed networks with each other following the advent of the Internet. Individuals and caregivers of people with food sensitivities learned they were not alone – and together they gained a greater sense of community and entitlement to safety. This new notion of shared experiences and advocacy concerns helped generate a consciousness about food sensitivity issues within the food sensitivity communities as well as the wider public at large:
Until recently, there was little awareness of food allergy in the United States. Beginning with reports of fatal food-allergic reactions in the past decade and culminating in programs such as the Food Allergy Awareness Week in the United States and the activities of national allergy societies, the Food Allergy and Anaphylaxis Network and others, awareness is increasing.[265]
During the 1990s individuals with food sensitivities increasingly contacted food companies and notified the FDA when products that appeared from the label to be safe caused allergic reactions. In the early 1990s some major food producers such as Kraft, General Mills, and the Kellogg Company began taking notice of these complaints.[266]
Given the growing numbers of individuals diagnosed with food sensitivities, their increased activism with regard to inadequately labeled products, and improved methods for testing foods for hidden allergens, the FDA reinforced the importance of preventing allergic reactions in 1991 by instituting the first food product recalls due to undeclared allergens. The steadily increasing numbers of FDA’s allergen-related product recalls during the 1990s[267] – resulting in allergen-related recalls surpassing all other causes of food recalls – gained the attention of the food industry, in turn spurring enhanced efforts among some food producers to control allergens. In response to increasing numbers of food recalls, complaints from consumers, and a warning letter to manufacturers regarding food allergens issued by the FDA in 1996, the issue of food allergens became a key issue at food industry conferences and generated buzz within many food companies. Industry groups joined together in 1999 to form the Food Allergy Issues Alliance to explore how the industry could regulate itself to address the problem of food allergens. This Alliance produced voluntary guidelines to help the industry manage food allergens during food processing and packaging.
With the proliferation of special dietary needs and products designed to meet them, and growing calls by consumers for information about the content of products for various health, environmental, ethical, and religious reasons, the issue of improving access to consistent and reliable information gained importance within the FDA and the food industry. With the wide variety of diets today, where consumers and the food industry have obsessed over foods low in carbohydrates, low-fat foods, organic foods, genetically modified foods, and vegetarian foods, the FDA and the public became more receptive to the concerns of people with life-threatening allergies.[268]
In 2000, food allergy issues had become an official priority for the FDA’s Center for Food Safety and Applied Nutrition (CFSAN).[269] That same year, Representative Nita Lowey of New York introduced in the House of Representatives the first bill proposing improving allergen disclosure on food labels. Despite legislative setbacks, the push for food allergen labeling continued to slowly, but persistently, develop momentum and policy prominence, such that food allergen labeling even became an issue in the 2004 Presidential election.[270]
All of these factors converged in 2004. Just as the FDA was about to issue a notice of proposed rulemaking to impose labeling requirements for major allergens, Congress – in consultation with the FDA (and relying heavily on information documenting the need for improved labeling gathered by the FDA), food industry representatives, and consumer groups – took action and passed the FALCPA. Ultimately then, it was Congress that forged new ground in food labeling to address the long-neglected issue of labeling for food allergens, just as it had in 1990 when it broke 50 years of relative food labeling inertia to amend the FFD&CA to legislate comprehensive nutrition labeling requirements.[271]
As modern dietary needs increasingly vary and as information about food ingredients has improved, consumer expectations about the right to know what they are eating have changed. The once-far-fetched claim that Americans deserve to have confidence in the labeling of the food on their table no longer appears quite as controversial. This trend of increasing public expectations regarding food transparency was reflected in 2004 in numerous successful initiatives, in addition to the FALCPA, that called for greater information disclosures on the food label, including an agreement by several produce and meat industry groups to employ country-of-origin labeling and the FDA’s mandating disclosure of the trans-fat content of foods.[272]
Throughout US history, food sensitivities have received little legal attention. Legal analysis as it relates to food sensitivities – the implications of food and drug laws and regulations on individuals with food sensitivities, tort and products liability claims a person might raise in response to products provoking allergic reactions, and theories of accommodation that might be argued under disability rights law – has been largely a desolate landscape. One measure of legal scholarship, a Westlaw search for law journal articles containing some permutation of “food allergy” in the title, yielded only a single article critiquing the medical insurance industry. A Westlaw search reveals no law journal articles mentioning food allergies before 1982, with the exception of a brief mention of food allergies in one 1952 review of a book concerning products liability.[273]
The discussion of food allergies emerged in legal articles only in the 1980s and 1990s. As gauged by a Westlaw search, however, American legal interest in the topic of food sensitivities has been almost exclusively limited to the debate about bioengineered foods. While some articles have discussed theories of liability, in general little legal attention has been paid to the rights of people who daily face the real dangers associated with negotiating food labels, restaurants, schools, and public transportation. Another measure of legal recognition of food allergies – a review of cases in which individuals with food sensitivities have asserted liability or disability claims – reveals scant case law concerning food sensitivities.[274] The issues that trouble people with food sensitivities are only recently garnering legal attention – a handful of articles over the past half dozen years have appeared regarding various liability and disability rights theories food sensitive individuals might raise.
The growing emphasis on food sensitivities in the United States at the turn of the twenty-first century was also experienced internationally. In significant ways, the United States has undeniably been an international leader in terms of food safety in general and food labeling in particular.[275] However, when it came to food allergen labeling, the United States was behind several other countries and international groups. Canada became active – and the international leader[276] – in addressing food sensitivity issues in the 1980s. In the wake of several highly publicized deaths from peanuts, Canada’s food safety agency began to initiate allergen-related product recalls and instituted advisory labeling; Canadian schools began to ban peanuts.[277] In 1997, the Canadian Food Inspection agency was formally established and charged with implementing allergen control activities.[278] By 2001 Canada had implemented guidelines for allergen-related food product recalls, increased the number of allergen-related recalls, adopted requirements to assure that ten major allergens are fully and consistently labeled, and developed a precautionary labeling policy.[279] The Codex Alimentarius Committee,[280] an international body that develops world-wide food standards, adopted voluntary labeling standards for major allergens in 1999 – the result of over a decade of discussions about whether and how to improve allergen labeling.[281] And the European Union enacted mandatory allergen labeling requirements just one year before the United States.[282]
B. Policy Treatment of Food Sensitivities Before 1996
“Food allergies have probably affected mankind since the dawn of time,” states leading food allergy expert Steve L. Taylor. “The first well recorded case histories of food-allergic patients appeared in the early part of the 20th century. Yet, food allergies were largely ignored by the medical community and regulatory authorities until recent years.”[283]
For most of the twentieth century, because Congress and the FDA presumed that the FFD&CA’s labeling requirements provided sufficient information to protect food sensitive consumers and general understanding and concern about food sensitivities was minimal, food sensitivities were largely a non-issue policy-wise.
1. A Survey of Food Labeling Legislation
i. The Federal Food and Drugs Act of 1906
The first federal law enacted in the United States to govern the regulation of food was the Federal Food and Drugs Act of 1906 (“1906 Act”).[284] The 1906 Act reflected a conception of food products as relatively standardized and composed of straight-forward ingredients. The Act prohibited the adulteration of foods, including the adding of any “poisonous or other added deleterious ingredient which may render such [food] article injurious to health.”[285] In its misbranding provisions, which prohibited the selling of any food labeled in a false or misleading manner, the 1906 Act provided that food articles labeled as “compounds,” “imitations,” or “blends” would not be deemed misbranded if the label clearly identified that fact. The product’s ingredients, including “harmless coloring or flavoring ingredients,” did not need to be disclosed so long as a food contained “no unwholesome added ingredient.”[286] Thus, the 1906 Act’s approach to preventing consumer deception was to regulate information placed voluntarily on food items by sellers, rather than to prescribe that certain information be disclosed on a label.[287] There is no indication that these provisions, which could plausibly be construed to apply to harmful food allergens, were ever interpreted in that light. Potentially life-threatening allergens were, thus, not required to be identified in food products at all.
ii. The Federal Food, Drugs, and Cosmetics Act of 1938
The 1906 Act was subsequently repealed in 1938 and replaced with the more comprehensive and forceful FFD&CA.[288] The FFD&CA’s ingredient labeling requirements – the likes of which was unprecedented in the world – revolutionized the U.S. food label.
The FFD&CA “introduced a then-novel concept in food labeling”[289]: its misbranding requirements mandated that certain information concerning a product – the name of the food, a statement of ingredients, the net quantity of contents, and the name and address of the manufacturer – be affirmatively declared, in a standardized format, on food labels.[290] The FFD&CA’s misbranding provisions divide foods into two types: standardized[291] and non-standardized. If a food article is one for which a standard of identity has been established, the product will be deemed misbranded if its quality falls below such standard.[293] For standardized foods, only the name of the food and names of optional ingredients (with the exception of spices, flavorings, and colors) need to be identified on the label.[294] If the food is a type with no standard of identity, the ingredients must be declared on the label (with the exception of spices, flavorings, and colors).[295]
Section 342(a)(1),(4) declared as adulterated any food that “bears or contains any poisonous or deleterious substance which may render it injurious to health;” however, allergens were deemed to not be “deleterious substances” within the purview of this provision:
In the consideration of these provisions of the bill, much discussion has centered around the question of “allergy.” ... To avoid any confusion that might possibly arise from the fact that so many persons are allergic to wholesome articles of food that can be eaten by the vast majority without harmful effect, the bill has not been drawn simply to ban food which may be harmful or dangerous but the test is predicated on whether or not the product contains a poisonous or deleterious substance. Certainly strawberries, eggs, wheat flour, and the like cannot be considered poisonous or deleterious substances and the fact that persons may be made ill by them would not authorize action under the terms of the bill.[296]
These labeling requirements have been subject to little alteration over time,[297] despite substantial changes in the American diet and food processing over the past 70 years.
The FFD&CA was designed with concerns over food quality and safety in mind. The Act’s legislative history indicates that the principal health condition cited in favor of the FFD&CA’s ingredient disclosure requirements was in fact the then little-known[298] and little-understood condition of food allergies. As food products became increasingly diverse and processed during the early twentieth century, it became more difficult for food sensitive individuals to simply look at a product or use common sense to avoid harmful allergens. A Senate Report declared in 1934 that the FFD&CA’s misbranding provisions not only promote fair dealing between manufacturer and consumer, but have “distinct public-health significance”:
A surprisingly large proportion of our population is allergic to some food or other which for most people is entirely wholesome. Many people are made ill – some violently so – by common ingredients of food which most people consume with impunity. That large group of unfortunates can protect themselves from the consumption of foods to which they are allergic by the information made available to them under [these misbranding provisions].[299]
The FDA Commissioner stated further that consumers have a right to know what they are eating not only because of economic reasons (which the 1906 Act’s misbranding provisions attempted to address), but also for health reasons (which the FFD&CA’s requirements for ingredient disclosure of non-standardized foods more fully addresses):
Our thought has been that the purchaser of food products, the one who is going to take those food products into his system, is entitled, as a matter of simple right, to know what he is eating. There are two reasons to justify that position. The first is an economic reason. It will prevent, in such circumstances, the substitution of products which may be of lesser food value or may be less expensive. And second, and the compelling reason, to my mind, is the element of health. ... Dr. Brown [an expert on hypersensitivity who testified before the Committee the day before] explained that the distressing physiological reactions that could be produced in those people who were hypersensitive to certain products could be caused by infinitesimally small quantities of the food product. ... I am bringing that out merely to show you the extremes to which these people who do have this hypersensitiveness suffer from the consumption of those foods which are wholesome in themselves to most people but are deadly poison in a way to them. I think on that basis that it is fair to let the individual know what is contained in the food product.[300]
Without a doubt, the FFD&CA’s imposition of more stringent ingredient disclosure requirements – the first of their kind in the world – have done much to benefit food sensitive individuals and have saved countless lives.
Yet despite these substantial benefits and the legislation’s excellent intentions with regard to helping food sensitive individuals, the FFD&CA’s ingredient disclosure requirements fell dangerously short of protecting the health and safety of people with food sensitivities. The FFD&CA did not require disclosure of ingredients in standardized foods because, in the words of the then-Commissioner of the FDA Walter Campbell, “we assume that there will be little contributed either economically, or from the standpoint of health of the consumer, in declaring on such products the list of ingredients.”[301] Furthermore, as discussed in Part II, the FFD&CA allowed for exemptions from its labeling scheme when compliance is deemed “impracticable.”[302] As interpreted by federal regulations, the FFD&CA contained problematic exceptions that have prevented food sensitive consumers from being able to make meaningful, informed decisions necessary to their health and safety: the sub-ingredients in spices, flavorings,[303] and colorings,[304] and additives at “insignificant levels” without technical effect in the product[305] – all ingredients pervasive in the food supply – did not need to be disclosed on the label. “Incidental additives” derived from spices and flavorings did not need to be disclosed at all, even by generic terminology.[306] Moreover, the sources of some ingredients did not need to be disclosed as part of the ingredient’s “common name,”[307] manufacturers could use “may contain” or “and/or” labeling when formulations of a product varied from batch to batch,[308] and “common or usual” ingredient names could be highly scientific and technical.
iii. The Nutrition Labeling and Education Act of 1990
A half century after the FFD&CA’s enactment, Congress first added additional food label requirements to the FFD&CA – the inclusion of nutritional information in a clear, consistent fashion on the food label – by passing the Nutrition Labeling and Education Act of 1990[309] (NLEA). “The NLEA shared the goal of the 1938-enacted section 403: to enable consumers to choose foods wisely by using the label as a vehicle for communicating essential information.”[310] It required the declaration in a format specified by the FDA of calorie, fat, carbohydrate, fiber, sugar, protein, vitamin, and other nutrient content.
Though not directed at helping food sensitive consumers,[311] the NLEA had some positive consequences for individuals with food sensitivities. The NLEA inaugurated increased emphasis on product content transparency and consumer choice. It marked the demise of the FFD&CA’s dated approach of exempting standardized foods from content disclosure requirements. The NLEA helpfully extended ingredient disclosure requirements beyond optional ingredients to mandatory ingredients in standardized foods:
“Originally, food standards were adopted to ensure uniformity. If you saw a product labeled mayonnaise, food standardization meant it had to be mayonnaise. People used to know what was in mayonnaise; nowadays they have to be told that mayonnaise contains both eggs and oil,” [Elizabeth J. Campbell, director of the division of programs and enforcement policy at FDA’s Center for Food Safety and Applied Nutrition (CFSAN),] says. “Years ago, when the law was first written to provide for standards of identity for certain foods, it only required that optional ingredients be declared. The [NLEA] stipulates that all ingredients in standardized foods must be declared.”[312]
Additionally, the NLEA required that certified color additives be declared by their common or usual names rather than the generic term “colorings.”[313] As one article written by the FDA noted shortly after the FDA’s regulations implementing the NLEA were issued, “the law is changing to catch up with the times.”[314]
Nonetheless, the NLEA did not significantly address the food sensitivity dimension of consumer health and consumer choice. The NLEA did not revoke other existing ingredient declaration loopholes for flavorings, spices, noncertified color additives, and other additives, nor did it attempt to remedy consumer confusion with regard to technical ingredient names.
iv. Food Labeling Legislation Conclusion
Congress and the FDA initially believed the FFD&CA would sufficiently safeguard the health of people with food sensitivities. As knowledge about biology of food sensitivities and awareness of food sensitivities grew, however, it became apparent that sufficient safety had not been achieved.
In response to allergenicity concerns, the FDA began to issue ad hoc regulations requiring the identification of certain allergens or the sources of certain ingredients on the food label. For instance, in 1985 the FDA required the specific source of “gluten” be identified on the label when it issued regulations recognizing as GRAS (generally recognized as safe) “corn gluten” and “wheat gluten.”[315] The FDA stated it believed gluten-sensitive individuals were adequately safeguarded and rejected consumer requests calling for the mandatory identification of products as “gluten-free.” The FDA’s stated rationale was that, because the source of gluten (wheat or corn) must be identified by name, “the labeling already required is adequate to alert the public and protect gluten-sensitive individuals.”[316] Although a “gluten-free” standard was likely scientifically infeasible at the time, the FDA’s statement nevertheless reflects a failure to appreciate the fact that “wheat gluten” is but the tip of the iceberg in terms of ingredients that individuals sensitive to gluten must avoid, and the identification of “wheat gluten” on the label would be but a partial remedy for people with celiac disease, in contrast to “gluten-free” labeling.
Over time the FDA came to recognize that even these case-by-case attempts to aid food sensitive individuals were inadequate. But policymakers believed the 1990 Nutrition amendments would help address the unmet needs of food sensitive consumers. The FDA touted that, given the NLEA’s passage, “consumers will [now] have the information they need to make correct food choices.”[317] The FDA also stated that “the information present in the ingredient list is adequate to enable the consumer to avoid ingredients of concern.”[318] According to Elizabeth J. Campbell, director of CFSAN’s division of programs and enforcement policy, furthermore, “For those with food allergies, I think it is more of a patient education problem.”[319]
Indicative of the persisting belief by some in the government that current laws were sufficient for people with food sensitivities, in 1996 U.S. delegates from the FDA to the Codex Alimentarius Commission, an international food standards-setting body, objected to a proposal requiring the declaration of major food allergens on the food label, arguing that “complete ingredient listings” – such as that found in the U.S. – was a better plan:
“The United States does not support the establishment of a positive list [of allergens] and does not believe there is a scientific basis that could justify establishing ‘minimum’ levels (or ‘safe’ levels) of potentially allergenic ingredients.... The United States believes the issue is nullified by the distinct declaration of all ingredients by meaningful common or usual names. ... [I]n our judgment, it is not possible to develop scientifically supportable criteria or lists that would permit the identification of all potentially allergenic food ingredients, or to develop ‘safe’ levels of those ingredients that would not require identification on the label,” [the U.S. delegates] said.[320]
This belief that U.S. laws and regulations were sufficient failed to address consumer confusion regarding complex ingredient terminology and the problem of allergens hidden within ambiguous terms. It reflected an erroneous assumption that if food sensitive consumers simply learned what they need to avoid and read a label, they would have adequate information upon which to base decisions.[321] Thus, despite the many labeling policy advances since the first food and drug law of 1906, current laws at the turn of the century were still deficient when it came to safeguarding individuals with food sensitivities. It wasn’t until the late 1990s that policymakers began to more fully recognize and take seriously these remaining inadequacies.
2. Regulatory Food Labeling Developments
With regard to the occasional proposals the FDA considered prior to 1996 to aid individuals with food sensitivities, the FDA endeavored to weigh the value of consumer choice, economic feasibility to manufacturers, the FDA’s understanding of the limits on its authority, and the agency’s determinations about consumer safety needs.[322] This difficult balancing act overall resulted in an ad-hoc, piece-meal approach to labeling disclosures, despite the agency’s few (unsuccessful) efforts to set general, broadly-applicable labeling policy in response to allergen concerns.
Beginning in the late 1970s, the FDA did take note of certain allergen-related hazards and considered – and in some cases issued – regulations to address them. By and large, however, the FDA’s approach to allergen declaration over the years – its justifications for and against allergen labeling in various contexts and the criteria it employed for what allergens to focus on – has largely been ad hoc and inconsistent. The FFD&CA’s labeling program as it relates to food allergens received little elaboration by the FDA until the mid 1990s. The agency did not recognize a need for a comprehensive strategy regarding food allergens until the mid 1990s and did not begin to formulate and implement such a plan until around the turn of the century.
Although the FFD&CA itself exempts from disclosure the specific ingredients in spices, flavorings, and colors, thereby limiting the options the FDA could pursue to benefit people with food sensitivities, the authority the FDA has possessed under the FFD&CA and the FDA’s active, post-1996 response to food sensitivity issues indicate that the FDA could have earlier pursued a variety of options to benefit individuals with food sensitivities. The FFD&CA gives the FDA the authority to fashion additional labeling requirements to prevent a food product from being “misleading in any particular,”[323] and hence, deemed misbranded. Section 321(n) of chapter 21 of the U.S. Code authorized the FDA to require information to appear on a food label, in addition to the information expressly prescribed by Congress in the FFD&CA, when a label “fails to reveal facts material with respect to consequences which may result from use of the article ... under such conditions of use as are customary or usual.” A petition submitted to the FDA by nine state Attorneys General in 2000 argued that the FDA could permissibly close via regulations the spices, flavorings, and colorings as well as the additives loophole within its existing authority:
Food labels that do not declare allergenic ingredients because they consist of either natural flavorings or incidental additives are misleading to food-allergic individuals since they do not provide sufficient information to permit such consumers to select foods that are safe for them to eat. Thus, the presence of these allergenic substances is a material fact that must be disclosed on food labels; without such disclosure, the foods are misbranded. ... The FDA has previously seen fit to exercise this authority by promulgating regulations which have eliminated the natural flavoring and incidental additives exemptions as they pertain to certain food substances. ... The definition of adulterated food includes foods that have been prepared, packed or held in insanitary conditions whereby it may have been rendered injurious to health. ... [A]llergenic ingredients can be inadvertently introduced into a food through ‘cross-contamination’.... The ingestion of foods that have been contaminated in this manner has proven to be injurious to the health of many food-allergic consumers. The FDA, under its authority to prevent adulteration, has in the past promulgated good manufacturing practices designed to prevent the contamination of food with microorganisms, filth or other harmful substances. [324]
The FDA’s ability – and, at various times, willingness – to seek measures to help food sensitive individuals despite the limitations of its authority imposed by the FFD&CA is illustrated by its joint efforts with the USDA and FTC in the late 1970s to attempt comprehensive revision of food labeling requirements. In 1979 the FDA noted that consumers in general desired more specific labeling of spices, artificial colors, and flavors, along with sugars, salts, fat, and oils, so they could make better nutritional and health decisions.[325] In response, the FDA stated its position that it believed the specific ingredients in spices and colors should be declared by specific names on food labels, since most products containing spices and colors contain no more than four or five. But because “as many as 125 flavors can be used in a single processed food,” the FDA supported label declaration of only those flavors “known to cause health problems, such as allergic reactions in particular segments of the population.”[326] The FDA stated its intention to “seek or support legislation” giving the FDA authority to require more specific declaration of spices, flavorings, and colorings. Between 1979 and 1996, however, it is not apparent that this issue received any further attention.
The FDA further observed in 1979 that some of the public wanted disclosure of incidental additives,[327] contrary to FDA regulations exempting incidental food additives from labeling requirements. The FDA concluded, however, that:
[T]he possible presence of incidental additives is not believed to be of any public health significance. Their presence in food is not always predictable, and even so, their safety is fully assessed. The agencies have concluded, therefore, that such a requirement would not be necessary, and may not be practical or worthwhile. It would require analysis of food lots for potential incidental additives between harvest or manufacture and consumption. Conducting screening analyses for possible additives would be extremely difficult and costly for both the government and industry, and the costs ultimately would be passed on to consumers, with little or no benefit obtained.[328]
Over time, the FDA gradually shifted its focus from defining food standards to improving labeling disclosure so that consumers themselves could make meaningful food decisions.[329] As part of this general trend, the FDA began to address food allergies on a food-by-food, allergen-by-allergen basis. One way the FDA pursued this goal was by considering modifying the standards of identity of foods to require the declaration of certain allergens in certain products.[330] As the FDA recognized in 2001, “On a case-by-case basis, FDA has used notice-and-comment rulemaking to require the declaration of individual allergenic flavorings, spices, and colors. This is a labor-intensive and time-consuming process for the agency.”[331]
Thus, over the years, the FDA has occasionally addressed specific allergens in specific contexts as consumer complaints brought allergen-related safety matters to the FDA’s attention. The FDA consistently rejected putting “warnings” on food packaging to alert food sensitive consumers to allergens,[332] asserting that warning statements may result in an overload of information and distract consumer attention from important information.[333] The FDA also rejected banning allergenic ingredients from the market.[334] Instead, the FDA opted for expanding consumer choice by improving labeling. The FDA has maintained that “[t]he agency’s primary tool for handling a situation where population subgroups may be at increased risk from a food ingredient that is safe for most people is to use labeling to inform those persons who need or want to avoid the ingredient.”[335]
Despite the FDA’s asserted intention to use the food label to disclose ingredients harmful to population sub-groups, the FDA’s actual record with regard to requiring disclosure of food allergens is more equivocal. A review of notices in the Federal Register during the 1980s and early 1990s reveals little FDA concern about precautionary labeling that restricted the choices of food sensitive consumers; numerous rejections by the FDA of calls for improved labeling of allergens and the extension of source ingredient declaration requirements to major-allergen-containing ingredients[336]; and FDA resistance to requests for mandatory “plain English” labeling of allergens, since the agency presumed that food sensitive consumers knew what terms to look for in the ingredient statement to effectively avoid harmful allergens.[337] The FDA indeed acted on several occasions to require mandatory declaration of certain allergenic ingredients, but these regulations usually[338] targeted allergens that were manufactured chemical compounds rather than “naturally” occurring allergens, such as the Big Eight.
For instance, in 1979 the FDA issued a landmark regulation when it for the first time required the labeling of a specific spice, flavoring, or color. It issued a rule requiring the disclosure of FD&C Yellow No. 5 on food labels.[339] The FDA subsequently adopted regulations requiring the declaration on food labels of several other chemical additives that provoke allergic or allergic-like adverse reactions in sensitive individuals: sulfites in concentrations of over 10 parts per million,[340] FD&C Yellow No. 6,[341] aspartame,[342] and monosodium glutamate.[343]
Sometimes when the FDA considered a request to mandate the labeling of an allergic ingredient, the FDA found it did not have sufficient scientific information to support taking action to address that allergen.[344] The lack of scientific information as a justification for FDA inaction created a “catch 22” – without scientific information, the FDA declined to press for changes to better manage allergens, yet without pressure from the FDA, there was little incentive to conduct the necessary research.
While some of the FDA’s early public comments regarding food allergenicity occur in the Federal Register related to consumer requests to not declare various foods GRAS (generally recognized as safe) due to allergenicity concerns,[345] in the 1980s references to food allergens in the Federal Register were dominated by the emerging debate regarding genetically modified foods and whether bioengineered foods may provoke allergic responses in unsuspecting consumers.[346] In 1992, the FDA issued a policy statement regarding the commercialization of genetically modified foods. The FDA stated that manufacturers must demonstrate the safety of new foods bioengineered using the DNA of the eight major allergens.[347]
The helpfulness of FDA’s case-by-case efforts to protect food sensitive consumers through ingredient declaration requirements should not be discounted. These regulations have benefited tens of thousands – if not millions – of Americans. Nevertheless, the FDA’s historical approach to the problem of allergens reflects a focus on new “man-made” allergens and bioengineered foods that may enter the food supply, while already known, potentially-lethal, “natural” food allergens in everyday products went largely unexposed and unaddressed. Perhaps the FDA’s decision to require labeling of manufactured “allergens” like FD&C Yellow No. 5 (to which only an estimated 50,000 to 100,000 people may be allergic and which causes mild adverse reactions not requiring medical treatment) and aspartame, along with the agency’s general limitation of its discussion of allergens to the context of genetically engineered foods, reflected the agency’s belief that the FFD&CA’s labeling scheme was sufficient to protect individuals sensitive to “natural” foods, so new “man-made” additives (subject to FDA pre-market approval) and bioengineered foods warranted the most scrutiny.
Several deviations from the agency’s typical as-necessary, ad hoc approach to allergens are noteworthy. As early as 1941, a scheme was designed to regulate claims of hypoallergenicity were regulated as a product claim.[348] In 1979, the FDA, USDA, and FTC attempted to update food labeling requirements by implementing coherent, broadly-applicable policy:
This is the first joint effort of the three agencies with responsibility for food labeling and advertising [FDA, USDA, and FTC] to review the entirety of the food labeling laws and regulations. (Previous efforts, usually initiated by an agency on its own, have been largely ad hoc.). ... The Federal agencies have attempted to anticipate and respond to industry’s technological advances and to consumers’ demand for increased information about food products through amendments to their labeling regulations. This approach has produced a complex set of food labeling rules that, because of the different statutes FDA and USDA enforce and their different regulatory responsibilities, have sometimes been duplicative or inconsistent. FDA, USDA, and FTC realized the need to pause and assess existing food labeling laws and policies before implementing further regulatory changes. Therefore, the agencies set out to develop an overall labeling strategy that will provide consumers with the information that they want and need about today’s foods.[349]
In 1984, “as a result of its experience with allergic reactions to Yellow 6, aspartame, and sulfites, FDA established an ad hoc advisory committee initially to review hypersensitivity to sulfites and, later, all food constituents.”[350] The FDA helpfully created a form for physicians to report complaints of injury from food products and, in a 1985 FDA Drug Bulletin article, asked health professionals to inform the FDA of “any severe and well-documented non-microbiologic reactions associated with food.”[351] And in 1986, the FDA adopted an integrated approach to the problem of sulfites, an additive which, the FDA noted, could provoke fatal adverse reactions in sensitive individuals.[352]
Seizing the momentum of reforming the food label ushered in by the NLEA, the FDA originally had ambitious plans to implement a somewhat comprehensive food allergen policy while it devised regulations to implement the NLEA. The Director of CFSAN in 1992, Dr. Fred R. Shank, stated optimistically that “ingredient labeling guidelines under the Nutrition Labeling and Education Act will allow people with allergies to know exactly what they are eating.”[353] The FDA issued a proposed rule that would have greatly limited the ingredient disclosure loopholes. The proposed rule would have required, inter alia, that soybeans be declared when present in “vegetable broth” in canned tuna and that the term “flavoring” be replaced by specific ingredients in the ingredient statement.[354] As part of its broad post-1990 food labeling vision, the agency also considered establishing more exceptions to the spices and flavorings loophole.[355]
In the end, few of the regulations proposed by the FDA to benefit food sensitive individuals in the wake of the NLEA were enacted.[356] While the NLEA’s elimination of the ingredients labeling exemption for mandatory ingredients in foods with standards of identity[357] marked a significant improvement, the FFD&CA’s and the federal regulation’s exemptions to full ingredient disclosure remained intact.
C. The 1996 Revolution and Beyond
An international technical consultation regarding food allergens held by the United Nations’ Food and Agriculture Organization in 1995,[358] during which consensus documents regarding major allergens and problems associated with current food labeling practices were developed, fueled a surge of interest in food sensitivities in the United States. In the late 1990s and at the turn of the century, the FDA, Congress, consumer groups, and the food industry all significantly enhanced efforts to address problems surrounding food sensitivities.
1996 witnessed a great change in attitude within the FDA toward food allergens. For decades a peripheral issue of varying importance, in the mid 1990s allergens moved more to the forefront of the FDA’s attention. As consumer complaints and scientific advancements regarding allergens increased, food sensitivity issues became more of a policy priority, garnering more consideration and resources from the FDA. The FDA’s new-found emphasis on food allergens in turn attracted the attention of the food industry, which began to think about and address food allergens more than ever before. Then, in 1999, New York Representative Nita M. Lowey introduced the problems of food sensitivities to the Congressional arena. She persistently introduced legislation each year thereafter, encouraging national attention and debate on the issues surrounding food sensitivities.
The turn of the century witnessed greater prioritization of food sensitivity issues by the FDA, improved food industry awareness and efforts to address allergen management, increasing grassroots advocacy by food sensitive consumers and consumer groups, and a Congressional push for national legislation to better address the needs of food sensitive individuals. As described in the following sections, the combined efforts of the FDA, concerned consumers, the food industry, and Congress ultimately resulted in the passage of the FALCPA.
What initiated the enhanced focus on food allergens in America in earnest was a Notice to Manufacturers letter (“Notice Letter”)[359] issued by the FDA in June 1996. Reports from consumers about adverse reactions from undisclosed allergens in food products “prompted FDA to develop an initiative on food allergen awareness.”[360] Prior to this warning letter, a few major food firms such as Kraft, General Mills, and Kellogg’s were aware of food allergen issues due to consumer complaints; the FDA warning letter, which raised the specter of future FDA rulemaking regarding allergens, made food allergen management an issue for food manufacturers on a widespread scale. Prior to 1996, the publication Food Labeling News scarcely mentioned labeling as it related to food allergens; in 1996 and afterwards, food allergens became a frequently discussed topic.
The 1996 Notice Letter signaled a recognition by the FDA that current labeling practices were inadequate to protect food sensitive individuals. In the Notice Letter, the FDA clarified its interpretation of the two labeling exemptions. Reversing its policy, the FDA declared that additives were not “insignificant” at any level – and hence the specific ingredients must be disclosed or else a product will be deemed misbranded – when the additive contains a “known allergen.” The FDA further asserted that advisory labeling should not be used in lieu of adherence to GMPs and that allergens introduced to a product through cross-contamination may be considered adulterated under 21 U.S.C. § 342(a)(4). The Notice Letter also encouraged manufacturers to also list allergens present in spices, flavorings, and colors, and stated that the FDA might consider rulemaking to that effect, despite the exemption of those constituents from disclosure provided in the FFD&CA.[361]
The Notice Letter marked a significant shift in the FDA’s approach toward allergen labeling, although the letter couched its new interpretation of the additive exception in terms that implied this had been the FDA’s policy all along:
In some of the instances of adverse reactions, failure to declare an ingredient appears to have been the result of a misinterpretation of the exemption from ingredient declaration provided for incidental additives in 101.100(a)(3). FDA reminds manufacturers that to qualify for the exemption from ingredient declaration provided for incidental additives and processing aids, a substance must meet both of the requirements of 101.100(a)(3), i.e., it must be present in the food at an insignificant level, and it must not have any technical or functional effect in the finished food. ... The recent adverse reaction reports indicate that some manufacturers have also incorrectly interpreted what constitutes an insignificant level of a substance. Clearly, an amount of a substance that may cause an adverse reaction is not insignificant. Because evidence suggests that some allergenic substances can cause serious allergic responses in some individuals upon ingestion of very small amounts of the substance, it is unlikely that such an allergen, when it is present in a food, can be present at an insignificant level.[362]
While a marked improvement, the Notice Letter afforded an incomplete remedy to meet the needs of food sensitive individuals because, most importantly, the Letter was merely guidance and was never codified in regulations.[363] Additionally, the Letter did not:
These are all issues that the FDA recognized publicly as problems for food sensitive individuals five years later, when the FDA took the lead in allergen reform and actively pursued comprehensive improvements to allergen labeling.
After issuing the Notice Letter, the FDA requested suggestions and comments regarding how to deal with food allergens, but did not pursue rulemaking regarding allergen labeling.[364] Because the FDA did not promulgate regulations implementing, or expend resources to enforce, its 1996 Notice Letter, the FDA came “under increasing pressure from the U.S. Congress, the states, and citizen groups to create labeling laws and policies for allergenic ingredients in food.”[365]
Food allergen-related product recalls were initiated by FDA in 1991, and during the 1990s such recalls went from “inconsistent”[366] to become the primary source of food Class I recalls.[367] Overall numbers of allergen-related recalls increased from 35 in 1991 to 121 in 2000.[368] As Robert Humbert, the Kellogg Company’s manager of food safety, stated in 1996, the increased number of allergen-related recalls is due to more attention and aggressive action by the FDA, not because food manufacturers were better about cross-contact and labeling prior to the 1990s.[369] In 2002, the FDA began a policy of automatically designating most allergen-related recalls as Class I recalls – the most serious form of product recall, reserved for products which could pose a serious risk of injury or death to consumers. Recalls require companies to notify the public of the product recall, creating negative publicity for food manufacturers and, hence, incentive for manufacturers to improve allergen management and labeling practices.[370] The FDA also created a place on its web site[371] where consumers can track “Allergen Alerts” notifying consumers of allergen-related product recalls.
In response to the increasing numbers of allergen-related product recalls and heightened concerns regarding cross-contamination, in 1998 the FDA formed a partnership with the departments of agriculture in Minnesota and Wisconsin (“the Partnership”)[372] to study the accuracy of labels and the prevalence and mechanisms of cross-contact between allergen-containing and allergen-free foods. The Partnership conducted inspections of 85 various-sized manufacturers of baked goods, ice cream, and candy in Minnesota and Wisconsin. While it examined allergen control mechanisms generally, the Partnership focused on peanut and egg allergens – two major allergens capable of detection and analysis. The Partnership found that incidents of mislabeling and cross-contamination, as well as inadequate label verification and recall procedures in food firms, were widespread:
In 2000, the FDA held a series of workshops to inform the food industry of the Partnership findings and to educate manufacturers about allergen control techniques.[373]
At this time, amidst a growing number of allergen-related food product recalls and the dissemination of the Partnership’s results, food allergies (and specifically, reducing the incidence of death from food-induced anaphylaxis) became a key focus of an HHS health initiative – Healthy People 2010.[374] FDA staff person Elisa Elliot called the Healthy People 2010 objective on food allergies “one of the most important” of the program, but admitted that it was also “one of the least worked on” because of a dearth of reliable food allergy data.[375] One goal of the Healthy People 2010 program was to generally “raise the prominence of the issue of food allergies” in an effort to increase public awareness of allergies to and federal funding for allergen-related initiatives.[376]
The FDA’s Center for Food Safety and Applied Nutrition (CFSAN) added improved food allergen labeling to its “priority list” in 2000,[377] where it remained in 2001[378] and 2002.[379] CFSAN launched several initiatives to improve industry awareness of the need for improved allergen control mechanisms, to better understand food allergies and the concerns of consumers, to help develop allergen test kits, to learn more about allergenicity thresholds, and to prepare guidance documents on allergen management.[380] It inaugurated a new emphasis on allergen-related inspections of food firms and opened discussions about whether and how to improve the food label. In 2000, the FDA for the first time included a question regarding consumers’ perceived food allergies in a consumer survey designed to help support the FDA’s consumer education programs and regulation development.[381] Dr. Ken Falci, Director of the Office of Scientific Analysis and Support, summarized this major change in the FDA’s treatment of food allergens in the following way:
It wasn’t very long ago, actually in 1999, that FDA first thought about being and becoming more active with food allergens, and we did have discussions and we did formulate a plan of action as far as food allergens were concerned. We formed an internal steering committee within the Center for Food Safety and Applied Nutrition, which is a center in FDA. And we also had a general committee on food allergens made up of a number of people within different offices that are in the Center for Food Safety. And at that time, one of the reasons for our action was because recalls of foods placed in the market, foods that contained undeclared food allergens were at high levels in the nation. And in 2000, we followed that up. We went out with industry, we went out to industry and to consumers. We gathered data at that time. We were seeking advice. We were trying to raise awareness of people in the industry as well as consumers as far as food allergens were concerned. At that time, too, we were trying to decide on accomplishable tasks, those tasks that would make a difference as far as food allergens were concerned in the nation.[382]
2001 was a year of major activity by the FDA with regard to food allergens. The FDA announced that, “[a]s part of the public health mission to keep food safe, the U. S. Food and Drug Administration (FDA) is increasing its activity on food allergen awareness.”[383] Pursuant to this invigorated mission, the FDA, through CFSAN, launched several allergen-related initiatives. The agency reported that it was in “beginning stages of negotiating and talking with the food industry about some things we’d like to potentially see on the label.”[384]
In a 2001 letter to manufacturers regarding the findings of the Partnership, the FDA declared that “[a]ddressing the very real issue of food allergens needs to be a priority for us all.”[385] To help address continuing cross-contamination problems made evident by the Partnership’s findings, and due to the FDA’s “concern[s] over the continued finding of undeclared allergens,”[386] the FDA placed greater emphasis on using manufacturer inspections as a way to encourage the food industry to take allergen control seriously. In early 2001 the FDA issued two food allergen guidance documents – a Compliance Policy Guide: Statement of Policy for Labeling and Preventing Cross-Contact of Common Food Allergens (updating the Notice Letter by announcing FDA’s internal enforcement priorities concerning undeclared food allergens, describing the FDA’s current thinking on allergens, and outlining policy and actions that the Agency “may or may not” take under the law) and a Guide to Inspection of Firms Producing Food Products Susceptible to Contamination with Allergenic Ingredients (providing guidance to FDA investigators and inspectors to assist them in evaluating conditions that may result in the introduction of undeclared allergens in foods).[387] With these non-binding advisory documents, the FDA made cross-contact management an aspect of GMPs and a subject of food firm inspections. The documents provided guidance to industry and regulators on how to manage allergens through appropriate manufacturing and labeling practices. They warned that undisclosed Big Eight allergens in additives may render a product misbranded and that food products cross-contaminated with Big Eight allergens might henceforth be deemed adulterated by the agency.[388] The FDA, moreover, trained inspectors and compliance officers with regard to allergen inspections.[389]
Although it appears that the FDA’s statements regarding adulteration and misbranding due to undeclared allergens were rarely enforced in the immediate aftermath of the Notice Letter,[390] between 2001 and 2004, the FDA conducted over 2,100 inspections of food firms in which inspectors checked for allergen control mechanisms.[391] It is unclear, however, if the FDA in implementing the Compliance Policy Guide ever sanctioned a firm by deeming a food product misbranded or adulterated due to undisclosed allergens.[392]
In August 2001, the FDA held an extremely instrumental public meeting (“Public Meeting”) regarding food allergen labeling – the first public meeting on the topic and the first effort by FDA to gather comments on a large scale in preparation for rulemaking regarding allergen labeling. The meeting was prompted in response to increasing numbers of allergen-related food product recalls, complaints from consumers and Congressional representatives on behalf of constituents, and a citizens petition and petition by nine state Attorneys General requesting agency action on food allergens.[393] The FDA sought comments from consumers and the food industry regarding whether and what types of further regulatory action might be warranted with regard to food allergens.[394] Reflecting the agency’s new attitude toward allergens, the FDA expressly acknowledged that food sensitive consumers (as first publicly recognized in the 1996 Notice Letter) continued to not receive sufficient information from food labels to protect their safety:
Each year FDA receives reports of consumers who experience adverse reactions following exposure to allergenic substances in foods. ... Most consumers are aware of their specific sensitivities and rely on the food label to avoid foods that might result in an allergenic reaction. However, adverse reactions often occur when an allergen-sensitive consumer consumes an allergenic substance that has not been declared on the food label. ... Thus, in some cases food labels may not provide consumers with food allergies with information about all the ingredients that are in the foods that they eat. The undeclared presence of allergens in foods is a serious public health issue because the ingestion of food allergens is potentially life-threatening to sensitive individuals. Therefore, as part of its public health mission to keep food safe, FDA has been focusing increased attention and activity on issues relating to food allergens, especially the proper labeling of products containing such allergens and the control of food allergens in products not intended to contain such allergens.[395]
In the Federal Register notice announcing the Public Meeting, the FDA further identified specific labeling inadequacies that continued to plague food sensitive individuals:
The purpose of the meeting is to stimulate discussion and to obtain information to help FDA determine what additional actions may be necessary to provide consumers with adequate information on product labels. The meeting will focus on: source or plain English labeling; advisory labeling (e.g., “May contain [name of food allergen]”); and labeling of ingredients exempted from declaration (common or usual names of flavorings, spices, and colors; incidental additives).[396]
The FDA stated that it was considering whether to issue regulations closing the disclosure loopholes for flavorings, spices, colors, and additives.[397]
The FDA displayed its continued commitment to improved food allergen control in 2002. In his first public address as the new commissioner of the FDA, Mark McClellan declared that the agency had an “unprecedented opportunity” to do even more than it had in the past by “containing food borne illness and reducing the number of allergens present in foods.”[398]
Then, at the end of 2003, the FDA took a truly tremendous step forward to address food allergen concerns: the agency issued a notice of proposed rulemaking calling for Big Eight allergens to appear on product labels “in plain English terms that clearly identif[y] the presence of these ingredients,” including disclosure of Big Eight allergens contained in spices, flavors, noncertified colors, and incidental additives.[399] The rule was never codified, however, because the FALCPA was passed before the comment period expired.[400]
Consumer activism and advocacy raised public, regulatory, and Congressional awareness of food allergen issues and helped pave the way for the passage of the FALCPA. Years before legislative initiatives were ever considered as a feasible possibility, food sensitive consumers recognized that they had to work actively to promote their safety.
Individual consumer complaints to manufacturers and the FDA about undisclosed allergens in foods led to FDA action in the form of food recalls starting in 1991. By the late 1980s and early 1990s, organizations for food allergic individuals and food sensitivity communities were developing due to the increase in awareness of food sensitivities, diagnosis of food sensitivities, and usage of the Internet. These organizations, such as the Food Allergy and Anaphylaxis Network (FAAN), the Food Allergy Initiative, Peanut Allergy.org, and the American Celiac Task Force (ACTF), as well as general pro-consumer groups such as the Center for Science in the Public Interest (CSPI)[401] and individual activists who created web sites to mobilize food allergic individuals, began to advocate for labeling changes to help food sensitive consumers. As legislative proposals became a political reality around the turn of the century, hundreds if not thousands of individuals made phone calls and sent letters to the offices of their congressional representatives. To a large extent, the FALCPA’s passage is a triumph of the persistence of consumer groups and individual consumers.
i. Pre-FALCPA Grassroots Action
Before legislation was introduced in Congress calling for improved allergen labeling, grassroots advocacy centered on efforts to raise awareness about the needs of people with food allergies. Additionally, various consumers and advocates organized to send several petitions to the FDA calling for improved food labeling.
a. Awareness and Advocacy
Before 1990, the FDA occasionally, but on the whole infrequently, received calls or comments from food sensitive consumers urging improved food labels. By 1990, as the number of people diagnosed with food sensitivities grew and more food sensitive individuals found supportive communities and organizations through city- and internet-based groups, Congress acted to improve nutrition labeling. With the disability rights movement of the 1980s in the background, food allergic consumers became more active with regard to their health. Gradually, people began to call manufacturers for information and to notify the FDA of adverse reactions they experienced from undeclared allergens. The FDA issued its first allergen-related product recalls in 1991 in response to increasingly vocal consumer complaints.
For even many food sensitive individuals, it took time, education, and outreach to enable them to recognize that food labeling laws and practices were inadequate. According to Melissa Taylor, co-founder of Food Allergy Survivors Together and an early advocate for coordinated grassroots activism regarding improved labeling, she found that many people resisted her early advocacy efforts because they did not believe it was legal for manufacturers to not list every ingredient on the food label. On her web site she addresses the negative reactions she received from people who did not believe legal exceptions to full ingredient disclosure existed:
I was once like you, until I got seriously ill from a legally unlabeled ingredient. ... I can tell just from some ‘snubs’ I get that it may seem like those who support labeling changes are ‘out there,’ ‘militant,’ or a little unrealistic. Many of us choose to ignore this problem rather than to face it head-on. If you would rather keep calling a manufacturer for each individual product you buy, then that, to me, is a little more ‘out there’ and unrealistic.[402]
While several consumer advocacy organizations contributed to food allergen-related awareness and activism among people with food sensitivities and the public at large, one organization deserves special mention. The Food Allergy and Anaphylaxis Network (FAAN)[403] has been at the forefront of allergen labeling efforts.[404] Advocacy on behalf of people with food allergies has been part of FAAN’s mission from the outset; it has advocated for improved food labeling since its inception in 1991.[405] Throughout most of the 1990s, aside from FAAN “there was really nothing out there as far as advocating for people with food allergy,” according to Chris Weiss, FAAN’s Director of Legislative and Regulatory Research since 2001. “No one really knew anything about it.”[406]
With a 26,000 member constituency, FAAN has been a powerful advocate for individuals with food allergies.[407] FAAN has sponsored and continues to sponsor research to improve knowledge and raise awareness about food allergies. It notifies its membership when products are recalled due to the presence of undeclared allergens and serves as a clearinghouse of information for its members, the media, and policymakers.[408] FAAN’s members have become more informed and mobilized.[409] The organization has been “meeting with people at FDA and various members of the food industry for years and years,” according to Chris Weiss.[410] FAAN was a member of the Food Allergy Issues Alliance, comprised mostly of food industry trade organizations, and helped contribute to the creation of the Voluntary Guidelines. Anne Muñoz-Furlong was a featured panelist at the 2001 Public Meeting; she and a representative of the CSPI were chosen to represent consumer interests in the Public Meeting’s panels.
b. FDA Petitions
One of the earliest consumer petitions sent to the FDA regarding improved allergen labeling was sent in 1982 by three consumers, a physician, a scientist, and representatives of CSPI, asking the FDA to take action to protect individuals sensitive to sulfites.[411] This petition called for the FDA to amend certain regulations and food standards to prohibit the use of or require warning labels where sulfating agents are used above a particular level per serving. Three years later, the FDA issued a regulation mandating the declaration of sulfites in concentrations of over 10 parts per million in food.
The first[412] organized consumer movement to petition the FDA for more comprehensive allergen labeling began in October 1997 by Food Allergy Survivors Together (FAST),[413] a supportive group and web site for individuals with food sensitivities. This was a truly grassroots, collaborative effort by concerned consumers who wanted to take action regarding the labeling difficulties they were experiencing.[414] Melissa Taylor, co-founder of FAST, and Lucy Shriver, the founder of the Gluten-Free Kitchen[415], worked together to draft and promulgate a petition for individuals to sign and send to the FDA (“FAST Petition”).[416] The FAST Petition called for the FDA to end the spices, flavorings, and colorings exemption completely and require the declaration of all source ingredients contained in those generic terms. Melissa Taylor posted a copy of the petition on the FAST web site which individuals could print, sign, and mail to the FDA, as well as advertised the petition in a magazine about food sensitivities and disseminated copies of the petition by various other means.[417] The FDA assigned the petition a docket number, filed it on its web site in June 1999, and placed correspondence from consumers about allergen labeling in this file.[418] The FDA cited this ground-breaking consumer effort as one of the reasons it was calling for the 2001 Public Meeting.[419]
In addition to attaining the attention of the FDA, these initial advocacy efforts also helped raise awareness within the food allergy community about the specific shortfalls of current labeling laws. Some food allergic individuals at that time believed that the law required disclosure of all food ingredients on the label. Melissa Taylor believes many consumers did not organize earlier in part because they didn’t know the loopholes to ingredient disclosure were sanctioned by law. “Some individuals with food allergies in the family wrote and told me how wrong I was [to assert that allergens could legally go undisclosed],” Melissa Taylor explained. “Without people knowing about the problem, they couldn’t ask for change. They perhaps didn’t realize that foods they thought were safe were in fact making them / their children sick.”[420]
In 2000, nine state Attorneys General petitioned the FDA to improve allergen labeling. Their petition (“Attorneys General Petition”)[421] detailed the problems that food sensitive individuals encounter due to labeling inadequacies, asserted and explained the FDA’s legal authority to regulate in this area, and requested several specific forms of relief:
Unlike the FAST Petition, the Attorneys General Petition focused only on the eight major allergens.
After receiving the Attorneys General Petition, the FDA assigned it a docket number[422] and collapsed the FAST Petition and accompanying file documents into the new Attorneys General Petition file.[423] Several consumer groups spoke out in support of the petition.[424] The Attorneys General Petition was a starting point for the discussion of food allergen labeling at the 2001 Public Meeting.[425] Catherine Tretheway, an attorney who assisted the New York Attorney General in preparing the petition and who is the parent of a child with a peanut allergy, explained the petition’s background at the Public Meeting:
I asked to speak today because I think it is important that the FDA know the source of this petition. This is truly a document prepared by consumers for consumers. In drafting the petition, I not only drew from my own experiences as the parent of a food allergic child, but also from the experiences of the many parents with whom I have talked or corresponded with during the recent years that I have started my work on food allergy issues. ... The petition is not a wish list for food allergic consumers. Rather, it represents what consumers truly need to protect themselves and their loved ones from unintended consumption of food allergens. ... As the parent of a food allergic child, I appreciate the efforts of the Food Allergy Issues Alliance in issuing [voluntary industry] guidelines for better good manufacturing practices and labeling. However, even after all our discussion today, I can only conclude that consistency in labeling can only be achieved through regulatory reform.[426]
The final major[427] petition to the FDA for improved allergen labeling was sent by CSPI in 2001. The CSPI petition called for the printing of ingredients in a way more consistent with the nutrition labeling: printing of ingredients in larger type using upper and lower case letters, the separation of major and minor ingredients, and, importantly, a clear presentation of allergy information in a separate section in a standardized fashion to alert sensitive consumers of allergens.[428] While it echoed many of the sentiments of the Attorneys General Petition, the CSPI petition opposed the use of an insignia out of concern that it “will overshadow other important nutritional and health information on the food label.”
ii. Grassroots Impact on the FALCPA
Consumers were involved in the passage of the FALCPA in several instrumental ways. Because many groups and individuals had different interests (such as food allergy groups versus celiac disease groups, or groups representing individuals with Big Eight allergens versus groups of individuals concerned about a wider range of allergens), their efforts were not completely united or coordinated under one front.[429]
Several consumer groups, including the Food Allergy Initiative, FAAN, and the ACTF, had the ear of the FALCPA’s Congressional sponsors. They gave some input into the draft legislation and provided talking points regarding problems faced by food sensitive individuals.[430] These groups also helped generate support among members of Congress for the bill by “put[ting] a human face on this problem.”[431]
Most of the groups involved in advocating for the FALCPA were food allergy groups. The American Celiac Task Force,[432] in contrast, represented individuals with celiac disease, and acted as the voice of the celiac community during the push to pass the FALCPA.[433] Advocacy by ACTF was a direct result of scientific advances and illustrates the interplay between research and consumer activism. ACTF was formed in 2003 after the celiac disease prevalence study results were released by the University of Maryland Center for Celiac Research.[434] This study “opened the doors for people paying much more attention” to celiac disease, according to ACTF Co-chair Andrea Levario.[435] “Dr. Fasano [who spear-headed the research] knew that more and more people were now going to be diagnosed. The next major hurdle was going to be how are you going to feed these people? ... You couldn’t read a food label and know what you’re eating is safe.” ACTF is composed of leaders of national celiac disease support groups, medical professionals, research institutions, and representatives of gluten-free food manufacturers. According to Andrea Levario, these groups came together as a coalition because of the recognition of a need for a “cohesive front.”
Although the interest of the consumer groups did not always align, the ACTF benefited from the strength and influence of the allergy groups. “The major push for this legislation came from the allergen community,” Andrea Levario says, because the number of people affected by food allergies is large and the adverse reactions associated with food allergies can be dramatically sudden and life-threatening.[436] The food allergy community pushed for disclosure of even extremely trace amounts of allergens. ACTF resisted such an approach in the context of defining a standard for “gluten-free”; zero tolerance is not possible or desirable for gluten, according to Levario.[437] ACTF worked closely with the Food Allergy Initiative in its advocacy efforts. Representatives of the Center for Celiac Research and the ACTF appeared on the Today Show to spread the word about the FALCPA.[438] Through Rep. Lowey, ACTF arranged to have individuals with celiac disease testify in May 2004 before the House Appropriations Subcommittee on Labor, HHS, and Education. This was the first time people with celiac disease had testified before a Congressional committee about the disease and the need for improved research, education of the medical community, and food labeling.[439] Andrea Levario credits these efforts with getting “the issue out in front” of the public and members of Congress.
“This was a true grassroots effort,” Levario says. Within the span of 18 months, ACTF was created, it mounted a lobbying effort, and it witnessed the successful passage of the FALCPA. ACTF “has no money. This was all done strictly via word of mouth, via the internet, via email. ... We were a voice in all this, and it was strictly, totally grassroots, every step of the way, which is pretty phenomenal.”[440]
FAAN’s legislative advocacy work was also influential. FAAN worked with Rep. Lowey and lobbied Congress for passage of allergen labeling legislation – even though it had consulted with the food industry in the creation of the Voluntary Guidelines – because with the Voluntary Guidelines, “no matter how you slice them, they’re still voluntary.”[441] FAAN adopted a multifaceted approach with regard to advocating for the passage of allergen labeling legislation. The organization worked with other food allergy consumer groups; met with staff members of “key players” on the Hill, supplied them with information, and showed them examples of confusing food labels; met with FDA officials and members of the food industry; and, through its web site and mass mailings, asked its members to contact their representatives in support of the legislation. FAAN found “pretty widespread response” among FAAN members to its call to action.[442]
In addition to the efforts of organizations, food sensitive individuals across the country were mobilized via the Internet. Several web sites[443] diligently tracked action regarding each proposed bill, organized information about each state’s Congressional representatives and their positions regarding the proposed legislation, and encouraged people to contact their members of Congress.
Some individuals organized writing campaigns to Congress. For instance, two parents of peanut-allergic children “launched a postcard campaign to educate members of Congress about the FALCPA” and “printed over 3000 postcards for various parents, with photos of their food allergic children on one side and information about the bill on the other” that people could send to their members of Congress.[444] After the passage of the FALCPA, they formed an organization to continue the grassroots momentum generated by the food sensitivity community’s mobilization in support of the FALCPA.[445]
In 1990, the food industry was largely uneducated about allergen concerns. It lacked awareness of the dangers posed by allergens and the industry’s failure to adequately deal with allergens, and the industry resisted change.[446] Thus, the initial food industry response to concerns about food sensitivities “was chaotic and confused because of a lack of knowledge and training.”[447] Over the next fifteen years, the food industry’s awareness of and response to problems faced by food sensitive individuals changed enormously.
i. Industry Efforts to Help Food Sensitive Consumers
During the 1990s, with growing consumer complaints about undisclosed allergens, rising FDA-initiated product recalls due to undisclosed allergens, FDA’s issuance of the 1996 Notice letter, and the specter of products liability or misbranding lawsuits,[448] regulation, and legislation on the issue,[449] the food industry began to take more coordinated and comprehensive actions to regulate itself in an effort to help its customers and to stave off regulatory or legislative action.[450] Various manufacturers and food industry organizations took numerous instrumental steps to improve allergen control management and allergen declaration. Ultimately, however, the food industry’s efforts to avoid government action proved to be too little, too late.
Promptly after the Notice Letter was issued, the Food Processors Institute held a conference for the food industry on food allergen labeling.[451] As buzz regarding food allergens persisted, a growing number of manufacturers instituted employee and management training regarding allergens. Consultant companies emerged to help food manufacturers develop allergen management programs.[452] Food industry groups began sponsoring conferences, workshops, and training programs on allergen control.[453]
One incident that illustrates the changing mood toward allergens in the food industry toward the end of the century was the industry response to the discovery in 1997 of undeclared sulfites in batches of canned tuna. The National Food Processors Association (NFPA)[454] and the U.S. Tuna Foundation promptly notified the FDA and worked to stop shipments of these products, to relabel them to disclose sulfites, and to establish a toll-free hotline consumers could call to determine whether specific tuna products contained sulfites.[455]
A major coalition of food industry representatives known as the Food Allergy Issues Alliance (“the Alliance”), with input from the consumer group FAAN and an allergen expert, formed after the issuance of the Notice Letter to discuss the industry’s response to food allergen-related concerns and to help the food industry “be proactively out front of and address this allergy issue.”[456] The Alliance met periodically with the FDA to update the agency about progress being made in the food industry:
Importantly, FDA recognizes the efforts of the food industry in addressing the presence of food allergens. For example, major industry representatives are supporting CFSAN priorities and have signaled development of a voluntary allergen labeling program. Industry’s senior management has made a commitment to managing allergens by training employees on allergens and plant-specific control procedures, evaluating rework procedures, working with ingredient suppliers to identify and label all allergenic ingredients in their products, requiring documentation of equipment cleaning, and sharing best allergen practices with other corporations.[457]
Following the publication of voluntary Allergen Usage Guidelines directed at bakeries by the American Bakers Association, in 2001, five years after the FDA issued its Notice Letter regarding allergen labeling, the Alliance issued Food Allergen Labeling Guidelines intended to encompass the entire food industry (“Voluntary Guidelines”).
The Voluntary Guidelines recognized the fact that, although manufacturers currently label ingredients in accordance with existing regulatory requirements, “consistency in labeling of food allergens could further address the needs of food allergic consumers.”[458] The Alliance assured the FDA that “the guidelines would address food allergen issues their member companies would be implementing soon without requiring FDA to amend or issue regulations.”[459] Additionally, that same year, the NFPA issued a Code of Practice describing voluntary good manufacturing practices and improved sanitation practices to address cross-contact.[460]
The Voluntary Guidelines called for the plain English identification (in any of four label formats) of the eight major allergens when present in ingredients purposefully added to food products, regardless of whether an exemption to the declaration of the allergen was provided under the law (because the allergen was in a spice, flavoring, coloring, or incidental additive). The Voluntary Guidelines also stated that precautionary labeling should be employed “judiciously,” and proscribed the circumstances under which food manufacturers should use such labeling.[461] Industry officials asserted that the Voluntary Guidelines were “sufficiently flexible to suit various situations” and argued that a mandatory approach to allergen labeling would “necessitate FDA revising a number of rules for standards of identity and other labeling rules,” which would “complicate a labeling approach that can be done, and it is now being done on a voluntary basis.”[462]
The shortfalls of the Voluntary Guidelines were several and substantial. The principal drawback was that the Guidelines were purely voluntary, rendering any benefits of the Guidelines subject to the extent to which manufacturers across the nation, large and small, prioritized compliance. By allowing four different formats in which allergens could be declared on the label, the Guidelines provided for less clear and consistent labeling than the scheme later proposed by the FALCPA. And although the Voluntary Guidelines went further than the FALCPA in limiting the circumstances under which manufacturers could employ advisory labeling, the Guidelines did not ask companies to test for allergenic ingredients (visual inspection was sufficient to deem a product not cross-contaminated). The limits of the Voluntary Guidelines were extensively discussed at the 2001 Public Meeting, during which the CSPI argued, “the time has long past for all this total voluntary flexible action on the part of industry.”[463]
The FDA’s response to the Voluntary Guidelines was positive, yet cautious – the agency reserved the possibility that further, mandatory requirements for the food industry might be necessary. The FDA heralded the Voluntary Guidelines a “significant step forward” in addressing the identification of the eight most common food allergens:
The Alliance’s plan complements FDA’s food allergen guidance and will help food processors diligently inform food allergic consumers about the presence of the eight major allergens in their products. This will be a major health benefit to the food allergy sensitive consumer. In addition, this guideline announcement is significant because it signals that industry recognizes the importance of food allergen control procedures. ... Your effort signals an appropriate and needed industry concern for the food allergy sensitive person. I encourage the Alliance to move forward swiftly to implement these important guidelines.[464]
The FDA also stated that the Voluntary Guidelines “la[y] the groundwork for addressing additional food allergen issues in the future.”[465] In the 2001 Public Meeting, the FDA used the Voluntary Guidelines as its “starting point” for discussion regarding allergen labeling.[466] The FDA characterized the agency and food manufacturers as “working together” to “increase public awareness of the seriousness of food allergen reactions and to ensure that allergens are appropriately labeled in food products.”[467]
Some food firms and industry groups moved swiftly to implement the Voluntary Guidelines. The International Dairy Foods Association in 2002 created a guidance document explaining how dairy plants could establish food allergen awareness programs.[468] Many food manufacturers attended workshops sponsored by the FDA to facilitate allergen awareness and the sharing of best practices in the industry.[469]
ii. Industry Response to, and Influence on, the FALCPA
The food industry was the primary[470] source of opposition to the FALCPA. According to Amie Rappoport, administrative director of the Food Allergy Initiative, there was “immense opposition from the food industry” to the FALCPA. “Their concerns, of course, were more regulation.”[471] The food industry primarily cited the following three arguments in opposition to proposed allergen labeling legislation: legislation would be costly as it would require manufacturers to update labels and implement allergen control programs (and on a government-imposed time frame); the Voluntary Guidelines were sufficient to meet the needs of food sensitive individuals; and the FDA had issued policy statements that already adequately closed labeling loopholes and instituted requirements to reduce cross-contact.
First, the food industry asserted that the costs of mandatory requirements would cause economic harm to manufacturers, and in particular, small businesses. NFPA stated that legislation “would impose undue economic hardship on the food industry.”[472] The International Dairy Foods Association characterized proposed legislation as “unnecessary and burdensome.”[473] A sample letter in opposition to S. 2499 that International Dairy Foods Association provided to member manufacturers on its web site emphasized the costs of mandatory regulations:
S. 2499 would require unnecessarily broad and sweeping new labeling requirements for virtually the entire food supply, imposing massive, unjustified costs on manufacturers, and siphoning resources from important priorities. Labels would have to be changed and discarded, costing food processors millions of dollars.... Lastly, S. 2499 would establish civil money penalties for misbranding violations. This provision would be most burdensome to small food companies. Resources are better spent identifying and correcting problems, not paying fines....[474]
Second, the food industry asserted that voluntary cooperation by manufacturers was sufficient. At the 2001 Public Meeting, large trade groups – the National Food Processors Association (NFPA), the Grocery Manufacturers of America (GMA), the Flavor and Extract Manufacturers Association, the American Spice Trade Association, and the International Association of Color Manufacturers – made their position known that they supported the Food Allergy Alliance Voluntary Guidelines and opposed mandatory, external regulation in the allergen area.[475] Industry officials defended that the Voluntary Guidelines were sufficient because manufacturers had a financial and public relations incentive to attract food sensitive consumers through improved labeling, and that “once a few companies start catering to those customers by providing more detailed accounts of their products, others may have to follow suit or risk developing a reputation for being unconcerned, or even misleading.”[476] The Alliance hoped that the marketplace and a desire to protect consumers would thus drive manufacturers to follow the Voluntary Guidelines.[477] At the Public Meeting, officials of the GMA, the world’s largest association of food, beverage and consumer producers, “fully expect[ed] widespread adoption and implementation” of the Voluntary Guidelines among its members.[478] NFPA and GMA asserted that education and outreach efforts by trade groups, coupled with enforcement actions by the FDA, would convince manufacturers to follow the guidelines.[479] In 2003, the GMA reported in an editorial published in the New York Times that a GMA survey found that 80% of food firms had taken steps to begin complying with the Voluntary Guidelines.[480] The food industry argued that voluntary industry compliance was, moreover, better for people with food sensitivities since it was already underway whereas FDA rulemaking would necessitate considerable delays in the implementation of allergen labeling.[481]
Third, industry groups maintained that legislative or regulatory action was unnecessary because the FDA already had authority pursuant to the FFD&CA and its 1996 Notice Letter to take enforcement actions against undeclared allergens and the FDA had already closed the spices, flavorings, colorings, and food additives loopholes in the Notice Letter. In response to an announcement by Rep. Nita Lowey that she would introduce legislation on the labeling of allergens in food products in 2001, Dr. Rhona Applebaum, Executive Vice President of Scientific and Regulatory Affairs for NFPA iterated NFPA’s position that new legislation was unnecessary:
The food industry takes the issue of food allergens very seriously. Food companies have taken the lead in developing manufacturing practices to help avoid the inclusion of any unlabeled allergens in food products, as well as in ensuring the accuracy of food labeling when it comes to the presence of allergens in food products. While Congressional interest in the important topics of food safety and food allergens is understandable, we believe that legislation is not necessary. Existing regulations clearly require that all ingredients be listed on food labels in order to protect consumers with food allergies, and FDA has ample authority to enforce those regulations.[482]
In a letter to Congress in opposition to S. 2499, an earlier version of the FALCPA, the American Bakers Association asserted:
The bill claims to close loopholes regarding the disclosure of food allergens. No such loopholes exist. Federal food law and regulation already clearly mandate food allergens and all food ingredients be disclosed. Contrary to assertions in S. 2499, an allergen is not eligible for an exemption from disclosure (whether in flavorings, colorings or spices) when necessary to protect consumers. The bill purports to be needed to require manufacturers to use the common name of allergens on ingredient labels. However, FDA has already made clear in regulations that food must be identified in terms that are readily understood. ... FDA already has ample enforcement authority including detention, seizure, injunction, and criminal penalties. S. 2499 would also require the FDA to develop Good Manufacturing Practices (GMP) requirements for food allergens. This provision is redundant. FDA already has GMP regulations and has recently issued a Compliance Policy Guide on allergen labeling and management.[483]
Thus, at first the food industry opposed legislative action outright, asserting that the Voluntary Guidelines and the FDA’s current policies effectively dealt with allergenicity problems. However, this position of the food industry was short-lived. As the FDA and Congress became more active in pressing for the codification of allergen labeling rules and these efforts gained momentum, the food industry gradually recognized the need to become a part of the creation of these new standards.
The food industry, therefore, worked closely with Congress in 2003 and 2004 to develop the final version of the FALCPA. A legislative assistant in Representative Lowey’s office explains that, “From the beginning the food industry had concerns with the legislation. But Congresswoman Lowey worked with her colleagues for years to take the food industry’s concerns into consideration.”[484] One key compromise involved setting the effective date for labeling changes to coincide with the new trans-fat regulations, thereby reducing the cost to the food industry since firms only need to change labels once. The food industry additionally worked to retain some flexibility in the format of allergen disclosure. The FALCPA ultimately gave industry the choice between two formatting options that had been endorsed in the Voluntary Guidelines and were the “most popular with both consumers and the food industry.” The FALCPA thus did not “penalize those [manufacturers] that have been good players by voluntarily providing information” under the Voluntary Guidelines.[485] Other compromises that the food industry worked with Congress to achieve include:
The food industry played a significant role in shaping the FALCPA’s provisions. The Voluntary Guidelines were the starting point of the FDA’s discussion regarding allergens at the Public Meeting, and the food industry had a large role at the Congressional drafting table. Although the food industry may not have obtained everything it wanted with regard to the FALCPA (the biggest drawbacks to industry were that the bill’s requirements are mandatory and lack the flexibility of the Voluntary Guidelines with regard to labeling format), the industry and the Voluntary Guidelines were, nevertheless, quite influential in shaping how the FDA and Congress approached the food labeling issue. By 2004, the NFPA and other food industry groups “urged” and subsequently “applauded” passage of the FALCPA.[487]
iii. The FALCPA’s Costs and Benefits to the Food Industry
The cost of the FALCPA to the food industry (costs associated with updating and printing new ingredient labels) is estimated to be not more than $75 million.[488] In comparison, the regulations implementing the NLEA were estimated to cost industry a total of $1.5 billion.[489] Congress intended that the January 1, 2006, compliance deadline (timed to coincide with new trans-fats labeling requirements) would help to minimize industry costs and disruption. The date allows manufacturers time to incorporate the changes during planned label revisions and use current label inventories in the meanwhile.[490] Committee Reports noted that many food labels already conform to the requirements of FALCPA so not all products will need new labels.[491] Moreover, although some manufacturers worried that allergen labeling might unintentionally deter non-food sensitive consumers from purchasing products, the FDA rejected such an argument in the context of issuing regulations requiring mandatory declaration of sulfites on packages, stating that concerns about overreaction from consumers were unwarranted.[492]
Despite the initial costs associated with updating food labels, in several ways food manufacturers will likely benefit from the FALCPA. As food industry consultant for food allergen management, the Food Allergy Research & Resource Program, notes, “The presence of unlabeled allergens in food products can lead to serious health, legal and financial complications.”[493] The industry will profit from good labeling practices that please consumers and demonstrate professional responsibility. As a food retailer trade publication points out, increased public awareness of food sensitivities “translates to a unique brand-building opportunity for many products, and a relationship-building one for those food retailers that take proactive positions” by promptly removing allergen-related recalled products from shelves, ensuring proper labeling of foods, and making more information available to shoppers.[494] The FALCPA’s clear requirements enable manufacturers to budget for predictable compliance costs. Manufacturers will less frequently be subject to allergen-related product recalls, thereby enabling manufacturers to avoid the financial burden of a recall itself – which can cost from $10,000 to $7 million[495] – and accompanying expenses such as harm to their product brand and company names. Additionally, liability claims from consumers who experience adverse reactions to hidden allergens has been a worry in the food industry for several years,[496] and the FALCPA helps reduce such risk by allowing consumers to make more informed decisions and giving consumers notice of allergens in products.[497]
Food product sales may increase as food sensitive consumers learn to trust food labels and discover more foods that are safe for consumption. As food allergy experts noted at the 1995 conference on food allergen labeling sponsored by the Food and Agriculture Organization (FAO) of the United Nations, “if the alternative [to allergen labeling] is that increasing numbers of consumers avoid prepackaged foods in order to eliminate any uncertainty as to what ingredients are actually present in the food, the cost of not changing may be even higher.”[498] Often family members of food sensitive individuals avoid buying foods containing offending proteins to simplify shopping, to prevent accidents while cooking, to keep food containing allergens out of the reach of children, and to provide moral support to the allergy sufferer. Thus, by clearly labeling packaged food products, manufacturers are broadening their market to include not only food sensitive individuals, but many others as well.[499]
Several food manufacturers have seized on the allergen-free foods niche market – a market that, unlike other specialty foods, is not a transitory “fad,” but rather, encompasses a customer base that will endure so long as avoidance is the only treatment for food sensitivities. Recent years have witnessed a growing market for gluten-free foods[500] as well as other allergen-free foods, allowing food sensitive consumers to consume in safety some of their favorite foods.
Due to the FALCPA and increasing numbers of food sensitive individuals, sales of allergen-free specialty products rose roughly 17% in 2004 alone.[501] The market for food products targeted for consumers with food sensitivities and intolerances is expected to reach $ 3.9 billion by 2008.[502]
Moreover, as the general public is increasingly nutrition and health conscious and as allergen-free products become more appealing and mainstream, allergen-free products may grow more attractive to non-food sensitive populations. According to Packaged Facts, a publication of research reports on a range of consumer industries, “allergen-free foods are also beginning to experience a crossover of interest with more general wellness and diet trends, especially in the dairy alternatives and baked goods, pasta, and wheat categories.”[503]
In addition, with the increasing awareness of food sensitivities, allergen control is itself becoming a big business – a veritable allergen control industry has developed. Several companies and organizations have developed allergen control consulting capabilities or specialties in recent years to meet a growing demand on the part of food firms to better manage allergens.[504] Computer software programs to track and manage product formulations and allergens have been created and marketed.[505] Assays to detect allergenic protein residues have and are continuing to be developed and commercialized for sale as test kits.[506] Companies that sell commercial allergen test kits reported marked growth in 2004, with one company noting an increase in test kit sales of 33% in the first nine months of 2004 in anticipation of legislative action on allergen labeling.[507]
Around the end of the century, as FDA, industry, and public attention to food allergen-related problems improved, so did Congressional awareness. Legislative efforts to improve allergen labeling spanned six years and three Congresses. The FALCPA’s passage was the result of truly bipartisan, bicameral efforts.
In the House of Representatives, allergen labeling advocacy was spearheaded by Rep. Nita M. Lowey of New York. Despite years of having bills she introduced never leave the committee phase of the lawmaking process, Rep. Lowey persisted in championing improved food allergen labeling. She was later joined by Senator Ted Kennedy of Massachusetts who, along with Sen. Judd Gregg of New Hampshire, led allergen labeling initiatives in the Senate.[508] Sen. Kennedy introduced sister bills to those introduced in the House and helped work out a compromise amendment that was critical to the enactment of the FALCPA.
i. Impetus for Legislative Action
Why at the turn of the century was legislative activity pursued to address food allergen issues? Only a few years earlier the FDA had issued the Notice Letter and had begun in earnest to make improved allergen disclosure and management a priority. The FDA reinforced this new-found prioritization with manufacturer inspections for undeclared allergens, product recalls, and the threat of enforcement action for violation of the FDA’s policy guidance regarding allergens. Furthermore, major players in the food industry had vowed to reform themselves – by 2001, many manufacturers had begun to implement the Alliance’s Voluntary Guidelines and expressed their commitment to educating smaller manufacturers about allergens to encourage full industry-wide compliance.
Why then, after over 60 years of inaction regarding allergens, and just as serious action was being taken on the regulatory front and by the private sector, did Congress feel the need to step in and amend the FFD&CA to address food allergens?
The answer to this question appears to be that the same forces at work driving the FDA and the food industry to seek reform – a larger and more vocal food sensitive consumer population, heightened public awareness of food sensitivities, and improved information regarding the dangers and prevalence of confusing and incomplete labeling – were also at work on the Hill, lending support for legislative action to improve allergen labeling.
For instance, Rep. Constance Morella of Maryland, who introduced a resolution in the House regarding allergen labeling in 1999 – the first proposed legislative action to improve allergen labeling – cited as an impetus for the resolution the fact that she had “a number of constituents” who have experienced life-threatening reactions to food because insufficient protections were in place to ensure their safety, “and I am sure that all of my colleagues will find the same in their districts.”[509] As she explained on the floor of the House, “[m]any children [with food allergies] spend their day at school in fear, afraid to touch a door knob or a desk top that might have a smear of peanut butter. While it would be difficult to control the school or the work environment, there are steps that can be taken to protect children and adults from severe allergic reaction to food.”[510]
Rep. Nita Lowey similarly cited as her motivation for promoting improved labeling the fact that several constituents told her that they or their children “had food allergies and had a hard time avoiding foods that could cause reactions because of unclear or inexact labeling.” It seemed to Rep. Lowey that “we could easily create a common sense solution by merely requiring that everyday terms for the eight major allergens are also used on labels .”[511] Rep. Lowey was also influenced by her work on the Agriculture Appropriations Subcommittee where she “took a great interest” in food safety issues.[512]
Rep. Bill Shuster of Pennsylvania, who urged his colleagues to support the FALCPA, stated on the floor of the House that he learned of the frustrations of food sensitivities when a member of his staff was diagnosed with celiac disease:
I have had the unfortunate experience to learn more about the trials and tribulations of food allergen sufferers when one of the members of my staff, Christy Farmer, was diagnosed with Celiac Disease earlier this year. ... Having a food allergy, especially to something that is found in so many different foods, can add a level of complication to a person's life that can be difficult to imagine. Christy was required to undergo a total lifestyle change due to her gluten sensitivity. Spontaneously stopping at a restaurant for dinner is no longer possible, traveling not knowing in advance what foods will be available is no longer an option, and giving up your favorite foods is not as easy as it sounds. I am pleased that this legislation will help ease some of the frustrations and make adhering to an allergy-free diet a little easier for the millions of Americans that suffer from food allergies.[513]
Legislation afforded an opportunity to make significant improvements over FDA and private industry action. Legislation gave teeth to the FDA’s current allergen policies which were not codified and rarely enforced,[514] it could be enacted faster than the slow process of FDA rulemaking, and it allowed for the inclusion of provisions calling for action outside the scope of the FDA’s authority (such as provisions to promote allergen-related research and data collection and the requirement that major allergens in spices, flavorings, and colors be disclosed). Jean Doyle, a Legislative Assistant in Rep. Lowey’s office, noted these benefits of Congressional, as opposed to FDA, action: “while the FDA has the authority to accomplish certain portions of the bill, on their limited budget and reduced staff, it would have been difficult for them to complete a rule-making on such a vital issue in a timely fashion,” and “FDA would not have had the authority to close the flavoring loophole - an important element to the success of this new manner of labeling.”[515] Importantly, legislation could also provide the FDA with resources to enforce the new law.
Legislation was substantially superior to voluntary private action by mandating consistency and uniformity among all manufacturers and food products. Legislation also had the power to hold the food industry accountable, giving consumers recourse if they discover inaccurate labels. Merely voluntary compliance with allergen labeling undercuts the purpose of labeling altogether by thwarting consumer confidence in products and requiring the consumer to continue to research food products manufacturer-by-manufacturer and brand-by-brand.
FAAN co-founder and CEO Anne Muñoz-Furlong observed a year after the Alliance issued the voluntary Guidelines that FAAN was “surprised and disappointed that not all of the food industry has embraced” the Guidelines, with small and mid-sized manufacturers, in particular, resisting compliance unless Congress requires it.[516] And even if 80 percent of the food industry was prepared to comply with the Voluntary Guidelines, as GMA asserted in a letter to the New York Times in 2003,[517] Rep. Lowey contended “[i]t’s just not enough to completely and accurately label some of the food some of the time.”[518] Rep. Lowey believed that voluntary compliance, while a “good start,” was nevertheless dangerously insufficient: “with so many children suffering from food allergies, the Federal Government is obligated to respond.”[519] A web site that facilitated grassroots organizing in support of allergen labeling legislation contends similarly that mandatory compliance was necessary to ensure consumer confidence in labels:
So-called ‘voluntary’ compliance is useless, since a single exception can cause a fatality. It’s impossible to know which companies have adopted voluntary labeling and have safe foods, and which have not and have improperly labeled foods. Only if 100% of all food labels can be trusted, can any food labels be trusted. The flip side of the coin is ‘may contain’ labeling, used as an ‘out’ to relieve manufacturers of the burden of proper labeling, while protecting them from litigation. Such labeling either places all such foods off limits to those with food allergies (some large manufacturers label virtually all of their foods with this catch-all phrase) or leads to a reverse false sense of security that even if foods are so marked, they are probably safe anyway. ... Only federal legislation can begin to generate the confidence needed for food allergy sufferers to truly feel safe.[520]
ii. An Overview of Proposed Allergen Labeling Legislation
Legislative efforts to improve allergen labeling, unprecedented before 1999, went through several iterations and adaptations over the course of six years until the FALCPA was eventually passed. During that time, legislative initiatives were frequently stymied, and numerous bills died in committee. As one publication noted in 2004, the FALCPA, which had been “lingering in ‘provision purgatory’ ... finally did see the light of day.”[521] After “much hard work and incredible efforts”[522] to reach compromises, language was drafted with which the food industry, Republicans, and Democrats could all finally agree.
By the time the FALCPA was voted on in 2004, the legislation had received broad co-sponsorship and wide, bipartisan support.[523] The FALCPA unanimously passed the Senate, and passed in the House by such a large margin that only a voice vote was needed, indicating at least a two-thirds majority in favor of the bill.[524] Thus, remarkably, over the course of just a few years, the concept of requiring the identification of food allergens on product labels transformed from being radical to virtually non-controversial. In the words of Rep. Lowey: “There is no doubt that this bill becoming law is cause for celebration. It isn’t often that we achieve true bipartisan, bicameral victories on Capitol Hill these days.”[525]
The first Congressional action with regard to food allergen labeling occurred in 1999, when Rep. Morella introduced a resolution into the House designed to “increase awareness of the serious impact of severe food allergies on the American people and the need to address this very important health problem.”[526] The resolution called for manufacturers to do the following:
In support of its requests, the resolution cited statistics that were later incorporated into the final version of the FALCPA regarding how eight major allergens are responsible for 90 percent of allergic reactions (gluten is not mentioned), the number of fatalities associated with anaphylaxis and numbers of people with food allergies (lower numbers than those cited in the FALCPA), and the fact that avoidance is the only treatment of allergies. “Previous threats to the public safety and confidence as a result of product tampering and poisonings have already set a precedent for undertaking improvements in manufacturing processes to better protect the American public from similarly grave and preventable risk, and at acceptable cost,” the resolution asserted.[528]
The resolution enjoyed the support of eight cosponsors, including Rep. Lowey. No action was taken on the resolution after it was sent to the Subcommittee on Health and Environment of the House Committee on Commerce.
One year after the resolution had been introduced, in October 2000, Rep. Lowey introduced a short bill entitled the Food Allergen Consumer Protection Act. This bill sought to amend the FFD&CA to require the labeling of “known allergens” (i.e. Big Eight allergens) on food labels, including known allergens in spices, flavorings, and colors.[529] It gave manufacturers six months to implement the Act’s requirements. While the proposed legislation contained no provisions regarding the formatting for allergen disclosure, cross-contact management, the labeling of gluten or establishing a standard for “gluten-free,” or support for research regarding food sensitivities, the bill did, nevertheless, establish a tactic subsequently adopted in future allergen labeling bills: it approached the problem of allergens by amending the FFD&CA’s misbranding provisions. This bill received no cosponsors and died in committee.
In the next Congressional session, Rep. Lowey along with four cosponsors introduced another brief allergen labeling bill, entitled the Food Ingredient Right to Know Act.[530] As the title of the bill implies, the scope of disclosure extended beyond allergens, Big Eight or otherwise. The proposed legislation was designed to help all Americans who have specialty diets, whether due to religious, cultural, ethical, health, or other reasons. As such, this bill amended the FFD&CA to demand ingredient disclosure of constituents in spices, flavorings, colors, and additives derived from animal products in addition to major allergens.[531] The bill was thus confined to closing the spice, flavorings, and coloring loophole of the FFD&CA. It never left committee.
Indicative of growing legislative momentum, in 2002 the House passed agriculture appropriations bills that included language asking the FDA to act on the Attorneys General Petition for allergen labeling.[532] Then significantly, during the spring of 2002, one year after the Alliance had announced and begun promoting its Voluntary Guidelines, bills entitled the Food Allergen Labeling Consumer Protection Act[533] were introduced in the House and Senate by Rep. Lowey and Sen. Kennedy, respectively. This was the product of a strategy to coordinate efforts “on both sides of the Hill” by creating a bill suitable for both chambers.[534] In the House, the legislation gained 28 cosponsors.
S. 2499 became “stymied” in the Senate Health, Education, Labor and Pensions (HELP) Committee, which Sen. Kennedy chaired, as “key Republicans” on the committee “sided with the food industry, which generally opposes any labeling changes.”[535] Thus, about four months after Sen. Kennedy introduced S. 2499, he “offered a substitute amendment as modified that was considered as original text by the committee” in an executive session.[536] In October 2002, the committee by unanimous vote favorably reported the amended S. 2499.
The amended S. 2499, “in a bid to appease Senate GOP concerns,”[537] made several compromises with the food industry. In addition to pushing back the date for compliance and introducing two formatting options for the labeling of allergens, the amended bill eliminated the following: disclosure requirements for gluten, the requirement that allergens appear in bold font on the label, a provision calling for manufacturers to print phone numbers on labels, a provision requiring the use of GMPs to minimize cross-contamination, specifications for when advisory labeling can permissibly be employed, recordkeeping and inspection requirements, and monetary fines for noncompliance.[538]
This compromise was crucial to the FALCPA’s passage. The compromise language remained largely intact in later proposed bills, essentially serving as the basis of S. 741, the final version of the FALCPA.
Even though Congress adjourned before the amended S. 2499 could be considered by the full Senate, the committee’s dedication of resources to issue a favorable report of the bill, as well as the fact that both bills obtained a significant number of cosponsors (more cosponsors than any prior version), indicated that the issue could likely find favor again when reintroduced in the 108th Congress.[539]
In November 2003, in a very promising move for food allergen legislation, the same allergen labeling text as that contained in the amended S. 2499 was, at Sen. Judd Gregg’s initiative, attached as an amendment (“Title II”) to an animal health bill, S. 741, which was already under consideration in the Senate HELP Committee. The committee favorably reported the combined legislation. Getting the FALCPA attached to the non-controversial Minor Use and Minor Animal Species Animal Health Act (MUMS) provided a vehicle for the FALCPA to be fast-tracked to the Senate floor for a vote after years of delay. The combining of the FALCPA and MUMS was intended to be a “coalition that could make something during a difficult Congress actually pass.”[540]
Rep. Lowey subsequently introduced in the House in December 2003 as a stand-alone bill H.R. 3684,[541] The Food Allergen Consumer Protection Act of 2003, to initiate House consideration in concert with Senate action. Both of these legislative initiatives enjoyed broad-based, bipartisan support, with H.R. 3684 ultimately garnering 57 cosponsors, and the combined legislation, S. 741, having 4 sponsors and 21 cosponsors. [542]
In the second session of the 108th Congress, action regarding S. 741 moved swiftly. S. 741 was reported out of the Senate HELP Committee on February 18, 2004, and passed unanimously in the Senate on March 8. Meanwhile in the House, H.R. 3684 had been approved by the Subcommittee on Health when S. 741 passed the Senate. House Congressional sponsors decided for purposes of expediency to accept the Senate version, rather than facing more negotiation with the Senate if the House were to pass a different bill. Following receipt in the House, S. 741 was referred to the House Energy and Commerce Subcommittee on Health on June 14, was marked up the following day, and was reported out of committee on July 15. Five days later the House passed S. 741 by a two-thirds majority voice vote. The legislation was presented to President Bush on July 23 and was signed into law on August 2.
After many years of hard work by policymakers, consumer advocates, and the food industry, in 2004 improved allergen labeling became a reality. Consumer groups,[543] the FDA, [544] members of Congress,[545] and several industry trade organizations[546] praised the passage of the FALCPA.
Chris Weiss, Director of Legislative and Regulatory Research of FAAN, described the coming together of these various forces and interests in this way: “Over the course of a couple years through meetings and exchanges all of the parties eventually found the same page, and that was the [FALCPA]. ... All the efforts just paid off. All the cosmic tumblers clicked into place.”[547]
On the day of the vote on S. 741 in the House, Rep. Lowey thanked many colleagues for their support of the FALCPA: “We spent a few years and many hours hashing out the bill before us, committed to crafting a noncontroversial, bipartisan product. And I believe we accomplished our goal.”[548]
Rep. Charles Pickering, who championed the MUMS legislation and supported combining MUMS with the FALCPA, summed up this momentous event by observing that the passage of S. 741 “is a great accomplishment after a long path to get to this place.”[549]
V. THE FALCPA’S UNFULFILLED PROMISES AND POTENTIAL
Since there is currently no cure for food allergies, consumers need to be empowered to know whether or not food allerg[ens] are present in the food they consume.
– House Committee Report on the FALCPA[550]
Passage of the FALCPA is a remarkable achievement that stands to benefit millions of Americans. The Act’s requirements for plain English labeling of major allergens, mandatory declaration of hidden ingredients, the coordination and publication of food sensitivity-related research, and the encouragement of the promulgation of guidelines for preparing allergen-free foods in food establishments represent significant advances that will daily benefit the lives of people with food sensitivities.
The Act may produce considerable positive secondary effects as well. As one participant in the Allergen Labeling Survey observes, the very fact that allergy issues gained national attention and made it onto the national policy agenda “itself is a victory.”[551] Media attention generated by the Act’s passage, and the fact that beginning in 2006 all consumers will find information concerning major allergens on their food products, will continue to enhance industries’ and the public’s awareness of the seriousness of food sensitivities. As a result, food establishment personnel, physicians, teachers, and airlines may become more responsive to the concerns of people with food sensitivities. As food manufacturers become more aware of the market for allergen-free products, they may choose to develop new products to meet this niche or to re-formulate current products in which non-allergenic ingredients can be substituted for allergen-containing ones.
In various ways, the FALCPA offers greater protection to food sensitive individuals than international allergen labeling initiatives implemented prior to the FALCPA. In 2003 the European Union issued the most stringent allergen labeling rules at that time in the form of an Amending Directive[552] mandating that manufacturers identify certain “common food allergens” and their derivatives on the food label regardless of their quantity in the final product.[553] Unlike the FALCPA, however, the Amending Directive does not provide for uniform terms that must be employed to identify allergenic ingredients,[554] research about food allergies, or the improvement of restaurant food preparation practices. Furthermore, the Amending Directive exempts an ingredient statement from allergen labeling if the name under which a food is sold “clearly refers” to the allergenic ingredient,[555] introducing inconsistency about where a consumer should look to obtain allergen information.
The FALCPA also provides more heightened requirements in some respects than the Codex Alimentarius – a set of internationally-adopted, voluntary food standards developed by a Commission of the Food and Agriculture Organization of the United Nations and World Health Organization Food Standards Programme to help facilitate international trade.[556] In 1999, the Codex Alimentarius incorporated standards for allergen labeling that require the declaration on the food label of any ingredients containing gluten, crustaceans, eggs, fish, peanuts, soybeans, milk, tree nuts, and sulphites in concentrations of 10 mg/kg or more.[557] In contrast with the FALCPA, the Codex’s food standards are merely voluntary, do not require the identification of allergens in easy-to-understand terms, and exempt from allergen labeling “small units” of “spices and herbs.”[558]
For many food sensitive individuals for whom the FALCPA was designed, however, the FALCPA disappoints in several significant ways. As Chris Weiss, Director of Legislative and Regulatory Research of the Food Allergy and Anaphylaxis Network, states, FAAN is “pleased in that [the FALCPA] got passed. We’re very pleased. It does mark a significant step in the right direction. It is progress. However, there is still a lot the bill doesn’t do.”[559]
The 19 food sensitive individuals or their caregivers who participated in the Allergen Labeling Survey[560] gave the legislation an average rating of 2.7,[561] where 0 (zero) meant the participant found the legislation “not helpful” (i.e. they are “no better off than before the Act was passed, or worse off now that the Act has passed”) and 5 meant the participant found the Act “extremely helpful.” Scores ranged from 0 (three responses) to 5 (two responses).
All respondents – even those who rated the legislation a 5 – suggested recommendations for further improvements related to allergen labeling. In fact, some of the respondents who expressed the most satisfaction with the FALCPA on the rating scale were also the most critical of the Act’s drawbacks when elaborating on the reasons behind their rating choice. This may reflect a general appreciation among food sensitive individuals who are aware of how much the Act fails to do that, at least, legislation has finally acknowledged the serious problem of food allergens; that the Act constitutes a victory for food allergy awareness; that any incremental improvement is preferable to the status quo;[562] and that, while the Act may not directly benefit the respondent, it helps others struggling with food sensitivities.
What can account for survey respondents’ varied assessments of the Act? What do the survey’s results suggest about the reform priorities of various food sensitive consumers? This Part explores the extent to which the FALCPA meets its avowed intention to empower consumers to know whether food is safe for consumption. By highlighting several significant shortcomings of the FALCPA, this Part suggests areas ripe for future allergen labeling reform. Drawing a rough distinction between two somewhat overlapping categories of limitations, Subpart A discusses drawbacks related to what the FALCPA’s provisions affirmatively provide and subpart B explores important issues that the FALCPA neglects.
A. Drawbacks of the FALCPA’s Provisions
The FALCPA’s wording raises concerns about the possibility that the labeling scheme may in some ways backfire on consumers and creates uncertainty about the implementation of some of its provisions.
1. Ways the FALCPA Backfires Against Consumers: Diminished Consumer Diligence, Deficiencies of the Label Formatting Scheme, and the Absence of Allergen Quantity Disclosure
i. The Problem of Diminished Consumer Diligence
At their basic level, labeling requirements are only as good they actually make labels more accurate. An unavoidable consequence of any codification of more strict labeling requirements for allergens is that consumers will place more trust in labels. People who have been vigilant researchers will now more readily accept labels at face value. This result – which is the FALCPA’s purpose and key benefit – may also potentially be problematic because the risks associated with accidental mislabeling or inadvertent cross-contamination will be heightened due to reduced consumer caution.
One Allergen Labeling Survey respondent stated that mislabeling was her biggest worry about the legislation. “I read ingredients very carefully right now, and if I begin to rely solely on the new labels, and they’re wrong, I would be in trouble.”[563] The full benefits of FALCPA depend on consistent and complete participation on the part of the food industry and effective enforcement by FDA.
ii. Deficiencies of the FALCPA’s Label Formatting Scheme
The FALCPA’s specific provisions may backfire against consumers by creating the dual problems of under- and over-inclusive labeling of allergens, thereby threatening the safety of highly sensitive consumers, limiting the choices of many food sensitive consumers, and resulting unnecessarily in lost sales for manufacturers and retailers.
The FALCPA could become a “nightmare” for food-allergy sufferers, asserts leading allergen expert Steve Taylor of the Food Science and Technology department at the University of Nebraska. “Congress didn't get this 100 percent right.”[564] The following three sub-sections will use soy lecithin to illustrate the dual problems of over- and under-labeling that the FALCPA’s label format provisions create.
a. The Problem of Over-Inclusivity
At least until certain ingredients or quantities of allergens are exempted through the FALCPA’s petition and notification processes (and manufacturers update their food labels to reflect such changes), the FALCPA poses the problem of over-inclusivity. Steve Taylor notes that the act may in some cases significantly, and unduly, burden consumer choice because it does not account for threshold tolerances. The FALCPA forces manufacturers to disclose extremely trivial amounts of allergens that would be safe for the majority of food sensitive individuals to consume:
The [identification and disclosure of allergens in food] situation has recently become more chaotic just when real progress was being made. The legislative arm of government weighed in with the passage of the Food Allergen Labeling and Consumer Protection Act of 2004. While most of the provisions of FALCPA are commendable, FALCPA will require the labeling of all ingredients derived from commonly allergenic foods regardless of the amounts present in the finished product. This will lead to the declaration of many more such ingredients on the product label thereby decreasing food choices and the quality of life for food-allergic consumers. Many of these ingredients are present at such miniscule levels that allergic consumers would not likely react to them, and most of these products have been safely consumed by food-allergic individuals for years. Thus, the food industry once again finds itself in the midst of chaos. The distinction is that many of the forthcoming changes will do little to further protect food-allergic consumers and the focus will switch from consumer protection to label compliance.[565]
For example, most people allergic to soy can safely consume soy lecithin. Soy lecithin, nevertheless, currently requires a “soy” declaration under the FALCPA. The FALCPA’s labeling scheme prevents a soy-allergic individual from determining that a product containing soy lecithin is nonetheless safe for consumption by sometimes making it impossible for a consumer to be certain which ingredient is responsible for an allergen declaration.
If the manufacturer chooses to disclose the name of an allergen at the end of the ingredient list, the manufacturer does not identify which particular ingredient(s) contains the allergen.[566] For instance, a soy-allergic individual who can safely consume soy lecithin would be unable to know whether he can safely consume a product with the following ingredient statement:
Flour, soy lecithin, hydrolyzed vegetable protein. Contains: wheat, soy.
The soy-allergic consumer who can safely consume soy lecithin cannot determine if this product is harmful because the label does not indicate whether the hydrolyzed vegetable protein ingredient contains soy. The declaration of soy at the end of the ingredient list fails to inform the consumer whether the declaration is due to the lecithin or the hydrolyzed vegetable protein.
If, instead, the manufacturer decides to place the plain English name of an allergen in parentheses after an allergen-containing ingredient, the consumer still may not know that the allergen is in that ingredient alone because of the following exception: if the plain English name of the allergen already appears elsewhere in the ingredient list, the FALCPA says it need not be declared again after subsequent allergen-containing ingredients.[567] Imagine the following ingredient statement:
Flour (wheat), soy lecithin (soy), hydrolyzed vegetable protein.
The appearance of “(soy)” after “lecithin” obviates the manufacturer’s need to disclose whether the hydrolyzed vegetable protein contains soy. The soy-allergic consumer who can safely consume soy lecithin again cannot determine the safety of the product.
Therefore, regardless of which format the manufacturer chooses to disclose allergens, the consumer may not be assured of which particular ingredient(s) contains the allergen. The unnecessary restriction posed by this scheme is particularly troubling with regard to ingredients such as soy lecithin that are pervasive in the food supply. Soy-allergic individuals wishing to not be so restricted will have to resort to the pre-FALCPA techniques of learning the complex terms for potentially allergenic ingredients and calling manufacturers if they do not want to be so unnecessarily restricted in food choice.
To avoid this over-inclusivity problem, manufacturers would simply need to be required to state the name of an allergen in parentheses after each ingredient containing the allergen. An Allergen Labeling Survey respondent who is the parent of a soy-allergic teen urged the adoption of this more precise labeling format:
[P]roducts which are fine for soy allergic [individuals] but contain soy lecithin – products that have been consumed with no adverse affect to date – will suddenly [after the FALCPA goes into effect] have the scary warning below the ingredient list that says “contains soy.” For the regular person to understand the inability for anyone who has anaphylaxis to overcome visceral fear prompted from those words “contains soy” and continue to consume the product despite the warning based on the ingredient list which displays soy lecithin, try to imagine a favorite product suddenly containing under ingredients the words “contains arsenic.” You could not get past that if you have spent your life looking for such warnings and heeding them. ... It is of major concern then for us as to what ingredient they are referring to. Is it saying the item is processed with other soy protein containing products, or can we relax and “assume” the “contains soy” warning is referencing the harmless ingredient soy lecithin? If we could go back to the ingredient list and observe the ingredients that prompted the allergy “warning” we can then say for ourselves that soy lecithin ... is not going to cause a life threatening event. So many of the products we buy contain soy lecithin .... It is very hard to explain that this makes it worse for us. We will be looking for information that is true and finding warnings that are inappropriate. This condition makes you nervous enough; so having warnings flashing at you as you peruse the shelves at the store that mean life and death for yourself or your child, but are not true, is cruel.[568]
The FALCPA’s problematic formatting design first appeared in a proposed compromise bill introduced by Senator Kennedy and reported in the Senate in October 2002.[569] Proposed bills related to allergen labeling prior to this did not specify how allergens should be declared on the label.[570] The Food Allergy Issues Alliance voluntary industry guidelines promulgated in 2001, in contrast, list five ways in which manufacturers can declare the presence of major allergens on the food label, and only one of these options (identifying the allergen following the ingredient list) did not require the identification of each allergen-containing ingredient.
b. The Problem of Under-Inclusivity
The petition and notification processes by which ingredients can be exempted from the FALCPA’s labeling requirements create the reverse dilemma for some consumers: that of under-inclusivity. The absence of scientific information about the threshold amounts of allergenic protein needed to trigger adverse reactions and the fact that thresholds differ among allergy sufferers means that some people will invariably be disserved by certain allergen declarations and by certain ingredient exemptions from allergen declarations.
On the one hand, as Steve Taylor observed, unless a given ingredient is exempted from the FALCPA’s labeling requirements through the petition or pre-approval procedures, manufacturers will be forced to declare that some ingredients contain an allergen even if the ingredient contains only extremely trace amounts of allergenic protein and the ingredient is not harmful to most food allergic individuals.
But on the other hand, if an ingredient does receive an exemption from the FDA, thereby relieving manufacturers of any obligation of disclosing the ingredient’s (albeit slight) allergenic potential, individuals highly sensitive to the allergen will be unable to discern whether absence of the name of the allergen on the label means the product is actually safe for consumption. These individuals will thus be little better off than they were before the FALCPA’s passage, forced to guess at whether a product that appears to be safe is actually safe for them. For these individuals, the FALCPA’s scheme is under-inclusive and fails to alert them to hazardous allergenic protein.
For example, several food industry trade associations have worked to develop proposals for an exemption for soy lecithin.[571] While this would benefit people like CM’s soy-allergic son, the exemption may harm individuals with acute food sensitivity who do experience reactions to soy lecithin.
c. The Inevitable Dilemma
This dilemma is not easily resolved and may be unavoidable. For the petition process to have its greatest effect, ingredients need to be exempted before manufacturers produce new labels to meet the January 1, 2006, new labeling enforcement deadline. Steve Taylor has expressed skepticism that all ingredients that should be reviewed to help avoid these problems will have the opportunity to be reviewed in time. “[T]he Food and Drug Administration will have to come up with that [petition] process, and they’ll need to do it quickly so companies can have 2005 to go through the process and come up with new labels.”[572] Moreover, exemptions granted by FDA are permissive only; manufacturers may continue to label an exempted ingredient as if it were allergenic to avoid relabeling products or to err on the side of caution. This result generates even more confusion because, given the FALCPA’s formatting scheme, consumers will not be able to discern whether an allergen declaration is due to the presence of an exempted ingredient or another ingredient.
Indicative of the predicament caused by the difficulty over where to draw the line regarding relative tolerances of food sensitive individuals and the problems inherent in the FALCPA’s scheme – its allowance of exemptions and formatting provisions that do not require the identification of each allergen-containing ingredient – is the mixed response of food allergy experts. Although Steve Taylor has criticized the FALCPA for requiring the disclosure of extremely slight amounts of allergens,[573] he has also advocated against an exemption for soy lecithin from the FALCPA’s scheme, despite its safety for most soy-allergic individuals:
The soybean allergens are found in the protein fraction. The vast majority of this protein is removed in the soy lecithin manufacturing process. Soy lecithin does contain trace levels of soy protein. However, apparently, soy lecithin does not contain sufficient soy protein residues to provoke allergic reactions in the majority of soy-allergic consumers. Many allergists do not even advise their soybean-allergic patients to avoid soybean lecithin when it is included as an ingredient on food products. From this practical standpoint, we can surmise that most soybean-allergic individuals do not react adversely to the ingestion of soybean lecithin. Yet, there is, of course, the possibility that some of the more sensitive soybean-allergic consumers might react to ingestion of soybean lecithin, so we do advocate the source labeling of lecithin when it is used as a direct food ingredient.[574]
The FALCPA’s labeling scheme is thus bad for soy-allergic people who do not react to soy lecithin, and an exemption harms those for whom soy lecithin does cause reactions. Identifying the presence of soy after each offending ingredient, however, would clear up this confusion. Consumers could then evaluate for themselves the reason for the declaration of soy and make an informed decision.
d. Other Examples of the Backfire Problem: Highly Refined Oils and Oats
This backfire problem also occurs in relation to the FALCPA’s explicit exemptions from the definition of “major food allergen” those ingredients derived from highly refined oils. Studies have shown that most allergenic proteins are removed during processing and these oils rarely provoke allergic reactions in food sensitive individuals.[575] Nevertheless, some people react to the trivial amounts of protein in these ingredients. As one peanut-allergic Allergen Labeling Survey respondent explained, “I am one of those folks who go into anaphylaxis with the slightest contact with peanuts. Pure peanut oil is distilled in such a way without particulate matter. I have had [it] and it caused less of reaction. The tiniest peanut has done me in.”[576] Given the still-evolving and preliminary scientific knowledge about threshold amounts of protein necessary to trigger reactions, it is likely any exemption will be disadvantageous for the extremely sensitive.
An analogous problem may also arise in relation to the FALCPA’s mandate for the creation of a standard to define and control use of the term “gluten-free” on food products. Controversy has long surrounded the question of whether oats contain gluten.[577] Definitive studies have demonstrated the safety of oats for the vast majority of individuals with celiac disease. Nevertheless, several notable authorities[578] continue to include oats among the grains people with celiac disease must avoid, and the oats controversy persists.[579] Dr. Alessio Fasano, the head of the Celiac Research Center of the University of Maryland, has stated that despite the safety of oats for most people with celiac disease, he is not confident recommending oats to all celiac individuals until more studies are conducted about the effect of oats and the problem of cross-contact between oats and wheat.[580]
When formulating the standard for “gluten-free” labeling, if the FDA considers oats a gluten-carrying grain, however, people with celiac disease may be tremendously disserved. Oat flour is one of the most common substitutes for wheat flour, and many products that are otherwise gluten-free contain oats. The largest and most scientifically rigorous study on oats published in 1995 notes that:
Adherence to a strict gluten-free diet is difficult. Therefore, any relief of dietary restrictions, such as those on oats, could make the diet more acceptable to patients. ... Adding oats to the celiac diet could increase compliance with a gluten-free diet by providing patients with more alternatives and reducing the otherwise high cost of gluten-free foods.[581]
Some believe that it is unlikely oats would erroneously be included as a gluten-containing grain not eligible for the “gluten-free” designation. Andrea Levario, co-chair of the ACTF, an organization that lobbied for the passage of the FALCPA and that will work to influence the development of the “gluten-free” standard, believes avoidance of oats will not be considered part of a gluten-free diet.[582] An authoritative consensus statement issued by a panel of celiac disease experts convened by the National Institutes of Health[583] in June 2004 did not list oats as a gluten-containing food.[584] Division, however, still exists among the three major American celiac disease support groups regarding oats.[585]
iii. The Detrimental Absence of Allergen Quantity Disclosure
The FALCPA’s labeling scheme does not require the declaration of the quantity of a given allergen in food. Including information about the quantity or percent content of an allergenic ingredient in a food might also help consumers make more informed decisions. The practicalities of such a scheme may appear daunting if not impossible, however, to U.S. manufacturers unused to providing this information and concerned about product formulas and costly label alterations.[586] In contrast to requirements in the United States, disclosure of the quantity of certain principal ingredients is required of EU member countries.[587]
Decades ago, the FDA acknowledged that percentage labeling of ingredients may be warranted “where this information has a material bearing on price or consumer acceptance of the food, or where such information may prevent deception,” in other words, where it would provide “proven benefits to consumers.”[588] In 1979 the FDA noted that over half of consumers surveyed by the FDA desired quantitative declaration of ingredients on the food label.[589] The agency stated its intention to FDA continue efforts to “encourage or require the use of quantitative ingredient labeling on more foods,” including seeking or supporting legislation explicitly giving FDA authority to require quantitative ingredient labeling and authority to inspect manufacturer records to ensure quantitative labeling compliance.[590] The FDA did not take action to pursue this goal, however.[591]
About 20 years later, the FDA again acknowledged “a longstanding, strong consumer interest in percentage ingredient labeling,” but simply stated that the FDA lacked authority to require full percentage labeling of ingredients.[592] Instead, the FDA endorsed optional percentage labeling of ingredients:
The agency is not convinced that voluntary percentage ingredient declaration would lead to consumer confusion. FDA has permitted manufacturers to declare voluntarily the percentage of ingredients, and it does not have information to indicate that consumer confusion has occurred as a result of such declarations. ... Furthermore, the agency believes that this information could educate consumers as to the individual contribution of a particular ingredient in the finished food, thereby assisting them in planning their diets. Consumers have the ability to discern and understand labeling information that is presented in a uniform, clear, and concise manner. Therefore, the agency is issuing new § 101.4(e) to establish a uniform method for voluntary percentage declaration of ingredients.[593]
Despite its support of percentage labeling in theory, FDA in the same notice rejected suggestions that it should require manufacturers to disclose the quantity of sulfites in a product on the label. The agency cited continuing scientific uncertainty about what constitutes safe levels of sulfites for sulfite-sensitive individuals:
Although the agency is aware that limited studies have been performed on sulfite-sensitive individuals to determine dose response reactions, the agency finds that the available evidence does not establish that a threshold level exists for sulfite-sensitive individuals. Furthermore, the agency does not believe that sulfite-sensitive individuals should be expected to determine their tolerance levels. Therefore, FDA finds that, given currently available information, there is no reason to require manufacturers to declare the concentration of sulfites on the label. Declaration of the sulfiting agent in the ingredient list will adequately inform all individuals who are sensitive to sulfites that sulfites are present in the food.[594]
Given the fact that studies still have been unable to identify threshold levels for allergens and that evidence indicates significant variability in thresholds and concomitant symptoms among allergic consumers,[595] and even among certain types of foods,[596] it is not clear that the FDA’s justifications for not seeking quantitative declarations for sulphites provides a persuasive case against quantity disclosure of allergens. The FDA’s reasoning is appropriate when it comes to celiac disease, where ingestion of gluten can damage a celiac’s intestine whether or not the person feels adverse symptoms from this exposure.[597] The FDA’s logic is less persuasive, however, in relation to people with food allergies for whom adverse events are themselves the dangerous consequence of allergen exposure.
The principal reason people with food allergies are unsure how much intake of a certain food is necessary to trigger a response is because such information about relative quantities is not available. Sulfite-sensitive individuals and people with food allergies have for decades struggled to manage their sensitivity and, essentially, tried to determine their own tolerance levels, as they attempted to discern whether “may contain” warnings for a certain product actually produce a reaction, whether products providing no indication they contain allergens are nonetheless contaminated, and whether they could consume products containing “spices” or “natural flavors.” People with food allergies have been left to trial and error in these dangerous experiments. Therefore, it is not obvious that providing consumers with more accurate quantity information would heighten the threat to consumer safety rather than empower consumer decision-making since the best evidence suggests tolerances are ultimately personal and unique.
iv. The FALCPA’s Backfire Effect: Conclusion
In sum, if the plain English name of an allergen were listed after each allergen-containing ingredient or if the quantity of the offending allergen were identified, consumers would be more empowered to make informed decisions about a food. Greater information disclosure would allow food sensitive consumers to make up their own minds about products and accept their own level of risk. One Allergen Labeling Survey respondent elaborated on her feeling of lack of power given the FALCPA’s labeling scheme and exemption provisions:
I’m not comfortable with the threshold aspect of the law. Just because a trace amount may not pose a risk to human health, a person should have the right to know what they are eating. I want to make the decision whether or not I feel comfortable eating a certain ingredient, as opposed to a manufacturer deciding for me that it’s ok to eat an ingredient that I would otherwise avoid.[598]
2. Implementation Uncertainties: Label Format Ambiguities, Exemptions of Certain Ingredients, Ambiguous Provisions
How effectively the FALCPA will benefit food sensitive individuals will to a large extent depend upon how the agencies charged with implementing the Act go about their interpretation and execution of their obligations. The provisions of the FALCPA leave much leeway to the Secretary of HHS, the FDA, and the CDC, which could markedly impact the Act’s ultimate outcome.
i. Label Format Ambiguities
The FALCPA permits some uncertainty regarding labeling format that may undercut the Act’s purported ability to make food labels consistent and easy-to-decipher.
First, the Secretary of HHS can allow allergen information to appear “in labeling in lieu of appearing on the label” if the Secretary finds that such other labeling is “sufficient to protect the public health.”[599] Given the FFD&CA’s definition of “labeling,” allergen information can thus, at the Secretary’s discretion, appear on any label or other written, printed, or graphic matter on a food’s container or accompanying the food.[600] The Secretary’s decision to allow allergen information to appear outside the food label is effective once the Secretary publishes in the Federal Register that determination and the food product involved.[601]
While this provision will likely provide the Secretary valuable flexibility to adjust the FALCPA’s requirements for atypical products and situations, it introduces an element of variability in labeling, the effects of which will be determined by how sparingly this provision is invoked in practice and by the specific alternative manifestations of allergen declaration that are utilized in the standard scheme’s stead. This exception to the uniform labeling format that consumers will come to rely on may pose special difficulties for children and caregivers trained simply to identify allergens by reading the ingredients list. Publication in the Federal Register will do little to put most consumers on notice that a given product will deviate from the traditional labeling system.
Second, another broad delegation of authority to the Secretary that may complicate the FALCPA’s labeling scheme is provided in the new 21 U.S.C. § 403(w)(5) which states that the Secretary may modify the allergen labeling scheme as necessary “to protect the public health.” The Secretary may modify the requirements that a major allergen be declared either in parentheses after a food containing the allergen or adjacent to the ingredients statement following the word “contains,” or the Secretary may eliminate one of those options entirely.
The Secretary’s freedom to adjust the label format scheme over time allows the Secretary to respond to consumer input about label clarity and may ultimately promote greater consistency (such as if the Secretary were to eliminate one of the options). The provision, nonetheless, introduces the potential for further labeling variation that could confuse consumers, depending on how frequently and in what ways this provision is employed. Recognizing this drawback, Congress drafted this provision in a way to narrow the possible options for variability and to encourage the FDA to use its authority sparingly:
First, FDA may modify one or both labeling options. Second, FDA may not eliminate all major food allergen labeling by eliminating both labeling options; rather, FDA may eliminate only one of the approaches. Third, and most significantly, FDA must demonstrate in the regulation that modification or elimination of an allergen labeling requirement is necessary to protect public health. The committee considers this standard to impose a high burden on the Secretary to justify changing these requirements of the legislation.[602]
ii. Exemptions of Certain Ingredients from the Labeling Requirements
The petition and notification processes provided in the FALCPA to exempt certain ingredients from the allergen labeling requirements have evoked serious concern among some food sensitive individuals. These exemptions have the potential to encourage needed research about the allergenicity of questionable ingredients and about the extent to which allergenic proteins are removed during various chemical and manufacturing processes. The exemption provisions may helpfully promote further study of the tolerance levels of food allergic individuals and encourage manufacturers to innovate new techniques to eliminate or significantly reduce the allergenicity of certain ingredients. On the downside, however, the exemption processes invite the FDA to make case-by-case judgments about what threshold levels of an allergen can be present in a food before requiring an allergen declaration – determinations that invariably will be over- and under-inclusive, as discussed previously in the prior section concerning the FALCPA’s potential to backfire against consumers. The deleterious potential of these exemption provisions is heightened by the fact that, because of the FALCPA, consumers will become more trusting of food labels and take fewer precautions – such as only trying new products at home or when they are carrying self-injectable epinephrine – than they do currently.
It is difficult to predict how the petition and notification provisions will be executed by the FDA since the FALCPA’s language, like most legislation authorizing administrative agency action, leaves the agency many interpretive gaps to fill. Manufacturers can seek to have ingredients exempted from the FALCPA’s labeling scheme if they provide “scientific evidence (including the analytical method used to produce the evidence)” that “demonstrates that such food ingredient, as derived by the method specified in the petition” does not contain allergenic protein or does not cause an allergic response that “poses a risk to human health.”[603]
The Senate Committee Report’s guidance to the FDA about these exemption provisions leaves the FDA wide implementation latitude and raises more questions about how the FDA should execute the exemption provisions than it answers:
The committee encourages FDA to adopt a reasonable standard for determining whether a food ingredient ‘does not contain an allergenic protein.’ ... The committee intends that the Secretary will provide guidance to industry on the information that would be useful for making a determination that foods that contain protein derived from one of the eight food allergens do not cause an allergic response that poses a risk to human health. The committee also intends that the Secretary provide an appropriate process for providing such information to the Secretary that minimizes the burden on the food manufacturer.[604]
The FDA is presently working to operationalize the FALCPA’s petition standard and establish the data petitioners must supply.[605] How liberally the FDA will interpret and implement the exemption provisions – what sort of “scientific evidence” is needed, what the FDA considers a sufficient “risk to human health” to justify allergen declaration, and how many and how frequently ingredients are exempted – casts a big question mark over the FALCPA’s entire labeling scheme.
Some people with food sensitivities argue that there should be no exemptions allowed for any ingredients derived from an allergenic food source. As one highly sensitive peanut-allergic individual contends, “the threshold provision is a bad idea. Disclosure must be complete. Allergies vary from person to person and the idea that it is less severe in a number of people does not rule out that in a few people the threshold is so low as to be negligible.”[606] Some people with food sensitivities are nervous about the petition process itself, whereby the FDA makes exemption decisions based on data provided only by manufacturers advocating for an ingredient’s exclusion from the labeling requirements. And one Allergen Labeling Survey respondent articulated a broad view of consumers’ interest in knowing what they are consuming, regardless of safety concerns: “just because a trace amount may not pose a risk to human health, a person should have the right to know what they are eating.”[607] This “zero tolerance” approach was adopted by early food allergen labeling bills.
A strict “zero tolerance” policy that would require automatic allergen declarations for derivatives of major allergen-containing food is not practical, however, given the reality that the FALCPA does not mandate the identification of each allergen-containing ingredient on the food label so that consumers can make informed, independent decisions about what particular ingredients they personally can tolerate. Such a policy is also not desirable since some ingredients like highly refined oils, certain distilled vinegars, and certain hydrolyzed ingredients contain virtually no allergenic protein and are believed to be safe for the vast majority of food sensitive individuals; under a zero tolerance regime, even those ingredients whose safety could be scientifically demonstrated would prompt allergen declarations, causing undue confusion and anxiety for most food sensitive individuals.[608] Furthermore, a zero tolerance policy would be unable to adapt to evolving technologies that may eliminate offending proteins from food or to new information about tolerances and food allergenicity.
Recognizing an interest in being able to adapt labeling requirements as information improves, the European Union also included an exemption provision in its labeling scheme for allergens. The Amending Directive provides that the list of allergen-containing ingredients requiring allergen declarations “shall be systematically re-examined and, where necessary, updated on the basis of the most recent scientific knowledge.”[609] The European Food Safety Authority has the power to exempt from allergen labeling those ingredients for which it has been “scientifically established that it is not possible for them to cause adverse reactions,”[610] although the European Food Safety Authority has expressed its skepticism that scientific knowledge at this time supports the exclusion of ingredients.[611]
The first proposed allergen labeling bills in the United States that acknowledged the value of exempting some ingredients were H.R. 4704 and S. 2499, introduced in the House and Senate in May 2002, which provided the Secretary of HHS with unfettered discretion to exempt a substance derived from a major allergen so long as the Secretary determined the substance did not “cause an allergic response that poses a risk to human health.”[612] It was almost a year later (and in a subsequent version to the compromise legislation S. 2499 that was reported in the Senate), in the version of S. 741[613] reported in the Senate at the end of March 2003, that the more elaborate exemption processes found in the FALCPA (containing guidance to the Secretary regarding scientific standards and presumptions) was first included in a proposed allergen labeling bill.
It is troubling that the people most in need of allergen labeling – those who are the most sensitive and, hence, most at risk for severe reactions – will be most harmed by the FALCPA’s exemption provisions that authorize the FDA to draw lines regarding acceptable threshold levels of allergens. The House Committee Report on the FALCPA reveals the Committee’s acknowledgment of threshold concerns and its cautious approach to the notification procedure. “The Committee recognizes that thresholds for the eight major allergens have not yet been established by the scientific community;” however, “if they are established, ingredients containing allergenic proteins below the established threshold would be eligible for the notification procedure.”[614] The hard decisions the FDA will have to make in determining these threshold levels and balancing the dual problems of over- and under-inclusivity seem to be unavoidable. How FDA resolves these issues – and, importantly, conveys those decisions to consumers – will significantly affect how helpful the FALCPA will be to food sensitive individuals.
iii. Ambiguous Provisions
The impact of the Food Code revision and food allergy-related research provisions of the FALCPA could be substantial or trivial, depending on how those provisions are executed.
a. Food Code Revision
With regard to developing guidelines for preparing allergen-free foods in food establishments, the FALCPA’s language is equivocal. The Act merely instructs the Secretary of HHS vaguely to “pursue revision” of the U.S. HHS’s Food Code.[615] No particular outcome, such as actual revision of the Food Code, is thus needed to satisfy this provision. This provision has the potential to improve the quality of life of people with food sensitivities by helping them eat more safely and comfortably outside the home,[616] but the mandate’s weak language makes it possible that the provision may yield no results. The ultimate effect of this provision may depend on the degree to which the Secretary prioritizes this issue.
b. Food Allergy Research
Besides the immediate benefit of an enhanced labeling system for major allergens, the provisions of the Act with the greatest potential to benefit food sensitive individuals are arguably those that call for HHS to conduct and support relevant research.[617] Knowledge about food allergies to a large extent remains uncertain and expanded in an ad hoc fashion. The FALCPA has finally made food allergy research a part of the national health agenda, and importantly, is helping to finance the effort.[618] Better documentation and coordination of findings about the prevalence of food allergies, adverse events, treatment methods, current clinical research efforts, as well as the provision of federal assistance to local first responders to treat adverse reactions, could improve the identification of allergies and the treatment of adverse reactions. It has the potential to lead to the discovery of prophylactic remedies, to the relief of millions diagnosed with known food allergies, not yet diagnosed, or currently misdiagnosed.
Whether and to what extent the FALCPA’s research provisions actually make a positive impact will turn entirely on the priorities and budgets of the implementing agencies. The FALCPA’s research provisions themselves speak in ambiguous generalities. The CDC and the FDA, for instance, are asked simply to “improve the collection of national data” and to “educate physicians and other healthcare providers” about the prevalence, diagnosis, and treatment of food allergies.[619] An ad hoc panel of allergy experts convened by the NIH shall “make recommendations” to the Secretary of HHS for “enhancing and coordinating research activities concerning food allergies.”[620] The House Committee Report does, however, elaborate somewhat on its expectations in its discussion of the cost of financing the information gathering and dissemination effort. The report expects the CDC to, among other things, increase the precision of surveys of healthcare providers regarding food reactivity, add allergy-identification laboratory tests to the National Health and Nutrition Examination Survey, and implement an automated system where care providers can record food allergy-related deaths.[621]
As an Editor of the Allergy and Asthma Disease Management Center’s web site notes, “[t]his legislation sounds very important but also quite ambitious to me, requiring a lot of effort on the part of food allergy experts, the food industry and the DHHS regulatory/enforcement apparatus.”[622] One Allergen Labeling Survey respondent stated that, based on her work experience on Capital Hill, she was skeptical about how much the Act’s research provisions could accomplish without the continued oversight of the Act’s congressional sponsors and some prioritization by the federal agencies charged with executing them: “Food allergen labeling just can’t compete with the likes of flu vaccine shortages, arthritis medicine scares, or bioterrorism threats when it comes to prioritizing the major public health challenges of our time. Allergen labeling won’t get the [Secretary’s] (or the media’s) serious attention.”[623]
iv. Implementation Uncertainties Conclusion
Much of the FALCPA’s power to improve the lives of people with food sensitivities thus hinges on how the FDA, the CDC, and the NIH execute the Act’s broad, well-intentioned provisions. As the FDA develops regulations to help the food industry comply with the new law and as other agencies implement the FALCPA’s provisions, numerous questions about the effect of the FALCPA will presumably be answered. Until then, many significant questions will persist.
B. The FALCPA’s Insufficient Scope
In several significant ways the FALCPA falls short of the ideal for food sensitive individuals. Due to the realities of political compromise, the FALCPA fails to address several key issues that would empower food sensitive individuals to know what is in the food they consume. This subsection discusses some of the Act’s major deficiencies due to its narrow scope, and in so doing, it notes areas in need of further legislative, regulatory, or voluntary reform.
1. The Neglected Food Allergy Sufferers: Looking Beyond the Big Eight Allergens
By far the most common criticism of the FALCPA among Allergen Labeling Survey respondents[624] was its confinement of its labeling requirements to only eight allergens – milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soy. The legislation’s failure to require the declaration of more allergens is a serious weakness of the FALCPA.
The FALCPA purports to benefit 90 percent of Americans with food allergies and the roughly 2 to 3 million who have celiac disease.[625] But what about the plight of the other 10 percent of people with food allergies? Are 90 percent of Americans with food allergies actually helped by clearer labeling of the Big Eight allergens? And to what extent are people with celiac disease truly empowered by the FALCPA to know what is in the food they consume? This subsection explores these questions and the missed opportunity to more widely benefit individuals with food sensitivities.
i. The Desirability of Labeling More Than Just the Big Eight Allergens
Numerous Allergen Labeling Survey respondents explained that legislation would have been more helpful if it had required the declaration of more allergens. Allergens besides the Big Eight can similarly provoke a range of adverse reactions, including intestinal distress, nausea, vomiting, migraines, hives, breathing difficulties, and life-threatening anaphylaxis. The same problems of complex ingredient terminology and lack of disclosure of sub-ingredients in spices, flavorings, colorings, and additives thwart the efforts of individuals attempting to maintain avoidance diets.[626] In the words of a survey respondent allergic to garlic, “It amazes me that we have a government that wants to dabble in our every day lives, make us wear seatbelts and helmets, but won’t [allow] us find out if a substance that could kill us is in our food.”[627] As the co-founder of FAST notes on her web site for food sensitive individuals, “If we have just one allergen not in the ‘big eight,’ this legislation is virtually useless to us. I know it will help some people with food allergies, but not all of us. Many (er, most!) ingredients will still be able to hide under guises.”[628]
Non-Big Eight foods to which several Allergen Labeling Survey respondents are allergic include sesame seeds, celery, corn, onion, strawberries, bananas, apples, grapes, plums, coconut, garlic, ginger, and cinnamon. The food most frequently urged for inclusion within FALCPA’s mandatory declaration scheme was corn.[629] Corn has only recently been receiving more attention and legitimacy as a serious food hypersensitivity.[630] A corn allergy is particularly debilitating. Adverse reactions to corn include life-threatening anaphylaxis and can require hospitalization.[631] Corn is present in most processed foods. It can be the source of or involved in the processing of over 170 different ingredients that do not mention the word “corn” on the label, such as alcohol, artificial sweeteners, baking powder, bleached flour, brown sugar, calcium stearate, citric acid, dextrose, distilled white vinegar, fructose, fruit juice concentrate, honey, hydrolyzed vegetable protein, iodized salt, maltodextrin, saccharin, vanilla, xanthum gum, and yeast.[632] Much of the wheat supply is cross-contaminated by corn. Since almost every food product contains an ingredient that raises a red flag for a corn-allergic consumer, adequate identification of the actual source foods in compound ingredients is imperative for these individuals to have any food choice freedom at all.[633]
Representative of some Allergen Labeling Survey respondents’ sentiments in favor of more widespread coverage of the FALCPA was one respondent’s entreaty that, when it comes to sources of ingredients, companies should be required to “list EVERYTHING” on food labels.[634] Food manufacturers and the FDA understandably balk at such an idea. Any food has the potential to cause allergic reactions in some individuals. To identify every single source ingredient in plain English could clutter the food label, overwhelming consumers and impeding the ability of children and caregivers to locate the information they need.[635] Some product packaging may not be large enough to support full declarations. Manufacturers would need to expend resources to research their ingredients and to ensure accurate labeling. Also, although complete formula recipes would not be disclosed, manufacturers may plausibly worry about harm from the release of their proprietary information.[636] Full disclosure, moreover, might take industry focus away from the Big Eight allergens, diluting industry efforts to address the allergens that affect the most Americans.
On the other hand, with regard to consumer confusion, for most food sensitive label readers, a label with more information and plain English declarations would probably save them time (allowing them to bypass calling manufacturers and mulling over ambiguous ingredients) as well as suffering. Many ingredient lists are already quite lengthy and contain perplexing terminology; plain English labeling would help children and caregivers overcome the added difficulties of reading a longer ingredient list. Label crowding would not harm the average consumer who is uninterested in ingredient content, and it would not deter a consumer interested in nutrition information from viewing the unaltered nutrition information panel. People who read ingredient lists, not surprisingly, want to know the ingredients in a product. Consumers with medical, religious, ethical, and other dietary needs have also been pressing for more detailed product information; they would likely welcome full disclosure.
Labeling-space concerns could be addressed by requiring manufacturers to print on labels their company web site or well-staffed customer service number and requiring firms to make full ingredient information available through those mediums. Some socially responsible food firms already engage in this practice.
Cross-contamination management efforts could continue to focus on the eight major allergens. Consumers with allergies to non-Big Eight foods might nevertheless be able to more easily obtain information from manufacturers regarding cross-contact of products with non-Big Eight allergens since the manufacturers will have gone through the process of determining the ingredients in their product lines to comply with the full disclosure obligation.
Furthermore, is it so fantastic and impractical to require food manufacturers to know what is in their products and to be able to disclose that information? Undoubtedly, in some instances on a product-by-product basis, full disclosure may raise substantial proprietary concerns.[637] But it is not self-evident that full disclosure would usually work a considerable detriment to manufacturers. Manufacturers already need to determine ingredient sources to comply with the FALCPA, and it is doubtful that significantly greater expense and effort would be required to discover all source ingredients as part of these current efforts. Under current labeling laws, competitors already have access to the vast majority of ingredients that compose food products.[638]
Uneasiness about disclosure may often be rooted in a manufacturer’s concerns about the costs associated with determining what is in its product and incorporating that information on the label, rather than reflect the manufacturer’s interest in protecting business secrets. Revealing all product information might produce an overall boon to manufacturers as people who cautiously avoided all ambiguous ingredients would be free to purchase more products after the ambiguity has been resolved.
How many allergens and which ones should potentially be subjected to mandatory disclosure was debated at the 2001 Public Meeting. One concern raised by food allergic individuals was that the food industry’s efforts to manage the major allergens might be diluted by requirements for more broad disclosure, or that more broad disclosure would be simply politically infeasible. When the founder and CEO of FAAN, Anne Muñoz-Furlong, was asked whether the eight major allergens should be the appropriate focus of labeling or whether additional efforts should be placed on less common allergens, she stated, “My belief is that if we focus on the eight major allergens, we’ve covered 90 percent of the problem, and once we clear that up, we should start looking in other areas, but keep it to the eight so that we can focus there.”[639] Anne Muñoz-Furlong had participated in the creation of voluntary labeling guidelines by the Food Industry Alliance in which only the major eight allergens were required to be declared.
In contrast, Dr. Michael Jacobson, Co-Founder and Executive Director of the Center for Science in the Public Interest, advocated for more expansive allergen disclosure. “We urge the FDA to require disclosure not just of the major eight allergens but others as well. To someone with an allergy to corn or carmine, it’s no satisfaction that wheat and shrimp are disclosed.”[640]
Indeed, the FDA’s own rationale for requiring manufacturers to identify known allergens on food labels outlined in its 1996 Notice Letter to manufacturers applies equally to all allergens, not just the Big Eight. In its letter to manufacturers, the FDA states that, although regulations exempt incidental additives present in insignificant levels from disclosure,
Clearly, an amount of a substance that may cause an adverse reaction is not insignificant. Because evidence suggests that some allergenic substances can cause serious allergic responses in some individuals upon ingestion of very small amounts of the substance, it is unlikely that such an allergen, when it is present in a food, can be present at an insignificant level.[641]
The FDA’s 1996 Notice letter further states that it has not formally defined “allergens,” and that a non-exhaustive list of allergens “commonly known to cause serious allergic responses” includes mollusks and legumes, in addition to the Big Eight allergens.[642]
In terms of legislative proposals for allergen labeling reform, requiring the disclosure of all food ingredients was a non-starter politically. None of the allergen labeling proposals introduced in Congress since 1999 advocated for the complete disclosure of all food ingredients in spices, flavorings, and additives. Some drafts did, however, call for more expansive labeling than the FALCPA provides. H.R. 5532, introduced by Representative Nita Lowey in October 2000, included in the list of “known allergens” requiring appropriate declaration mollusks, “other legumes” in addition to peanuts and soybeans, as well as “such foods as the Secretary may by regulation determine cause a serious allergenic response.”[643] In May 2002, Representative Lowey introduced a bill that called also for the labeling of gluten-containing grains and “any food that the Secretary by regulation determines causes an allergic or other adverse response that poses a risk to human health.”[644]
Although the FALCPA rejects a full disclosure approach, the FALCPA makes clear that it does not preclude the FDA from expanding via regulation the list of major allergens requiring identification under the Act’s labeling scheme. [645] The FALCPA’s new labeling requirements “do not prevent the Secretary from requiring labels or labeling changes for other food allergens that are not major food allergens.”[646]
While it is too early to speculate as to the frequency with which the FDA may actually expand the list of allergens that must be declared, significant expansion of the list appears doubtful. The effort and expense that updating the allergen list would impose upon the food industry, the FDA’s historical fixation on the Big Eight allergens, and the FDA’s belief that only 10 percent of people with food allergies are not already helped by the FALCPA all weigh against the FDA exercising its power to expand the allergen list. One FDA insider stressed the fact that the law covers all but 10 percent of allergic reactions. She explained that whether the FDA would include other allergens depends on establishing a scientific basis for designating another food as a major allergen. There exist several practical difficulties associated with conducting the requisite research, including variation in sensitivity between individuals and even within a given individual, and the fact that people likely to experience severe adverse reactions are less likely to be willing to participate in experiments. In her assessment, “We’ve got enough to deal with right now with the eight major allergens.”[647] It is possible that resistance by the food industry and the inertia and limited resources of the FDA may never be overcome.
ii. The FALCPA’s Impact on People with Celiac Disease
The FACLPA is the first bill to become law that addresses celiac disease and the issue of gluten labeling.[648] It provides a much-needed first step toward providing celiac disease with national recognition and improving the lives of people with celiac disease. Nevertheless, the FALCPA leaves much to be desired for individuals with the disorder. As Dr. Alessio Fasano, the head of the Celiac Research Center at the University of Maryland, describes the FALCPA, it is an important start – but more remains to be done.[649]
Unlike the European Union Labeling Directive,[650] the international labeling standards promulgated in the Codex Alimentarius,[651] and an earlier proposed U.S. allergen labeling bill,[652] the FALCPA does not require the labeling of grains containing gluten on food products (even though, according to some scientific literature, gluten-containing grains are included in lists of the Big Eight[653]). Although the FALCPA mandates that wheat be disclosed on food labels, other grains toxic to individuals with celiac disease – such as rye and barley – need not be disclosed in plain English or when present in spices, flavorings, colors, or additives.[654] Several Allergen Labeling Survey respondents noted this deficiency. According to one survey responder, “The labels will note the presence of wheat and that is extremely helpful. Yet without including the term gluten, the legislation falls short of allowing me to feel totally empowered. I will still have to call manufacturers to ensure that the products I buy do not contain any gluten.”[655] At least one of the three national celiac disease support groups, the Celiac Sprue Association, supported the FALCPA but advocated for the further labeling of all gluten-containing source ingredients.[656] A provision in a 2002 bill that called for the inclusion of all gluten-containing grains in an allergen labeling scheme was dropped as a part of compromises reached while the bill was in committee.[657]
The clear labeling of wheat established by the FALCPA may in fact have the perverse effect of harming those who must avoid gluten. A gluten-free product is always wheat-free, but the reverse is not true. Children or caregivers of children with celiac disease may wrongly assume that a wheat-free product is gluten-free because they may not be familiar with or remember the various terms for gluten-containing ingredients (such as rye, barley, and malt) besides wheat – the most familiar and widespread gluten-containing source food in the food supply.
The FALCPA does, helpfully, call for the development of a definition of the claim “gluten-free.”[658] The FDA is instructed to consult with experts and stakeholders before issuing a proposed rule by August 2006 and a final rule by August 2008. “Given the devastating nature of celiac disease, the Committee urges the Secretary to move expeditiously in implementing the requirements of this section,” the House Committee Report stresses.[659] Canada, Australia, Europe, and the Codex Alimentarius all have standards for what constitutes a “gluten-free” product,[660] but the United States has yet to develop its own.[661] In 1993 the FDA stated that manufacturers could use the term “gluten-free” on packaging, despite the lack of a definition of that term, so long as the phrase was not used in a “false or misleading” way[662] – needless to say, a difficult standard to apply without a definition of the meaning of “gluten-free.”
The unregulated use of the term “gluten-free” has caused confusion and placed people with celiac disease at risk.[663] The 2004 NIH Consensus Statement on celiac disease stresses that a definition of standards for gluten-free foods is necessary to “lay the foundation for rational food labeling.”[664] As Representative Lowey, the principal Congressional supporter of improved food allergen labeling, stated in a press conference celebrating the passage of the FALCPA, the Act will “give those with celiac disease the green light to consume foods without hesitation by setting guidelines for the use of the term ‘gluten-free.’”[665] The four year delay between the passage of the FACLPA and the enactment of a final rule defining “gluten-free” should allow sufficient time for interested parties to weigh in and for scientific consensus to develop in the U.S. regarding an appropriate standard for that term.
While this provision to define “gluten-free” is a significant step in the right direction, use of this declaration by manufacturers is merely voluntary rather than mandatory.[666] Although people with celiac disease will be able to trust “gluten-free” declarations beginning in 2008, the degree to which safety and convenience will improve for those with celiac disease depends on how widespread voluntary usage of the “gluten-free” claim becomes. Earlier legislative allergen labeling efforts included provisions requiring the Secretary of HHS to assess after a “gluten-free” standard is defined whether additional labeling of gluten is necessary on the label.[667] This provision was cut from the FALCPA.
Although the lack of mandatory gluten labeling has been criticized by some consumers with celiac disease, some celiac disease advocacy groups believe these limitations of the Act with regard to gluten were unavoidable. According to Andrea Levario, co-chair of the ACTF, it was not possible for legislation to require the declaration of gluten-containing cereal grains on food labels given the current state of disagreement about what constitutes a gluten-free food. When an allergen labeling bill was initiated in the 107th Congress, the food industry contended it would only allow the bill to go through the Senate Health committee if the mandatory gluten declaration requirement were removed.[668] The food industry was concerned about legal liability given the dearth of scientific knowledge about gluten tolerance levels.[669] When the bill was reintroduced in the 108th Congress, the starting point for the bill was the earlier compromise legislation that did not require the labeling of gluten. There was “no way to get the term back in.”[670]
A lack of science confounded efforts to include more strict provisions regarding “gluten-free” labeling. People within the celiac community couldn’t agree on how to define gluten-free.[671] To have a standard for gluten-free, it is necessary to be able to test a food product to determine if that standard is met, and until recently tests of sufficient accuracy were not available.[672] Scientific knowledge of celiac disease at present is inadequate to determine gluten tolerance thresholds among people with celiac disease.[673] Moreover, the food allergy community expressed reluctance about allowing a standard for gluten-free that permitted any amount of gluten, no matter how slight, to be present in a food. “The food allergy community was a tight ally [with us in lobbying for] the legislation. For them, zero is zero – once you provide for leeway, you’re setting yourself up for allergic reactions.”[674] “We weren’t in a position to get the ideal,” Andrea Levario said of the legislation. “We don’t have some of the research behind us to get us there.”[675]
Andrea Levario believes that requiring the standardization of the meaning of the term “gluten-free” and imposing mandatory timelines for the promulgation of a proposed rule and final rule by FDA[676] were themselves significant victories given the scientific and political realities. The ACTF attempted to speak for people with celiac disease and urged the passage of the FALCPA because it recognized that “for any changes to take place, it would require the celiac community speaking with one voice, and the same message.”[677]
Furthermore, some celiac disease advocacy groups believe the Act will greatly benefit people with celiac disease, despite its failure to require the identification of rye and barley in its labeling scheme. Several celiac disease groups praised the enactment of the FALCPA.[678] Andrea Levario explained the FALCPA’s welcomed reception within the celiac community by the fact the Act addresses most of the labeling needs of celiacs. “Eighty percent of the problem [for people with celiac disease] is in wheat or a wheat derivative,” she explained.[679] Rye is “virtually never” used as a spice, flavoring, or additive. Barley is usually listed plainly as a key ingredient or, if hidden, is hidden in the term “malt,” in which case a person with celiac disease should avoid the food or inquire further about its contents. It was difficult to justify the inclusion of rye and barley from the food allergy (not celiac disease) perspective since rye and barley are not among even the most common 20 allergens for people with food allergies.[680]
The FALCPA’s establishment of a standard definition of “gluten-free” and mandatory disclosure of wheat in products will certainly do much to benefit people with celiac disease. It is clear, however, that including barley and rye in the FALCPA’s allergen labeling scheme or requiring the “gluten-free” declaration on products without gluten could have gone significantly further to help people living with this disorder.
iii. Are 90 Percent of Food-Sensitive Americans Helped by the FALCPA?
The FALCPA touts a statistic that the Big Eight allergens are responsible for 90 percent of “food allergies.”[681] Congress, the FDA, and the media all seized on this figure that implies that the problems faced by 90 percent of food sensitive individuals are alleviated by the FALCPA. Are 90 percent of people with food sensitivities actually helped by the FALCPA? This question is worth exploring insofar as it sheds light on why the FALCPA requires the declaration of only eight foods. Also, the meaning and accuracy of this statistic is important because it may generate a sense of complacency by the FDA, the food industry, and Congress with regard to expanding the list of allergens warranting attention; the belief that problems have been remedied for 90 percent of food allergic individuals lessens the impetus to work to provide more widespread allergen labeling coverage.
First, it is inaccurate to view the statistic as asserting that 90 percent of Americans with food sensitivities are helped by the FALCPA. As the term “food allergies” may make plain to the initiated, but not to the general public, the 90 percent figure refers only to people with IgE-mediated, immediate hypersensitivity reactions to food, not to people with delayed hypersensitivity reactions such as those with celiac disease. The 90 percent claim is, thus, an assertion limited to people with food allergies proper.
Second, the history behind this statistic reveals that it is not the case that an estimated 90 percent of food allergic people are allergic to Big Eight allergens, as the media and the FALCPA’s preamble itself may imply;[682] rather, Big Eight allergens are responsible for about 90 percent of adverse reactions.[683] Although 90 percent of allergic reactions may be caused by the Big Eight, that does not mean that 90 percent of allergy-sufferers are helped. The same people could experience multiple reactions and be counted multiple times, meaning the percent of food allergic individuals with a Big Eight allergy is actually less than 90.
Third, within the subset of food sensitive individuals who have food allergies, many people allergic to a Big Eight food also are allergic to non-Big Eight foods, meaning that for some people theoretically helped by the Act the FALCPA may have little, if any, benefit. As one Allergen Labeling Survey respondent explained, “A lot of my allergens aren’t covered [by the Act, so] I will still have to avoid any products that contain natural flavorings or spices.”[684] Another respondent noted that she is allergic to some Big Eight foods and some non-Big Eight foods, and she has found her reactions from the non-Big Eight foods to be “more dangerous” than those from the Big Eight.[685] A 2001 study demonstrated that among children with food allergies, over 30 percent were allergic to two or more foods.[686] A study published in 1990 found that among children allergic to more than one food, about 7.5 percent were sensitive to at least one Big Eight and one non-Big Eight food.[687] Another study discovered that among children allergic to milk, 35 percent were also allergic to oranges, 18 percent were allergic to bananas, 14.5 percent were allergic to beef, 12 percent were allergic to tomatoes, and 11 percent were allergic to strawberries.[688] An internal survey conducted at FAAN’s annual member conference in 2004 found that, of the approximately 500 members responding to the survey, roughly one third of respondents who indicated that they were affected by a Big Eight food allergy stated they were also allergic to at least one non-Big Eight food.[689]
Thus, use of the 90 percent figure as it has been touted in the media can leave the false impression that the FALCPA solves the problems of 90 percent of Americans with food sensitivities. Because people with multiple food allergies and those with celiac disease are not fully helped by the Act, the actual percentage of people with food sensitivities who are empowered by the Act to know if a food is safe for consumption is likely less than 70 percent. If the FDA, Congress, the food industry, or the public believes almost all Americans with food sensitivities have already received adequate assistance, the impetus to work to add more allergens to the labeling requirement or to implement new food allergy-related reforms may be hindered.
iv. The Sources of the Big Eight and the 90 Percent Statistic
It is not self-evident that the eight allergenic foods covered by the FALCPA are the only ones that warrant labeling. Other countries have adopted more expansive lists of major allergens requiring mandatory declaration. The European Union requires the labeling of gluten-containing cereals, celery, mustard, sesame seeds, sulfur dioxide, and sulfites in addition to the Big Eight.[690] As the European Public Health Alliance notes, “The new U.S. rules do not go as far as the new EU Directive ... on the indication of ingredients in food.”[691] Most of the contemporary discussion about food allergens in America has centered on the Big Eight allergens and the Big Eight have consequently gained a carved-in-stone quality.[692] But as one Allergen Labeling Survey respondent asked, “Who decided how many are the ‘top’ number of allergens to include?”[693] This question warrants attention since the provision requiring declaration of only the Big Eight “major allergens” is perhaps the most crucial – and controversial – element of the FALCPA.
The proposition that the Big Eight allergens identified in the FALCPA are responsible for 90 percent of allergic reactions is somewhat more muddled than media and rhetoric tossed around in the debate surrounding the FALCPA suggest. The authoritative aura surrounding the major eight allergens is typically traced back to an expert panel at a 1995 conference convened by the FAO.[694] A similar list of allergens that also included mollusks and a broader category of legumes than just peanuts and soybeans appeared three years earlier in the Federal Register.[695]
The Codex Committee on Food Labelling (sic) convened an FAO Technical Consultation on Food Allergies in Rome in 1995, bringing together 13 experts on food allergies representing nine countries to provide guidance on the development of science-based criteria to determine which foods are known to cause hypersensitivity and, because of their allergenic properties, should always be declared in the ingredients list on the food label.[696] This list was intended to serve as guidance for countries to standardize labeling for international trade purposes. In addition to the Big Eight allergens, the FAO Report’s list included gluten-containing cereals and sulfites. The FAO Report did not purport to speak definitively on the prevalence of known allergens:
[T]hese studies are not fully conclusive as the prevalence of food allergy is also influenced by genetic and geographic factors as well as regional diets. ... It was recognized that there is significant information available concerning food allergies, but that there are also significant gaps in that information particularly in regard to prevalence, and that much research remains to be done on a number of additional issues.[697]
The Consultation began with a list of proposed foods and ingredients that should always be declared and recommended modifications to the list. It based its recommendations of what should be included in the list on three factors: severity of reaction provoked by the allergen, estimated prevalence internationally, and amount of the allergenic protein in the food.[698] The Consultation thus composed the list not just on the basis of what types of food allergies are most common but on the severity of the reaction and the prevalence of adverse reactions globally.[699] The Consultation understood that its list was not inviolable. The group “recognized that the proposed listing would also require modification in the future as new allergenic problems are identified.”[700] The Consultation noted that rice, celery, and certain seeds (e.g. cottonseed, poppy, sesame and sunflower), in particular, are prevalent in certain geographic regions and should be studied further for possible inclusion in the list.[701] Elsewhere the Report states that “among the major sensitizing foods are fruits, legumes ..., eggs and milk ..., crustaceae ..., tree nuts..., fish, vegetables (celery and other foods of the Obelliferae family), wheat and other cereals, sesame seed and other seeds.”[702] The Consultation recommended that future research investigate the prevalence of serious adverse reactions due to food allergy using appropriate experimental designs and that the list of foods known to cause hypersensitivity be expanded as appropriate.
Major studies of allergen prevalence prior to the 1995 FAO Technical Consultation reveal disagreement but a growing scientific consensus about the most common and severe allergens. A study of 480 children published in 1990 concluded that “[f]oods purported to produce adverse reactions compose a long list, but those which regularly elicit symptoms form a much shorter list. Ninety-five percent of the food reactions objectively confirmed in this study were to egg, peanut, milk, tree nuts, soy, fish, and wheat.”[703] At a 1994 food industry conference, allergen experts discussed various top allergen lists.[704]
In addition to the 1995 FAO Technical Consultation, the origins of the 90 percent figure are also rooted in a 1996 article by food allergy experts who surveyed and summarized the scientific literature studying food allergies.[705] They developed a list of the most common allergenic foods and food groups based on “a thorough search of the medical literature.” The list of allergens and the number of documented reactions due to those allergens is thus influenced by the allergens that researchers decided to test in the underlying studies upon which this list was generated.
The article identifies over 170 allergenic foods, some of which have also been documented to cause severe, life-threatening allergic reactions. “The absence of a particular food on this list may not mean that it is nonallergenic, but may indicate that its allergenicity has not been documented.” The authors note that allergies to certain fresh fruits and vegetable are common, but those “allergens tend to be liable to processing and cooking and the symptoms are mild and confined primarily to the oropharyngeal area.” The prevalence of allergic sensitivities to specific foods also varies depending on the frequency with which the food is eaten in a given country and the typical age at which the food is introduced into the diet.
According to food allergy experts and authors of the article Susan Hefle and Steve Taylor, mollusks (clams, oysters, etc.), seeds (sesame, poppy, sunflower, and cotton) and certain legumes (dry beans, peas, lentils, and garbanzo beans) are also significant allergens in America.[706] These allergens can produce severe reactions, although they impact fewer people than the Big Eight. In fact, “a rather large percentage of the 160 or more other allergenic foods has been reported to elicit severe allergic reactions in isolated cases.”[707]
In sum, over the past decade, the lists of major allergens have been largely harmonized within the international scientific community, with the exception of a few outliers. The prudence of Congress’ and the FDA’s decision to focus its attention solely on the Big Eight allergens is not, however, obvious. The Big Eight allergens did not receive this designation because they are necessarily the most prevalent in terms of people affected. The list was constructed using not just prevalence, but also typical severity, of adverse reactions due to the allergen. What constitutes a major allergen differs according to age group and geographic region. Several other “second-tier” allergens have been documented to be widespread and provoke serious reactions. Even foods that rarely provoke allergic responses can cause serious adverse reactions in some sensitive individuals. Moreover, the original Big Eight list as determined in the 1995 FAO Food Consultation, unlike the list adopted by the FALCPA, included gluten-containing grains in addition to wheat. There appears to be scientific agreement that information on the prevalence of various food allergies and the severity of adverse reactions is still incomplete, and that as research progresses other allergens may deserve attention. The confinement of the FALCPA’s scope to the Big Eight allergens to the exclusion of other allergens should, therefore, not be viewed as a forgone conclusion. Whether the FALCPA should have included more allergens – and more importantly, whether the FDA should authorize the inclusion of more allergens in the future – thus warrants critical consideration.
2. The FALCPA’s Weaknesses With Regard To Cross-Contamination
The FALCPA takes important steps toward addressing the problem of the inadvertent contamination of non-allergenic foods with major allergens. The Act requires the Secretary of HHS to provide to Congress by February 2006 a detailed report on the issue of cross-contact since cross-contact “deserves further study by both FDA and the food industry.”[708] The report will analyze a host of areas:
Also helpfully, the FALCPA instructs FDA to conduct inspections of food producers to ensure that facilities comply with practices to reduce or eliminate cross-contamination with major allergens and to ensure that major food allergens are properly labeled on foods.[710]
Nevertheless, the FALCPA leaves several conspicuous gaps with regard to managing the problem of cross-contamination. Before the bill was passed, critics of the FALCPA objected to the legislation’s failure to regulate the problem of cross-contamination.[711] Dr. Alessio Fasano, head of the Celiac Research Center, has cited the problem of cross-contact and advisory labeling as a major ongoing concern,[712] as has FAAN.[713] Allergen Labeling Survey respondents identified the problem of cross-contamination as one of the top three areas in need of further reform after the passage of the FALCPA.[714] One major D.C. law firm in a memo to its clients goes so far as to call the FALCPA’s failure to expressly address cross-contamination “the most glaring omission” of the Act.[715]
The Act’s detrimental shortfalls with respect to cross-contamination are several. It appears that Congress does not intend for the FALCPA’s labeling scheme to apply to allergens that inadvertently become a part of a food product through cross-contact. The Act provides no guidance as to the continued use of precautionary “may contain” language, neither standardizing the meaning nor the format of such warnings. The Act has, in fact, exacerbated the problem of advisory labeling; the use of “may contain” language on food labels has already skyrocketed since the passage of the FALCPA as more allergen-aware manufacturers seek to insulate themselves from liability.
The FALCPA fails to direct the FDA to act on the report on cross-contamination’s findings by issuing any guidance or amending its regulations regarding management of precautionary labeling or practices to reduce cross-contact.[716] The Act further falls short of codifying the FDA’s policy that advisory labeling cannot be used in lieu of GMPs.[717]
The Act’s inspection provision is intended to check whether facilities are “engaging in efforts to reduce the possibility of” and are “taking appropriate steps to reduce or eliminate” cross-contamination.[718] It is not clear, however, what steps are sufficient to “comply with practices to reduce” cross-contact and whether visual inspections or scientific testing will be employed to determine the existence of cross-contact. It is unclear what repercussions, if any, a manufacturer may face if inspectors are not satisfied.[719] Moreover, it is doubtful how effective FDA inspections can be policing cross-contact without providing FDA with more funding to increase the number of FDA inspections.[720]
Thus, it appears any advances made in allergen labeling under the FALCPA’s labeling scheme are incomplete; consumers may still encounter undeclared allergens due to cross-contact or overly-broad precautionary labeling that will unnecessarily deter consumers from purchasing a product.
Other regulatory and legislative proposals more helpfully addressed the problem of cross-contact than the FALCPA does. In terms of efforts to reduce cross-contamination using regulatory means, the Attorneys General Petition supported much greater specificity in relation to tackling cross-contamination. The Petition asked the FDA to amend 21 C.F.R. Part 110, which sets forth GMPs, to require manufacturers to adopt several specific practices aimed at preventing cross-contamination such as:
On the legislative front, an earlier proposed allergen labeling bill addressed cross-contamination more directly and fully. H.R. 4704 and S. 2499 (before it was amended) proclaimed that a food would be deemed misbranded if a label bore precautionary allergen labeling that was not in compliance with regulations issued by the Secretary of HHS to provide for advisory labeling of known food allergens. [722] The legislation required FDA to issue regulations outlining GMPs to “minimize, to the extent practicable, the unintentional presence of allergens in food” and authored the use of advisory labeling only when compliance with GMPs would not eliminate the unintentional presence of the known allergen and its presence in the food posed a risk to human health.[723] Succumbing to opposition from the food industry and political pressures, these provisions were eliminated in the compromise amendment to S. 2499, and subsequently, are not in the FALCPA.
Then again, what the FACLPA lacks in mandatory obligations it could potentially make up for in the specificity of the cross-contact provisions it does contain. With the data it gathers for its report to Congress, the FDA will have the background information upon which it could develop an informed approach to curtailing cross-contamination. In fact, as part of its efforts in 2004 to update GMPs generally,[724] the FDA already began collecting some data regarding cross-contamination before the FALCPA was enacted. A 2004 announcement in the Federal Register asks food manufacturers and the public to comment on, among other things, the principal contributors to the presence of undeclared allergens in food and what preventive controls could help control the presence of undeclared allergens in food.[725] The FDA additionally made the development of “a comprehensive food allergen strategy to address considerations such as cross-contamination problems” a 2005 CFSAN program priority, an initiative that it expects may span several years.[726] Moreover, the FALCPA’s provision requiring FDA inspectors to monitor cross-contact may increase awareness among food producers about the seriousness of cross-contamination and may lead to voluntary efforts to reduce it.
The report on cross-contact and explicit mandate for FDA to check for cross-contact during its inspections thus represent a significant start – but the FALCPA does not go nearly as far to address cross-contamination issues as many had advocated.
3. The Continuing Challenge of Restaurants
Plain English labeling and successful revision of the Food Code to help food preparers prepare allergen-free foods will assuredly improve the experiences of food sensitive individuals dining out. Now when people allergic to a major allergen communicate their allergy to food establishment staff, food service personnel will be able to read labels for a single, clearly-identifiable word.[727] The FALCPA’s labeling requirements for prepackaged foods apply equally to bulk items typically used in restaurants.[728] A food-sensitivity-aware Food Code will certainly contribute to a greater appreciation of the seriousness of food sensitivities among food preparers and reduce the many opportunities for cross-contact that occur during food preparation. More reform is needed, however, for people with food sensitivities to safely eat out. The desirability of further improvement when it comes to food establishments ranked high among the concerns of Allergen Labeling Survey respondents, second only to the expansion of the list of allergens covered by the Act’s labeling scheme.
As food allergy expert Steve Taylor of the University of Nebraska’s Food Allergen Research and Resource Program observes, commercial food preparation is made dangerous by a “lack of restaurant labeling,” shared utensils and frying oils, uninformed wait staff or cooks, and ‘creative’ recipe formulations.[729] It is at this point only conjectural how effectively a revision of the Food Code promoted by the FALCPA may address these problems; while a revised Food Code would likely help reduce cross-contamination, improving information through the labeling of restaurant food is assuredly beyond the scope of the Food Code.
Without requiring restaurants to disclose food ingredients, food sensitive customers are still at risk. Customers’ explanations about their food sensitivities can still become lost in the translation from the wait staff to the kitchen and among food preparers once inside the kitchen. Even supposing a restaurant keeps the food labels of its ingredients and checks them in an effort to meet the needs of its food sensitive customers, it only takes one missed food label or one disruption in communication along the chain of food preparers for a mistake to occur.[730] Additionally, clearer terms on the food label offer little relief for people with non-Big Eight allergies.
Many food sensitive individuals argue that, to better meet the FALCPA’s objective of empowering people with food sensitivities to know what is in the food on their table, restaurants should be obligated to make ingredient lists available to customers. The following words of an Allergen Labeling Survey respondent capture this desire:
What is really needed is legislation that gets the food service industry up to speed. Dining out feels like Russian roulette. The wait staff are clueless, try to help from kindness, but cannot because they are not educated. It would be great if all selections on the menu revealed ingredients. Not necessarily on the menu but available if asked. ... The menus are set, the food they have in kitchen is ordered, inventoried and known. Why can’t they have a system to accurately reveal ingredients for any food selection? This information coupled with the request that the allergic person’s safe selection not be contaminated in any way with other food would go a long way in making life good, and will save lives long term.[731]
For years “fast food” restaurants have provided basic nutrition information to consumers,[732] yet disclosures regarding hazardous allergens have by and large been conspicuously – and detrimentally – lacking. Ingredients could be printed on the menus or appear as supplemental information[733] upon request.
Even short of full ingredient disclosure, eating out would be a markedly more safe experience if food establishments provided lists of foods that are or can be prepared free of various allergens.[734] One Allergen Labeling Survey respondent suggested, moreover, if mandating restaurants to disclose ingredient information would be too burdensome for restaurants, legislative or regulatory incentives to encourage voluntary disclosure would, nevertheless, help.[735]
Ingredient or allergen disclosure may understandably be more feasible[736] – and beneficial (due to their prevalence and national scope) – for chain restaurants with standardized ingredients and menus than independent restaurants. Under growing scrutiny in recent years due to nutritional (and increasingly) allergens concerns, many major fast food chains have recently undergone significant changes with regard to ingredient disclosure. In 2001, McDonald’s was one of the first national fast food chains to provide some allergen information to consumers.[737] Now most of the major fast food chains, including the fast food behemoths Burger King, Wendy’s, and Subway provide allergen information for each menu item on their web sites and sometimes on materials in their restaurants.[738] Other fast food chains such as Kentucky Fried Chicken and Taco Bell, in contrast, require customers to call the restaurant customer service line when they have questions about allergen information.
For sit-down chain restaurants, allergen labeling is still rare. A handful of sit-down restaurant chains do, however, provide separate gluten-free menus that identify which dishes are safe for customers with celiac disease, but similar menus for people with Big Eight food allergies are exceptionally rare.[739] A national restaurant trade publication in the month after the FALCPA was passed hailed food allergies as a “front-burner issue for restaurant chains.”[740] Several chains have improved training, management, and disclosure of food allergens explicitly in response to the increased media coverage of the problems of food sensitivities in the wake of the FALCPA, concerns over liability,[741] and worries that “restaurants are next in line for mandatory ingredient disclosures on menus.”[742]
As an alternative to or in conjunction with improving ingredient disclosure or utilizing allergen-free-themed menu designs, food sensitive individuals would be aided if food establishments designated a trained staff person to the task of allergen management. This person would communicate allergy information between the customer and the kitchen and facilitate the ordering and preparation of food for sensitive individuals. Several restaurants have been leaders in this area and have adopted this helpful practice. One example of a restaurant that has made a stellar effort to respond to food sensitivity concerns is highlighted in a 2004 restaurant trade publication:
At Levy Restaurants’ upscale Bistro 110 in Chicago, executive chef-partner Dominique Tougne created a multipoint food-allergy response system that offers personalized service to customers. The restaurant, which serves about 700 people daily, typically has at least one customer per day with a food allergy. Tougne developed the system after his 4-year-old son developed a life-threatening peanut allergy. Under the restaurant's procedure, when a diner mentions having a food allergy, the staff member alerts the floor manager. The manager then talks with the customer, finds out about the severity of the allergy and asks if the guest has emergency medication. The manager then communicates that information to the chef. One cook at Bistro 110 is designated to make all food for allergic customers on surfaces that are free from cross-contamination. The cook then personally delivers the dish to the table to ensure that it has not been contaminated or switched inadvertently in coming from the kitchen. Bistro 110 also prepares custom meals for its food-allergic customers with alternative ingredients, such as gluten-free pasta and gluten-free cookies, Tougne said. Levy Restaurants, which has 91 restaurants and other foodservice operations, said it hopes to implement similar food-allergy response systems in its other restaurants. [743]
Despite the recommendation of the National Restaurant Association in 1992 that restaurants designate a specific manager or chef during each shift to answer customer inquiries about ingredients,[744] and examples provided by restaurants such as Bistro 110, such allergen management practices remain aberrations.
Numerous efforts in the past have attempted – and failed – to improve the transparency of food establishment menus. While most of the debate about restaurant labeling has centered on nutrition content rather than allergen and ingredient information,[745] the FDA as early as the late 1970s recognized the deleterious effects of unlabeled restaurant ingredients that provoke hypersensitivity reactions.[746] In 1979, the FDA decided that restaurant food ingredient disclosure was not possible, but left open the possibility that the FDA might revisit the issue:
Although the agencies [the FDA, USDA, and FTC] can understand why some consumers want ingredient information about restaurant-served foods, enforcing such a requirement in the more than 350,000 restaurants in the United States would not be feasible. Not only is there a multitude of ingredients in each food on a menu, but many restaurants also vary menus frequently or change recipes according to the availability of raw commodities. Ingredient labeling would increase cost for restauranteurs, and be a particularly burdensome requirement for small restaurant operators. These costs ultimately would be passed on to the restaurant customers. State and local governments have primary authority over eating establishments. ... The agencies will not at this time initiate any action to require that ingredients in restaurant-served foods be declared. This policy will be reexamined in the future as necessary.[747]
In 1987 the FDA recognized the particular allergenicity harm of sulfites in restaurant food but rejected the idea of restaurants labeling sulfite-containing potato products via menu statements or signs as not a practical option since restaurants do not ordinarily label foods and any labeling requirement would be “extremely difficult to enforce at any level of government, be it Federal, State, or local.”[748]
A few years later, the FDA again considered the question of restaurant food ingredient labeling, this time on a more extensive basis. In a June 21, 1991 proposal, the FDA requested comments on “the practicability and feasibility of requiring ingredient labeling of restaurant foods” as well as “suggestions for appropriate ingredient labeling formats for restaurant foods if such labeling were required.”[749] This notice sparked a debate about the merits and feasibility of restaurant food labeling.[750] The FDA declined to issue regulations requiring the disclosure of ingredient information by chain or fast food restaurants with standardized food preparation and ingredient specifications, however, because it stated it did not yet have enough information to determine the “appropriateness and manner” of requiring ingredient labeling by restaurants. The FDA proclaimed it, nevertheless, encourages restaurants to voluntarily “provide written information regarding ingredients used in prepared foods when practical.”[751] But efforts to promote restaurant ingredient labeling, once a viable endeavor, “lost much of its popularity after the mid 1980’s,” whereas support for and controversy surrounding restaurant nutrition labeling experienced more longevity.[752]
Little federal legislative pressure has been exerted on restaurants to label food. Congress, in enacting the first significant alteration to food labeling laws in the Nutrition Labeling and Education Act of 1990, expressly exempted food establishments from disclosure of nutrition information such as serving size and calorie and fat content.[753] Similarly, the FDA has continued its hands-off approach to restaurant labeling. The Director of FDA’s Center for Food Safety and Applied Nutrition (CSFAN) in 1997 stated his belief that imposing allergen labeling rules for restaurants goes beyond FDA’s permissible regulatory scope.[754] The agency “encourages” restaurants to voluntarily label ingredients on menus for standard dishes, promote general familiarity of food ingredients by staff, and select a person to serve as a liaison for customers with food sensitivities.[755] Discussion of restaurant labeling was off-limits at the 2001 Public Meeting on allergen labeling as it was beyond the intended scope of the meeting.[756]
Despite the lack of initiative of Congress and the reluctance of FDA to forge new ground in the long-stalled area of restaurant labeling, restaurant labeling is not merely a fanciful, completely politically obsolete concept. State legislative efforts have revived attempts to provide for restaurant allergen labeling. In 2003, for instance, legislation was introduced in several states – including New York, New Jersey, and Massachusetts – to require restaurants to identify or make available information about the presence of major allergens in foods.[757] The Massachusetts bill further called for restaurants to have an “on-site person” available to answer consumer questions about ingredients.[758]
Illustrative of the political non-viability of allergen labeling in restaurants at the federal level, however, is the fact that none of the proposed allergen labeling bills attempted to alter restaurant practices further than the limited pursuit of revision of the Food Code. Had the FALCPA become embroiled in the long-standing debate about restaurant food labeling, the bill would have undoubtedly died, like so many allergen labeling proposals before it, in committee.
Efforts by the restaurant industry to voluntarily improve allergen management and ingredient disclosure in the wake of the FALCPA’s passage is a promising sign to people with food sensitivities that the industry will in the future better respond to the concerns of food sensitive individuals. Depending on the level of zeal and commitment the restaurant industry brings to the problem of addressing food allergy concerns in the upcoming years, the creation of standardized, consistent restaurant labeling and allergen management practices may still be important areas for further reform.
4. The Continued Lack of Adequate Customer Service Information
Because of the FALCPA’s failure to standardize or require mandatory cross-contamination advisory labeling and the fact that its labeling scheme encompasses only the major eight allergens, leaving other allergens still hidden in a product, some food sensitive consumers will continue to find it necessary to contact manufacturers to obtain information about a product that is not available on the label. While the FFD&CA does mandate that manufacturers include their name and place of business on the product package,[759] writing letters to manufacturers to obtain product information is cumbersome, slow, and an impractical solution for inadequate ingredient information, as was discussed in Part I. The FALCPA fails, however, to require manufacturers to train customer services representatives regarding allergen information or to print a customer service telephone number on food packaging. Although many food producers do already provide a telephone number or web site address on their products, many do not make sufficient allergen information available. Countless (particularly smaller) companies do not provide phone numbers at all.
Imposing obligations on manufacturers with regard to identifying customer service hotlines on labels and appropriately staffing and training customer service personnel enjoys tremendous popular support among consumer groups. A proposed bill[760] and at least two proposals submitted to the FDA by state representatives calling for regulatory reform[761] with regard to food allergen labeling directed manufacturers to list phone numbers on labels that customers can call with allergen-related inquiries. Anne Muñoz-Furlong, founder and CEO of FAAN and one of the strongest driving forces behind consumer efforts for improved labeling, has urged manufacturers to include toll-free numbers on packaging.[762] The Center for Science in the Public Interest similarly supported imposing a telephone number requirement on manufacturers.[763] Likewise, two Allergen Labeling Survey respondents cited the lack of mandatory publication of customer service contact information on the label as a serious limitation of the FALCPA.
It would also be beneficial to consumers if manufacturers maintained up-to-date ingredients lists for their food products on-line. One Allergen Labeling Survey respondent recommended that grocery stores provide internet kiosks to allow easy consumer access to such web-based information.[764]
Providing phone numbers or web site addresses where consumers can obtain fast, accurate, detailed allergen information may provide an overall benefit to manufacturers, even small firms for whom such a requirement would presumably be the most burdensome. A telephone number on every package would ease the task of shopping since consumers could call and ask questions at the point of decision – while determining whether to purchase a product in the grocery store, before feeding a child a packaged food item on a field trip, or before using an ingredient in cooking at home. Consumers are more likely to purchase a product after they have promptly discovered that it is safe, rather than waiting to receive a reply from a letter or calling multiple numbers (and, frequently, giving up on a product before an answer is attained). A telephone number helps obviate the need for potentially cumbersome complete ingredient disclosure on the food label. It may result in more sales for manufacturers since, as consumers feel confident in a product’s safety, they will be more apt to experiment with new products. Moreover, as H.R. 4704 provided, customer service-related requirements could be tailored based on the size of a business to ease the financial burden on small companies.
5. Food and Other Products Outside the Scope of the FALCPA
Congress had the opportunity to address issues beyond the scope of the FFD&CA and outside the purview of the FDA when fashioning a law to improve food allergen labeling. Instead, Congress limited the FALCPA’s scope to food products regulated by the FDA, thereby exempting alcoholic beverages and meat and poultry products from its labeling requirements. Congress also failed to extend the FALCPA’s labeling scheme to over-the-counter or prescription drugs and cosmetic products within the FDA’s jurisdiction, even though Big Eight allergens in these products can also trigger allergic reactions.
i. Alcoholic Beverages
The European Union requires its manufacturers to provide allergen information on alcoholic drinks in addition to packaged foods.[765] Conversely, the food items regulated by the FALCPA do not encompass alcoholic beverages.[766] This is problematic for food sensitive individuals who want to determine if a beverage or a restaurant meal or food product flavored with alcohol is safe to consume.
Many popular types of alcoholic beverages can be derived from a variety of grains, including wheat and barley.[767] Alcohol also is vexing for people with allergies to corn, apples, grapes, and potatoes. The name of a beverage is often not enough to determine a product’s safety; ingredients in a particular drink may vary depending on the specific type or name brand.[768] Although allergenicity decreases through the distilling process, there is as yet no scientific consensus regarding at what point distillation sufficiently reduces allergenicity, and it is furthermore impossible for a consumer to discern from taste or appearance to what extent a product has been distilled.
Additionally, some drinks include additives that are harmful allergens. For instance, due to their allergenicity, FD&C Yellow No. 5[769] and sulfites[770] have since the mid 1980s been subject to mandatory disclosure when present in alcoholic drinks at a level of ten or more parts per million. Similar requirements for other allergens remain notably absent.
A debate has long surrounded the labeling of ingredients on alcoholic beverages.[771] Currently, alcohol labels are subjected to few labeling requirements whatsoever.[772] Alcoholic beverages are within the jurisdiction of the Alcohol and Tobacco Tax and Trade Bureau (ATTTB), not the FDA.[773] As early as 1974 the federal government had evidence that alcohol could endanger the safety of individuals with food sensitivities and the then-Bureau of Alcohol, Tobacco and Firearms (BATF) first proposed regulations (which never became a final rule) requiring ingredient disclosure on alcoholic beverages.[774] Subsequently, in 1980, the BATF again proposed regulations and, after receiving input from 1,873 comments, issued a final rule for the labeling of wine, distilled spirits, and malt liquors.[775] While this rule allowed manufacturers to provide ingredient lists in materials in lieu of on the beverage itself in some cases, the labeling of FD & C Yellow No. 5 on the item itself was mandatory. In its notice of the final rule, the BATF asserted that “strong evidence” in the medical research literature indicated “ingredients used in alcoholic beverages can cause adverse health effects in humans,” including “allergic reactions.”[776] The BATF rescinded this rule about a year later, citing a reappraisal of the cost-benefit analysis of imposing such regulations on the alcoholic beverages industry.[777] When the BATF later revisited alcohol ingredient labeling, it promulgated a rule requiring only the labeling of FD&C Yellow No. 5, concluding that there was insufficient evidence of a substantial consumer interest in having disclosure of allergen information.[778] The BATF later expanded disclosure requirements to include sulfites based on the FDA’s determination that “undeclared sulfites pose a risk to public health.”[779]
Thus, in the 1980s, both the FDA and BATF implemented mandatory labeling of sulfites and Yellow No. 5 (for foods and alcoholic beverages, respectively), but fell short of requiring labeling for natural food allergens, despite the fact that the number of people sensitive to a Big Eight food allergen dwarfs the (albeit still substantial) number of people afflicted with allergies to sulfites and FD&C No. 5.[780]
Congressional initiatives to require alcoholic drink labels to include a list of ingredients have been unsuccessful.[781] No Congressional proposals for alcoholic beverage ingredient labeling have been initiated since 1996.
Even though the FALCPA does not mandate the labeling of alcoholic beverages, some sparse legislative history indicates that Congress anticipates the ATTTB will issue separate rules regarding allergen labeling for alcohol-containing products.[782] The House Committee Report cites a 1987 Memorandum of Understanding between the FDA and ATTTB[783] that provides that if the FDA determines that an ingredient must be identified on the label of a food product for health or safety reasons, BATF will initiate rulemaking proceedings to promulgate labeling regulations for alcoholic beverages.
Under the terms of the Memorandum, however, the ATTTB retains discretion to decide whether a rule is needed and, if so, what requirements such a rule would entail. The Memorandum of Understanding merely requires the ATTTB to “initiate rulemaking proceedings” consistent with ATTTB’s health policy with respect to alcoholic beverages when FDA has determined an ingredient poses a public health problem and requires disclosure on the food label.[784] Congress declined to seize the opportunity provided by the FALCPA to codify any expectations regarding this process, including what allergens such a rule should encompass, guidelines for a labeling format, or timing specifications. The ultimate influence of this legislative history and the result of a possible consideration of allergen labeling by the ATTTB is thus, at this point, highly speculative.[785]
ii. Meat and Poultry Products
The FALCPA’s labeling requirements are restricted to foods under the jurisdiction of the FFD&CA, and therefore, they fall short of covering meat and poultry products which are regulated by the U.S. Department of Agriculture (USDA). The USDA interprets the statutes governing meat and poultry products as requiring the disclosure in the ingredients statement of all ingredients used to formulate a meat or poultry product, otherwise the product will be deemed misbranded.[786] USDA regulations exclude from specific identification, however, the constituents in colors, spices, and flavors.[787] Although the USDA encourages producers to voluntarily alert consumers to the presence of major allergens by using the plain English terms for the allergen in parentheses following the offending ingredient or employing a phrase such as “Contains: soy and milk” at the end of the ingredients list, disclosure and the use of plain English names are not required.[788]
These are potentially serious limitations given the fact that use of ingredients derived from Big Eight allergens are “becoming more common as meat and poultry product manufacturers search for ways to lower product fat levels and provide consumers with an array of differently priced proteins.”[789] Today meat and poultry products commonly incorporate a multitude of ingredients to enhance flavor or improve a product’s nutritional value. Undeclared food allergens comprised nearly one-fourth of the total recalls of meat and poultry products in 2003, an increase from less than one-tenth of recalls in 1999.[790] Allergen labeling for meat and poultry products is particularly important given the fact that the presence of a Big Eight food allergen such as milk or soy is generally more unexpected in these types of “natural” foods than with other packaged, processed foods.
This deficiency in the FALCPA may very well prove to be inconsequential. The Director of Labeling and Consumer Protection Staff at USDA’s Food Safety and Inspection Service (FSIS), Robert Post, has stated that FSIS will “likely endeavor” to “be as consistent as possible with the requirement that FDA establishes in response to the Food Allergen Labeling and Consumer Protection Act.”[791] FSIS has yet to publish the requirements for meat and poultry manufacturers in a notice in the Federal Register. The consequences of the FALCPA’s failure to address meat and poultry products will depend upon how the USDA proceeds to fashion and enforce an allergen labeling scheme.
iii. Drugs and Dietary Supplements
Another shortfall of the FALCPA’s labeling scheme is that it does not extend to pharmaceuticals, and, although most probable, it is not yet certain whether the Act extends to vitamins and dietary supplements. The labeling of medicines and dietary supplements is an area of particular concern for food sensitive individuals since these products are ingested, sometimes on a regular basis, and often contain Big Eight and other food allergens – frequently under imprecise terms for additives such as “starch.”[792]
Prescription drugs presently must provide on physician package inserts a “warning” when sulfites are present and a “precaution” for the presence of FD&C Yellow No. 5.[793] The FALCPA does nothing to remedy the fact that no equivalent warning or labeling requirements exist for the major allergens.
Specific, comprehensible labeling of over-the-counter drugs is vital if food sensitive consumers are to be able to make informed product selection decisions. And plain English labeling of allergens in ingredients of prescription pharmaceuticals is critical not only so the patient can feel confident in a product’s safety, but also for the ease of prescribing physicians who may be unfamiliar with the myriad terms for major allergens. Clear labeling of drugs is especially important since a particular drug is often administered on a physician’s orders without the patient’s input and, if patients are hospitalized or ill, they may not be in a position to be as vigilant about scrutinizing labels as they would ordinarily. When a food sensitive person is ailing and decisions regarding drugs must be made at the drug store, the hospital, or the doctor’s office, it is all the more essential that the individual, physician, or pharmacist be able to obtain information promptly and easily and be able to recognize potentially hazardous substances in medications.
Four Allergen Labeling Survey respondents criticized the FALCPA’s failure to address the labeling of drugs. As one Survey respondent opines, “We also need labeling for medications. I have severe reactions to soy-derived hormones, but finding out which are soy-derived and which are not is extremely challenging.”[794] According to a former president of the national Celiac Sprue Association:
For a celiac patient who requires medicines on a daily long-term basis, information about all ingredients in each medicine is of vital concern in order to avoid any [gluten]. Obtaining the necessary information about generic drugs is a difficult situation and becomes more challenging for older individuals, particularly those with multiple drug needs.[795]
Some consumer groups are already considering mobilizing to garner Congressional support for allergen labeling of medicines to address this significant shortfall in the FALCPA.[796]
As for dietary supplements, these products are considered “a food” for purposes of the FFD&CA,[797] so it appears that the amendments to the FFD&CA rendered by the FALCPA apply to dietary supplements as well. Although the Act’s legislative history does not mention the treatment of dietary supplements, so Congress’ views on the issue are unclear, nothing suggests dietary supplements would be exempt. That the FALCPA covers vitamins and dietary supplements “is the operating assumption of the people implementing the law,” CFSAN Policy Advisor Catherine Copp explained in March 2005, “but we have not received a legal opinion on that.”[798] She speculated that, as is often the case with how FDA’s positions are articulated, the FDA may issue guidance about whether the FALCPA embraces dietary supplements once it receives a question about the issue, such as via a letter from a dietary supplement trade association. Given the immense effort the FDA must expend to implement the Act with regard to prepackaged food products, dietary supplements are “not high on FDA’s list” of priorities.[799]
6. Beyond Packaged Food: the Potential Dangers of Bioengineered Raw Foods
The FALCPA would be more comprehensive if it addressed the issue of hidden allergenicity of bioengineered foods. The FALCPA’s labeling scheme applies only to food products that are “not a raw agricultural commodity.”[800] Through biotechnology, unprocessed vegetables, fruits, and grains, however, can be produced using the DNA of other foods. Except in an unclear, narrow set of circumstances, U.S. law does not require genetically modified foods to bear warnings or label disclosures identifying when a food has been produced through biotechnology. The FDA has consistently resisted calls to impose mandatory labeling of genetically modified foods.
Uncertainties surrounding the long-term health effects of bioengineered foods, sometimes referred to derogatorily as “Franken-foods,” have caused concerns among consumers for a variety of reasons. Whether and how to label bioengineered foods has provoked much debate over the past 20 years. This section provides a brief overview of this issue as it relates to the problems biotechnology raises for consumers with food sensitivities.
Biotechnology certainly offers many present and potential virtues, such as increased crop yields and quality, improved resistance to disease and pests, enhanced flavor or nutritional content of foods, and even the possibility that allergenic foods may one day be engineered to reduce or eliminate their allergenicity.[801]
Bioengineered foods can also pose substantial dangers to food sensitive individuals. While most claims of alleged harm from genetically modified foods are as yet dubious, one concrete harm about which groups on both sides of the debate agree is that genetically altered foods that incorporate the DNA of known allergens may contain allergenic protein sufficient to provoke allergic reactions in unsuspecting food sensitive consumers. According to food allergy expert Steve Taylor, “[A] clear need exists to pay particular attention to allergenicity when assessing the safety of foods produced through genetic modification.”[802] The FDA has noted that “proteins transferred from one food source to another, as is possible with recombinant DNA and protoplast fusion techniques, might confer on food from the host plant the allergenic properties of food from the donor plant.”[803] For example, in one highly publicized case, analysis demonstrated that soybeans produced utilizing Brazil-nut proteins to enhance nutritional quality caused allergic reactions in individuals allergic to Brazil nuts.[804] The hazard of bioengineered foods is particularly insidious since unprocessed foods that outwardly appear to be safe could, in fact, carry allergenic protein and cause a serious adverse reaction. Although genes used in the development of commercial transgenic varieties are rarely obtained from known allergenic sources, if a gene from a known allergen is used, allergy experts warn that firms should assume the “gene encodes for an allergenic protein unless proven otherwise.”[805]
Questions about genetically modified foods have multiplied throughout the past decade as production of genetically altered plants has increased.[806] In response to concerns and uncertainties surrounding genetically engineered foods, the European Union in 1997 instituted the mandatory labeling of all genetically modified food products.[807] The European Union requires manufacturers to indicate in the labeling of a genetically modified product, inter alia, “the characteristics or properties modified, together with the method by which that characteristic or property was obtained.”[808] In 1999 the Codex Alimentarius adopted a rule requiring allergen declarations for genetically modified foods as well as food ingredients containing proteins from any of the major allergens it had identified.[809] In strong language the Codex Alimentarius states that when it is not possible to “provide adequate information on the presence of an allergen through labeling, the food containing the allergen should not be marketed.”[810]
The United States has no similarly comprehensive labeling program for bioengineered foods. While the FDA has authority to regulate the safety and labeling of bioengineered foods, the agency has embraced a biotechnology policy that generally regulates foods produced through biotechnology no differently than other foods.
The FDA has, however, in some ways departed from its typical hands-off approach to the labeling of bioengineered foods when it comes to the introduction of “known allergens.” Nevertheless, the impact of the FDA’s heightened concern about food bioengineered from known allergens remains ambiguous and uncodified. Various consumer and environmental groups have noted the FDA’s troubling lack of leadership in addressing the safety risks posed by allergens added to foods through genetic engineering.
Since 1992, the FDA in some cases has required producers of raw commodities to disclose the presence of allergens that are introduced through bioengineering.[811] According to the FDA’s policy guidelines for foods made using biotechnology, “a protein copied by genetic engineering from a food commonly known to cause an allergic reaction is presumed to be allergenic unless clearly proven otherwise. Any food product of biotechnology that contains such proteins must list the allergen on the label.”[812] Labeling is not required if a manufacturer can demonstrate that the allergenicity of the protein was not transferred to the new food. The FDA encourages companies creating genetically engineered foods to seek a voluntary consultation with agency officials before introducing new commercial products. This “policy guideline” issued by FDA as its interpretation of the FFD&CA, moreover, has never been codified in federal regulations.
Whereas the European Union’s approach provides food sensitive consumers with information about source proteins in bioengineered foods upon which they can base decision-making, the American approach to bioengineered foods has in practice been limited to identifying source protein only in the case of the Big Eight allergens. The Federal Register notice announcing the FDA’s policy toward biotechnology is unclear with regard to what allergenic proteins must be identified when present in genetically altered foods. The notice lists the Big-Eight allergens merely as “examples” of foods that commonly cause an allergic response. The notice states that “[l]abeling of foods newly containing a known or suspect allergen may be needed to inform consumers of such potential,” and elsewhere cites a tomato containing peanut protein as an example of a genetically-modified food requiring label disclosure.[813]
The FDA originally expressed the view that the Big Eight list was not exhaustive and the agency desired to update the list as scientific information regarding allergenic foods emerged.[814] The FDA has since failed, however, to issue guidance for industry regarding how to assess the allergenic potential of proteins beyond those cited as examples in its policy notice.[815] The FDA Commissioner in 2000, Dr. Jane A. Henney, has more recently formulated FDA’s policy in this way: “If a food had a new allergy-causing protein introduced into it, the label would have to state that it contained the allergen.”[816] This position does not clarify the fundamental question – what constitutes an “allergy-causing protein”? The FDA has never interpreted this policy to encompass the hundreds of proteins that have been documented to produce allergic reactions. Thus, the FDA’s policy has been interpreted by default to apply only to the Big Eight allergens, to the detriment of individuals sensitive to non-Big Eight foods.
Although the legislative history of the FALCPA of 2004 does not speak to the problem of genetically modified foods, a Senate Report accompanying a 2002-version of the FALCPA, S. 2499, iterates the ability of the FDA to deal with the potential allergenicity of genetically modified foods under existing misbranding and adulteration provisions of the FFD&CA. “[R]aw agricultural products into which major food allergens have been introduced by any means would be considered to be misbranded by FDA if not appropriately labeled under sections 201(n) and 403(a)(1) of the FFD&CA, and even so may be considered to be adulterated by FDA under section 402(a)(1).”[817] As discussed above, however, FDA has chosen to limit its enforcement of misbranding and adulteration provisions with regard to genetically modified foods to the Big Eight allergens.
It is not obvious why the FDA’s policy regarding allergen disclosure for genetically modified foods should not be extended to all source ingredients derived from known allergens, not just Big Eight allergens, or why some intermediate scheme should not be developed to safeguard individuals with food sensitivities. Novel proteins created through biotechnology, and not derived from existing allergenic foods, also have the potential of triggering reactions in people with food allergies and harming individuals with celiac disease.[818] The FALCPA missed an opportunity to codify a policy in regulations or strengthen or simply clarify the language of its current policy. Such reforms regarding hidden allergens in genetically altered foods would reduce consumer anxiety and help to ensure the safety of consumers against allergens that no amount of vigilance, label reading, and researching would enable them to avoid.
7. Beyond Ingestion: Other Hazards to Food Sensitive Individuals
Some products not specifically intended for ingestion, such as lipstick, mouthwash, and adhesives (like that found on stamps and envelopes), pose hazards to food sensitive individuals. Additionally, for some food allergic individuals (particularly those highly sensitive to peanuts or tree nuts) and for people with a form of celiac disease known as dermatitis herpetiformis, mere skin contact with an allergen can trigger severe adverse reactions. These consumers must thus also be wary of products such as shampoos, lotions and detergents.
Cosmetics are the most frequent non-food-related subject of phone calls made by concerned consumers to FAAN.[819] Perfumes (by themselves and incorporated in other cosmetic products), for instance, may contain “vegetable oil” (and include peanut, corn, soy, or other allergens). Several threads on discussion boards at PeanutAllergy.com deal with consumers’ concerns about what cosmetic, soap, and detergent products are safe for peanut-allergic individuals to use.[820]
Consumers must educate themselves to discover that product ingredients such as “benzaldehyde” and “palmitic acid” may contain tree nuts and peanuts and cottonseed, respectively.[821] Many cleaning, hygiene, and cosmetic products, moreover, contain no statement of ingredients whatsoever. The accurate, easy-to-read labeling of a wide range of ordinary household and personal care products is thus important to many individuals.[822]
8. Beyond Labeling: Using Disability Rights to Address Other Areas of Concern
Although largely beyond the scope of this paper, other areas that food sensitive individuals find in pressing need of reform outside the realm of labeling deserve some mention. Many of the areas that are considered the next big issues on the food allergy agenda implicate rights that might be vindicated under disability rights law, raising questions concerning the interpretation and application of the Americans with Disabilities Act (ADA),[823] the Individuals with Disabilities Education Act of 1997,[824] and Section 504 of the Rehabilitation Act of 1973[825].
Exploring the protections and accommodations afforded to individuals with food sensitivities that have been recognized by disability law exceeds the scope of this paper. It is sufficient to note that food allergies have been argued to constitute a disability under the ADA,[826] and that two key areas where food sensitive individuals are advocating for accommodations (briefly highlighted below) are primed for further development and/or litigation. These are but two issues that illustrate the potential for the food sensitivity community to advocate for further reforms under existing disability rights law.
i. Schools
Improving school policies and preparedness when it comes to dealing with children with food sensitivities is an urgent issue that merits critical attention.[827] Under USDA guidelines, school cafeterias should accommodate children with life-threatening food allergies,[828] however, in practice, some parents have found it difficult to obtain such accommodation in the school lunch program[829] or worry that the level of care with which allergen-free meals are prepared in terms of preventing cross-contact may be inadequate. The creation of allergen-free zones in the cafeteria and a school’s cleaning policies to eliminate allergens from tables, chairs, and food service utensils and preparation surfaces are issues of concern for the food allergy community.[830]
Parents are concerned about a school’s plan for dealing with anaphylaxis, including which personnel are designated to administer epinephrine and where epinephrine is kept on the school premises.[831] Efforts to allow students to carry self-injectable epinephrine at school is “moving toward reaching a peak,” according to Chris Weiss, the Director of Legislative and Regulatory Research of the Food Allergy and Anaphylaxis Network. Approximately 15 bills are currently pending in state legislatures on this issue.[832] Parents of children with food allergies worry about when their children leave the school premises to participate in extra-curricular activities or field trips, wondering where the children will eat and whether a chaperone will be trained to administer epinephrine. The training of school personnel to recognize an anaphylactic reaction and to treat it appropriately, and who should receive such training, are important issues. Classroom safety is also a cause of concern. The food allergy community is invested in helping shape school policies regarding whether food is allowed in the classroom and, if allowed, whether certain restrictions should be imposed such as requiring classroom food to not contain peanuts or limiting classroom food to prepackaged foods.[833]
Food allergies in some cases may qualify a child as an individual with a disability,[834] thereby entitling a student to certain school-provided services and resources to enable the student to safely obtain a free appropriate public education. Some parents resist pursuing legal remedies, however, because they do not want their children to be perceived as having a “disability.”[835] Other parents advocate on behalf of their children but are worn down in the face of resistance by schools. As ATCF co-chair Andrea Levario notes, celiac disease “falls within the realm” of disability rights protections, but “even though the rights are on their side, parents basically give up because the push-back from the school district is not worth it.”[836] As one parent of children with food allergies notes, “It’s ridiculous that each of us has to fight the battle with each school, on our own....”[837]
ii. Travel
Public transportation can pose serious dangers for some people with food allergies sensitive to airborne allergens or dermal contact with allergens. FAAN lists airlines as one of their top five advocacy issues.[838] As one Allergen Labeling Survey describes the problem, “it would be good to make more efforts to keep common allergens out of enclosed areas, since, at least in my case, just the smell of the allergen can send me into anaphylactic shock.”[839]
Now, after so much hard work and incredible efforts to secure passage of the legislation, the food allergy and celiac communities can finally let out a collective sigh of relief. Starting January 1, 2006, they will be able to conduct shopping trips at the local supermarket with far less stress and anxiety because food ingredient statements will be straightforward, accurate, and easy to read.
– Representative Nita M. Lowey[840]
The primary justification for passage of the FFD&CA in 1938 was the desire to protect consumers economically and health-wise by allowing consumers to make informed decisions about the products they purchase and consume. Aiding people with food allergies was a stated aim and claimed benefit of the FFD&CA, and certainly, it is difficult to overstate the benefit that the FFD&CA’s labeling requirements had on the lives of people with food sensitivities. Nevertheless, the FFD&CA contained exceptions and gaps that left ingredient disclosure considerably – and dangerously – inadequate.
These inadequacies became increasingly apparent as knowledge about food sensitivities improved. Awareness of food sensitivities has greatly advanced over the past 20 years, and scientific understanding of food sensitivities is now continuing to rapidly expand.
The effort to improve food labeling to benefit food sensitive consumers began in earnest in 1999 with a one-page bill introduced by Representative Nita Lowey and culminated in August 2004 when President Bush signed the FALCPA into law. This ground-breaking legislation overcame years of a dearth of information about food sensitivities, a lack of consumer organization and mobilization, an absence of prioritization of food sensitivity issues within the FDA, resistance from the food industry, and general deficiency in public awareness and concern about food sensitivities. The FALCPA represents the incredible labors of the FDA, the political leadership of a few Congressional champions, impassioned and mobilized consumers, growing scientific knowledge and consensus, and the initiative of the food industry. The Act embodies a watershed coming together of diverse interests that created a singular window of opportunity to finally address on a national scale food sensitivity issues that deeply affect millions of Americans.
For people with food sensitivities, the FALCPA is a remarkable achievement, but it is not ideal. Several key drawbacks of the Act’s provisions and scope and questions concerning the Act’s implementation restrict the Act’s assistance to food sensitive individuals and render the ultimate benefits of the legislation uncertain.
Unquestionably, however, the FALCPA is a promising start to improving the lives of people with food sensitivities. And an examination of the Act’s limitations helps illuminate several legal and policy areas related to food sensitivity that offer great potential for future reform.
[1]Responses to an informal survey posted by the author on the Food Allergy Survivors Together web site at http://www.angelfire.com/mi/FAST/news.html between Jan. 9 and April 20, 2005, to gauge the reaction of people with food allergies to the FALCPA [hereinafter “Allergen Labeling Survey”]. The Food Allergy Survivors Together web site provides information and support for people with food allergies and their caregivers. The site is not geared toward a particular food allergy and is thus visited by people who are concerned about a variety of food allergies. In addition to being announced on the Food Allergy Survivors web site, existence of the Allergen Labeling Survey was also spread by email and word of mouth. The purpose of the survey was to obtain anecdotal responses about the perceived effect of the FALCPA on the lives of individuals who responded to the survey, not to obtain a random sample and produce quantifiable or statistically significant results. All survey responses are on file with the author.
[2] About one in 27 Americans has a food allergy and another 1 in 133 has celiac disease. See S.H. Sicherer, et al., Prevalence of Seafood Allergy in the United States Determined by a Random Telephone Survey, J. ALLERGY CLIN. IMMUNOL. 159-65 (2004) (discussing the prevalence of food allergies in America); American Celiac Task Force, University of Maryland Center for Celiac Research, Celiac Disease: Facts and Figures (2003), at 2, at http://www.celiaccenter.org/taskforcefactsheet.pdf (discussing the prevalence of celiac disease in America). Thus, based on the current population of the U.S., roughly 1 in 23 Americans has a food sensitivity of the type that will be discussed in this paper.
[3] One parent whose son is allergic to soy, for instance, likened a food label stating “contains soy” to a label stating “contains arsenic.” Email from CM, Allergen Labeling Survey (Jan. 11, 2005).
[4] See, e.g., Hugh A. Sampson & Dean D. Metcalfe, Food Allergies, 268 JAMA 2840, 2841 (Nov. 25 1992); Susan L. Hefle, et al., Allergenic Foods, 36(S) CRIT. REV. IN FOOD SCI. AND NUTRITION S69, S70, S81 (1996) (“The variability in symptoms is quite large both between individual patients and between different studies (groups of patients). Even individual patients display variable responses depending on such factors as the exposure dose to the offending food. Certainly, some symptoms are more serious than others. Systemic anaphylaxis, asthma, and laryngeal edema are potentially life-threatening. Some foods are primarily associated with mild adverse reactions, such as the so-called oral allergy syndrome, which is associated with itching, hives, and other mild reactions in the oropharyngeal area only after ingestion of fresh fruits, and only rarely with systemic reactions.”); Hugh A. Sampson, Food Allergies, 278(22) JAMA, Dec. 10, 1997; Jean Bousquet et al., Food Allergy, Report of the FAO Technical Consultation on Food Allergies, Food and Agriculture Organization of the United Nations, Rome, Nov. 13-14, 1995, Annex 3, at 5-6.
This list includes some symptoms only associated with food allergies (such as anaphylaxis), some symptoms associated only with celiac disease (such as malabsorption and increased risk of cancer and osteoporosis), and many symptoms associated with both types of food sensitivity. For further discussion of the differences between food allergies, food intolerances, and celiac disease, see subsection A(1), “Biology Basics,” infra.
[5] S. Allan Bock, et al., Fatalities Due to Anaphylactic Reactions to Foods, 107 J. ALLERGY. CLIN. IMMUNOL. 191, 193 (2001).
[6] S. Allan Bock, et al., Fatalities Due to Anaphylactic Reactions to Foods. 107 J. ALLERGY. CLIN. IMMUNOL. 191, 191 (2001).
[7] The Act constitutes Title II of P.L. 108-282, 118 Stat. 891, and is so named by § 201 of the FALCPA. Title I of P.L. 108-282, the Minor Use and Minor Species Animal Health Act, is an unrelated law that seeks to improve the availability of pharmaceuticals for certain “minor” animal species and to promote the use of drugs to treat less prevalent animal diseases. The FALCPA was combined with the Minor Use and Minor Species Animal Health Act to help ease the FALCPA’s passage. For further discussion of this merger, see Part IV(C)(3) of this paper, concerning the history of Congressional action with regard to food sensitivities, infra. When citing the FALCPA, this paper will employ the FALCPA’s internal labeling system and, where helpful, parallel citations to the U.S. Code.
[8] 21 U.S.C. § 301 et seq. When citing the FFD&CA this paper will employ the FFD&CA numbering system found in the U.S. Code.
[9] See, e.g., H.R. REP. NO. 108-608, at 3 (2004) (“There are no labeling standards currently in place for food allergies.”).
[10] Nutrition Labeling and Education Act of 1990 (“NLEA”), Pub. L. No. 101-535, 104 Stat. 2353, codified at 21 U.S.C.A. § 343(q)(1). The FFD&CA has been amended over a hundred times since its passage in 1938. However, the only other change to food labeling provisions since the NLEA was enacted occurred with the comprehensive reform of the FFD&CA accomplished in 1997 with the passage of the FDA Modernization Act, 111 Stat. 2296. The FDA Modernization Act altered some provisions regarding health and nutrition labeling claims and the disclosure of irradiation, but otherwise had little effect on the labeling of foods.
[11] Ray Formanek, Jr., Food Allergies: When Food Becomes the Enemy, FDA CONSUMER MAGAZINE, July-August 2001, available at http://www.fda.gov/fdac/features/2001/401_food.html.
[12] Renny (Mar. 22 2005), PeanutAllergy.com, Thread: Living With Peanut Allergy, Topic: Do You Worry Every Time the Phone Rings?, at http://www.peanutallergy.com/bbpage.htm.
[13] Hugh A. Sampson & Dean D. Metcalfe, Food Allergies, 268 JAMA 2840, 2840 (Nov. 25 1992).
[14] Jean Bousquet et al., Food Allergy, FAO TECHNICAL CONSULTATION ON FOOD ALLERGIES, Annex 3, at 1 (Rome, 1995). Lactose intolerance, for instance, is experienced by as many as 30 to 50 million Americans. National Digestive Diseases Information Clearinghouse, National Institutes of Health, Lactose Intolerance, at http://digestive.niddk.nih.gov/ddiseases/pubs/lactoseintolerance.
[15] See, e.g., Steve L. Taylor, Emerging Problems – Food Allergens, FAO Conference on International Food Trade Beyond 2000 (Oct. 1999), at http://www.fao.org/docrep/meeting/x2670e.htm (“From a practical viewpoint, true food allergies should be distinguished from other types of food sensitivities because they can elicit serious adverse reactions in some individuals and because individuals with food allergies can tolerate little of the offending food in their diets. For example, it is important to distinguish between milk allergy and lactose intolerance. Milk allergy can involve systemic and sometimes serious reactions, and individuals with milk allergy can tolerate little milk in their diets. In contrast, lactose intolerance, which results from an enzyme deficiency in the small intestine, involves only gastrointestinal symptoms, and affected individuals can often tolerate appreciable quantities of milk in their diets.”).
[16] See, e.g., National Digestive Diseases Information Clearinghouse, National Institutes of Health, Lactose Intolerance, at http://digestive.niddk.nih.gov/ddiseases/pubs/lactoseintolerance (“For those who react to very small amounts of lactose or have trouble limiting their intake of foods that contain it, lactase enzymes are available without a prescription to help people digest foods that contain lactose.”).
[17] See, e.g., Steve L. Taylor, Joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology (held in Geneva May 29-June 2, 2000), at 2 (Jan. 2001), available at http://www.fao.org/es/esn/food/pdf/bi03al.pdf; Hugh A. Sampson & Dean D. Metcalfe, Food Allergies, 268 JAMA 2840, 2840 (Nov. 25 1992).
[18] See, e.g., Steve L. Taylor, FAO Conference on International Food Trade Beyond 2000: Emerging Problems – Food Allergens (Oct. 1999), at http://www.fao.org/docrep/meeting/x2670e.htm (“The most frightening symptom associated with food allergies is anaphylactic shock. Anaphylactic shock involves the gastrointestinal tract, the skin, the respiratory tract, and the cardiovascular system, with symptoms often occurring in combination and developing rapidly. Severe hypotension can occur, and death can ensue within minutes of ingestion of the offending food without proper treatment. Only a few people with food allergies are at risk of such serious consequences, but numerous deaths resulting from inadvertent exposure to the offending food have been documented among individuals with food allergies.”); Hugh A. Sampson, Fatal Food Induced Anaphylaxis, 53 ALLERGY 125, 127 (1998).
[19] Celiac disease is also known as “celiac sprue” or “gluten-sensitive enteropathy”.
[20] Including types of wheat known as triticale, spelt, and kamut.
[21] Susan L. Hefle & Steve L. Taylor, Food Allergies and Other Food Sensitivities, 55(9) FOOD TECHNOLOGY 69, 75 (Sept. 2001), available at http://www.ift.org/publications/docshop/ft_shop/09-01/09_01_pdfs/09-01-sss-allergies.pdf.
[22] American Celiac Task Force, University of Maryland Center for Celiac Research, Celiac Disease: Facts and Figures (2003), at 1-2, at http://www.celiaccenter.org/taskforcefactsheet.pdf (“Undiagnosed and untreated, celiac disease can lead to the development of other autoimmune disorders, as well as osteoporosis, infertility, neurological conditions and in rare cases, cancer. ... 610,000 women in the US experience unexplained infertility; 6% (36,600) of these women might never learn that celiac disease is the cause.”). See also S. REP. NO. 107-322, at 2 (2002) (accompanying S. 2499, as reported in Senate) (“When gluten from certain cereal grains is ingested by individuals with celiac disease, damage to the gastrointestinal tract, central nervous system, and other organs may occur over time.”). But see generally Celiac Disease Does Not Affect Fertility in Women, 128 GASTROENTEROLOGY 849-855 (2005) (discussing recent findings by researchers in the United Kingdom that suggest there is no significant discrepancy in fertility rates between women with and without celiac disease).
[23] CONG. REC. H6100 (July 20, 2004) (statement of Rep. Lowey).
[24] I do not intend to discount the affliction of food intolerance. This paper focuses on food allergies and celiac disease because these two disorders pose particularly serious health and safety risks, such as anaphylaxis and intestinal damage, respectively, that are not associated with food intolerance. No medicine exists that can allow people with food allergies or celiac to ingest the offending food; the only treatment for people with food allergies and celiac disease is to strictly avoid exposure to the dangerous ingredients. Furthermore, these are also the two disorders the FALCPA is designed to address. Although people who experience an intolerance to a food that is one of the eight major allergens may also benefit from some of the FALCPA’s labeling requirements, the FALCPA’s scheme will in some instances be overly-inclusive. For instance, not every product that must be labeled under the FALCPA as containing milk necessarily contains lactose. The new labeling scheme imposed by the FALCPA, therefore, won’t necessarily provide a lactose-intolerant individual with the information needed to make an informed decision about whether to consume a product.
[25] See, e.g., 44 Fed. Reg. 75990, 75999 (Dec. 21, 1979) (“The [FDA and USDA] recognize and sympathize with those individuals who may be allergic to the protein fractions in some fats and oils. Although the agencies know this medical problem occurs, they do not know the extent of the problem.”).
[26] See S. REP. NO. 107-322, at 4 (2002).
[27] See Food Allergy & Anaphylaxis Network (FAAN), Published Research Highlights, at http://www.foodallergy.org/Research/publishedresearch.html (providing a non-exhaustive list of summaries of peer-reviewed, published food allergy research articles, many of which were funded in full or in part by FAAN, a consumer group that seeks to “raise public awareness, to provide advocacy and education, and to advance research on behalf of all those affected by food allergies and anaphylaxis.” See FAAN, About FAAN, at http://www.foodallergy.org/about.html).
[28] See CDC, Diseases and Conditions A – Z, Health and Safety Topics, at http://www.cdc.gov/az.do/id/0900f3ec8000e035#A.
[29] See National Center for Health Statistics of the CDC, FastStats A to Z, Data and Statistics, at http://www.cdc.gov/nchs/fastats/Default.htm.
[30] See S. REP. NO. 107-322, at 4 (2002).
[31] Kenneth J. Falci et al., Food Allergen Awareness: An FDA Priority: New Initiatives Focus on Allergens in 2001, at 3, at http://www.cfsan.fda.gov/~acrobat/alrgawar.pdf.
[32] See FALCPA § 207, 42 U.S.C.A. § 242r(note).
[33] See FALCPA § 208, 42 U.S.C.A. § 242r(note). See also, e.g., S. REP. NO. 107-322, at 8 (2002) (“The committee is concerned that the prevalence of food allergies is uncertain and the incidence of clinically significant and serious adverse events is not being systematically monitored. In response to these concerns, the legislation requires the Centers for Disease Control and Prevention to better capture information on the prevalence of food allergies, the incidence of clinically significant or serious adverse events related to food allergies, and the use of different modes of treatment for and prevention of allergic responses to foods. In addition, the legislation requires the National Institutes of Health to convene a panel of nationally recognized experts to review current clinical research efforts and develop a plan for expanding research activities concerning food allergies.”).
[34] See, e.g., Jean Bousquet et al., Food Allergy, FAO Technical Consultation on Food Allergies, Annex 3, at 14 (Rome, 1995) (“These studies combine to indicate that using double-blind food challenge, the prevalence of food allergy is below 1% of the population in adults and may be slightly greater in children. However, this may be a somewhat low estimate since food challenge may not identify the entire population of food allergic individuals and there are some genetic and environmental factors that can increase the prevalence of food allergy.”).
[35] Hugh A. Sampson & Dean D. Metcalfe, Food Allergies, 268 JAMA 2840, 2840 (Nov. 25 1992) (“In clinical surveys, 8% of children younger than 6 years had evidence of food intolerance; 2% to 4% of these children experienced reproducible allergic reactions to foods. Similar studies are not available in adults, although some surveys suggest that 1% to 2% of the general adult population are sensitive to foods or food additives.”).
[36] The bills introduced by Representative Nita Lowey in recent years to improve food allergen labeling reflect the rapidly increasing numbers and evolving estimate of the number of food allergic individuals in the United States. Compare H. RES. 309, 106th Cong. (1999) (stating that an estimated 5.2 million Americans have a food allergy) with H.R. 4704, 107th Cong. § 2(1) (2002) (stating that approximately 7 million Americans, or over 2% of Americans, suffer from food allergies). The findings section of the FALCPA of 2004 states that food allergies afflict approximately 2 percent of adults and about 5 percent of children in the United States. See FALCPA § 202(1)(A), 21 U.S.C.A. § 343(note) [the parallel citation for FALCPA § 202, the findings section, will hereinafter be omitted]. By the time the FALCPA reached the floor of the House of Representatives for a vote, a 2004 study had been released reporting that the number of individuals with food allergies in America is roughly 11 million. See, e.g., CONG. REC. H6100 (July 20, 2004) (statement of Rep. Lowey) (“[T]he 11 million Americans with food allergies face a daily struggle.”); S.H. Sicherer, et al., Prevalence of Seafood Allergy in the United States Determined by a Random Telephone Survey, 114(1) J. ALLERGY CLIN. IMMUNOL. 159-65 (2004). See also Susan L. Hefle & Steve L. Taylor, Food Allergies and Other Food Sensitivities, 55(9) FOOD TECHNOLOGY 69, 71 (Sept. 2001), available at http://www.ift.org/publications/docshop/ft_shop/09-01/09_01_pdfs/09-01-sss-allergies.pdf (stating that the prevalence of food allergy among children appears to be 5% to 8%).
[37] The new figure reflects a rise in seafood (fish and seafood) allergies discovered by a 2004 nationwide, cross-sectional, random telephone survey that found that approximately 2.3% of the general population, or 6.6 million Americans, have a seafood allergy. See generally S.H. Sicherer, et al., Prevalence of Seafood Allergy in the United States Determined by a Random Telephone Survey, 114(1) J. ALLERGY CLIN. IMMUNOL. 159-65 (2004); see also National Institute of Allergy and Infectious Diseases, National Institutes of Health, Allergy Statistics, Dec. 2004, at http://www.niaid.nih.gov/factsheets/allergystat.htm (“Experts estimate food allergy occurs in 6 to 8 percent of children 4 years of age or under, and in 4 percent of adults.”). An estimated 3 million people are allergic to peanuts or tree nuts. See generally Sicherer, et al., Prevalence of Peanut and Tree Nut Allergy in the United States Determined by Means of a Random Digit Dial Telephone Survey, 112(6) J. ALLERGY CLIN. IMMUNOL. 1203-7 (Dec. 2003).
[38] See generally Sicherer, et al., Prevalence of Peanut and Tree Nut Allergy in the United States Determined by Means of a Random Digit Dial Telephone Survey, 112(6) J. ALLERGY CLIN. IMMUNOL. 1203-7 (Dec. 2003). European Public Health Alliance, EU and US Laws on Food Labelling for Common Allergens, at http://www.epha.org/a/1384 (last modified Aug. 25, 2004) (“Recent studies estimate that over 11 million Americans have a food allergy. Over six million are allergic to fish and shellfish alone. Over three million are allergic to peanuts and tree nuts and the number of children with peanut allergy has doubled in the past five years.”).
[39] Food Allergy Initiative, Food Allergy Information, at http://www.foodallergyinitiative.org/ (“More than 11,000,000 Americans have food allergies of varying degrees of severity – at least 8% of children less than 3 years of age and 2% of the adult population in the United States.”).
[40] See, e.g., American Celiac Task Force, University of Maryland Center for Celiac Research, Celiac Disease: Facts and Figures (2003), at 2, at http://www.celiaccenter.org/taskforcefactsheet.pdf; National Institutes of Health, Final Statement, Consensus Development Conference Statement on Celiac Disease, June 28-30, 2004, released Aug. 9 2004, available at available at http://consensus.nih.gov/cons/118/118celiac.htm (“Celiac disease has been considered until recently to be a rare disease in the United States. Studies, primarily in Europe but also in the United States, now suggest that its prevalence is much greater than previous estimates, possibly affecting as many as 3 million Americans (roughly 1 percent of the U.S. population), indicating that the disease is widely under recognized.”); FALCPA § 202(6)(C) (stating that it is estimated that the prevalence of celiac disease in the United States is 0.5 to 1 percent of the general population).
[41] David Brown, An Ailment’s Common Grain: Survey Finds Surprising Incidence of Gluten Reaction, WASHINGTON POST, Feb. 11 2003, at A01.
The rapid expansion of a disease’s prevalence is not a new phenomenon, but the rise in celiac disease is virtually without precedent. A generation ago, physicians were taught the disease was so rare that a practitioner might go a lifetime without seeing a case. In 1993, researchers at Children’s Hospital in Buffalo published a study estimating celiac disease’s prevalence to be 1.3 cases per 10,000 children. Mayo Clinic researchers the next year measured a rate of 1.1 cases per 5,000 people in the Minnesota population the clinic serves. [The work of Dr. Alessio Fasano, the gastroenterologist who heads the Center for Celiac Research at the University of Maryland School of Medicine in Baltimore] suggests, however, that celiac disease is 50 times more common than that. ... The new estimate “is basically in the same ballpark as Europe,” said Stephen P. James, head of digestive diseases research at the National Institutes of Health.
Id.
[42] See, e.g., Susan L. Hefle & Steve L. Taylor, Food Allergies and Other Food Sensitivities, 55(9) FOOD TECHNOLOGY 69, 71 (Sept. 2001), available at http://www.ift.org/publications/docshop/ft_shop/09-01/09_01_pdfs/09-01-sss-allergies.pdf (“An increase in prevalence, however, is difficult to confirm because good baseline data from earlier years for comparative purposes are lacking. Certainly, the awareness of food allergy has increased. More individuals may seek specialized medical attention from allergists as a result of this increased awareness. But, almost everyone agrees that the prevalence of severe food allergies seems to be increasing. The reasons for this apparent increase are unknown.”).
There is no doubt that allergies in general have been on the rise. See, e.g., National Institute of Allergy and Infectious Diseases of the National Institutes of Health, U.S. Dept. of Health and Human Services, Current Trends in Allergic Reactions: A Multidisciplinary Approach to Patient Management, 21(3) CLINICIAN (Sept. 2003), at ii, 1 available at http://www.niaid.nih.gov/research/Allergy_Monograph_FINAL.pdf. (“The prevalence of allergic diseases is rising, and their impact on health, productivity, and quality of life is now much more acutely and widely felt. ... Allergic disorders are extremely common, and their prevalence has risen steadily over the past several decades, in the United States and in developed countries worldwide”).
[43] See generally Sicherer, et al., Prevalence of Peanut and Tree Nut Allergy in the United States Determined by Means of a Random Digit Dial Telephone Survey: a 5-year Follow-up Study, 112(6) J. ALLERGY CLIN. IMMUNOL. 1203-7 (Dec. 2003). This study employed a cross-sectional telephone study of 13,493 people using a standardized questionnaire to research the self-reported prevalence of peanut allergies in children between 1997 and 2002. A Canadian study similarly found an increase in the prevalence of peanut allergy among children. See American Academy of Allergy, Asthma & Immunology, Prevalence of Peanut and Tree Nut allergies on the Rise: New research from the Journal of Allergy and Clinical Immunology, Dec. 9, 2003, at http://www.aaaai.org/media/news_releases/2003/12/120903.stm. See also CONG. REC. H6100 (July 20, 2004) (statement of Rep. Lowey) (citing this statistic while encouraging representatives to pass the FALCPA); S. REP. NO. 108-226, at 3 (2004).
[44] American Academy of Allergy, Asthma & Immunology, Prevalence of Peanut and Tree Nut allergies on the Rise: New research from the Journal of Allergy and Clinical Immunology, Dec. 9, 2003, at http://www.aaaai.org/media/news_releases/2003/12/120903.stm. See also, e.g., Jennifer Mann, United States to Require Food Allergy Alerts, THE KANSAS CITY STAR (Aug. 7 2004), available at 2004 WL 55803892. (“[T]he number of people who are allergic to one or more foods is on the rise. Hugh Sampson, professor of pediatrics and biomedical sciences at the Mount Sinai School of Medicine in New York City and one the country’s experts on allergies, said the medical community does not know why more people are developing reactions to foods. ‘The only thing we do know is that in general they have been increasing over the past two decades,’ Sampson, a physician, said.”).
[45] See Hugh A. Sampson et al., Fatal and Near-Fatal Anaphylactic Reactions to Food in Children and Adolescents, 327 NEW ENG. J. MED. 380, at 384 (1992) (“It is our belief and that of other investigators studying food allergy that the frequency of fatal and near-fatal food-induced [allergic] reactions has risen over the past several years.”).
[46] Ray Formanek, Jr., Food Allergies: When Food Becomes the Enemy, FDA CONSUMER MAGAZINE, July-August 2001, available at http://www.fda.gov/fdac/features/2001/401_food.html (“‘The prevalence of food allergy is growing and probably will continue to grow along with all allergic diseases,’ says Robert A. Wood, M.D., director of the pediatric allergy clinic at Johns Hopkins Medical Institutions in Baltimore. Wood says that research over the last three decades indicates that the number of people with allergies is skyrocketing in developed and developing countries, but not in underdeveloped areas.”).
[47] The CDC estimates that as of 2002 13.4 million American adults were diagnosed with diabetes. National Center for Health Statistics, CDC, Fast Stats A to Z, at http://www.cdc.gov/nchs/fastats/diabetes.htm.
[48] Epilepsy Foundation, Epilepsy: An Introduction, at http://www.epilepsyfoundation.org/answerplace/About-Epilepsy.cfm.
[49] Alzheimer's Disease Education & Referral Center, National Institute on Aging, General Information, at http://www.alzheimers.org/generalinfo.htm.
[50] National Center for Health Statistics, CDC, Fast Stats A to Z, at http://www.cdc.gov/nchs/fastats/stroke.htm.
[51] National Center for Health Statistics, CDC, Fast Stats A to Z, at http://www.cdc.gov/nchs/fastats/cancer.htm.
[52] National Center for Health Statistics, CDC, Fast Stats A to Z, at http://www.cdc.gov/nchs/fastats/heart.htm.
[53] Susan L. Hefle & Steve L. Taylor, Food Allergies and Other Food Sensitivities, 55(9) FOOD TECHNOLOGY 69, 71 (Sept. 2001), available at http://www.ift.org/publications/docshop/ft_shop/09-01/09_01_pdfs/09-01-sss-allergies.pdf.
[54] S. Allan Bock, et al., Fatalities Due to Anaphylactic Reactions to Foods, 107 J. ALLERGY. CLIN. IMMUNOL. 191, 193(2001) (“A number of recent reports of food-induced anaphylaxis and food-related fatalities provide insight into the magnitude of this problem. From 1983 to 1987, investigators found an anaphylaxis occurrence rate of 30 per 100,000 person-years in a population-based study of Olmstead County, Minn. In their emergency department, allergic reactions to food were the leading identifiable cause of anaphylactic reactions. Extrapolating from these data would predict that there are about 29,000 anaphylactic episodes due to food allergy in the United States each year, resulting in about 150 deaths. A Danish study reported a fatality rate of 5%.”). See also, e.g., FALCPA § 202(1)(B).
[55] S. Allan Bock, et al., Fatalities Due to Anaphylactic Reactions to Foods, 107 J. ALLERGY. CLIN. IMMUNOL. 191, 193(2001).
[56] Anne Muñoz-Furlong, A Public Meeting: the Challenge of Labeling Food Allergens sponsored by FDA, Public Meeting transcript at 32 (Aug. 13, 2001), available at http://www.fda.gov/ohrms/dockets/dockets/00p_1322/00p1322tr.htm.
[57] H.A. Sampson, Food Allergy: From Biology Toward Therapy, HOSPITAL PRACTICE (May 2000), available at http://www.hosppract.com/issues/2000/05/sampson.htm (“Four studies, including one at the Mayo Clinic in Minnesota, another by a Florida group, and two in England, have now tallied the causes of anaphylactic episodes addressed in emergency rooms. The leading cause, accounting for a third of all cases, is food, with twice the incidence, and three times the mortality, of anaphylactic reactions to bee sting.”). See also National Institute of Allergy and Infectious Diseases, U.S. Department of Health and Human Services (Dec. 2004), at http://www.niaid.nih.gov/factsheets/allergystat.htm (stating that between 40 and 100 Americans have been reported to die annually from anaphylaxis to insects); S. Allan Bock, et al., Fatalities Due to Anaphylactic Reactions to Foods. 107 J. ALLERGY. CLIN. IMMUNOL. 191, 193 (2001).
[58] See Chris Bodendorfer, Jennifer Johnson, & Sue Hefle, Got (Hidden) Food Allergens?, THE NATIONAL PROVISIONER, (Oct. 2004) at http://www.nationalprovisioner.com/content.php?s=NP/2004/10&p=8 (citing CDC E. Coli estimates).
[59] Chris Bodendorfer, Jennifer Johnson, & Sue Hefle, Got (Hidden) Food Allergens?, THE NATIONAL PROVISIONER, (Oct. 2004) at http://www.nationalprovisioner.com/content.php?s=NP/2004/10&p=8 (“Use of ingredients derived from several of the ‘Big 8’ food allergens (soy, milk, wheat, and egg) is becoming more common as meat and poultry product manufacturers search for ways to lower product fat levels and provide customers with an array of differently priced proteins.”).
[60] See Susan L. Hefle, et al., Allergenic Foods, 36(S) CRIT. REV. IN FOOD SCI. AND NUTRITION, S69, S70, Table 2 (1996) (summarizing a comprehensive review of scientific literature regarding allergic reactions to food).
[61] Fish allergy includes all species of finfish, both fresh water and salt water. Steve L. Taylor, Emerging Problems – Food Allergens, FAO Conference on International Food Trade Beyond 2000 (Oct. 1999), at http://www.fao.org/docrep/meeting/x2670e.htm.
[62] For food allergy purposes, “crustacean shellfish” includes shrimp, prawns, crab, lobster, and crayfish. Steve L. Taylor, Emerging Problems – Food Allergens, FAO Conference on International Food Trade Beyond 2000 (Oct. 1999), at http://www.fao.org/docrep/meeting/x2670e.htm.
[63] The category “tree nuts” comprises almonds, walnuts, pecans, cashews, Brazil nuts, pistachios, hazelnuts, pine nuts, macadamia nuts, chestnuts, and hickory nuts. Steve L. Taylor, Emerging Problems – Food Allergens, FAO Conference on International Food Trade Beyond 2000 (Oct. 1999), at http://www.fao.org/docrep/meeting/x2670e.htm.
[64] See, e.g., Susan L. Hefle & Steve L. Taylor, Food Allergies and Other Food Sensitivities, 55(9) FOOD TECHNOLOGY 69, 71 (Sept. 2001), available at http://www.ift.org/publications/docshop/ft_shop/09-01/09_01_pdfs/09-01-sss-allergies.pdf; FDA, Compliance Policy Guidance for FDA Staff, update to the Compliance Policy Guides Manual (Aug. 2000 edition), issued Apr. 19, 2001, Sec. 555.250, available at http://www.idfa.org/reg/fda/guide.cfm#b1 (appendix B) (“FDA believes there is scientific consensus that the following [Big Eight] foods can cause serious allergic reactions in some individuals and account for more than 90% of all food allergies”); S.A. Bock & F.M. Atkins, Patterns of Food Hypersensitivity During Sixteen Years of Double-Blind, Placebo-Controlled Food Challenges, 117(4) J. OF PEDIATR. 561, 565 (1990) (“Foods purported to produce adverse reactions [in the children studied] compose a long list, but those which regularly elicit symptoms form a much shorter list. Ninety-five percent of the food reactions objectively confirmed in this study were to egg, peanut, milk, tree nuts, soy, fish, and wheat. Seventy-three percent of the symptomatic reactions were triggered by egg, peanut, and milk.”). See also FALCPA § 202(2)(A).
For a more detailed analysis of this statistic that became the basis of the principal provisions of the FALCPA, see Part V Limitations, subpart B(1), infra.
[65] See H.A. Sampson, Food Allergy: From Biology Toward Therapy, HOSPITAL PRACTICE (May 2000), available at http://www.hosppract.com/issues/2000/05/sampson.htm (estimating that these foods are responsible for 90% of allergic reactions in American children). See also, e.g., S.A. Bock & F.M. Atkins. Patterns of Food Hypersensitivity During Sixteen Years of Double-Blind, Placebo-Controlled Food Challenges, 117(4) J. OF PEDIATR. 561, 561-2 (1990); Hugh A. Sampson, Food Allergies, 278(22) JAMA 1888-94 (Dec. 10 1997); Ray Formanek, Jr., Food Allergies: When Food Becomes the Enemy, FDA CONSUMER MAGAZINE, July-Aug. 2001, available at http://www.fda.gov/fdac/features/2001/401_food.html.
[66] A seminal study of 480 children with food allergies found that nearly 30% of the children were sensitive to more than one food. See S.A. Bock & F.M. Atkins. Patterns of Food Hypersensitivity During Sixteen Years of Double-Blind, Placebo-Controlled Food Challenges, 117(4) J. OF PEDIATR. 561, 564 (1990). Another study found that over 50% of children allergic to milk appeared to be hypersensitive to one or more other foods. Auckland Allergy Clinic, Multiple Food Allergies, June 2002, at http://www.allergyclinic.co.nz/guides/45.html, citing J.M. Bishop et al., Natural History of Cow’s Milk Allergy: Clinical Outcome. 116 J. PEDIATRICS 862 (1990).
[67] See, e.g., H.A. Sampson, Food Allergy: From Biology Toward Therapy, HOSPITAL PRACTICE (May 2000), available at http://www.hosppract.com/issues/2000/05/sampson.htm (estimating that these foods are responsible for 85% of allergic reactions in American adults).
[68] See, e.g., Susan L. Hefle & Steve L. Taylor, Food Allergies and Other Food Sensitivities, 55(9) FOOD TECHNOLOGY 69, 73 (Sept. 2001), available at http://www.ift.org/publications/docshop/ft_shop/09-01/09_01_pdfs/09-01-sss-allergies.pdf; Hugh A. Sampson, Food Allergies, 278(22) JAMA 1888-94 (Dec. 10 1997).
[69] See, e.g., Hugh A. Sampson, Food Allergies, 278(22) JAMA 1888-94 (Dec. 10 1997); Hugh A. Sampson & Dean D. Metcalfe, Food Allergies, 268 JAMA 2840,2843 (Nov. 25 1992).
[70] See, e.g., Hugh A. Sampson & Dean D. Metcalfe, Food Allergies, 268 JAMA 2840, 2841 (Nov. 25 1992); S. Allan Bock, et al., Fatalities Due to Anaphylactic Reactions to Foods, 107 J. ALLERGY CLIN. IMMUNOL. 191, 191 (2001).
[71] See, e.g., Hugh A. Sampson & Dean D. Metcalfe, Food Allergies, 268 JAMA 2840,2843 (Nov. 25 1992).
[72] See, e.g., Hugh A. Sampson & Dean D. Metcalfe, Food Allergies, 268 JAMA 2840, 2842 (Nov. 25 1992) (“Once the diagnosis of celiac disease is established, life-long elimination of gluten-containing foods is necessary to control symptoms and to avoid the increased risk of malignancy.”).
[73] See, e.g., Steve L. Taylor, Emerging Problems – Food Allergens, FAO Conference on International Food Trade Beyond 2000 (Oct. 1999), at http://www.fao.org/docrep/meeting/x2670e.htm (“In some countries, a much higher percentage of the population believes that they have food allergies because of self-diagnosis, parental diagnosis, and misconceptions and misdiagnosis by some physicians.”).
[74] D.R. Altman & L.T. Chiaramonte, Public Perception of Food Allergy, 97(6) J. ALLERGY CLIN. IMMUNOL. 1247-51 (June 1996) (finding that roughly 15% of homes surveyed in 1989, 1992, and 1993 reported an average of 1.17 household members with a food allergy, and concluding that perceived food allergy is widespread and persistent despite the fact that such beliefs are not reflective of known food allergy epidemiology derived from double-blind placebo-controlled food challenges). See also H.A. Sampson, Food Allergy: From Biology Toward Therapy, HOSPITAL PRACTICE (May 2000), available at http://www.hosppract.com/issues/2000/05/sampson.htm (“In some surveys, as much as 20% to 25% of the American public reports being allergic to one or another food. Likewise, respondents in about a fourth of American households say they have changed their dietary habits to accommodate a food problem. Most such beliefs are erroneous.”).
[75] See, e.g., S.A. Bock & F.M. Atkins. Patterns of Food Hypersensitivity During Sixteen Years of Double-Blind, Placebo-Controlled Food Challenges, 117(4) J. OF PEDIATR. 561, 564 (1990) (“For those skeptics who do not believe that food hypersensitivity exists, these objective observations and those of other authors demonstrate the ability of food proteins to produce immunologically mediated reactions.”); H.A. Sampson, Food Allergy: From Biology Toward Therapy, HOSPITAL PRACTICE (May 2000), available at http://www.hosppract.com/issues/2000/05/sampson.htm (“[F]ood allergy is more common than some physicians may think.”).
[76] Dr. Alessio Fasano (Director, Center for Celiac Research, University of Maryland), speech given to the Washington Area Celiac Sprue Support Group, Aspen Hill Public Library, Rockville, MD (Mar. 5, 2005). According to Dr. Fasano, NIH stated it would not recognize celiac disease until the science was further developed regarding how to diagnose the disorder and regarding its prevalence in the United States. The disorder did not achieve recognition until a June 2004 conference sponsored by the National Institutes of Health. See generally National Institutes of Health Consensus Development Program, NIH Consensus Development Conference on Celiac Disease June 28-30, 2004, available at http://consensus.nih.gov/cons/118/118cdc_intro.htm.
[77] Susan L. Hefle & Steve L. Taylor, Food Allergies and Other Food Sensitivities, 55(9) FOOD TECHNOLOGY 69, 80 (Sept. 2001), available at http://www.ift.org/publications/docshop/ft_shop/09-01/09_01_pdfs/09-01-sss-allergies.pdf.
[78] National Institute of Allergy and Infectious Diseases of the National Institutes of Health, U.S. Dept. of Health and Human Services, Current Trends in Allergic Reactions: A Multidisciplinary Approach to Patient Management, 21(3) CLINICIAN (Sept. 2003), at 18, available at http://www.niaid.nih.gov/research/Allergy_Monograph_FINAL.pdf (“Allergic diseases affect millions of Americans annually, and their prevalence continues to increase. Although they have a tremendous impact on daily functioning and quality of life and predispose patients to much more serious and costly conditions, they are too often dismissed as nuisance conditions. Even when healthcare providers are committed to treatment, the time constraints of today’s clinical practice limit the amount of attention that can be devoted to meticulous analysis of symptoms, repeated adjustments of therapy, and thorough patient education.”).
[79] Susan L. Hefle & Steve L. Taylor, Food Allergies and Other Food Sensitivities, 55(9) FOOD TECHNOLOGY 69, 73 (Sept. 2001), available at http://www.ift.org/publications/docshop/ft_shop/09-01/09_01_pdfs/09-01-sss-allergies.pdf.
[80] H.A. Sampson, Food Allergy: From Biology Toward Therapy, HOSPITAL PRACTICE (May 2000), available at http://www.hosppract.com/issues/2000/05/sampson.htm (“One of the difficulties in appreciating the impressive prevalence of food allergy is that it presents as a broad spectrum of syndromes, many of which are not hives (the classic food reaction) or IgE-mediated (the classic allergy mechanism). ... Instead, physicians may be confronted by complaints such as unexplained wheezing or eczema. Even the purely gastrointestinal manifestations of food allergy can be remarkably varied.”); Susan L. Hefle, et al., Allergenic Foods, 36(S) CRIT. REV. IN FOOD SCI. AND NUTRITION S69, S70 (1996) (“The variability in symptoms is quite large both between individual patients and between different studies (groups of patients). Even individual patients display variable responses depending on such factors as the exposure dose to the offending food.”); Susan L. Hefle & Steve L. Taylor, Food Allergies and Other Food Sensitivities, 55(9) FOOD TECHNOLOGY 69, 70 (Sept. 2001), available at http://www.ift.org/publications/docshop/ft_shop/09-01/09_01_pdfs/09-01-sss-allergies.pdf (“With the wide range of symptoms that can be involved in IgE-mediated food allergies and the possibility of other causes for many of these symptoms, the diagnosis of IgE-mediated food allergies can sometimes be challenging.”).
[81] See P.H. Green, Characteristics of Adult Celiac Disease in the USA: Results of a National Survey, AMERICAN JOURNAL OF GASTROENTEROLOGY (2001); see also David Brown, An Ailment’s Common Grain: Survey Finds Surprising Incidence of Gluten Reaction, WASHINGTON POST (Feb. 11, 2003), at A01 (“[M]ost doctors miss the diagnosis of celiac disease. It’s now clear that the textbook description of this once-obscure ailment is woefully incomplete and describes only a minority of cases. Below the tip of the so-called celiac iceberg is a diverse world of illness that may include thousands of people suffering from various, seemingly unrelated conditions, such as anemia, osteoporosis, infertility, irritable bowel syndrome and chronic fatigue.”).
[82] Hugh A. Sampson & Dean D. Metcalfe, Food Allergies, 268 JAMA 2840, 2843 (Nov. 25 1992) (“The diagnosis of food allergy remains a clinical exercise dependent on a careful history, selective skin tests or RASTs if an IgE-mediated disorder is suspected, appropriate exclusion diet, and blinded provocation.”).
[83] See S.A. Bock & F.M. Atkins. Patterns of Food Hypersensitivity During Sixteen Years of Double-Blind, Placebo-Controlled Food Challenges, 117(4) J. OF PEDIATR. 561, 561 (1990) (stating that the double-blind, placebo-controlled food challenge should be the “gold standard” for both research and clinical diagnostic evaluations); Hugh A. Sampson, Food Allergies, 278(22) JAMA 1888-94 (Dec. 10 1997).
[84] For discussion of the persisting confusion surrounding diagnoses of food sensitivities within the medical and scientific community, see, e.g., Allison Hoover Bartlett, The Hunger: A Food Allergy Mystery, THE WASHINGTON POST (June 25, 2002), at HE01.
[85] See, e.g., Hugh A. Sampson & Dean D. Metcalfe, Food Allergies, 268 JAMA 2840, 2843 (Nov. 25 1992) (“Strict elimination of the offending allergen is the only proven therapy once the diagnosis of food hypersensitivity has been established.”). See also FALCPA § 202(2)(B),(C). Some symptoms of immediate hypersensitivity allergic reactions can be mitigated after-the- fact through use of antihistamines and epinephrine.
[86] See, e.g., Susan L. Hefle & Steve L. Taylor, Food Allergies and Other Food Sensitivities, 55(9) FOOD TECHNOLOGY 69, 74 (Sept. 2001), available at http://www.ift.org/publications/docshop/ft_shop/09-01/09_01_pdfs/09-01-sss-allergies.pdf (“The precise threshold doses for allergenic foods have not been carefully investigated and are likely to be variable from one allergic individual to another. ... While this experiment
clearly demonstrates that the threshold level is not zero, the threshold dose is quite low. Whether other allergenic
foods have thresholds as low as those for peanuts remains to be determined.”). See also Steve L. Taylor, Emerging Problems – Food Allergens, FAO Conference on International Food Trade Beyond 2000 (Oct. 1999), at http://www.fao.org/docrep/meeting/x2670e.htm (“Celiac sufferers are thought to react to ingestion of trace amounts of the offending food, although the threshold dose has not been carefully established.”).
[87] H.A. Sampson, Food Allergy: From Biology Toward Therapy, HOSPITAL PRACTICE (May 2000), available at http://www.hosppract.com/issues/2000/05/sampson.htm (“For patients with a food allergy, places such as supermarkets, restaurants, and even a home dining room can be a minefield. Unable to be certain that what they eat is free of allergen, many patients do not dine at restaurants at all and become uneasy whenever human sociability includes food consumption.”).
[88] Email from CM, Allergen Labeling Survey (Jan. 12, 2005).
[89] Email from CM, Allergen Labeling Survey (Jan. 12, 2005).
[90] CONG. REC. HR 6100 (July 20, 2004) (statement of Rep. Shuster).
[91] See, e.g., Leers (Apr. 13, 2005), PeanutAllergy.org, Thread: Living With Peanut Allergy, Topic: Aside from Legalities Etc. Do You Consider Your Child a Special Needs Child at School, at http://www.peanutallergy.com/bbpage.htm (“As I don’t perceive [my peanut-allergic son] as special needs, I think society [and the] school do because they have to make special accomodations for him. Kinda of sucks because as I have posted elsewhere I think that is why [he] is sometimes picked on. ... He seldom gets invited to parties or anyones home because I think some people find my lifestyle a hassle and don’t want to have to accomodate for [him].”); CSC (Apr. 13, 2005), id. (“I have really noticed through the years, and notice more as my non-[peanut-allergic] daughter gets older, that my [peanut-allergic] son is definitely excluded from birthday parties, play-dates, etc. because of his [peanut allergy] (or, our lifestyle, as you say). ... I think most people are simply afraid to have him around. ... I honestly believe most people are scared. ... It’s just one of the facts of our life.”).
[92] Some peanut-allergic individuals react severely to airborne exposure to peanut proteins. Confined spaces, such as airplanes, generate particular risks. FAAN has worked to educate airlines and people who fly about these dangers and to encourage airlines to discontinue service of products containing peanuts. “The good news is that there are now more options for passengers with peanut allergy. The bad news is that there are still some carriers, namely Continental, ATA, and America West, who refuse to make any accommodations for passengers with peanut allergy,” FAAN reports. FAAN, Advocacy: Airlines, at http://www.foodallergy.org/Advocacy/airlines.html (advising peanut-allergic flyers to contact airlines in advance to request a peanut-free flight, to ask for a written confirmation of the request and the airline’s response, and to bring physician documentation of the food allergy to the airport, especially if the flyer is bringing self-injectable epinephrine on the flight). See also, e.g., H.A. Sampson, Food Allergy: From Biology Toward Therapy, HOSPITAL PRACTICE (May 2000), available at http://www.hosppract.com/issues/2000/05/sampson.htm (“One highly publicized outcome has been the decision by several airlines to stop serving bags of peanuts in-flight. Some highly susceptible patients had experienced reactions when passengers throughout a plane popped their bags open, expelling allergenic dust.”).
[93] See generally N.J. Avery et al., Assessment of Quality of Life in Children with Peanut Allergy, 14(5) PEDIATR. ALLERGY IMMUNOL. 378-82 (Oct. 14 2003).
[94] S.H. Sicherer, et al., The Impact of Childhood Food Allergy on Quality of Life, 87(6) ANN. ALLERGY ASTHMA IMMUNOL. 461, 461 (Dec. 2001).
[95] S.H. Sicherer, et al., The Impact of Childhood Food Allergy on Quality of Life, 87(6) ANN. ALLERGY ASTHMA IMMUNOL. 461, 461-2 (Dec. 2001).
[96] S.H. Sicherer, et al., The Impact of Childhood Food Allergy on Quality of Life, 87(6) ANN. ALLERGY ASTHMA IMMUNOL. 461, 461, 463 (Dec. 2001).
[97] See generally PeanutAllergy.com, Thread: Living With Peanut Allergy, Topic: Hate to Hear the Phone Ring, at http://www.peanutallergy.com/bbpage.htm.
[98] To name but a handful: Celiac.com (www.celiac.com), Food Allergy & Anaphylaxis Network (www.foodallergy.org), Food Allergy Initiative (www.foodallergyinitiative.org), Food Allergy News for Kids and Food Allergy News for Teens (http://www.fankids.org/), Food Allergy Survivors Together (http://www.angelfire.com/mi/FAST.com), PeanutAllergy.com (www.peanutallergy.com), Parents Of Food Allergic Kids (www.pofak.com).
[99] Sarah Gitlin, Public Meeting transcript, A Public Meeting: the Challenge of Labeling Food Allergens (Aug. 13, 2001), at 223, available at http://www.fda.gov/ohrms/dockets/dockets/00p_1322/00p1322tr.htm.
[100] U. S. Food and Drug Administration, Food Allergies: Rare but Risky, FDA CONSUMER (May 1994, updated Dec. 2004), at http://www.cfsan.fda.gov/~dms/wh-alrg1.html.
[101] See, e.g., H.A. Sampson, Food Allergy: From Biology Toward Therapy, HOSPITAL PRACTICE (May 2000), available at http://www.hosppract.com/issues/2000/05/sampson.htm (stating in an article for physicians that “telling a patient simply not to drink milk or eat peanuts displays a dangerous naiveté about food. The patient needs to be given an idea of how ubiquitous – and unexpected – an allergen can be in today’s food supplies.”); Greg Winter, Calls Increasing for Clarity on Food Labels, The New York Times on the Web (July 2, 2002), www.nytimes.com (“Part of the problem, some experts say, is that most doctors tell patients to stay away from allergy-provoking ingredients without offering any tips on deciphering labels. ‘I don’t think most doctors even know that the words ‘casein’ and ‘whey’ are even listed on products,’ Dr. Scott H. Sicherer, an author of the [a 2002 label study conducted by the American Academy of Allergy, Asthma and Immunology], said.”).
[102] See, e.g., Susan L. Hefle & Steve L. Taylor, Food Allergies and Other Food Sensitivities, 55(9) FOOD TECHNOLOGY 69, 74 (Sept. 2001), available at http://www.ift.org/publications/docshop/ft_shop/09-01/09_01_pdfs/09-01-sss-allergies.pdf (“The construction of safe and effective avoidance diets is often a challenge for individuals with food allergies. With packaged foods, these individuals must spend considerable time in the scrutiny of ingredient declarations on product labels. They must be taught to recognize the many terms that may signify the presence of food components or ingredients derived from their offending food(s). Some foods, especially in foodservice settings, are sold without ingredient statements. Clearly, the allergic consumer can encounter many hazardous situations in such circumstances and must be trained to be extremely vigilant. Also, exposure to very small amounts of the offending food may be sufficient to elicit allergic reactions in some sensitive individuals, further complicating the necessary vigilance in the implementation of effective avoidance diets.”).
[103] Ray Formanek, Jr., Food Allergies: When Food Becomes the Enemy, FDA CONSUMER MAGAZINE, July-August 2001, available at http://www.fda.gov/fdac/features/2001/401_food.html. See also FDA, Compliance Policy Guide (Apr. 19, 2001), at § 555.250, available at http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg555-250.htm (“Frequently [allergic reactions] occur because the presence of the allergenic substances in the foods is not declared on the food label.”). Additionally, the absence of plain English labeling was one of the three primary issues addressed at a 2001 Public Meeting sponsored by the FDA regarding food allergen labeling. 66 FED. REG. 38591, 38591 (July 25, 2001).
[104] In 1995, food allergy experts from around the world discussed the critical importance of the food label and what standards food labels in the global marketplace should follow during a conference sponsored by the Food and Agriculture Organization of the United Nations:
The food label is the vehicle used by the consumer, and the retailer, for that matter, to obtain information about a product at the point of purchase. If the label is deficient or not transparent as to contents, the health of the consumer may be at risk. The label is the vehicle for risk communication with consumers, probably the most effective vehicle available. It is doubtful that experts involved with the treatment of individuals suffering from a food allergy, hypersensitivity or intolerance can do other than advise their patients to avoid certain specific foods or ingredients. They may have limited information on specialized products or refer patients for diet counseling and design to eliminate problem foods or substances. Consumers, for their part, must educate themselves about their particular needs. They must be prepared to exercise extreme caution when approaching a new food product and deny themselves any questionable choice. Ultimately, however, governments have the responsibility, as they approve an ever increasing number of technological innovations, ingredient modifications and the manipulation of familiar foodstuffs, to meet the information needs of consumers and ensure even more transparency about the food products they allow into national markets.
Jean Bousquet et al., Food Allergy, FAO TECHNICAL CONSULTATION ON FOOD ALLERGIES, Annex 4, at 9 (Rome, 1995).
See also 44 FED. REG. 75990, 75991-2 (Dec. 21, 1979) (“The purpose of food labeling is to enable consumers to select and use products that meet their individual needs and preferences. To achieve that purpose, labeling must provide sufficient information to enable the public to identify foods and their characteristics, including their ingredients and nutritional value.”).
[105] A mother of twin 20 month old boys with multiple allergies expressed frustrations typical of food sensitive individuals in response to the Allergen Labeling Survey: “I can tell you first hand that it is a part time job reading and investigating food labels.” Email from DT, Allergen Labeling Survey (Jan. 10, 2005).
[106] See, e.g., Ray Formanek, Jr., Food Allergies: When Food Becomes the Enemy, FDA CONSUMER MAGAZINE, (July-Aug. 2001), available at http://www.fda.gov/fdac/features/2001/401_food.html (“Current labeling guidelines allow the use of ‘nondairy’ when the foods contain milk byproducts.”).
[107] Meat and poultry products are, in fact, increasingly a source of concern to food sensitive individuals. The use of ingredients derived from soy, milk, wheat, and egg in meat and poultry products has been increasing as “manufacturers search for ways to lower product fat levels and provide customers with an array of differently priced proteins.” See Chris Bodendorfer, Jennifer Johnson, & Sue Hefle, Got (Hidden) Food Allergens?, THE NATIONAL PROVISIONER (Oct. 2004), available at http://www.nationalprovisioner.com/content.php?s=NP/2004/10&p=8.
[108] Wheat flour may be used as an anti-clumping agent for shredded cheese.
[109] In 1979 the FDA publicly recognized the changing nature of food products and the difficulty consumers have in determining the contents of products by simply looking at the product or relying on food “standards of identity” that had been established by the agency. “Since [the FFD&CA was] enacted, significant changes have occurred in the food industry, in Americans’ attitudes toward the food supply, and in their dietary habits. Widespread and rapid advances in food processing and distribution have made a greater variety of foods available to more people. This new technology has so increased the number of processed foods on the market that such products now account for more than half of the American diet. ... The central point that emerges from the comments is this: as the number of processed foods and the number of unfamiliar ingredients in these foods has grown, the task of interpreting names of ingredients and their functions has become extremely difficult for many consumers.” 44 FED. REG. 75990, 75991, 76000 (Dec. 21, 1979).
[110] Contamination of non-processed foods can occur during the preparation and/or packaging of the items, through pesticide use, and through genetic engineering. The FDA encourages the presence of colors, preservatives, and waxes be declared at the point of sale of fresh fruits and vegetables, but this practice is not enforced, and the FDA has not sought statutory authority to impose similar requirements for pesticides and fertilizers. See 44 FED. REG. 75990, 76000 (Dec. 21, 1979).
In 1998, the EPA, of its own initiative, gave blanket permission for food to be used in pesticides when it issued an exemption to its normal tolerance requirements for residues on crops. In recognition of the allergenicity problems this new position posed for consumers, the EPA at least helpfully contiued to require compounds containing the eight food allergens responsible for the serious adverse reactions to undergo the typical approval procedure. See 63 FED. REG. 66999 (Dec. 4 1998) (“This document establishes an exemption from the requirement of a tolerance for residues of any edible food commodity (except for peanuts, tree nuts, milk, soybeans, eggs, fish, crustacea, and wheat) used as a pesticide, when applied in accordance with good agricultural practices, in or on all food commodities.”) (emphasis added); 67 FED. REG. 1925, 1227 (Jan. 15, 2002) (“[O]n December 4, 1998, [the EPA established] a tolerance exemption for all edible food commodities. That exemption excepted certain foods known to have allergenic properties. ... [T]he Agency is proposing to place 3-year expiration dates on the eight tolerance exemptions that will remain. This will give the Agency a period of 3 years to continue its examination of the uses of these food commodities, and discuss product re-formulation with affected registrants. The Agency recognizes that various factors such as restrictions on post-harvest applications or information on the environmental degradation/metabolism of the allergen may enable the Agency, at a future date, to (1) make a determination of safety, (2) reassess these tolerances, and (3) establish tolerance exemptions with limitations on the use pattern, that would not be time-limited.”); 70 FED. REG. 1357 (stating the final rule establishing an “exemption from the requirement of a tolerance for residues of peanuts, tree nuts, milk, soybeans, eggs, fish, crustacea, and/or wheat when used as inert or active ingredients in pesticide products, for certain use patterns.”).
[111] H.R. REP. NO. 108-608, at 9 (2004).
[112] This point was stressed by Representative Lowey, the primary sponsor of the FALCPA in the House, when she spoke on the floor to urge the FALCPA’s passage. CONG. REC. H6100 (July 20, 2004) (statement of Rep. Lowey) (“Navigating insufficient labels is much more than an irritation for the millions with food allergies. It is a matter of life and death.”).
[113] I in no way suggest that food manufacturers have tried to deceive or imperil consumers or subvert existing law. Cf. Llewellyn H. Rockwell, Jr., Do Food Makers Want to Kill You?, LewRockwell.com (July 24, 2003 (sic)), at http://www.mises.org/fullstory.aspx?control=1572 (arguing that government regulation of food labels with respect to allergens is not needed since market forces are sufficient to allay problems of asymmetrical information, and suggesting that people concerned about undeclared food allergens are maligning the intentions of food manufacturers):
Many politicos on Capitol Hill are under the impression that food manufacturers are neglectfully poisoning the 6-11 million Americans who have food allergies by sneakily failing to point out on labels that the food contains deadly ingredients. So here we have the ultimate paranoid-socialist fantasy at work: business rakes in profits through fraud while people die! ... But think about this. It is rather implausible that anyone selling food would somehow be reluctant to say that this or that product contains milk, eggs, peanuts, or whatever. This is not information anyone would have a reason to hide. These are not ingredients that somehow gross out consumers, or chemicals that producers would just as soon people not know about. (emphasis added)
The asymmetrical information between food manufacturers and consumers that has historically existed can be attributed to numerous factors, some of which will be discussed more fully in this subsection as well as in Part III B concerning the response of industry to food sensitivity issues. Contributing factors include the following: ingredient disclosure can be technically accurate but nonetheless unintelligible; the law does not require full disclosure of ingredients; good manufacturing practices have not been updated to account for allergen concerns; lack of awareness in industry of food allergies as a priority food safety concern; the cost – in some cases sizeable – of improving practices and disclosure to accommodate people with food sensitivities; and manufacturer reluctance to reveal proprietary information.
[114] 21 U.S.C. § 343(i).
[115] See, e.g., 44 FED. REG. 75990, 75995 (Dec. 21, 1979) (discussing results of a survey conducted by the FDA in 1978 of consumers regarding the food label and stating that “the most frequently cited problem was the use of technical and chemical names in the ingredient list, noted by a third of those expressing problems with labels.”). See also id at 75993 (“The majority [of commenters on the FDA’s proposed rule] urged that ingredient labeling be precise and easily understood by the average consumer.”).
[116] The FALCPA cites concerns about confusing ingredient terminology as a primary impetus for labeling reform. See FALCPA § 202(5)(B), 21 U.S.C.A. § 343(note) (“[I]n some cases, the common or usual name of an ingredient may be unfamiliar to consumers, and many consumers may not realize the ingredient is derived from, or contains, a major food allergen.”).
[117] For more information regarding other common and usual names for the Big Eight allergens, see generally H.A. Steinman, Hidden Allergens in Foods, 98(2) J. ALLERGY CLIN. IMMUNOL. (1996), 241-250, available at http://www.allergyadvisor.com/hidden.htm.
[118] Preeti Joshi et al., Interpretation of Commercial Food Ingredient Labels by Parents of Food-Allergic Children, 109(6) J. ALLERGY CLIN. IMMUNOL. 1019, 1020 (June 2002).
[119] Preeti Joshi et al., Interpretation of Commercial Food Ingredient Labels by Parents of Food-Allergic Children, 109(6) J. ALLERGY CLIN. IMMUNOL. 1019, 1020 (June 2002).
[120] FAAN, Consumers Find Food Allergen Labeling Confusing, Inconsistent, PRNEWSWIRE (June 28, 2002), at http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/06-28-2002/0001756038&EDATE=.
[121] Preeti Joshi et al., Interpretation of Commercial Food Ingredient Labels by Parents of Food-Allergic Children, 109(6) J. ALLERGY CLIN. IMMUNOL. 1019, 1020 (June 2002).
[122] This argument was one that Representative Lowey emphasized while advocating for the passage of the FALCPA. See, e.g., CONG. REC. H6100 (July 20, 2004) (statement of Rep. Lowey) (“[I]f adults cannot easily determine terms like whey, casein, lactose, how can you expect food-allergic children to remember so many complicated terms? The answer is, we cannot and we should not.”).
[123] One parent of a milk-allergic son who responded to the Allergen Labeling Survey illustrates this problem with a personal example:
The other problem was when my husband or someone else says, “no, I read the label, there is no milk in [this product].” I then read the label and say, “no, he cannot have it, there is whey protein in it, which is milk.” I made the mistake of letting [my son once] have some salad dressing ... which contained whey in it, and I noticed he was clearing his throat continually. I looked at him and noticed his lips were swelling and hives were breaking out all over his body. At this point I was aware he had a milk allergy but was never told of all the other names it could be called. I am now very educated – which I had to do. The problem is that mistakes like this could cost my son his life. I truly feel that labels need to be in plain print with the ingredients printed clearly right after it.
Email from DT on Jan. 10, in response to the Allergen Labeling Survey. Thousands, if not millions, of Americans have similar stories and share DT’s anxiety and frustration.
[124] Public Meeting transcript, A Public Meeting: the Challenge of Labeling Food Allergens, held Aug. 13, 2001, at 222, available at http://www.fda.gov/ohrms/dockets/dockets/00p_1322/00p1322tr.htm.
[125] S. Allan Bock, et al., Fatalities Due to Anaphylactic Reactions to Foods, 107 J. Allergy. Clin. Immunol. 191, 192 (2001). More than 90% of the fatalities were caused by an adverse reaction to peanuts and tree nuts. Id. at 191. Four individuals appeared to have received epinephrine in a timely fashion and yet did not survive. Id. at 193.
[126] S. Allan Bock, et al., Fatalities Due to Anaphylactic Reactions to Foods, 107 J. Allergy. Clin. Immunol. 191, 192 (2001). (For instance, a three-year-old child reacted fatally to milk at day care. A six-year-old died after inadvertently ingesting fish during lunch at school.)
[127] S. Allan Bock, et al., Fatalities Due to Anaphylactic Reactions to Foods, 107 J. ALLERGY. CLIN. IMMUNOL. 191, 193 (2001).
[128] See Anne Muñoz-Furlong, Public Meeting transcript, A Public Meeting: the Challenge of Labeling Food Allergens (Aug. 13, 2001), at 34, available at http://www.fda.gov/ohrms/dockets/dockets/00p_1322/00p1322tr.htm.
[129] Email from CM, Allergen Labeling Survey (Jan. 23, 2005).
[130] Eliot Spitzer, et al., Petition for Rules Regarding the Labeling and Manufacture of Foods Containing Allergenic Substances (May 26, 2000), available at http://www.idfa.org/membonly/reg/labeling/allergen.pdf.
[131] See Anne Muñoz-Furlong, Public Meeting transcript, A Public Meeting: the Challenge of Labeling Food Allergens (Aug. 13, 2001), at 34, available at http://www.fda.gov/ohrms/dockets/dockets/00p_1322/00p1322tr.htm.
[132] See Anne Muñoz-Furlong, Public Meeting transcript, A Public Meeting: the Challenge of Labeling Food Allergens (Aug. 13, 2001), at 141, available at http://www.fda.gov/ohrms/dockets/dockets/00p_1322/00p1322tr.htm.
[133] See Anne Muñoz-Furlong, Public Meeting transcript, A Public Meeting: the Challenge of Labeling Food Allergens (Aug. 13, 2001), at 141, available at http://www.fda.gov/ohrms/dockets/dockets/00p_1322/00p1322tr.htm.
[134] Email from MP, Allergen Labeling Survey (Jan. 10, 2005).
[135] Email from CM, Allergen Labeling Survey (Jan. 12, 2005). In the words of another Allergen Labeling Survey respondent, “I find it very frustrating finding food that my boys can have, and some I choose not to feed them because they are just too vague.”). Email from DT, Allergen Labeling Survey (Jan. 10, 2005).
[136] See, e.g., Steve L. Taylor, Emerging Problems – Food Allergens, FAO Conference on International Food Trade Beyond 2000 (Oct. 1999), at http://www.fao.org/docrep/meeting/x2670e.htm (“As with IgE-mediated food allergies, the cereal grains involved in celiac disease can be ‘hidden’ in foods as a result of the lack of source labelling (sic) of certain ingredients.”).
[137] The statement of findings in the FALCPA sites these “loopholes” as a primary reason for the legislation. See FALCPA § 202(5)(C), 21 U.S.C.A. § 343(note).
[138] 21 U.S.C.A. § 343(g),(i).
[139] 21 C.F.R. § 101.100(a)(3). See also 44 FED. REG. 75990, 76000 (Dec. 21, 1979).
[140] 66 FED. REG. 38591, 38591-2 (July 25, 2001).
[141] Susan L. Hefle & Steve L. Taylor, Food Allergies and Other Food Sensitivities, 55(9) FOOD TECHNOLOGY, 69, 73 (Sept. 2001), available at http://www.ift.org/publications/docshop/ft_shop/09-01/09_01_pdfs/09-01-sss-allergies.pdf.
[142] For instance, the degree of hydrolysis for hydrolyzed vegetable protein affects the ingredient’s ultimate allergenicity. See, e.g., Chris Bodendorfer et al., Got (Hidden) Food Allergens?, THE NATIONAL PROVISIONER (Oct. 2004), available at http://www.nationalprovisioner.com/content.php?s=NP/2004/10&p=8.
[143] See Preeti Joshi et al., Interpretation of Commercial Food Ingredient Labels by Parents of Food-Allergic Children, 109(6) J. ALLERGY CLIN. IMMUNOL. 1019, 1019 (June 2002).
[144] See generally Office of Scientific Analysis and Support, U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition, Food Allergen Partnership (Jan. 2001), available at www.cfsan.fda.gov/~dms/alrgpart.html (“Food allergens may become a part of a food through unintended routes. Examples of these are inadequate scheduling to protect against cross-contamination; improper cleaning between different products without analytical verification methods; use of allergen containing rework in non-allergen containing products. A firm should address these critical control points of manufacturing in an allergen control plan.”).
[145] Michael Jacobson, Public Meeting transcript, A Public Meeting: the Challenge of Labeling Food Allergens (Aug. 13, 2001), at 96, available at http://www.fda.gov/ohrms/dockets/dockets/00p_1322/00p1322tr.htm.
[146] Eliot Spitzer, NY State Attorney General, Petition for Rules Regarding the Labeling and Manufacture of Foods Containing Allergenic Substances, submitted by nine State Attorneys General, FDA Docket No. 00P-1322 (May 26, 2000), at 9, available at http://www.idfa.org/membonly/reg/labeling/allergen.pdf.
[147] House Joint Resolution 2 (Delegate Stern), United States Food and Drug Administration - Labeling Laws and Policies Relating to Allergenic Ingredients in Food, Maryland General Assembly (2001 Session), Department of Legislative Services, available at http://mlis.state.md.us/PDF-Documents/2001rs/fnotes/bil_0002/hj0002.PDF (asking the FDA to, inter alia, “create guidelines to prevent the migration of allergenic ingredients from one food product to another during processing and preparation.”).
[148] The Food Allergen Partnership found that opportunities for cross-contamination during production are great:
Product changeover presents an unintentional opportunity for product that contains an allergen to contaminate a product that does not contain that particular allergen, thus resulting in an undeclared allergen. Equipment cleaning is a critical allergen control point for the production of a non-allergen-containing product following product changeover. ... [The study found that p]roduction was frequently not scheduled or sequenced for allergen control. Bakeries would schedule production “First-in / First-out” or based on product color. ... Many firms did not have dedicated equipment for allergen and non-allergen product lines. Non-dedicated product lines were observed to be inadequately cleaned between products, rinsing equipment with water alone or only cleaning equipment at the end of the production day.
Office of Scientific Analysis and Support, U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition, Food Allergen Partnership (Jan. 2001), available at www.cfsan.fda.gov/~dms/alrgpart.html.
Allergy expert Dr. H.A. Sampson provides an example of the pervasive and perilous nature of cross-contamination:
Another child allergic to milk is given a box of assorted “dairy-free” fruit-flavored popsicles. He enjoys the orange one and the red one. The blue one causes a severe reaction, requiring intervention in an intensive care unit. The physicians are aware that food dyes very rarely cause reactions. On detailed inquiry, the manufacturer explains that “we always run the blue ones after the creamsicles.”
H.A. Sampson, Food Allergy: From Biology Toward Therapy, HOSPITAL PRACTICE (May 2000), available at http://www.hosppract.com/issues/2000/05/sampson.htm.
[149] See Office of Scientific Analysis and Support, U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition, Food Allergen Partnership (Jan. 2001), available at www.cfsan.fda.gov/~dms/alrgpart.html (“In many establishments common utensils were used in production of allergen and non-allergen containing products.... Cross-contamination also occurred when baking sheets were reused without cleaning, or when baking parchments were reused. Several firms [were] reported to reuse baking parchment six to ten times.”).
[150] See Sec. 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens (Apr. 19, 2001), Compliance Policy Guide, available at http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg555-250.htm.
[151] Office of Scientific Analysis and Support, U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition, Food Allergen Partnership (Jan. 2001), available at www.cfsan.fda.gov/~dms/alrgpart.html (“In an ideal situation there would not be rework or re-feed. Thirty-seven of the 85 firms inspected utilized rework. Of firms that utilized rework, 40 percent of Minnesota and 55 percent of Wisconsin firms had product that tested positive for undeclared allergen residues.”).
[152] See, e.g., Diane Eve Paley, Celiac Disease and Generic Drugs, Celiac Sprue Association (