For almost a century, the Food and Drug Administration (FDA) has regulated nutrients and other dietary supplement ingredients and products1 under the food provisions initially of the Federal Food and Drugs Act of 19062 and now of the Federal Food, Drug and Cosmetic Act of 19383 ("FD&C Act"), as amended. Congress amended the FD&C Act through the Food Additives Amendment of 19584 and the Color Additive Amendments of 1960(5) to strengthen FDA authority over food ingredient safety. In 1976, Congress enacted the Vitamin-Mineral Amendments6 which provides that FDA may limit the contents of dietary supplements only for safety reasons. In 1994, Congress enacted the Dietary Supplement Health and Education Act ("DSHEA")7 to continue the regulation of dietary supplements under the food provisions of the FD&C Act but to replace the food additive provisions with separate safety requirements for dietary supplements and dietary ingredients. Most recently, Congress enacted the Public Health Security and Bioterrorism Preparedness and Response Act of 20028 to provide additional authority to assure the safety of the food supply.
This article summarizes the safety requirements applicable to dietary supplements and dietary ingredients under the FD&C Act (as amended by DSHEA and the other statutes referenced above), describes the safety requirements applicable to conventional food, and compares these two overlapping regulatory programs.
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.9 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").10 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.12
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.13 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.15 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.16 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. …