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SOWING THE SEEDS:

AN ANALYSIS OF FDA REGULATION OF HERBAL DIETARY SUPPLEMENTS

I. Introduction

Herbs, the first medicine used by humans,¹ are the seeds of folk medicine, as well as bitter administrative debate. Thousands of years ago, the Chinese, Suinerians, and Egyptians used plants for medicinal purposes, and documented their use.² Over 500 medicinal plants were named in a treatise prepared by a Greek physician named Dioscorides in the first century A.D.³ During the Middle Ages, the monks preserved the knowledge of herbal medicine by copying ancient manuscripts, cultivating their own herb gardens in the monasteries, and using herbs for the treatment of common disorders.⁴ In fact, in most parts of the world, natives used herbs, roots, and barks in the "healing art."

Herb use today is becoming increasingly prevalent:

"[t]he worldwide rise in the use of herbal medicines over the last decade or so has been well documented and is worth some $3.37 billion in over-the-counter sales in the G7 countries alone."⁵ Most "herbal medicines are sold [overthe-counter] and it is this sector that is generating the greatest growth. . . However, the major problem faced by herbal medicines is their acceptance by the medical

¹Jethro Kioss, Back to Eden 54 (1939).

²1d.

³1d. at 55.

⁴1d.

⁵Global Herbal Medicine Use on the U~, Marketletter, Feb. 7, 1994.

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profession."⁶ The orthodox medical profession turned its back on natural methods of healing and embraced chemistry.

Unlike the monks in the Middle Ages, most people do not grow their own herb gardens today. Instead, health food stores are stocked with dietary supplements of herbs, as well as vitamins and minerals. Herbs are sold individually in capsules or caplets, or as part of homeopathic remedies for specific ailments. Homeopathic remedies are generally considered over—the-counter drugs.⁷

Sunsource, a manufacturer of homeopathic products, sells remedies for cold, flu, arthritis, sinus, allergies, and insomnia. Sunsource products present a picture of many of the regulatory issues that will be discussed in this paper.

Next to the stand where the neat little boxes of Sunsource sit is a pamphlet entitled "All About Homeopathy

Sunsource ... A Natural Way of Healthy Living." And, at the bottom, it states, "this brochure is being provided to you as a service to answer your questions about Homeopathic Medicine." Inside, there are three sections, the first entitled "All About Homeopathy;"⁸ the second entitled "The

⁶1d

⁷compliance Policy Guideline 7132.15, "Conditions Under Which

Homeopathic Drugs May Be Marketed," May 31, 1988, provides guidance on

the regulation of prescription and overt-the—counter Homeopathic drugs.

⁸The section reads:

"Germs and viruses are around you all the time. Normally your body is "in balance" and you stay well. When your body goes "out of balance" your resistance is lowered and you get sick. When that balance is restored, you become well again.

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History of Homeopathic Medicine;"⁹ and the third entitled, "We invite you to try these products," followed by advertisements for the various Sunsource products.

The labeling on the package looks similar to that of over-the-counter drugs: there are paragraphs for indications, directions! dosage, ingredients, warnings, and guarantees. Inside the package is a pamphlet that is even more extensive than the one found on the stand next to the products. For instance, there is a question and answer section. The first question is, "Are homeopathic medicines regulated by the FDA?" The answer: "Homeopathic medicines are manufactured in strict compliance with FDA regulations. In 1938 the Food, Drug and Cosmetic Act recognized the Homeopathic Pharmacopoeia of the U.S. (HPUS) as the legal equivalent of the allopathic US Pharmacopoeia. All Sunsource homeopathic ingredients have been tested and listed in the HPUS."

Until now the medicines that have been most readily available in your pharmacy without a prescription have been conventional, or "allopathic" medicines. These medicines have helped you by masking the symptoms of your illness to make you feel better. They have not, however, helped to restore your body to its normal, healthy balance. In addition, some of these medicines may have undesirable side effects —— one of the reasons why it can take a long time before you feel like you're "back on your feet again."

Sunsource Traditional Homeopathic Medicines are not synthetic. They are all natural. They provide temporary relief from symptoms without suppressing them and have no side effects."

⁹One relevant portion of this section reads:

"Homeopathic medications, just like all conventional over—the— counter drugs, are manufactured in strict compliance with FDA regulations."

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Homeopathic drugs, like Sunsource are over-the-counter drugs, but are subject to less strict regulation. For instance, the FDA exempted homeopathic drug products from requirements that there be laboratory determinations of identity and strength for each active ingredient.¹⁰ Sunsource presents numerous regulatory issues, such as whether consumers should be able to buy Sunsource, whether Sunsource is labeled truthfully and properly, whether the pamphlet is part of the labeling, whether the product is safe, and whether the health Claims it makes are false or misleading.

II. History of the Recrulation of Dietary Su~olements All of these interesting regulatory issues have been

addressed by the FDA and Congress for years. Congress recently took control of regulating dietary supplements in the Dietary Supplement Health and Education Act of 1994 ("the Dietary Supplement Act"). From congress 's perspective, "for over 30 years, the FDA has pursued a single—minded regulatory agenda which has stifled the ability of consumers to have access to safe dietary supplements and information about those supplements."¹¹

The history of FDA regulation of dietary supplements paints a picture of an agency struggling against public pressure, the courts, and Congress. Starting in 1962, the

1021 CFR S 211 (1983).

11140 Cong. Rec. 511710 (August 13, 1994)(statement of Sen. Hatch); S. Rep. No. 103—410, 103d cong., 2d Sess. 14—17 (1994).

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FDA published minimum and maximum levels for supplements. These regulations were withdrawn in response to citizen

protests.¹² From 1966 to 1973, the FDA issued proposed regulations on the labeling and content of dietary food products. If a vitamin exceeded 150 percent of the recommended daily allowance, FDA tried to classify the vitamin as an over-the-counter drug. These regulatory efforts were nullified in 1976 with the Proxmire/Rogers amendment to the FD&C Act. Later in the 1970s, the FDA tried to regulate vitamins by claiming they were toxic, but this strategy was rejected by the federal courts. In 1980, the FDA proposed an over-the—counter monograph for vitamins and minerals. This proposal was also withdrawn due to strong opposition.¹³

The FDA tried to use the food additives provision of the Food, Drug, And Cosmetics ACT ("FD&C Act") for enforcement of dietary supplements. The theory was that any ingredient added to a capsule or tablet made the ingredient a food additive. This approach was rejected in the courts in United States v. Two Plastic Drums -- Viponte Ltd. Black Current Oil —— Traco Labs, Inc.¹⁴ and United States v. 29 Cartons of -— an Article of Food -— Oakmont Investment Co.¹⁵ In these cases, the FDA asserted that black current oil was a food additive in capsules. In rejecting the claim, the

¹²1d. See also Mark A. Kassel, From a History of Near Misses: The Future of Dietary Su~vlement Reaulation, 49 Food Drug L.J. 237 (1994).

¹³1d

14984 F.2d 814 (7th Cir. 1993).

15987 F.2d 33 (1st Cir. 1993).

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seventh circuit described the FDA's effort as an "Alice and Wonderland" approach, and the first circuit described it as nonsensical.¹⁶

The Nutrition Labeling and Education Act ("NLEA") of

1990 directed the FDA to apply the "significant scientific

agreement" standard in determining whether foods could make

a claim about the relationship of a nutrient to a disease.

The statute specifically stated that FDA could recommend a

different standard and approval process for supplements.¹⁷ In 1991, the FDA issued proposed rules to implement the

NLEA. The FDA rejected all claims except one for calcium's link to osteoporosis in Asian and white women. Only one other claim has been approved since that time, for folic acid and neural tube defects.¹⁸

FDA has proposed using the same standard and procedure for health claims for foods on dietary supplements. Congress imposed a one—year moratorium in 1992, and then again in 1993, preventing FDA from implementing the rule changes. This history led to the enactment of the Dietary Supplement Health and Education Act of 1994.

The Dietary Supplement Act was hailed as an agreement of "an extremely contentious issue."¹⁹ On the House Floor, Congressman Waxman announced: "This legislation will assure consumers access to all supplements on the market so long as

16140 cong. Rec. S11711 (August 13, 1994).

¹⁷1d

¹⁸1d

19140 cong. Rec. H11173—02 (October 6, 1994).

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they are not unsafe. It will allow manufacturers to distribute certain scientific publications and make certain statements about supplements if those publications and statements are not false and misleading."²⁰ During deliberations of the bill, Senator Hatch announced, "Today, we honor the wishes of 100 million people, consumers of dietary supplements, people who simply want the ability to lead healthy lifestyles without the constant intervention of one tiny agency which is possessed by a regulatory zeal equaling none."²¹ Although the law reflected several

compromises, not every point had been an issue. For instance, most agreed that a definition of the term "dietary supplement" was necessary, as well as express FDA authority to regulate dietary supplements.²²

The law is perceived as a victory for the proponents of dietary supplements -- the dietary supplement industry and its consumers. Proponents said the Hatch/Richardson bill "'would remove the scientific evaluation process from an agency that has shown time and again that it either does not understand the important role that supplements can provide in modern preventive health care, or is perhaps too biased against them to properly evaluate them. ~t~23 The American Botanical Council Executive Director said that FDA has shown

²⁰1d.

21140 cong. Rec. S11709 (August 13, 1994)(statement of Sen. Hatch).

²²Lecgislative Suggestions Abound at Surn~lement Hearino, Food chemical

News, July 16, 1993.

²³FDA Anti—Su~lement Stance Seen Threatenina to Public Health, Food

Labeling News, May 12, 1994.

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"it has a bias against herbal products, as well as other supplements, by engaging in a campaign to remove safe products like evening primrose from the market on the pretext that they were 'unsafe food additives."'²⁴ This paper will examine whether FDA's regulatory position was mere harassment or a desperate attempt to remove unsafe

products.

III. Recrulatorv Issues Introduced

As discussed above, the sordid history of dietary supplements, and in particular herbs, has presented several interesting regulatory issues which will be discussed. Part IV of this paper will address the question of whether herbs are foods or drugs. For centuries people have recognized the medicinal properties in herbs, and many people today take them as drugs. On the other hand, herbs, nature's bounty, are also consumed in teas and treated as food. The

decision of whether to categorize herbs as food or drugs was critical, because the Food and Drug Administration's

regulatory scheme is bifurcated; new drugs, and not foods, are subject to the costly pre-market approval process.

One purpose of the Dietary Supplement Act was "to clarify that dietary supplements are not drugs or food additives, that dietary supplements should not be regulated

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as drugs."²⁵ Part IV will discuss whether the new definition of dietary supplements is too broad.

Part V will discuss whether consumers should have unlimited choice in the dietary supplements and herbs they consume. The choice issue is similar to a "right to treatment" issue with drugs. That is, should government deprive citizens of products if there is inconclusive evidence about safety? Greater safety regulations are linked to limited choice. This section will examine the strength of the choice argument.

Part VI will address the safety and healthfulness of herbs. Safety and health are linked because some argue that depriving citizens of herbs infringes on their right to live healthy lives while others argue that herbs may not be safe and their use could cause injury or death.

Part VII will address health claims and labeling issues. How should false and misleading statements be determined and regulated? Preventing false and misleading statements protects both the consumer and the industry from fraud.

IV. Is it a Food? Is it a Drucr? No. It's a Dietary Su~~lement

The awkward distinction between food and drugs is evidenced by comparing Sunsource cold remedy, an over—the— counter drug, with "Mama Bear's Cold Care" tea by Celestial 2S~. Rep. No. 103—410, 103d cong., 2d Seas. 2 (1994).

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Seasonings, a food. Both can be consumed to ease the discomfort of the common cold, but one is a drug and one is food.

The awkwardness is reflected in the FD&C Act. The definitions of food and drugs have never been mutually exclusive. It is generally the manner in which a product is used that will determine whether it is a food or a drug. However, herbs, like many other products, are not easily classified. Many people drink Mama Bear's Cold Care tea for its medicinal properties. Therefore, one could argue that this "use" classifies the tea as a drug. On the other hand, many people drink the tea for its pleasant and soothing taste and aroma.

Foods and drugs are subject to different regulatory schemes. Foods are regulated as to their labeling, identity and quality, nutrient content, and sanitation. Vitamin and mineral supplements have separate regulations. Under the NLEA, food products are prohibited from making health claims unless specifically authorized by the FDA.

Drugs are regulated as to their therapeutic claims, labeling, directions for use, and sanitation. Prescription drugs and over—the—counter drugs are separately regulated. Most importantly, all new drugs require pre-market approval by the FDA. Pre-market approval is the key mechanism used by the FDA to promote safety in drugs.

The creation of a new statutory category, that of "dietary supplement" adds to the confusion. It seems that

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the change was made to allow some foods to make health claims and still remain in the food category. However, vitamins and minerals, included within the definition of dietary supplement, still have separate regulations in Section 411 of the Food, Drugs and Cosmetic Act, while herbs are regulated as other foods.

The Dietary Supplement Act defines dietary supplements and provides specific regulatory requirements. The term "dietary supplement" means "a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: . . . (C) an herb or other botanical . . . (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake."²⁶ One important feature of the Act is that it unequivocally includes herbs in the definition of "dietary supplement."

The Act attempts to resolve the question of whether dietary supplements are food or drug with the statement:

"Except for purposes of section 201(g) [the definition of a

²⁶A greater portion of the definition reads as follows:

"(ff) The term 'dietary supplement' --

"(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

"(A) a vitamin; "(B) a mineral; "(C) an herb or other botanical; "(D) an amino acid;

"(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or

"(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (B);. . . Pub. L. No. 103—417, 108 Stat. 4325, 4327 (1994).

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"drug"], a dietary supplement shall be deemed to be a food within the meaning of this Act."²⁷ Thus, if a dietary supplement meets one of the definitions of a drug, it is a drug as well as a food. This statutory change will cause confusion, because Section 201(g) (1) (C), which defines drugs, includes "articles (other than food) intended to affect the structure or any function of the body of man or other animals; H28 Therefore, it is unclear whether the exclusion in the Dietary Supplement Act is meant to exclude dietary supplements from the definition of drugs, or exclude dietary supplements from the "other than food" exception to the drug definition. As a result, the question of whether herbs are food or drug is still unresolved. An interesting point is that, in an earlier draft of the Dietary Supplement Act, the definition of drug was to be amended to specifically exempt dietary supplements from the definition of "drugs." In fact, the Senate report describes such a provision in its section-by-section analysis. However, this provision is not in the ratified law.²⁹

The law also explicitly states that dietary supplements may not be regulated as food additives. As previously discussed, the FDA had for some time relied on the food additives theory to regulate dietary supplements. By

²⁷1d

2821 U.S.C. 321(g)(1)(C)

²⁹See S. Rep. No. 103—410, 103d Cong., 2d Seas. 2, 19 (1994). ("Section

3(b) of the bill would add a new sentence to the "drug" definition of Section 201(g)(l) of the Federal Food, Drug, and Cosmetic Act to explicitly state that, 'The term 'drug' does not include a dietary supplement as defined in paragraph (ff) of this section.'").

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³⁰See infra Part VII.

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eliminating the food additive theory, Congress also eliminated the concept of "GRAS," generally recognized as safe. Although the FDA's use of the food additives theory had been rejected by the courts, this legislative amendment significantly curtails the FDA's enforcement options.

Thus, the definitions section of the Dietary Supplement Act classifies dietary supplements as foods, and not as food additives. Had Congress classified dietary supplements as drugs, the FDA would have had greater enforcement capability and could have better protected the safety of dietary supplements. On the other hand, if dietary supplements had been classified as drugs, the availability of dietary supplements would potentially decrease, providing fewer health care options for consumers. The FDA might unnecessarily block consumers from obtaining harmless, and potentially healthful dietary supplements. As the law stands, dietary supplements are, in some ways, less strictly regulated than foods because they are held to a lower standard of proof for nutritional claims than that required for food under the NLEA.³⁰ Dietary supplements are also regulated more strictly than foods because the "new dietary ingredient" is subject to pre-market notification, although not approval.

There is another possible approach Congress could have taken with respect to herbs. Congress could have reviewed the data on specific herbs, and, according to their toxicity

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levels and safety, classified some herbs as foods and some as drugs. Or, Congress could have returned to the "use" standard and classified herbs according to their uses.

Presently, there is the ironic result that an Echinacea capsule that has no aromatic or taste benefit is considered a food, while teas produced by the Traditional Medicinals Co., but which have a pleasant taste and aroma, are drugs.

V. The Liberty to Choose

The issue of whether herbs should be regulated more strictly -— as food or drug -- squarely presents the issue of choice. Should Americans be able to choose among many herbal products? The percentage of Americans who actually use dietary supplements probably lies within the range of 40% to 80%. In one estimate, "national surveys have revealed that almost 50 percent of the 260,000,000 Americans regularly consume dietary supplements of vitamins, minerals, or herbs as a means of improving their nutrition."³¹ The FDA has estimated that "40 percent of the adult population in the United States consumes dietary supplements on a daily basis."³² And, according to a recent poll, 78% of Americans take dietary supplements to improve their health.³³

One purpose of the Dietary Supplement Act was "to improve the health status of the people of the United States and help constrain runaway health care spending by ensuring

31108 Stat. 4325 — 26.

³²Kassel, supra note 12.

³³Herb Research Foundation, Reoulatorv Update 3, Jan. 31, 1994.

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that the Federal Government erects no barriers that impede the ability of consumers to improve their nutrition through the free choice of safe dietary supplements."³⁴ Consumers want to be able to purchase herbs and other dietary supplements. Strict regulation, such as the enforcement of the NLEA, could prevent manufacturers from bringing herbal products to the markets. The cost would be prohibitive.

It is important to consider that dietary supplements, and sometimes herbs alone, are the only form of preventive medicine that consumers have access to without a prescription. In fact, the only OTC preventive medicines are fluoride toothpaste, motion sickness pills, and sunscreen.³⁵ With rising health costs, it is in society's interest, as well as individual desire, to promote preventive medicine. Aside from prevention, some people want to use dietary supplements, particularly herbs, as alternative therapies, because FDA approved drugs are not working. Desperate people who face life-threatening diseases should be able to take dietary supplements without government interference.

However, choice exists within a context. In order to have meaningful choices, consumers must be fully informed. The current law decreases the quality of information available to consumers because it requires a lower standard of evidence for nutrition claims. It is difficult to argue

³⁴5.Rep. No. 103—410, 103d Cong., 2d Seas. 2 (1994).

³⁵Herb Research Foundation, Reaulatorv Update 3, Jan. 31, 1994.

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36ioa Stat. 4325, 4328.

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for consumer choice when consumers do not know the risks and benefits of what they are choosing.

Nonetheless, individual choice is a powerful argument for accessibility of herbs. Many herbs have been used by humans for centuries, and are consumed by millions of people throughout the world. Choice, a basic element of liberty, is part of American constitutional culture. Only serious safety concerns should justify depriving people of their choices.

VI. Are Herbs Healthy or Unsafe?

The critical questions, then, are 1) whether the FDA has adequate mechanisms under the Dietary Supplement Act to regulate safety; and 2) whether or not herbs are generally safe. The Dietary Supplement Act creates a framework for evaluating the safety of dietary supplements and their "dietary ingredients." The law provides that dietary supplements are adulterated if they contain an ingredient that "presents a significant or unreasonable risk of illness or injury," an "imminent hazard to public health or safety," or a "poisonous or deleterious substance which may render it injurious to health" under conditions of use recommended in the labeling, or under ordinary conditions of use.³⁶ Significantly, the Act specifies that the United States shall bear the burden of proving adulteration.

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Notwithstanding the FDA's heavy burden, some industry advocates fear that the FDA can still unreasonably wield its discretion to remove dietary supplements from the market. One attorney who did an analysis of the Act complained that "[u]nder the act, in proving a dietary supplement is unsafe, FDA must show the product presents 'an unreasonable risk.' According to [the attorney], in evaluating whether a product has 'any value or usefulness,' FDA may decide it does not have value or usefulness and conclude that 'any possible risk is unreasonable."'³⁷ It is possible that the FDA will stretch the meaning of "unreasonable," but history has demonstrated that public protests, the courts, and Congress are quick to step in when the FDA too heavily regulates dietary supplements. Perhaps a bigger question is whether there will be enough regulation.

The Dietary Supplement Act also regulates the use of another new statutory category, "new dietary ingredients." The presumption is that new dietary ingredients are adulterated unless they meet one of two requirements: 1) "The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered"³⁸; or 2) pre-market notification. Under pre-market notification, the manufacturer must have adequate information to reasonably assure safety, and the

³⁷The Tan Sheet 1994; 2(45):6—7.

Stat. 4325, 4331.

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manufacturer must submit the information to the FDA at least 75 days prior to marketing the product.

Prior to the enactment of the Dietary Supplement Act, Dr. Kessler, the Commissioner of Food and Drug stated that "'[t]he public has to be aware that [dietary supplements] have not been regulated in any systematic way. We have not set any product standards, any manufacturing controls, nor required any safety testing. If you walk into a health food store you have to recognize that we have not approved the safety of those products nor substantiated their claims.'"³⁹ The question then becomes whether FDA is not provided enough authority under the law, or whether it does not exercise the authority it has.

In analyzing the safety and health of herbs, this Part will first discuss the known or claimed health benefits, and then will discuss the known or claimed health risks. Herbs behave differently than drugs; "the role of the herbal dietary supplements is to enhance the diet by adding safe and natural plants and their constituents to support and protect bodily functions and processes."⁴⁰ Congress identified garlic, ginkgo, ginseng, and ginger as herbs found to be effective in reducing blood serum cholesterol levels, promoting peripheral circulation, enhancing endurance and stamina, and relieving nausea and stomach distress, respectively.⁴¹

³⁹Kassel, supra note 12.

⁴⁰5.Rep. NO. 103—410, 103d Cong., 2d Seas. 10, 11 (1994).

⁴¹1d

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Congress clearly believes herbs and other dietary supplements are healthful and safe. The Dietary Supplement Act states that "improving the health status of United States citizens ranks at the top of the national priorities of the Federal Government;"⁴² "the importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies."⁴³ Herbs can provide many health benefits, such as "enhancement of the general immune system to ward of f colds and flu"; "protection of the liver from dietary and environmental toxins"; "improvement of night vision"; and "reduction of risk factors associated with cardiovascular disease. . . and possibly even some forms of cancer.

Congress identified several medical authorities that have recognized the "important role of herbs as dietary adjuncts and advocate their proper use."⁴⁵ These include the World Health Organization, which recently approved Guidelines for the Assessment of Herbal Medicines.⁴⁶ The Guidelines state, with respect to safety:

A guiding principle should be that if the product has been traditionally used without demonstrated harm no specific restrictive regulatory action should be undertaken unless new evidence demands a revised risk— benef it assessment . . . Prolonged and apparently

42i~ Stat. 4325 — 26.

⁴³1d.

⁴⁴S.Rep. No. 103—410, 103d Cong., 2d Seas. 10 (1994).

⁴⁵1d at 11.

⁴⁶Herb Research Foundation, Herb Safety Retort 2 (1993).

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uneventful use of a substance usually offers testimony

of its safety.⁴⁷

The Herb Research Foundation ("HRF") researched the toxicity of herbs. They searched the National Library of Medicine's Medline Database and reports of the American Association of Poison Control Centers for incidents of herb— related toxicity.⁴⁸ HRF found that "[n]either these sources, nor the Centers for Disease control, could provide any substantial evidence that herbs are causing toxicity problems. In fact, the AAPCC report clearly shows that reported poisonings from plants are not from commercial herbal products, but are mostly from toxic home and garden ornamentals, and poisonous weeds."⁴⁹ Given the extent of the health benefits presented by Congress and other groups, strict regulation appears excessive, and consumer choice appears to outweigh safety.

However, several groups strongly disagree and argue that herbs and other dietary supplements are in fact dangerous. Scientific research indicates "a significant correlation between dietary supplements and toxic reactions, illness and death."⁵⁰ The consequences for misuse of dietary supplements are grave.

On December 3, 1993, the Center for Disease Control and Prevention "underscored the potential health risks associated with the use of herbal products' by releasing

⁴⁷1d.

⁴⁸1d at 3.

⁴⁹Id.

⁵⁰Kassel, supra note 12.

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case studies of three Los Angeles women who suffered acute hepatitis from the Chinese herbal product Jin Bu Huan, used as a sedative and analgesic, this past summer."⁵¹ And, earlier in 1993, "public health and health-care providers in Colorado reported three children with unintentional JBH overdoses suffered central nervous system and respiratory depression 'with rapid onset of life-threatening bradycardia. tt~52 CDC said that "in the three cited cases, the plant source and percentage of the active ingredient indicated on the JBH labels were incorrect."⁵³

Others warn about the potential dangers of Jin Bu Huan:

Alternative therapies are popular and appear to be gaining political and scientific interest, but their possible dangers should not be overlooked. A recent report described cases of serious liver toxicity cause by the Chinese herbal product Jin Bu Huan. Despite similar reports of adverse effects of alternative therapies, Congress passed a law that weakens the Food and Drug Administration's regulatory powers over dietary supplements and herbal products.⁵⁴

Furthermore, "[a]n increasing number of adulterated Asian patent herbal remedies —— mostly from China —— are being imported into the United States . . . .Some of these products have been laced with steroids, sedatives, even toxic substances such as arsenic and mercury, and have been

⁵¹CDC Urges Caution on Herbal Products Use. Pluas "Medwatch." Food Chemical News, Dec. 13, 1993.

⁵³1d.

⁵⁴B2Ltter herbs: mainstream, magic and menace, 121 Annals of Internal

Medicine 803, Nov. 15, 1994.

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linked by health officials with illness and death."⁵⁵ Reports have been made that false or misleading labeling in these products is common.⁵⁶

Those who oppose the Dietary Supplement Act argue:

In raw form, and when properly combined and used, many of these herbs are valued as traditional remedies, but some of them contain dangerous and undisclosed substances. And the problem is worsened by the Hatch Dietary Supplement Bill, according to the Center for Science in the Public Interest (CSPI), which points to the difficulties the FDA would face under this proposed legislation in blocking dangerous products from the market. The Hatch Bill creates a separate regulatory category for dietary supplements that includes herbs which relies on what many believe to be sorely inadequate safety standards —— particularly for medicinal herbs. Many people mistakenly believe that FDA regulations will result in a federal ban on supplements and therefore support the Hatch Bill without considering its flaws, says the CSPI.⁵⁷

One group found that several specific herbal products raised concerns. These include: "white billow bark, which contains no Reye's disease warning although it is a naturally occurring form of aspirin; chaparral, comfrey and germander, which contribute to severe liver toxicity; and blue and black cohosh, marketed without warnings for pregnant women although they cause oxytocic reactions and stimulate uterine contractions, respectively."⁵⁸ Prior to the Dietary Supplement Act, warning labels could transform a

⁵⁵lncreasinglv. Chinese herbal remedies are found unsafe, 24 Natural

Health 18, Sept. -Oct. 1994.

⁵⁶1d.

⁵⁷1d.

⁵⁸Dietarv Su~lement Office in FDA Uroed by Heart Association, Food

Labeling News, Sept. 16, 1993.

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food into a drug. The Act permits warnings without such a transformation.

Given the severity of the possible reactions to dietary supplements, and particularly herbs, safety concerns may dictate the need for stricter regulation. How do we weigh these competing views on safety and health? Both sides of the debate permit the conclusion that many herbs, if not most, are safe if taken in moderation. Therefore, pre— market approval of all herbs is not necessary. The long history of herbal use is proof enough of safety for most herbs. However, a few herbs should be strictly regulated.

Because research is inconclusive, the FDA should have an efficient mechanism for removing unsafe herbs from the market quickly once they are discovered. Placing the burden of proof for unsafe products and false claims on the FDA slows the process. Current enforcement mechanisms are probably inadequate.

Another important safety issue to consider is that people take herbal products and other dietary supplements without medical supervision. Consumers may not take moderate amounts and may consume toxic levels. A public education campaign is necessary to educate consumers on the safe and healthy use of dietary supplements.

The FDA recently instituted a program called MedWatch in which doctors are asked to question patients about their

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use of alternate, unconventional therapies.⁵⁹ The doctors will report adverse reactions to the FDA. The system is supported by the Centers for Disease Controls and is an intelligent means for getting more information about the safety of dietary supplements.

VII. What's on the Box?: Claims and Labelinci

The last issue, related to consumer choice and safety, is labeling. Congress intended the legislation to "strengthen the current enforcement authority of the FDA against unsafe or fraudulent products and to establish a Commission on Dietary Supplement Labels within the executive branch to develop recommendations on a procedure to evaluate health claims for dietary supplements."⁶⁰

Under existing law, "labeling" encompasses printed materials that "accompany" a product. This language has been interpreted to include those materials that promote specific products. The Dietary Supplement Act creates a new exemption from labeling: "An article, a chapter in a book, or an official abstract of a peer-reviewed scientific publication" is not labeling when used in the sale of a dietary supplement as long as the material is not false or misleading, it does not promote a specific brand or manufacturer, it is displayed in a balanced fashion, separate from the products, and it has no "appended"

⁵⁹CDC Urges Caution on Herbal Products Use. Pluas "Medwatch." Food

Chemical News, (Dec. 13, 1993).

⁶⁰5.Rep. 103—410, 103d Cong., 2d Seas. 3 (1994).

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information.⁶¹ The FDA has the burden of proving material is false or misleading.

The health claims provision of the NLEA created controversy over whether structure-function claims could be made about nutrients. The Dietary Supplement Act permits nutrition claims on dietary supplements that describe the role "of a nutrient or dietary ingredient" in affecting structure or function, characterize the "documented mechanism" or describe resulting "general well-being."⁶²

Nutrition claims are permitted if the manufacturer has "substantiation" that the claim is truthful and not misleading; if the manufacturer notifies the FDA within thirty days of its first marketing of the product; and if the following statement is prominently displayed:

"This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." Section 403(r) (6) (C).

This disclaimer approach applies only to dietary supplements, and not to other foods. In addition, a dietary supplement will no longer be deemed misbranded if it has directions for use or warnings. The "substantiation" standard is much lower than the "significant scientific agreement" standard required under the NLEA.

Thus, with respect to labeling, Congress may not have achieved its purpose of strengthening the FDA's enforcement

⁶¹Covington & Burling Memorandum 4, October 12, 1994.

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powers. The establishment of the Commission on Dietary Supplement Labels may provide greater informed choices for consumers and increase safe usage of herbs.

The small amount of information currently on most herbal packages (excluding homeopathic remedies) is startling. No information appears regarding toxicity. If manufacturers are permitted to make nutrition claims like "calcium builds strong bones," but are not required to make competing claims about toxicity, dietary supplements could become a safety hazard.

It is unclear whether the structure-function exception for dietary supplements will actually effect herbs. Many herbs are used for their therapeutic claims, and these claims are still restricted under the NLEA. In order to make therapeutic claims, herb manufacturers would have to satisfy the new drug approval process. Many argue that "[t]his 10-year and $360 million process is clearly inappropriate and unachievable for non—proprietary, non— patentable products such as vitamins, minerals, and herbs. t~63

Most people find out about therapeutic benefits from books, many of which present a balanced picture of the benefits and the risks. However, the danger exists that manufacturers could inundate the market with literature that is not well balanced. Then the FDA will face the burden of

⁶³No Regulatory Niche for Herbals. Magazine Editorializes, Food Labeling News, Jan. 13, 1994 (citing Herbalgram editorial, Winter, 1994).

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proving the literature is misleading. Given the FDA's limited resources, we could face another food tragedy.

Conclusion

Herbs are complex; they defy regulation. There is significant research about herbs, and most researchers disagree about their safety. For instance, James A. Duke, PhD., compiled a list of herbs and ranked them according to toxicity, along with two other researchers.⁶⁴ The ranking system compared the dangerousness of herbs to coffee. In only a handful of cases were the three rankings the same.

Nonetheless, some herbs are clearly safer than coffee and others are clearly more dangerous. Consider the following proposal.⁶⁵ Herbs fall into five distinct categories, each of which should be regulated differently:

l)Simple foods

2)Foods and supplements with health benefits;

3) Traditional medicines

4)OTC drugs;

5) Prescription drugs.

Panels of experts are needed to evaluate each of these categories. Dividing herbs into categories, will provide necessary sophistication and complexity to the regulatory scheme. A new system must acknowledge the complexity of

⁶⁴CRC Handbook of Medicinal Herbs (1985).

⁶⁵The proposal is based on a scheme proposed by Robert McCaleb,

representative of the Herb Research Foundation, and published in

Legislative Suggestions Abound at SuDDlement Hearing, Food Chemical

News, July 25, 1993.

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herbs as food and drugs, permit consumers choices in leading healthful lives, promote safety, and provide adequate labeling information. Until Congress and the FDA recognize that herbs are as different as people, the regulatory system will at the same time be too strict and too weak.

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