Detailed Analysis of the Dietary Supplements Health and Education Act of 1994

1994 Dietary Supplements Health And Education Act
Life Flow One
The Solution For Heart Disease

Click Here to read an article written by the FDA to explain the actual law under which most vitamin products are currently sold. This page contains a much more detailed analysis of the Law. Click Here to read a popular story about this Act, published in the Wall Street Journal.

Click Here to see the most current FDA "warnings" about unsafe nutritional products.

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This article appears in Volume 2, Issue 1 of the West Virginia Journal of Law & Technology (1998) <http://www.wvjolt.wvu.edu>.
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Drugs and Dietary Supplements: Ramifications of the Food, Drug, and Cosmetic Act and the Dietary Supplement Health and Education Act

¶ 1 The purpose of this Article is to inform the medical and legal professional about the Federal Food, Drug, and Cosmetic Act (FFDCA), and its amendment, the 1994 Dietary Supplement Health and Education Act (DSHEA). Both of these acts regulate the types of information drug manufacturers must give consumers regarding dietary supplements and other substances. The Article will provide a historical overview of the FFDCA and DSHEA. It will also explain the basic regulations of the DSHEA and the legal ramifications involved if the regulations are not followed. The Article will be a reference for the medical and legal professional by explaining the legislation in a short, concise form, and providing a brief history of its legal enforcement.

¶ 2 The World Health Organization estimates that between sixty-five and eighty percent of the world's population uses non-traditional medicine as its primary form of health care.[1] The United States market for herbal remedies is booming, with an estimated annual growth rate of fifteen percent.[2] In 1994, sales reached well over $1.5 billion.[3] A 1993 survey of over 1,500 Americans concluded that one in three adults uses at least one unconventional means of therapy.[4] Originally, the Food and Drug Administration used the Federal Food, Drug, and Cosmetic Act to regulate the manufacture of these types of remedies. Later, the Dietary Supplement Health and Education Act was passed to allow for certain substances to be regulated less stringently than drugs, thus escaping the rigors of the drug approval process. As will be discussed, both the FFDCA and the DSHEA have been tested in this nation's court system.

¶ 3 The Federal Food, Drug, and Cosmetic Act was passed in 1938 in response to a tragedy involving elixir of sulfanilamide, which reportedly killed nearly one hundred people.[5] In 1937, the S.E. Massengill Company marketed an elixir that contained diethylene glycol, a component of today's anti-freeze.[6] Toxicity tests were not performed on this product because, although prior laws had prohibited adulteration and misbranding, they did not address safety.[7] The Massengill problem and other similar occurrences demonstrated that the public did not have adequate information to make informed decisions about compounds marketed as medications. Thus, the main objective of the FFDCA was to ensure that a marketed drug was safe and effective.[8] However, under this Act, while a new drug application (NDA) submitted by the manufacturer to the FDA provided proof of safety, it usually cited anecdotal information for proof of efficacy.[9]

¶ 4 In 1962, the FFDCA was amended by the Kefauver-Harris Act.[10] This Amendment, which applied to all drugs marketed after 1938, required drug manufacturers to provide substantiation to the FDA of a drug's safety and efficacy before marketing.[11] The Kefauver-Harris Act was prompted by the thalidomide tragedy in Europe. Thalidomide, a drug previously used as a tranquilizer, was found to cause birth defects when taken by pregnant women as an anti-nauseant.[12] Although the compound had undergone several years of safety testing, it was not until the drug was marketed for a new indication that the birth defects became evident. Thus, the Kefauver-Harris amendment provided for more stringent regulations on the drug industry by the federal government.[13]

¶ 5 Since the approval process set by the FFDCA and its amendments requires manufacturers to invest significant amounts of time and money, it is imperative that the Act provide strict definitions. A "food" is generally defined as articles used for food, drink, chewing gum, or components of these articles.[14] The Kefauver-Harris Act defined a "drug" as:

However, even with these seemingly strict definitions, it is possible for a product to be at once both a food and a drug.[16]

¶ 6 The Dietary Supplement Health and Education Act began as a grassroots campaign designed to give the general population access to methods of self-treatment. The increasing emphasis on health, fitness and disease prevention in the 1980s and early nineties provided a prime setting for such an Act to pass through Congress.[17] Americans desired to become more involved in making health care decisions, including the use of non-traditional products.[18] Also, the ever-increasing cost of health care precipitated an increase in the use of alternative methods of treatment to avoid the costs of traditional medicine.[19] Because of these reasons, the DSHEA was designed to provide a framework for the regulation of one of the most widely used forms of non-traditional medicine, dietary supplements.

¶ 7 A "dietary supplement" is defined in the DSHEA as a product (other than tobacco) intended to supplement the diet that contains a vitamin, mineral, amino acid, botanical or herbal product, or other dietary substances.[20] Since, under the DSHEA, the dietary supplement becomes an entity legally different from drugs, it cannot be intended to treat, cure or mitigate a disease.[21] The DSHEA also allowed manufacturers to process a supplement in any form, as long as it was not considered a meal replacement product.[22] Therefore, the definition of a dietary supplement encompasses a wide variety of products.

¶ 8 Under the DSHEA, dietary supplements must be manufactured in compliance with current "good manufacturing practices" (GMPs) for safety purposes.[23] However, the GMPs applicable to dietary supplements are those used for foods, not for drugs.[24] The DSHEA also developed standards for labeling which include a truthful ingredient statement.[25] Those ingredients for which there is an FDA recommendation for daily consumption should be listed first, if present in a significant amount. The DSHEA also requires that dietary supplements be labeled as such.[26] Finally, nutrition content labeling must comply with the National Labeling in Education Act (NLEA).[27]

¶ 9 Presently, there are four types of label claims permitted by the FDA.[28] A product may state a benefit related to a classical deficiency of disease as long as the prevalence of the disease is disclosed.[29] The manufacturer is able to imply a structure or function claim in which the dietary supplement either affects or maintains the structure or function of part of the human body.[30] Finally, a statement of general well-being is permitted.[31] These statements must be truthful and not misleading, and, if these claims are made, the label must include a statement informing consumers that the product has not been approved by the FDA.[32] It is up to the manufacturer to substantiate efficacy claims.[33] However, if at any point a dietary supplement comes under suspicion, it is the burden of the Food and Drug Administration to supply proof of adulteration.[34]

¶ 10 The DSHEA also provides regulations regarding other information that can be provided to consumers. This is generally referred to as third-party information.[35] Third-party information is considered exempt from the labeling standards provided that the information: (1) is not false or misleading; (2) does not promote a particular brand or manufacturer; (3) is displayed with other items to provide a balanced view; (4) is displayed physically apart from the dietary supplement; and (5) does not contain any appendages, such as a sticker.[36] Once again, the government bears the burden of proving that such information is false or misleading.[37]

¶ 11 Although the DSHEA amendment was passed in order to allow the public access to information regarding dietary supplements, many feel this access has been one of its biggest failures. Manufacturers fault the government for restricting the type of information distributed regarding these products, while others fault the manufacturers for attempting to provide false and misleading information. Nevertheless, in general, the information available about dietary supplements is largely anecdotal, and there is little scientifically valid information present. Health care practitioners should be aware of other problems that could occur as the result of this Act. First, there is the danger of a person relying on dietary supplements to treat a disease.[38] Patients may perceive dietary supplements to be appropriate substitutes for their present prescription medication, or may not consult a health care professional until their disease state is too far advanced.[39] Also, there is a perception that "natural" is equivalent to harmless.[40] Many patients would prefer to take a natural product instead of a "drug." However, many prescription drugs are derived from natural sources.[41] In addition, there are widely available herbal preparations that can cause serious or fatal side effects.[42] Ephedrine alkaloids, stimulants affecting the heart and nervous system, have been recently implicated by the FDA regarding their safety profile.[43] Also, there have been numerous reports of adulteration in which a product does not contain what is listed on the label.[44] Many consumers are unaware that the contents of dietary supplements are not regulated by any agency at this time. The efficacy, potency, and purity of dietary supplements can vary widely depending on the manufacturer and its standards. One study indicated that sixty percent of commercially available ginseng products contain an insignificant amount, and twenty-five percent contain no ginseng at all.[45] Although much of the supplement industry is attempting to find a way to develop quality control, there are still many clandestine laboratories operating.

¶ 12 Finally, most health care practitioners are in a quandary regarding dietary supplements and natural products. Traditional training has provided them with a less-than-adequate information base to answer questions or guide patients in this arena. The widely read medical journals also provide little information regarding dietary supplements. Therefore, most practitioners are left with nowhere to turn to educate themselves.

¶ 13 When looking at the case law in this area, one must keep in mind the statutory definitions of "drug" and "food."[46] One must also be aware of the "vitamin and mineral" section of the FFDCA, which expands the classification of food.[47] This section seems to anticipate the DSHEA, by allowing exceptions for non-traditional "foods."[48] The exception only applies to natural or synthetic vitamins or minerals.

¶ 14 The FDA is responsible for ensuring compliance with the label regulations presented in the FFDCA and the DSHEA. In the interest of public safety, the definition of a drug is to be construed liberally, and once this label has been established, the courts will give the FDA's determination considerable deference.[49]

¶ 15 National Nutrition, a manufacturer of a dietary supplement, sold vitamins A and D in amounts exceeding 10,000 IU and 400 IU per dosage,[51] respectively.[52] Although these dosages surpassed the limits prescribed by the USRDA, they were not enough to bring the vitamin within the statutory definition of a drug.[53] To show that these vitamins were drugs, the government demonstrated that the manufacturer intended to distribute them for therapeutic uses. This intent can be proven on the basis of objective as well as subjective evidence.[54] The court found that if it can be shown that the high dosage vitamins are used almost exclusively for therapeutic purposes, and that they lack nutritional use, intent to use in the treatment of disease may be inferred.[55] If such an intent is proven, the substances may be governed by the FDA as drugs.

¶ 16 Nutrilab v. Schweiker laid important ground work for defining the food-drug dilemma. In Nutrilab, several manufacturers of starch blockers brought suit against the FDA because the FDA classified the products as drugs instead of as foods. Starch blockers are generally derived from beans, where the protein is removed from the bean and made into pills.[57] The protein inhibits the normal functioning of alpha-amylase, an enzyme produced by the pancreas that aids in digestion.[58] The manufacturers contended that by blocking the alpha-amylase, a dieter can avoid calories by allowing starch to pass through the body undigested.[59]

¶ 17 Nutrilab wanted its product to be labeled a food, while the government wanted to label it a drug.[60] The court, in finding that starch blockers are drugs, held that a product that is naturally occurring or derived from natural foods is not necessarily exempt from the drug label.[61] The court further held that the fact that the classifying of a substance as a food in one instance does not preclude it from being classified as a drug in another.[62] When a product is in this gray area, the intended use becomes important. If labeling and promotional claims show that the product was intended to be used as a drug, it will be so designated.[63] If a product makes substantiated claims of drug-like effects, the court will designate the product a drug. Therefore, the court concluded that starch blockers were not foods because they were intended to be used as diet drugs.[64]

¶ 18 American Health, another manufacturer of starch blockers, lead a group of manufacturers and distributors of starch blockers in a suit against the FDA, again for classifying the products as drugs. The American Health court reviewed the definition of drug as a substance affecting the structure of the body. It found that starch blockers have no food use and are useless for any food purpose, and should therefore be labeled drugs under the FFDCA.[66] The court added that even a food product could be classified as a drug if it was sold for its physiological effects.[67] This stance follows the "manufacturers intent" argument outlined in National Nutrition and in Nutrilab.

¶ 19 The DSHEA created a new category of products: dietary supplements. As stated before, the DSHEA allows for some products to escape the classification of "drug." This was a great boost to the already growing dietary supplement field because it created a category for many products that fell in the gray area between foods and drugs. Only one major case dealing with the Act has been litigated.

¶ 19 The first in this trilogy of decisions began in 1991, before the passage of the 1994 DSHEA.[69] However, during the appellate process the Act was passed. Nature's Bounty manufactured and marketed a product named Ener-B Nasal Gel, a vitamin B-12 gel administered by placing drops on the membranes inside the nose.[70] The FDA confiscated the gel, calling it a "new drug" that had not been approved.[71]

¶ 20 Consistent with existing precedent, the court found that when a substance is not included in the official pharmacopeia, the manufacturer's "intent in selling the product is the key element"[72] in determining the classification of food or drug.[73] The government narrowed the definition of food to material ingested through the mouth for the primary purpose of nutrition taste or aroma, and which is absorbed into the body through the gastrointestinal tract.[74] This definition is followed strictly in the case law. Nature's Bounty argued that the newly passed DSHEA substantially affected this case.

¶ 21 DSHEA removed certain substances from the "drug" realm if they have a special dietary use. Even under the DSHEA amendment, a vitamin still must be ingested in tablet, capsule, powder, softgel, gelcap, or liquid form to qualify as a food.[75] Because Ener-B was taken nasally, its method of application, not its contents, caused it to be regulated as a drug. The court has shown that when a substance can be considered both a food and a drug, the FDA has the discretion to decide its classification.[76] No major cases have challenged the DSHEA since Ten Cartons.

¶ 22 The DSHEA did not change the application of the law in the judicial setting. It reclassified some of the contents of products as well as the products themselves as dietary supplements instead of drugs. The rules regarding ingestion and intended use of the product were not disturbed. Only the initial classification of a substance has changed. Although there has been only one major court battle, the FDA is still active in checking and reprimanding manufacturers for false representations about their dietary supplements.[77]

¶ 23 Upon the inception of the DSHEA, President Clinton appointed a seven member Commission on Dietary Supplement Labels.[78] This commission is responsible for providing recommendations on the regulation of claims and statements in order to provide truthful and valid information to consumers about dietary supplements.[79] The final commission report became available at the end of November 1997, and provides several suggestions for solving certain problems.[80] Also, the DSHEA provides for an Office of Dietary Supplements to be established within the National Institutes of Health to explore the roles of, and promote the scientific study of, dietary supplements.[81] Hopefully, the information provided by these new agencies will help clarify some of the gray areas in the DSHEA and allow health care practitioners to expand their knowledge about dietary supplements.

¶ 24 In its attempt to better govern the ever-changing health care industry, the federal government has provided regulation on drugs and dietary supplements by enacting the FFDCA and the DSHEA. These acts provide guidelines and definitions, but as the case law suggests, these definitions are inexact and must be interpreted by the courts. Thus far, the courts have been consistent in their interpretation of the law. Additionally, they have supported the findings of the FDA. However, conflicts will continue to occur between the government and manufacturers concerning the types of information provided to consumers. Hopefully, further decisions will clarify the definitions and allow more accurate information to be dispersed to health care professionals and the general public regarding dietary supplements.

*. Cameron Simmons is currently a second year law student at the West Virginia University College of Law. He has undergraduate degrees in Chemical Engineering (B.S.ChE.) and Mathematics (B.S.) from West Virginia Institute of Technology. Following his undergraduate work, Cameron completed a Master of Science in Safety Management at West Virginia University. Cameron has worked as an Engineer with FMC Corporation and in the field of asbestos testing and abatement with Tracor Technologies. Mr. Simmons has also successfully completed the fundamentals of engineering exam.

**. Melissa Simmons is currently a Family Medicine Resident with the Departments of Family Medicine and Pharmacy Practice at the Medical University of South Carolina. She has a Bachelor of Science (B.S.) degree from West Virginia University. Following her undergraduate work, Dr. Simmons worked as a hospital pharmacist at Charleston Area Medical Center. She then returned to school and received her Doctor of Pharmacy (Pharm.D.) degree from West Virginia University.

1. Anna K. Drew & Stephen P. Myers, Safety Issues in Herbal Medicine: Implications for the Health Professions, 166 MED. J. OF AUSTRALIA, 538-41 (May 1997). Non-traditional medicine generally encompasses any type of unorthodox, non-standardized treatment.

4. Karen Capen, Courts, Licensing Bodies Turning their Attention to Alternative Therapies. 156(9) CANADIAN MED. ASS'N J. 1307-8 (May 1, 1997).

5. FACTSAND COMPARISONS, INC., PHARMACY LAW DIGEST DC-4 (Joseph L. Fink et al. eds., 27th revision 1996). Federal Food, Drug, and Cosmetic Act of 1938, § 201(h), Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. § 321(h)(1994)).

6. FACTSAND COMPARISONS, INC., PHARMACY LAW DIGEST DC-4 (Joseph L. Fink et al. eds., 27th revision 1996).

10. FACTSAND COMPARISONS, INC., PHARMACY LAW DIGEST DC-4 (Joseph L. Fink et al. eds., 27th revision 1996).

11. FACTSAND COMPARISONS, INC., PHARMACY LAW DIGEST DC-4 (Joseph L. Fink et al. eds., 27th revision 1996).

16. Thomas F. McGuire, Food, drug or both?: Dual Classification Under the Federal Food, Drug, and Cosmetic Act, 1984 U. ILL L. REV. 987 (1984).

17. GARY A. HOLT, EDWIN L. HALL, HANDBOOKOF NONPRESCRIPTION DRUGS 1-4 (Timothy R. Covington et al. eds., American Pharmaceutical Association, 10th ed. 1990).

19. The national health care expenditure has escalated to more than $1 trillion and engulfs about twelve percent of the Gross National Product. Id. at §§ 2, 11.

20. Melatonin would fall into the category of other dietary substances. 21 U.S.C. § 321(ff) (1994).

25. Including USP standards, potency, quantity of the ingredient, part of plant the ingredient comes from (bark, leaf, etc). 21 U.S.C. § 343(q)(5)(F) (1994).

30. Structure or function claims may include such statements as "calcium builds strong bones," "phytochemicals promote normal cell metabolism," "glyconutritionals promote cell to cell communication." 21 U.S.C. § 343(r) (1994).

31. A dietary supplement may make a claim that "it makes you feel good." 21 U.S.C. § 343(r) (1994).

32. "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." Appendix II: Dietary Supplement Health and Education Act. (visited Feb. 14, 1998) <http://foodnet.fic.ca/industry/appii.html#1>.

35. Third-party information can include journal articles, book chapters, abstracts from peer-reviewed scientific publications. Summaries of this type of information is not allowable. 21 U.S.C. § 403(B)(a) (1994).

36. Id. Appendages were included as part of labeling standards to prevent manufacturers from placing a brand name or other information on third party information by way of a sticker.

38. Alfred J. Bollet, Natural Remedies, Medical Care, and Politics. SOUTHERN MED. J., Apr. 1997 at 457-9.

40. Thomas Y.K. Chan, Monitoring the Safety of Herbal Medications, DRUG SAFETY, Oct. 1997 at 209-215.

41. For instance, digoxin, paclitaxel, and warfarin are all derived from natural sources, but are manufactured and regulated as drugs under the FFDCA.

42. Pennyroyal a dietary supplement that is traditionally used as flea repellent or abortifacient has numerous cases of liver toxicity documented that have been associated with its use. Jacintha S. Cauffield, Herbal Medicine; Unsafe at Any Dose? Ambulatory Care Practice and Research Network Newsletter, Aug. 1997 at 5-7.

43. Over 800 adverse events have been reported to the FDA since 1994 regarding ephedrine alkaloids including: increases in blood pressure and heart rate, tremors, headaches, seizures, and heart attacks. These events generally occurred in healthy adults using the products for weight control or energy. Ephedra is found in products that contain Ma huang, herbal Fen-Phen, and others. MedWatch Safety Summaries-Ephedrine. (visited Feb. 14, 1998) <http://www.fda.gov/medwatch/safety/1997/ephedr.htm>.

44. The FDA has issued a warning about Chomper, a dietary supplement promoted as an "internal cleanser" because of a report of complete heart block upon ingestion. It seems that instead of containing plantain, as the label claimed, the product contained Digitalis lanata leaves. These leaves contain cardiac glycoside compounds which are precursors to potent prescription heart medications such as digoxin. FDA Warns Against Dietary Supplement Product, "Chomper". (visited Feb. 14, 1998) <http://www.fda.gov/medwatch/safety/1997/chompe.htm>

45. Jacintha S. Cauffield, Herbal Medicine; Unsafe at Any Dose? Ambulatory Care Practice and Research Network Newsletter, Aug. 1997 at 5-7.

49. National Nutritional Foods Ass'n. v. Weinberger, 512 F.2d 688, 701 (2d Cir. 1975).

51. The recommended daily allowance ("RDA") published by the Food and Nutrition Board of the NAS/NRC was between 4,500 and 5,000 IU of Vitamin A for older children and adults, 6,000 IU during pregnancy and 8,000 IU during lactation. For Vitamin D preparations the RDA was 400 IU for all age groups. Id. at 692.

68. United States v. Ten Cartons, 1991 WL 641573 (E.D.N.Y. 1991);United States v. Ten Cartons, 888 F.Supp. 381 (E.D.N.Y. 1995); United States v. Ten Cartons, 72 F.3d 285 (2d Cir. 1995).

71. "(1) Any drug . . . the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof; or (2) Any drug . . . the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions." Id. at 5 (quoting, 21 U.S.C. § 321(p) (1994)).

80. The executive summary of the committee's report includes recommendations for the supplement industry to accept responsibility for the safety of its products, the establishment of an expert advisory committee to provide scientific review of labeling statements, the provision of a botanical OTC evaluation board, and various other attempts to provide safe products and educational material to consumers and health care providers. Report of the Commission on Dietary Supplement Labels, (visited Feb. 14, 1998) <http://web.health.gov/dietsupp/final.pdf>.

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