Nutrients and other ingredients intended to supplement the daily diet-whether added to a dietary supplement or to a conventional food product-have been regulated by FDA under the food provisions of the 1906 and 1938 Acts for almost a century. The same regulatory requirements have been applied by FDA to these nutrients and related ingredients in whatever type of product they are used. These products have been regulated as drugs only where the labeling or the advertising has specifically represented them for therapeutic use. It is widely and erroneously believed that DSHEA eviscerated the FD&C Act safety requirements for dietary supplements. In fact, DSHEA did not alter the basic food safety provision in the FD&C Act that has since 1906 prohibited any poisonous or deleterious substance in food. For both old (pre-1994) and new dietary ingredients, DSHEA prohibits any significant or unreasonable risk of injury, authorizes an immediate ban of an imminent hazard, and authorizes FDA to impose requirements for good manufacturing practices ("GMPs"). None of these statutory provisions applies to conventional food. DSHEA excludes old and new dietary ingredients from the food additive provisions of the FD&C Act, but requires that all new dietary ingredients be the subject of a premarket notification submitted to FDA with adequate safety information at least seventy-five days before marketing, unless the ingredient has been present in the food supply as an article used for food and in a form in which the food has not been chemically altered. All of the FD&C Act enforcement provisions apply to both old and new dietary ingredients and dietary supplements. DSHEA contains three procedural provisions that are applicable only to dietary supplements. First, DSHEA specifically places the burden of proof in a civil enforcement action relating to the safety of a dietary supplement on FDA. This is the same rule that applies in litigated court cases involving conventional food adulteration.14 Second, the court must decide the issue of adulteration of a dietary supplement on a de novo basis. This is the standard rule in any case where FDA institutes litigation against a product or company, but it reverses the current rule where a company challenges an FDA regulation. Third, FDA must provide a person an opportunity to present both oral and written views at least ten days before the agency refers a matter to the Department of Justice for civil court enforcement. This is a new provision, applicable only to dietary supplements, but because of a Supreme Court precedent it is questionable whether it is enforceable. Since they were enacted in 1994, these three procedural provisions have been invoked in only one FDA regulatory action. Conventional food is subject to the same prohibition of poisonous or deleterious substances that applies to dietary supplements, but it is not subject to the prohibition of significant or unreasonable risk of illness or injury or to the immediate ban of an imminent hazard or to the explicit statutory requirement for compliance with good manufacturing practices. Conventional food ingredients are subject to the requirements of the Food Additives Amendment of 1958 rather than to the premarket notification requirements applicable to new dietary ingredients. A new conventional food ingredient may therefore be marketed solely on the basis of a manufacturer's own determination that it is generally recognized as safe ("GRAS"), and this is in fact the primary basis on which most new conventional food ingredients are marketed. There is no requirement that FDA be notified or that FDA approve the GRAS determination. If FDA disagrees, it must initiate an enforcement proceeding to prohibit use of the ingredient. Thus, DSHEA requires premarket notification for all new dietary ingredients except those that are derived unchanged from food, whereas FDA is not informed about new conventional food ingredients that the manufacturer determines are GRAS. The failure to submit a premarket notification renders the dietary ingredient unlawful. A new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury is also illegal. If FDA makes such a determination in response to a premarket notification and the company nonetheless markets the ingredient, FDA has the authority to bring legal action in the courts and has the burden of proof of demonstrating inadequate information. Accordingly, the requirements for initial marketing of a new ingredient are more rigorous for dietary ingredients than for conventional food ingredients. As the chart attached at the end of this article demonstrates, on balance the FD&C Act, as amended by DSHEA, provides somewhat greater FDA regulatory authority over dietary supplements than over conventional food. DSHEA provides greater FDA scrutiny of new dietary ingredients than exists for new conventional ingredients and adds safety enforcement authority for all dietary supplements that extends beyond the FDA authority applicable to conventional food. DSHEA adds three additional procedural safeguards for dietary supplement court actions to assure that FDA will act fairly and equitably in its enforcement of safety requirements, but it does not substantially change the requirements applicable to court action involving conventional food.28 Thus, the current food safety provisions of the FD&C Act provide FDA with greater substantive authority over dietary supplements than they provide for conventional food, and the modest procedural changes in the court enforcement requirements have thus far had little if any impact and are unlikely to have a significant impact in the future. © 2005 American Society of Law, Medicine & Ethics. Boston University School of Law.
