About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline
LOG IN
LOG IN

42 N. Y. L. Sch. L. Rev. 261 (1988)
Where There's Smoke There's Fire: The Dangers of the Unregulated Dietary Supplement Industry

handle is hein.journals/nyls42 and id is 271 raw text is: WHERE THERE'S SMOKE THERE'S FIRE: THE DANGERS OF THE UNREGULATED DIETARY SUPPLEMENT INDUSTRY I. INTRODUCTION Today, standards placed on the drug industry to assure safety' and efficacy2 are very demanding. In contrast, dietary supplements, which are often diluted drugs3 with similar benefits and dangers, have managed to elude the regulatory scrutiny of the Food and Drug Administration (FDA). Presently, when vitamins, minerals, herbs, botanicals, and amino acids (all classified as dietary supplements) reach the marketplace, they do so without established clinical proof of safety or efficacy.4 Instead, the marketplace serves as the forum for such assessment.5 This note will discuss how under today's definition, what classifies a product as a drug or a dietary supplement is not necessarily what it does, but often what it claims to do.6 Dietary supplements in many 1. See Dixie Farley, Benefit vs. Risk: How FDA Approves New Drugs, FDA CONSUMER, Jan. 1995, at 23, 29 (discussing the definition of safety in terms of submitting test results adequate to show the drug is safe under the conditions of use in the proposed labeling and that safety is determined case by case in which the benefits of the drug must outweigh the risks). 2. See id. at 28 (discussing the absorption rates of generic and brand name drugs, their influence on a disease, and that efficacy is proven by substantial evidence consisting of well-controlled investigations, including human studies, which demonstrate that the drug will have the effect claimed in the labeling). 3. See Judith Mandelbaum-Schmid, NaturalRemedies, SELF, Sept. 1996, at 206, 209 (explaining how some herbal medicines which are classified as dietary supplements are as potent and, arguably, as dangerous as drugs). 4. See id. at 209 (discussing how consumers cannot be sure of what they are buying when purchasing these supplements). 5. See id. 6. See Edgar R. Cataxinos, Regulation of Herbal Medications in the United States: Germany Provides aModelforReform, 1995 UTAH L. REV. 561, 566 (discussing how an herbal medication's intended use determines its classification under a food or drug category and that the manufacturer, through labeling and advertising representations, can determine the herbal medication's use and thus influence the herbal product's respective classification by the FDA); see also Sheryl Gay Stolberg, F.D.A. Warns Consumers About Herbal Weight Loss Mixtures, N.Y. TIMEs, Nov. 7, 1997, at A19 (stating that it is not illegal for a manufacturer to sell a dietary supplement like fen-phen, but it is illegal to refer to fen-phen as something that is exactly like a medication and to make medical claims like the prescription products do).

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Short-term subscription options include 24 hours, 48 hours, or 1 week to HeinOnline.

Purchase Access

Contact us for annual subscription options:

Contact Us

Already a HeinOnline Subscriber?

Log In

profiles profiles most