LEDA at Harvard Law School LEDA at Harvard Law School
MSG:
T h e C o n t r o v e r s y
*
Marc Cavan
Food and Drug Law
Mr. Peter Barton Hutt
Harvard Law School
January 24, 1997
*chemical structure for monosodium glutamate (MSG)
"My whole family is allergic to [MSG]. [We] [g]et the
sweats, dizz[iness], headache, sleepnessness . . . and once I passed out in a Chinese restaurant because of it . . . ."
"By the way, my neurologist, bless his heart, says there is no way MSG can make me have a headache; but, I know better."[1]
-- America Online subscribers
The above quotes highlight an important aspect of the current controversy over the flavor enhancer monosodium glutamate (MSG): abundant popular anecdotal evidence persists in support of the theory that MSG causes health problems despite numerous scientific studies concluding that MSG does not harm healthy individuals. This paper will outline the history of FDA's treatment of MSG, describe the positions and claims of the protagonists in the controversy, and evaluate possible resolutions.
I. MSG: Properties and General History
MSG is a white, almost odorless powder with the chemical formula: NaOOCCHNH3CH2CH2COOH. MSG is the monosodium salt of L-glutamic acid, which is an important naturally-occurring amino acid.[2] Amino acids are the building blocks of all proteins and are essential to functioning in the human body. In the body and in food, glutamic acid exists mostly in its salt form -- glutamate.[3] Glutamate occurs in either a "bound" (incorporated into an intact protein) or "free" (unincorporated) state. When bound to other amino acids, glutamate is not biologically-active externally; therefore, glutamate in its "free" form is the only form that contributes to flavor enhancement.[4] MSG does not have a distinct flavor on its own. How it adds flavor to other foods is not fully understood, though scientists believe that when someone ingests MSG it reacts with glutamate receptors on the tongue to enhance meat-like taste.[5]
MSG is the most commonly used form of "free" glutamate added to food for flavor-enhancing purposes. The use of MSG in food dates back to ancient times in Asia, where cooks used a seaweed called Sea Tangle to make a type of starch.[6] In 1908, Professor Kikunae Ikeda of the University of Tokyo discovered the link between the flavor-improving qualities of seaweed and the presence of glutamate in the seaweed, and soon thereafter, Japan began to mass produce glutamate.[7] In about 1940, production began in North America, where producers used corn and wheat gluten instead of seaweed.[8] In the U.S. today, MSG is produced through a fermentation process using starch, sugar beets, sugar cane, or molasses.[9] MSG is presently produced in fifteen countries around the world, amounting to about 200,000 tons produced annually,[10] and the United States consumes approximately 28,000 tons of MSG per year.[11]
Glutamate-responsive tissues exist in various parts of the body, including the brain, and free glutamate plays a primary role as a stimulatory neurotransmitter and precursor- neurotransmitter in the central nervous system.[12] The improper functioning of glutamate receptors has been linked with neurological disorders such as Alzheimer's and Huntington's disease.[13] Though there have not been any confirmed studies linking these diseases to the ingestion of glutamate,[14] some scientists are still investigating this possibility. The Food and Drug Administration (FDA), in its own "backgrounder" statement on MSG, presents a troubling question: "Can MSG and possibly some other glutamates harm the nervous system?"[15] Ironically, FDA raises this question in the sentence immediately after they flatly assert that "[c]onsumption of glutamate in food, however, does not [damage nerve cells in the brain]."[16]
Before discussing the current state of the MSG controversy, the next section will outline FDA's historical treatment of MSG and glutamates.
II. FDA's Historical Treatment
In 1958, Congress added the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act,[17] which required premarket approval for new food additives. The amendment prodded Congress to issue regulations exempting substances "generally recognized as safe" (GRAS). In 1959, substances having a history of safe use, including common ingredients such as salt, vinegar, and baking powder, were classified as GRAS substances.[18] MSG was also classified as GRAS and is described in C.F.R. 182.1 as an example of a common safe food ingredient. The GRAS uses of other substances with chemical structures very similar to MSG, including glutamic acid, glutamic acid hydrochloride, monoammonium glutamate, and monopotassium glutamate, are codified in 21 C.F.R. 182.1045, 182.1047, 182.1500, and 182.1516, respectively.[19]
For the past three decades FDA has undertaken extensive reviews on the safety of MSG and other glutamates as part of a greater effort to review the safety of GRAS substances.[20] The Select Committee on GRAS Substances (SCOGS), convened by the Federation of American Societies for Experimental Biology (FASEB), completed studies on MSG and other glutamate-containing substances in 1978 and 1980. SCOGS concluded that the substances were safe at ordinary consumption levels, but also suggested that further research was needed to determine their safety at much higher levels.[21] In 1986, FDA's Advisory Committee on Hypersensitivity to Food Constituents stated that MSG was safe for the "general public," but suggested that some individuals might experience adverse reactions for a short time even at normal levels of ingestion.[22] The following year, the Joint Expert Committee on Food Additives of the United Nations Food and Agriculture Organization classified MSG in its safest food ingredient category.[23] Then, in 1991, the European Community's (EC) Scientific Committee for Foods issued a report confirming the safety of MSG; and the next year, the American Medical Association's Council on Scientific Affairs produced a report in which they stated that MSG and other forms of glutamate are not a "significant health hazard."[24] Finally, the World Health Organization (WHO) has also placed MSG in its safest category of food ingredients.
Despite the accumulation of these studies from reputable organizations around the world reaffirming the safety of MSG, two important countervailing forces have emerged -- one rooted in science and the other in popular culture -- which have coalesced and gained momentum in recent years in their fight to prove that MSG is dangerous. The first of these two forces is a subsection of the scientific community who have gained a better understanding of the role glutamate plays in neurological functioning and who believe that ingesting free glutamates such as MSG may interfere with certain neurological mechanisms. Dr. John W. Olney, a neuroscientist at Washington University in St. Louis, was one of the first researchers to publish studies exploring the deleterious effect elevated glutamate levels can have on neurons in certain regions of the brain.[25] In 1969, he published a study in Science[26] showing that regions of the brain, such as the hypothalamus, that are not protected by a blood-brain barrier suffer extensive neuron destruction when exposed to excess glutamate. This finding has spawned numerous studies and has led some members of the scientific community to hypothesize that ingesting glutamate may interfere with proper brain glutamate metabolism,[27] if the glutamate is able to bypass the blood-brain barrier.
The second force that has risen up in opposition to the supposed safety of MSG is essentially a societal one. The public's backlash has resulted from a compelling amalgamation of primarily anecdotal evidence among individuals that MSG causes harmful side effects. Many people have popularly referred to the cluster of symptoms they experience after ingesting MSG as Chinese restaurant syndrome (CRS) because such adverse reactions were first identified in association with Chinese restaurant foods that contained high concentrations of MSG.[28] Recently, the Expert Panel convened by the FASEB has urged that the term "MSG symptom complex" should be substituted for "Chinese restaurant syndrome (CRS)." They consider "CRS" to be "pejorative and inappropriate because 'CRS' is reflective of neither the extent nor nature of symptoms potentially associated with exposures to MSG."[29] Commonly reported symptoms of MSG symptom complex include headache, flushing, dizziness, and nausea.[30]
Occurrences of MSG symptom complex have proliferated in recent years. For instance, between 1980 and 1995, FDA's Center for Food Safety and Applied Nutrition received 661 complaints of adverse reactions purportedly related to MSG.[31] Growing consumer activism against MSG and the growth of web pages and user groups on the Internet entirely devoted to MSG further testify to the extent of public concern. For instance, there is a popular NOMSG web page,[32] sponsored by the National Organization Mobilized to Stop Glutamate, aimed at disseminating as much anti-MSG information (both substantiated and unsubstantiated) as possible.
In response to the rising tide of public criticism and the increasing number of glutamate-related studies (including some of dubious scientific validity), FDA contracted with FASEB in 1992 to analyze the full panoply of existing MSG-related studies to answer 18 core questions, including: "What are the symptoms and signs of acute, temporary, and 'self limited' adverse reactions that have been reported to occur with the oral ingestion of MSG?" and "What, if any, serious (life-threatening) reactions have been reported to occur with oral ingestion of MSG?"[33]
The FASEB submitted its completed report, entitled "Analysis of Adverse Reactions to Monosodium Glutamate (MSG)", to FDA on July 31, 1995. FASEB concluded that no scientifically verifiable evidence exists documenting adverse effects in most individuals, but found that the "oral ingestion of 3 or more grams of MSG without food can cause adverse reactions in certain otherwise healthy individuals."[34] Based on FASEB's findings, FDA issued an Advance notice of proposed rulemaking (ANPRM) on September 12, 1996 to aid FDA in considering "what action is necessary to protect consumers from inadvertently ingesting levels of MSG or other forms of free glutamate that could cause an adverse reaction."[35] The ANPRM also solicited public comment on whether additional labeling requirements are necessary to protect against adverse reactions and what criteria should be established to help guard against misleading claims.[36] The initial deadline for written comments was November 12, 1996, but FDA has extended the comment period until March 12, 1997.[37] The stage is therefore set for a reasoned resolution to what has been an ongoing and heated controversy. Before addressing FDA's pending decision in part IV, the next section will elaborate on the positions of the major protagonists in the MSG debate.
III. The Protagonists in the Controversy
At its core, the MSG controversy is simply a debate about what is best for the American public in terms of safety and health and consumer expectation. Yet, like so many difficult issues that can be framed rather succinctly on a theoretical level, in the practical context of the real world, resolving these issues can be enormously complex. In order to better understand the problem, therefore, this section will detail the positions of the principal parties involved in the dispute.
A. Consumer Activists, the Glutamate Industry, and the FDA:
The Battle over Safety
Led by scientists such as John Olney and Adrienne Samuels[38] and bolstered by a ground-swelling of public support, the crusade against MSG achieved its most important step yet with FDA's recent ANPRM. Enough anecdotal reports and provocative, though not conclusive, scientific evidence have accumulated to warrant FDA's renewed scrutiny of MSG, and MSG opponents therefore deserve credit for bringing the issue of MSG to the center of FDA's, and indeed national, attention.
MSG activists have leveled charges that many of the studies confirming the safety of MSG over the years have been biased and funded by powerful companies with significant stakes in the glutamate business. For example, activist Mark Gold lambastes an article, written by L. Tarasoff and M.F. Kelly in Food and Chemical Toxicology,[39] which concluded that "rigorous and realistic evidence linking [Chinese Restaurant Syndrome] to MSG could not be found."[40] Gold criticizes the study's experimental design as being "bad almost to the point of being fraudulent,"[41] and believes that it was only published because, according to Gold, the editor of Food and Chemical Toxicology, Dr. Joseph Borzelleca and his associates had received grants from the International Glutamate Technical Committee (IGTC).[42] According to Gold, three of the critical flaws in the study are:
(1) Aspartame was used in the placebo, which would tend to make the experimental and placebo groups have similar reactions since aspartame contains an excitotoxin that acts very similarly to MSG.
(2) The patient interviews occurred only two hours after consuming the MSG or placebo. This aspect is defective because it screens out commonly occurring delayed reactions.
(3) The researchers excluded persons who experienced an aftertaste from the results (13 people -- 11 took MSG and 2 took the placebo), even though it is quite possible that people who feel an aftertaste also suffer more adverse reactions.[43]
Gold feels that this study is indicative of the type of self-serving research that has masked the dangers of MSG over the years. Gold and many MSG opponents believe that glutamate manufacturers have banded together to perpetuate misinformation about MSG to ensure its continued use as a prevalent ingredient in the food supply. In addition to IGTC, Gold also denounces the International Life Sciences Institute (ILSI). Interestingly, ILSI trumpets the scientific nature of the Tarasoff and Kelly study in its article entitled, "IFIC Review of Monosodium Glutamate: Examining the Myths."[44] The IFIC discusses the Tarasoff and Kelly study in a section that begins "double-blind placebo-controlled studies [are] . . . [c]onsidered the 'gold standard' . . . [and] provide dependable findings that are free of bias introduced by either the patient or the researcher."[45] The evaluations of Gold and ILSI could not be more diametrically opposed -- where one sees a fraud the other sees a 'gold standard' -- and it highlights the difficult task that agencies, such as FDA, face in terms of mediating between extreme positions and objectively evaluating scientific data in order to reach proper decisions.
Although Gold and other activists have helped bring potential biases to light, they have unfortunately also clouded the debate at times with their fervent language and allegations of cover-up. While fanning the flames has helped them build public support, over-zealousness at times has done them a disservice. Statements, such as Mark Gold's complaint that "we have been used as 'lab rats' for a number of years"[46] and Adrienne Samuel's proclamation that "[w]e are aware of no person, institution, or agency that has claimed that MSG is 'safe,' that does not have close ties to the food and/or drug industries, or that has not been remunerated by them,"[47] ring more of paranoia than informed activism.
Activists have also pointed fingers at FDA alleging bias, because several officials migrated to FDA after holding positions of importance in businesses tied to the glutamate industry. Transfers of this type are hardly out of the ordinary, however, as FDA requires the assistance of experienced scientific and corporate leaders to help it keep pace with the changing pace and expertise of industry.[48]
B. The Labeling Debate
Despite their advances, MSG activists have recently received two setbacks in their campaign to change FDA's glutamate labeling policy. Though the comment period in FDA's most recent ANPRM is still open,[49] FDA has already ruled against the advocacy group Truth in Labeling Campaign (TLC) on two counts. First, the FDA denied TLC's petition requesting that FDA require all free glutamic acids to be labeled as "MSG."[50] The agency made the correct decision on this count, because although the public is most familiar with the term "MSG," MSG is simply one type of free glutamate and is "sufficiently different" from other types of glutamate.[51] Furthermore, as FDA points out in its response, "declaring monopotassium glutamate as MSG would be misleading because the presence of potassium would not be disclosed, and it would be false because sodium is not present in the ingredient."[52] In addition to fighting this uphill battle, MSG opponents have also clamored for FDA to make a distinction between naturally occurring glutamate and manufactured glutamate. Adrienne Samuels alleges that "FDA has refused to differentiate between potentially toxic glutamic acid that occurs in food as a consequence of manufacture and 'truly natural' glutamic acid."[53] This statement is telling in that reveals a sense of confusion on Samuels' part. Samuels appears to be confusing the distinction between free (potentially toxic) and bound (unreactive) glutamate by saying that one is unnatural and the other is natural. Free glutamate, however, indisputably exists in a variety of natural products, such as tomatoes, and so Samuels' distinction is illogical. FDA Associate Commissioner for Regulatory Affairs Ronald Chesemore rejected Samuels' contention that there is a difference between natural and manufactured glutamate,[54] since their chemical and functional properties are identical.
On the other side of the labeling debate, the glutamate manufacturers have also taken some suspect positions. For instance, some manufacturers have attempted to label their products with "No MSG" or "No Added MSG" even when the products contain high concentrations of free glutamates, though not in the specific form of monosodium glutamate molecules. In many cases manufacturers have substituted ingredients such as hydrolyzed protein[55] or autolyzed yeast, which contain high levels of free glutamate, or an MSG analog such as monopotassium glutamate to achieve the same flavor-enhancing effect as MSG. Current FDA regulations require these ingredients to be listed in the label's ingredient section, however some manufacturers using these substances have tried to make the technically accurate, though blatantly misleading claim, of "No MSG" or "No Added MSG."[56] This deceptive labeling scheme is intended to dupe the American public, by preying on those individuals who might have concerns about MSG but who do not understand that the active free glutamate molecules exist in other substances like hydrolyzed vegetable protein. FDA has ruled that claims of "No MSG" or "No Added MSG" in these instances are misleading under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act,[57] and has stated its commitment to "continue to take regulatory action as appropriate against false or patently misleading claims about the absence of MSG."[58]
IV. FDA's Present Position
FDA is the ultimate arbiter in the MSG controversy, and it must strike a middle ground between the opposing protagonists in order to make the best possible decision to protect the public health and maintain the safety and integrity of the food supply.
A. The FASEB Report
In 1995, FASEB completed its report, "Analysis of Adverse Reactions to Monosodium Glutamate (MSG)," which is an extensive review of the scientific literature relating to MSG and glutamates. As of its 1993 tentative report, FASEB's Expert Panel reviewed 665 scientific references.[59]
The FASEB report is a critical piece of the present MSG-puzzle that FDA is evaluating. FDA took the right step in 1992 when it commissioned the report, largely in response to widely diverging scientific and popular opinions on the safety of MSG, and the FASEB's findings have prompted the agency to issue its recent ANPRM.
FDA is especially concerned with FASEB's Expert Panel's conclusion that "there is a subgroup of presumably healthy individuals within the general population that responds, generally within one hour of exposure, with manifestations of the MSG symptom complex to an oral bolus [dose] of MSG > 3g in the absence of food."[60] Based primarily on this finding, FDA is proposing additional labeling requirements for glutamate.
While FASEB's finding does raise valid concerns, an internal Health & Human Services memorandum from the Director of the Division of Health Effects Evaluation, David G. Hattan, Ph.D., questions the extent to which officials can extrapolate from the studies that formed the basis of FASEB's conclusion. Hattan suggests that although FASEB did base its conclusion on "scientifically verifiable evidence" (as well as "testimonial reports"),[61] the reviewed studies are "less than definitive."[62] According to Hattan, "The studies of Kenney (1979) and Kenney and Tidball (1972) were judged by the Expert Panel to demonstrate
'. . . the only reproducible adverse effects that have been reported to occur in otherwise healthy individuals.'"[63] Hattan also noted that the studies were of "limited size" and had an element of "demand bias" in that the subjects were aware of the intention of the study and were told about the symptoms of MSG symptom complex.[64] Because of these shortcomings, the it is unclear whether a certain subgroup of the population has a consistent response to oral glutamates or whether "the response to MSG is variably expressed within a broader spectrum of the whole population."[65]
Hattan also does not concur with the Expert Panel's determination "that asthma is a documented predisposing medical condition associated with the ingestion of MSG" and he "question[s] the inclusion of bronchospasm as a symptom of the MSG symptom complex."[66] In its recent ANPRM, FDA agrees with Hattan on this point, stating that the asthma studies upon which FASEB relied had "considerable limitations."[67]
Hattan does, however, fully concur with the Expert Panel's conclusion that there is no evidence to support a link between "ingested glutamate in the etiology or exacerbation" of diseases such as Alzheimer's, Huntington's chorea, and amyotrophic lateral sclerosis.[68]
Based on FASEB's findings, FDA has taken a prudent step in soliciting comments before it makes a decision on labeling requirements. Perhaps some important data will be submitted during the comment period, though more likely FDA will have to make a decision with the extensive, though not perfect, evidence before it. More research is obviously needed to confirm the findings in the Kenney and Kenney and Tidball studies and to resolve the debate over MSG's effect on asthmatics.
B. Approaches to Labeling
At this stage, FDA appears poised to institute some change in its glutamate labeling requirements. Based on the information before it, FDA confronts a difficult decision in regard to labeling, and hopefully the comment period will bring forth data from both sides of the debate to help FDA in its determination.[69] FDA received and recently rejected a petition from TLC to amend 21 C.F.R. section 101.22 (h)(5) and add a new section 101.23, which would require a conspicuous warning statement.[70] Despite the rejection, TLC still has a lawsuit pending for which a May trial has been set.[71] Additionally, in a December 30, 1996 letter to TLC, Associate Commissioner Chesemore stated that "the presence of free glutamate in a food may well be a material fact under 201(n) of the [FD&C] Act . . . ,"[72] which is a good indication that FDA will make a change in glutamate labeling.
In its ANPRM, FDA announced that it is considering a number of labeling approaches. One strategy would be to use a certain cutoff level for claims declaring the absence of free glutamate. In its ANPRM, FDA lays out four possibilities for determining the cutoff level:
(1) Quantitation limit -- the analytical limit of quantitation (LOQ) for free glutamate (approximately
100 ppm) described in the procedure of Hattula and Wallin[73] commonly used to determine free glutamate levels
(2) Functional level -- the level (approximately 500 ppm)
below which free glutamate does not have flavor-
enhancing effects
(3) Labeling threshold -- fixed at 0.2 g or more of free
glutamate per serving.
(4) "Substantial amount" standard -- a more subjective standard.[74]
The first standard appears to be the most sensible one and would lead to the lowest amount of public confusion because, for affirmative claims, such as "contains no MSG" or "no glutamate," a high standard is appropriate. In its ANPRM, however, FDA reasons that this standard may be too stringent, since "glutamate is ubiquitous in the food supply" and the vast majority of foods would be disqualified.[75] FDA appears to favor the other less stringent levels. Yet, given FDA's earlier observation in the same ANPRM that "consumers are likely to perceive a "No MSG" or "No added MSG" claim on a label as indicating the absence of all forms of free glutamate in the food,"[76] pushing for a more relaxed standard works at cross-purposes with FDA's goal to minimize public misperception and bolster public confidence. When producers wish to make a declaration that their product is "MSG-free" in order to exploit the market of people for whom this claim is attractive, relaxed standards are inappropriate because of the much greater potential for "misleading" claims.
Groups such as TLC have also brought the issue of quantitative labeling before FDA. FDA has opposed quantitative labeling, stating that it "is not necessarily any more useful than a general label statement alerting the glutamate-intolerant consumer to the presence of free glutamate in food when the level is significant."[77] Yet, arguably, the limited reliable research available shows there is a threshold trigger level for glutamate, and quantitative labeling would better facilitate the public's ability to restrict their consumption to a level below this threshold.
The president and CEO of Maple Leaf Farms, Terry Tucker, has proposed the following label as an example of quantitative glutamate labeling:
"Free Glutamate*: 0.4 g (17% EOV).
*This information is provided for those individuals who
suffer negative reactions from the ingestion of free
glutamate. The % EOV is based on 2.4 g, the lowest
level of free glutamate that has been reported to cause
these reactions on a single eating occasion (or meal)."[78]
While admittedly this label is long and may prove costly to industry (and in turn raise prices to consumers), it has merit in that it would allow people to exercise their own judgment in staying below the reported trigger level for MSG symptom complex.
Glutamate manufacturers point out another problem, however, in that this type of labeling would open the doors for any number of warning labels for a variety of substances that cause allergies or reactions in a subsection of the population. For instance, the American Meat Institute (AMI) notes that about 8% to 24% of the population are lactose-intolerant, which is far more than the percentage of those who are glutamate-sensitive.[79] AMI's main argument is a simple one: on FDA's list of priorities why should glutamate be at the top? This is a good question, but scientists have not resolved the debate over the dangers of glutamate to the same extent that they have with lactose.
At a minimum, FDA should require that producers place the phrase "(contains glutamate)" in parentheses in the product's list of ingredients if substances such as autolyzed yeast or glutamate flavorings are present. In 1993, FDA proposed just such a requirement,[80] and any new proposal should include this change. It would be relatively unburdensome and would help ensure that glutamate-sensitive individuals could detect free glutamate in the food that they purchase.
V. Toward a Meaningful Resolution
Any successful FDA decision will need to address the critical component of public education and understanding. The activist campaign deserves credit on this front for helping to alert glutamate-sensitive individuals to "offending" substances (such as hydrolyzed vegetable protein) that contain free glutamate. Activist scientists have also raised questions about pervasive bias in the testing of MSG over the years, which is not far-fetched given the mountain of anecdotal evidence that has accumulated linking MSG ingestion with the symptoms of MSG symptom complex.
While MSG opponents have played an important role in informing the public, they have also confused the MSG controversy at times by trying to link MSG with myriad maladies and negative symptoms with the ingestion of MSG. Additionally, MSG activists have frequently overlooked the fact that FDA faces many difficult choices in regulating the food supply, and that achieving a food supply that is 100%-risk free is impossible.
In order to restore public confidence and reach a sound decision, FDA must rigorously review all of the glutamate industry-sponsored studies submitted in response to the current ANPRM. Exacting scrutiny of any new data would also redound to FDA's benefit in terms of legitimacy.
As in any controversy, FDA must evaluate the issues from all sides in order to reach a compromise. FDA must rely on trustworthy scientific data to reach a balanced decision -- one that is neither too draconian nor too lax. Any FDA proposal should include the "(contains glutamate)" labeling requirement to help glutamate-sensitive individuals avoid glutamate. This step would also help educate the public in terms of showing that free glutamate is what is active, not just MSG in particular. Furthermore, it would allow people to identify the ingredients, such as hydrolyzed protein, that contain glutamate. Finally, as discussed in part IV(B), FDA should require the highest threshold in determining whether a product can affirmatively declare "Contains No MSG."
Hopefully the comment period will produce reliable and useful information to aid FDA in its difficult decision about MSG labeling. However, given the short duration of the comment period (even with the extension), it is likely that more research will be necessary in order to confirm FDA's findings or to provide the basis for modification down the road. Even though the FASEB was very comprehensive, a number of important questions still remain. First, as mentioned previously, Director Hattan disagrees with the Expert Panel's conclusions that asthmatics are at a higher risk for MSG symptom complex,[81] and therefore more research is needed to adequately resolve this debate. Secondly, the FASEB review, like many of the previous safety studies on MSG, was retrospective in nature. The Expert Panel essentially surveyed the entire landscape of existing references pertaining to MSG. However, given the limitations of the Kenney and Kenney and Tidball studies,[82] such a review still may not be adequate. In order to overcome this shortcoming, Hattan has suggested a new clinical double-blind challenge study.[83] Tailored, unbiased, prospective studies such as this one would provide FDA with valuable new data.
At present, the MSG controversy has attained its crest. The protagonists are marshaling arguments and proposals to present to FDA, and hopefully they will aid FDA in reaching a reasoned, equitable decision for the American public. Where the research proves unconvincing or lacking, FDA and the interested parties should redouble their efforts to gather reliable data to resolve lurking questions about MSG symptom complex and other possible effects of glutamate.
[1]"Monosodium Glutamate (MSG) Reaction Samples," (available at www.tiac.net/users/mgold/msg/msg.txt).
[2]Memorandum from David G. Hattan, Director, Division of Health Effects Evaluation, Dept. of Health & Human Services, to Lawrence Lin (August 30, 1996), p. 1. [hereinafter "HHS memo"]
[3]61 Fed. Reg. 48,103 (1996) (to be codified at 21 C.F.R. pt. 101) (Advanced Notice of Proposed Rulemaking, Sept. 12, 1996).
[4]HHS memo, p. 1-2.
[5]U.S. FDA, "Monosodium Glutamate (MSG)" Backgrounder, August 31, 1995, p. 2, (available at vm.cfsan.fda.gov/~lrd/msg.txt). [hereinafter "FDA backgrounder"]
[6]"A Short Background on the History of Monosodium Glutamate," (available at www.nomsg.com/history.txt).
[7]Id.
[8]Id.
[9]FDA backgrounder, p. 2.
[10]"A Short Background on the History of Monosodium Glutamate," (available at www.nomsg.com/history.txt).
[11]61 Fed. Reg. 48,103 (1996) (to be codified at 21 C.F.R. pt. 101) (Advanced Notice of Proposed Rulemaking, Sept. 12, 1996).
[12]HHS memo, p. 1-2.
[13]FDA backgrounder, p. 1.
[14]HHS memo, p. 10.
[15]FDA backgrounder, p. 1.
[16]Id.
[17]Id., p. 2.
[18]Id.
[19]Notice, 15 Fed. Reg. 13,495 (1993).
[20]FDA backgrounder, p. 2.
[21]61 Fed. Reg. 48,104 (1996) (to be codified at 21 C.F.R. pt. 101) (Advanced Notice of Proposed Rulemaking, Sept. 12, 1996).
[22]Id.
[23]FDA backgrounder, p. 2.
[24]Id., p. 3.
[25]Federation of American Societies for Experimental Biology, "Tentative Report: Adequacy of Existing Scientific Information on Possible Adverse Reactions to Monosodium Glutamate," Feb. 1993, p. 64. [hereinafter "FASEB tentative report"]
[26]Olney, "Brain lesions, obesity, and other disturbances in mice treated with monosodium glutamate." Science, 164: 719-21, 1969.
[27]61 Fed. Reg. 48,105 (1996) (to be codified at 21 C.F.R. pt. 101) (Advanced Notice of Proposed Rulemaking, Sept. 12, 1996).
[28]HHS memo, p. 2.
[29]Id., p. 3 n.1.
[30]Id.
[31]61 Fed. Reg. 48,104 (1996) (to be codified at 21 C.F.R. pt. 101) (Advanced Notice of Proposed Rulemaking, Sept. 12, 1996).
[32]http://www.nomsg.com
[33]Notice, 57 Fed. Reg. 57,467 (1992).
[34]61 Fed. Reg. 48,104-05 (1996) (to be codified at 21 C.F.R. pt. 101) (Advanced Notice of Proposed Rulemaking, Sept. 12, 1996) (discussed further infra part IV(A)).
[35]61 Fed. Reg. 48,102 (1996) (to be codified at 21 C.F.R. pt. 101) (Advanced Notice of Proposed Rulemaking, Sept. 12, 1996).
[36]Id.
[37]61 Fed. Reg. 58,151 (1996) (to be codified at 21 C.F.R. pt. 101) (Advanced Notice of Proposed Rulemaking; extension of comment period, Nov. 13, 1996). FDA received two requests from trade associations that together represent over 90 percent of the food industry. FDA believed the extensions to be necessary and prudent to allow for the collection and analysis of data.
[38]Samuels is one of the leaders of the advocacy group, Truth in Labeling Campaign, which has filed several petitions and issued comments in response to the FDA's position on MSG.
[39]Tarasoff, L. & Kelly, M.F., "Monosodium L-glutamate: a double-blind study and review," Food and Chemical Toxicology, 31: 1019-1035, 1993.
[40]Mark Gold, "Monosodium Glutamate (MSG)," May 8, 1995, p. 7, (available at www.tiac.net/users/mgold/msg/msg-mark.txt)
[41]Id.
[42]Id.
[43]Id.
[44]Id.
[45]"IFIC Review on Monosodium Glutamate: Examining the Myths," Reprint from the International Food Information Council Foundation, May 1994, p. 7, (available at www.social.com/health/ ific/food_additives/ir~msg.html). Unfortunately, FASEB did not review the Tarasoff and Kelly study in (at least the tentative version of) its report to FDA.
[46]Mark Gold, "Monosodium Glutamate (MSG)," May 8, 1995, p. 7, (available at www.tiac.net/users/mgold/msg/msg-mark.txt).
[47]Adrienne Samuels, "Monosodium Glutamate (MSG)," Sept., 1995, p. 3, (available at www.tiac.net/users/mgold/msg/msg~basics.txt)
[48]A May 21, 1991 Letter from Richard E. Cristol, Executive Director of The Glutamate Association of the United States, FDA Commissioner David Kessler provides a representative insight into the objectivity of FDA vis-a-vis the glutamate industry. The letter has the tone of an industry appealing to FDA's sense of public duty rather than to some underhanded collusion.
[49]51 Fed. Reg. 58,151 (1996) (to be codified at 21 C.F.R. pt. 101) (Advanced Notice of Proposed Rulemaking; extension of comment period, Nov. 13, 1996) (extended until March, 12, 1997).
[50]Food Chemical News, Jan. 13, 1997, p. 18.
[51]Id., p. 19.
[52]Id., p. 19.
[53]Food Chemical News, Jan. 6, 1997 p. 11.
[54]Food Chemical News, Jan. 13, 1997, p. 19.
[55]"Protein hydrosylates are not listed as GRAS food ingredients, but are considered GRAS by a number of FDA opinion letters." Notice, 58 Fed. Reg. 13,495 (1993).
[56]61 Fed. Reg. 48,108 (1996) (to be codified at 21 C.F.R. pt. 101) (Advanced Notice of Proposed Rulemaking, Sept. 12, 1996).
[57]Id. Also, a product with hydrolyzed protein containing some of its glutamate molecules in the form of MSG molecules and claiming "No added MSG," would be false in addition to being misleading.
[58]Id. Samuels contends that FDA has been lax in its enforcement of MSG labeling requirements and recounts only one instance in the last 5 years where FDA sent a regulatory letter and threatened seizure. See "Monosodium Glutamate," (available at www.tiac.net/users/mgold/msg/msg~basics.txt). A cursory review of the FDA enforcement log at www.fda.gov also turned up one firm-initiated recall in November, 1993. Yoder's Old Fashioned Bread Stuffing was recalled because it contained an ingredient consisting in part of MSG without declaring so on the product label.
[59]FASEB tentative report, p. 33-92.
[60]HHS memo, p. 3.
[61]HHS memo, p. 3.
[62]HHS memo, p. 5.
[63]HHS memo, p. 3.
[64]HHS memo, p. 5.
[65]HHS memo, p. 5.
[66]HHS memo, p. 7.
[67]61 Fed. Reg. 48,106 (1996) (to be codified at 21 C.F.R. pt. 101) (Advanced Notice of Proposed Rulemaking, Sept. 12, 1996).
[68]HHS memo, p. 9.
[69]Additionally, as if domestic pressures were not enough, the EU's Scientific Committee on Food has stated that if FDA requires additional labeling for glutamate it will request that it be noted under WHO's ... Technical Barriers to Trade Agreements. See Food Chemical News, Jan. 6, 1997, p. 10.
[70]Food Chemical News, Jan. 6, 1997, p. 11.
[71]Food Chemical News, Jan. 13, 1997, p. 18.
[72]Id., p. 19.
[73]61 Fed. Reg. 48,109 (1996) (to be codified at 21 C.F.R. pt. 101) (Advanced Notice of Proposed Rulemaking, Sept. 12, 1996). See Hattula, M.T. and H.C. Wallin, "Enzymatic Determination of Free Glutamic Acid in Dried Soups and in Minced Sausages: NMKL1 Collaborative Study," Journal of the Association of Official Analytical Chemists, 74: 921-925, 1991.
[74]61 Fed. Reg. 48,108-09 (1996) (to be codified at 21 C.F.R. pt. 101)(Advanced Notice of Proposed Rulemaking, Sept. 12, 1996).
[75]61 Fed. Reg. 48,108 (1996) (to be codified at 21 C.F.R. pt. 101) (Advanced Notice of Proposed Rulemaking, Sept. 12, 1996).
[76]Id.
[77]Food Chemical News, Jan. 13, 1997, p. 19.
[78]Food Chemical News, Jan. 6, 1997, p. 9.
[79]Id., p. 10.
[80]Brad Stone and Larry Bachorik, "FASEB Issues Final Report on MSG," Aug. 31, 1995, (available at www.fda.gov/bbs/topics).
[81]HHS memo, p. 7.
[82]HHS memo, p. 5.
[83]HHS memo, p. 15.