ELIMINATION OF PREMARKET SAFETY EVALUATIONS UNDER THE DIETARY SUPPLEMENTS ACT OF 1994: NEW HEALTH RISKS FOR THE CONSUMER SUSAN S.

Transcription

1 ELIMINATION OF PREMARKET SAFETY EVALUATIONS UNDER THE DIETARY SUPPLEMENTS ACT OF 1994: NEW HEALTH RISKS FOR THE CONSUMER SUSAN S. JARVIS* I. INTRODUCTION As an increasing number of consumers in the United States purchase dietary supplements, reports of serious health risks associated with the supplements have also increased. Until 1994, the Federal Food and Drug Administration had regulatory authority over dietary supplements. With the passage of the Dietary Supplements Health and Education Act of 1994, dietary supplements became exempt from the premarket evaluations required for new food ingredients. In addition, the Act extended the definition of dietary supplements to include substances such as enzymes and amino acids. This article addresses the following topics: (I) An Overview of the Dietary Supplements Health and Education Act of 1994; (II) The Expanded Definition of Dietary Supplement Under the Act; (III) Reports of Health Risks Associated with Dietary Supplements; and (IV) Potential Liability Associated with Dietary Supplements II. AN OVERVIEW OF THE DIETARY SUPPLEMENTS HEALTH AND EDUCATION ACT OF 1994 The first major federal legislation regulating the sale of food was the Federal Food, Drug and Cosmetic Act. 1 The original act was amended in 1958 with the passage of the Food Additives Amendments. 2 This amendment addressed the evaluation by the Food and Drug Administration (FDA) as to the safety of new ingredients. The original act was again amended in 1994 with the passage of the Dietary Supplements Health and Education Act of 1994 (DSHEA). 3 The latest legislation provides that ingredients found in dietary supplements are now exempt from the premarket evaluations for safety that are required for other new food ingredients. Congressional findings in the DSHEA included: *Professor of Business Law, College of Business Administration, The University of Texas Pan American 1 21 U.S.C.A Id Dietary Supplements Health and Education Act of 1994, Pub. L. No , 108 Stat (1994). Proceedings of the Southern Academy of Legal Studies in Business March 2000

2 (1) improving the health status of United States citizens ranks at the top of the national priorities of the Federal Government; (2) the importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies; (3) (A) there is a link between the ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis; and (B) clinical research has shown that several chronic diseases can be prevented simply with a healthful diet, such as a diet that is low in fat, saturated fat, cholesterol, and sodium, with a high proportion of plant-based foods;...(6)(b) reduction in health care expenditures is of paramount importance to the future of the country and the economic well-being of the country.... (8) consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements; (9) 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; (10 ) studies indicate that consumers are placing increased reliance on the use of nontraditional health care providers to avoid the excessive costs of traditional medical services and to obtain more holistic consideration of their needs (12)(A) the nutritional supplement industry is an integral part of the economy of the United States; (B) the industry consistently projects a positive trade balance; and (C) the estimated 600 dietary supplement manufacturers in the United States produce approximately 4,000 products, with total annual sales of such products alone reaching at least $4,000,000,000;.... (14) dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare; and (15)(A) legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness; and (B) a national Federal framework must be established to supersede the current ad hoc, patchwork regulatory policy on dietary supplements. 4 The above findings relevant to the economic impact of nutritional supplements demonstrate the strong influence the dietary supplement manufacturers and sellers had in the passage of this legislation. Relevant to its current role vis-à-vis the introduction of dietary supplements to the public, the federal Food and Drug Administration states, [The] FDA does not analyze supplement products before they are sold to consumers. The manufacturer is responsible for ensuring that the ingredient list is accurate and that the ingredients are safe. They are also required to make sure that the content matches the amount declared on the label. The FDA does not have adequate resources to analyze dietary products sent by 4 Id / Proceedings of the Southern Academy of Legal Studies in Business

3 consumers who want to know their content. Instead, consumers may contact the manufacturer or a commercial laboratory. 5 On January 5, 2000 the FDA issued a rule holding that manufacturers of dietary supplements could publish claims relevant to the product s effect on the function or structure of the body without prior FDA review. The rule allows claims relevant to certain common conditions associated with pregnancy, aging, menopause and adolescence. 6 III. THE EXPANDED DEFINITION OF DIETARY SUPPLEMENT UNDER THE ACT Following the passage of the original Federal Food, Drug and Cosmetic Act, the FDA s definition of dietary supplements included supplements made of the essential nutrients (minerals, proteins, vitamins). In 1990, the Nutrition Labeling and Education Act expanded the definition to include herbs, or other similar nutritional substances. 7 According to the Dietary Supplement Health and Education Act, a dietary supplement is further expanded and can include a variety of substances including fish oils, ginseng, garlic psyllium, enzymes, and glandulars as well as hormones and amino acids. According to the Act, 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 (E). 8 The Act further provides that a dietary supplement is intended for ingestion in capsule, tablet, pill or liquid form; is not represented as a conventional food or as the sole item of a meal or diet and is labeled dietary supplement. According to the Act, a dietary supplement includes an article that is approved as a new drug under Section 505, certified as an antibiotic under Section 507 or licensed as a biologic under section 351 of the Public Health Service Act 9 and prior to the approval, certification or license was marketed as a dietary supplement or food absent a regulation by the Secretary to the contrary. Section 403B of the DSHEA permits sellers of dietary supplements to display in their stores publications that advocate the benefits of a supplement if certain conditions are 5 U.S. FOOD & DRUG ADMIN., CENTER FOR FOOD SAFETY & APPLIED NUTRITION, OVERVIEW OF DIETARY SUPPLEMENTS, available at, last visited Aug ). 6 U.S. FOOD & DRUG ADMIN., FDA FINALIZES RULES FOR CLAIMS ON DIETARY SUPPLEMENTS, available at (last visited Aug. 23, 2000) U.S.C.A Pub. Law. No (ff) U.S.C.A March 2000/ 33

4 met. These publications are exempt from the dietary supplement labeling requirements of the DSHEA. III. REPORTS OF HEALTH RISKS ASSOCIATED WITH DIETARY SUPPLEMENTS The sale of dietary supplements is expected to exceed $14 billion this year. Claims associated with these supplements range from reversing the aging process to improving the immune system. Despite the Congressional finding that these supplements are safe within a broad range of intake, an increasing number of medical reports are documenting the dangers involved in taking certain of these supplements especially in excessive dosages. One possible reason for the increased documentation of dangers may be that dietary supplements are not monitored for potency and purity as is required for regulated drugs. Thus, some of the adverse effects and drug interactions reported for herbal products could be caused by impurities (e.g., allergens, pollen and spores) or batch-to-batch variability. In addition, the potency of an herbal product may increase the possibility of adverse effects. 10 Among the most commonly used herbal dietary supplements are ginkgo, St. John s wort, ephedra, ginseng, and kava. Serious adverse reactions have been reported when each of these have interacted with other drugs the consumer was taking. Gingko biloba interacts adversely with aspirin, Coumadin, Ticlid, Plavix and Persantine. The most common adverse reaction is bleeding, with reports of ocular hemorrhages and intracebral bleeding. 11 St. John s wort interacts adversely with antidepressants; ephedra with caffeine, decongestants and stimulants; ginseng with warfarin and kava with numerous sedatives, sleeping pills, antipsychotics and alcohol. The herb ephedra (also called ma huang ) is used in over 200 supplements. The active ingredient in ephedra is ephedrine, which acts as a stimulant on the central nervous system. Ephedrine has been widely studied over the past few years, and studies suggest that it can produce a wide array of possible side effects, including anxiety, insomnia, hypertension, tachycardia, psychosis, kidney damage, dependency, heart attack, stroke and death. And the Federal Food and Drug Administration says it has received hundreds of reports from physicians, health authorities and others about adverse reactions to ephedrine-based products. 12 The Center for Science in the Public Interest, a nonprofit consumer organization, reported that royal jelly, a honeybee derivative classified as a dietary supplement, was 10 Melanie Cupp, Herbal Remedies: Adverse Effects and Drug Interactions, AM. FAMILY PHYSICIAN, March 1, 1999, at Id. at M. Duffy, Side Effects Raise Flag on Dangers of Ephedra, N.Y. TIMES, Oct. 12, 1999, at F7. 34/ Proceedings of the Southern Academy of Legal Studies in Business

5 linked to an 11-year-old girl s death due to an asthma attack. The jelly was also linked to nine other serious asthma attacks. 13 Relevant to dietary supplements, recent reports have found the supplements may contain the substances listed on the label in the amounts claimed, but they need not; the sale is not prevented in the latter case. In analyses of ginseng products, the volume of the active ingredient in an individual pill varied by as high as a factor of 10 among brands that were labeled as containing the same amount. In some brands, there was none of the ingredient. 14 In November 1999, the Food and Drug Administration warned the public about the weight-loss product called Triax Metabolic Accelerator. Sold as a dietary supplement, the FDA warned the product s main ingredient, tiratricol (a derivative of a thyroid hormone) could cause serious illnesses including strokes and heart attacks. 15 Another dietary supplement raising concern is oral creatine, which is used by athletes seeking to enhance their athletic performances. It is a nitrogenous amino acid compound occurring naturally in the brain, heart, retina, skeletal muscle and other tissues. Potential adverse effects include muscle cramping, gastrointestinal pain and diarrhea, renal dysfunction and dehydration. 16 Dr. Juhn also refers to unstudied potential adverse effects. It is unknown, for example, what effect oral creatine supplementation has on creatine concentration in the heart, brain, and reproductive organs. Furthermore, oral creatine supplementation results in the attenuation or suppression of endogenous creatine synthesis by the liver, and the long-term effects of this on the liver and other organ systems are not known. 17 IV. POTENTIAL LIABILITY ASSOCIATED WITH DIETARY SUPPLEMENTS Potential legal liability for the manufacture and sale of dietary supplements which cause harm to the user may lie in both contract and tort law. Contractual liability claims may be based on breach of express warranty 18 and implied warranty of merchantability 19 under Article 2 of the Uniform Commercial Code and fraudulent misrepresentation. Potential tort liability associated with harm caused by dietary supplements may be based on negligence, battery, and fraud or in some instances strict product liability. The negligence issue relates to those situations where a court finds the defendant manufacturer had a duty to provide a safe product; breached that duty; and the breach was the proximate and actual cause of plaintiff s injuries. A manufacturer who fails to exercise reasonable care in the manufacture of a chattel (movable good) which, unless carefully made, he should 13 Jane Brody, With Few Regulations, Consumers of Dietary Supplements Risk Health, HOUSTON CHRON., Sept. 27, 1998, at M. Angell & J. P. Kassirer, Alternative Medicine The Risks of Untested and Unregulated Remedies, NEW ENG. J. MED., Sept. 17, 1998, at S. Stolberg, F.D.A. Issues a Health Warning on a Weight-Loss Supplement, N.Y. TIMES, Nov. 12, 1999, at 25A. 16 M. Juhn, Oral Creatine Supplementation, PHYSICIAN & SPORTS MED., May 1999, at Id. at U.C.C Id March 2000/ 35

6 recognize as involving an unreasonable risk of causing physical harm to those who lawfully use it for a purpose for which the manufacturer should expect it to be used and to those whom he should expect to be endangered by its probable use, is subject to liability for physical harm caused to them by its lawful use in a manner and for a purpose for which it is supplied. 20 Relevant to potential negligence liability, Due care must be exercised in designing the product, in selecting the materials, in using the appropriate production process, in assembling and testing the product, and in placing adequate warnings on the label informing the user of dangers of which an ordinary person might not be aware. The duty of care also extends to the inspection and testing of any purchased products that are used in the final product sold by the manufacturer. 21 The intentional tort of battery may be argued based on the plaintiff s right to personal safety. If a plaintiff can prove that the defendant manufacturer sold an unsafe product knowing the possibility of harm, a court may rule in plaintiff s behalf. The intentional tort of fraud may be applicable when the plaintiff can prove the defendant intentionally misstated or omitted relevant information that the injured plaintiff reasonably relied on. The elements of fraud include: 1. Misrepresentation of facts or conditions with knowledge that they are false or with reckless disregard for the truth. 2. Intent to induce another to rely on the misrepresentation. 3. Justifiable reliance by the deceived party. 4. Damages suffered as a result of reliance. 5. Causal connection between the misrepresentation and the injury suffered. 22 Strict product liability may also apply under the following circumstances: (1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer or to his property, if (a) the seller is engaged in the business of selling such a product, and (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold. (2) the rule stated in Subsection (1) applies although (a) the seller has exercised all possible care in the preparation and sale of his product and (b) the user or consumer has not bought the product from or entered into any contractual relation with the seller. 23 Strict liability may be applicable due to a manufacturing flaw, inadequate warning or inadequate packaging and labeling. If strict liability is applicable, all parties in the distribution change (dietary supplement manufacturer, wholesaler, supplier, and retailer) may face potential liability. 20 RESTATEMENT (SECOND) OF TORTS 395 (1966). 21 ROGER LEROY MILLER & GAYLORD A. JENTZ, FUNDAMENTALS OF BUSINESS LAW 316 (4 th ed. 1999). 22 Id. at RESTATEMENT (SECOND) OF TORTS 402A (1966). 36/ Proceedings of the Southern Academy of Legal Studies in Business

7 A recent lawsuit filed in New York alleges both contract and tort liability. A wrongful death suit has been filed by the family of a 37-year-old fashion designer who suffered a fatal stroke during a workout at a New York health club. 24 The plaintiff, the surviving spouse, alleges the health club s trainer/nutritionist instructed the victim to take specific supplements. The victim was suffering from hypertension and the suit claims the club knew of this. Defendants include the shop that sold the supplements and four supplement manufacturers and distributors. Among the supplements involved was Thermadrene, which is made of ephedra, willow bark, guarana, caffeine, ginger root and cayenne. Two of the supplements the victim took contained the amino acid phenylalanine. The complaint includes eight causes of action: (1) negligence on the part of the health club; (2) negligence by the supplement sellers and manufacturers (3) strict product liability; (4) breach of warranty; (5) wrongful death against the health club; (6) wrongful death in negligence against the manufacturers and marketers; (7) wrongful death based on strict liability against the manufacturers and marketers; and (8) wrongful death based on breach of warranty against the manufacturers and marketers. VI. CONCLUSION The number of consumers using dietary supplements in this country is increasing on a daily basis. The Dietary Supplements Health and Education Act of 1994 exempts these supplements from premarket evaluations. The increased usage of dietary supplements combined with the exemption from premarket evaluations has lead to an ever-increasing number of health risks associated with the ingestion of the supplements. The potential for legal liability is also increasing and can apply to not only the manufacturer but to all parties involved in the distribution of the product as well as consultants, advisers and marketers. 24 Capati v. Crunch Fitness Int l, Inc., N.Y. Sup. Ct., Index No /99, June 28, March 2000/ 37