Dietary Supplements and Lessons to Be Learned from GRAS

The demand for dietary supplements by the public has transformed this once cottage industry into a 12-billion-dollar-per-year business. Restrictive actions against dietary supplements by the Food and Drug Administration (FDA) prompted Congress to enact new and more permissive amendments governing dietary supplements (Dietary Supplement Health and Education Act, DSHEA) to the Federal Food, Drug and Cosmetic (FFD&C) Act in 1994. A comparison is made between the present status of dietary supplement regulation and the concept of general recognition of safety (GRAS) under conditions of intended use as set forth by the landmark 1958 Food Additive Amendment to the FFD&C Act. An argument is posited for use of applicable principles learned in nearly 40 years of experience with determining the GRAS status for hundreds of substances to problems posed by dietary supplements.