This Week In FDA History - April 22, 1976
April 22, 1976:
Congress passes the Vitamin-Mineral Amendment to the Federal Food, Drug, and Cosmetic Act. Also known as the Proxmire amendment (after Sen. William Proxmire, D-Wisc., its principal sponsor), the legislation prohibited the FDA from establishing standards to limit the potency of vitamins and minerals in food supplements or regulating them as drugs based solely on their potency.
FDA in 2006
|Today's regulation of vitamins and minerals was established by the Dietary Supplement Health and Education Act of 1994 (DSHEA). The legislation placed dietary supplements in a special category under the general umbrella of "foods," not drugs. Under DSHEA, dietary supplements do not need FDA approval before they are marketed. A firm is responsible for determining that the dietary||
supplements it manufactures or distributes are safe and that there is enough evidence to prove that claims made about them are not false or misleading. The exception is "new dietary ingredients" (substances not used in dietary supplements before 1994): The company must demonstrate to the FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement.