THE REGULATION OF DIETARY SUPPLEMENTS - FDA'S NEW JURISDICTIONAL DILEMMA

Abstract

For purposes of enforcement, the jurisdictional prerequisites to the exercise of regulatory authority by the Food and Drug Administration are found in the specific definition of regulated substances. Prior to 1994 the two major classes of FDA substances were foods and drugs. The 1994 passage of the Dietary Supplement Health and Education Act (DSHEA) created a new class of regulated substances known as dietary supplements and set up a new regulatory framework for their regulation. Although DSHEA legally classifies dietary supplements as a special category of foods, it has had the effect of expanding the traditional definition of dietary supplements to practically exclude them from the definition of either a “food” or a “drug” and therefore also from FDA scrutiny and premarket approval. DSHEA, therefore, creates a new class of regulated substance for which the extent of FDA regulatory jurisdiction is primarily postmarket and for which FDA's ability to regulate the safety of dietary supplements remains unclear.