American Journal of Law & Medicine

What lies beneath: an examination of the underpinnings of dietary supplement safety regulation.(The Dietary Supplement Health and Education Act: Regulation at a Crossroads)


In response to the increasing attention to the link between health and nutrition, a wealth of information--and misinformation--is becoming available, especially via the Internet. Consumers are advised to carefully assess the reliability of information they use to determine whether a product is safe. (1) Meanwhile, regulators are sorting out the facts themselves, but despite the ever-increasing availability of scientific research, our evolving understanding of nutrition is still supplemented by our perceptions about risk.

The primary framework for the regulation of dietary supplements is the Dietary Supplement Health and Education Act of 1994 ("DSHEA"). (2) Underlying DSHEA is the congressional intent to support two goals: "(1) to facilitate consumer access to dietary supplements, given that many dietary supplements are used by consumers to help them maintain and improve their health; and (2) to give the Food and Drug Administration ("FDA") the authority to step in where safety problems arise and to ensure proper labeling." (3) Thus, dietary supplement regulation seeks to balance consumer access against product safety. This article will focus on the latter goal-product safety. Rather than address the ultimate question of whether the current regulation is sufficient to ensure product safety, this article takes a step back to address what is perhaps the penultimate question: What premises should guide dietary supplement regulation?


To analyze and evaluate the underpinnings of product safety regulation, we begin at the surface by describing the current safety scheme.

A food product is presumed safe unless the government proves that the food "pose[s] a reasonable possibility of injury," in which case the government can remove the food from the market. (4) The Federal Food, Drug, and Cosmetic Act ("FDCA"), (5) enacted in 1938, sets forth this "after-the-fact policing" system for foods. (6) Food products include "(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article." (7) New food ingredients, on the other hand, are presumed unsafe. (8) New food ingredients must be approved by FDA before the new food ingredient is available to consumers. (9) Pre-market approval for a new food ingredient may be obtained by (1) filing a food additives petition for the new ingredient, or (2) showing that the ingredient is "generally recognized as safe" ("GRAS"). (10) The second method requires the manufacturer to show by "scientific procedures" that the new ingredient is "safe under the conditions of its intended use." (11) Both options for pre-market approval can be costly and time-consuming.

When dietary supplements first appeared, FDA attempted to regulate them using the procedures for new food ingredients. (12) A manufacturer wanted to market black currant oil capsules in which the only ingredients were black currant oil, glycerin, and the gelatin capsule. (13) FDA took action against the manufacturer by arguing that the black currant oil was a food additive, and, as such, the product could not be marketed without the requisite pre-market approval for food additives. (14) FDA's proposition that dietary supplements must comply with food additive procedures was unanimously rejected by both the United States Court of Appeals for the Seventh Circuit (15) and the United States Court of Appeals for the First Circuit:

   FDA's reading of the [FDCA] is nonsensical ... The proposition 
   that placing a single-ingredient food product into an inert capsule 
   as a convenient method of ingestion converts that food into a food 
   additive perverts the statutory text, undermines legislative intent, 
   and defenestrates common sense. (16) 

With no evidence that the dietary supplement was adulterated or otherwise harmful, FDA's stance against dietary supplements was viewed as a misguided campaign to prohibit the marketing of safe dietary supplements. (17) In response, legislators enacted DSHEA to protect consumer access to safe dietary supplements. (18)

Under DSHEA, dietary supplements need not satisfy the safety requirements that FDA imposes on food additives. (19) A dietary supplement is defined as a vitamin, mineral, herb or other botanical, amino acid, or "dietary substance for use by man to supplement the diet by increasing the total dietary intake," or a "concentrate, metabolite, constituent, extract, or combination of [such an ingredient]." (20) The dietary supplement must be intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form. (21) If it is not intended to be taken in such form, it must not be represented as conventional food and must not be represented for use as the sole item in a meal or diet. (22)

DSHEA provides that dietary supplement manufacturers must merely notify FDA and provide some evidence that the ingredient can "reasonably expected to be safe" (23) seventy-five days before marketing the new product. (24) Ingredients marketed prior to October 15, 1994, are exempt from even this minimal requirement. (25) Thus, DSHEA requires pre-market notification for new dietary supplements, while the FDCA requires pre-market approval for new food additives. The standard for adulterated products is virtually identical; a dietary supplement is deemed adulterated if it presents "a significant or unreasonable risk of illness or injury under ... condition of use recommended or suggested in labeling, or ... if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use." (26) DSHEA also provides an emergency measure by which the Secretary of Health and Human Services may immediately remove a dietary supplement from the market if the supplement poses an imminent hazard to the public health or safety. (27) Dietary supplement manufacturers are encouraged, but not required, to report adverse events to FDA. (28)


Because dietary supplements are a subcategory of foods, the logical starting point for a comparative analysis begins with foods. But a thorough analysis of safety regulation should compare dietary supplements to drugs, as these two classes of products share some similarities. By viewing a broad range of products side by side, including dietary supplements, foods, and drugs, one can more easily discern the general premises that guide safety regulation. A brief overview of the regulatory scheme for drugs follows.

A drug is a product that is "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease." (29) Accordingly, drug manufacturers are required to submit evidence regarding both the safety and efficacy of the drug product. (30) The category of drugs is further subdivided into over-the-counter ("OTC") drugs, generic drugs, and prescription drugs. (31) While consumers can purchase OTC drugs without intervention from a healthcare professional, other categories require a prescription. (32)

OTC drugs are products that generally have these characteristics:

a) their benefits outweigh their risks;

b) the potential for misuse and abuse is low;

c) consumers can use them for self-diagnosed conditions;

d) they can be adequately labeled; and

e) health practitioners are not needed for the safe and effective use of the product. (33)

OTC drugs are regulated more stringently than dietary supplements in that OTC drug manufacturers must provide evidence of both safety and efficacy in order to show that the benefits outweigh the risks. (34) OTC drugs marketed in the U.S. before May 11, 1972, are reviewed for safety and efficacy by an advisory review panel. (35) For newer OTC drugs, the manufacturer must provide evidence that the drug's benefits outweigh its risks. (36)

The regulatory frameworks for OTC drugs and dietary supplements are similar in that OTC drugs, like dietary supplements, do not require pre-market approval: "Marketing pre-clearance of OTC drug products by FDA is not required if the standards of the applicable monograph are met. …

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