Dietary Supplements: A Definition That is Black, White, and Gray

Abstract

The Dietary Supplement Health and Education Act of 1994 (“DSHEA” or “the Act”) was a seminal event in the world of food and drug law. The Act took a controversial category of product traditionally regulated by FDA as either a food or a drug, depending upon the product claims and formulation, and created a new regulatory category called “dietary supplement” that was placed within the “food” definition. As such, products meeting the “dietary supplement” definition benefited in two significant ways, (1) dietary supplements could make “structure/function” claims traditionally within the realm of drug products; and (2) unlike food ingredients, dietary ingredients could be used in dietary supplements without being either approved food additives or generally recognized as safe (“GRAS”) ingredients. These legislative provisions significantly changed the legal, corporate, and consumer landscape, allowing products to enter the marketplace with broadbased claims without FDA premarket review or approval of the ingredients, formulation, or product claims.