On Oct. 25. 1994, the Dietary Supplement Health and Education Act was enacted establishing specific labeling requirements, provided a regulatory framework, and authorized the U.S. Food and Drug Administration (FDA) to promulgate good manufacturing practice (GMP) regulations for dietary supplements. Senators Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) were instrumental in the passage of the legislation.

This act defined “dietary supplements” and “dietary ingredients” and classified them as food. The act also established a commission to recommend how to regulate claims.  Supplement manufacturers do not need to receive FDA approval before marketing dietary supplements that were marketed in the United States before 1994.

New Dietary Ingredients 21 U.S.C. 350b(d), not grandfathered by the 1994 law must be reviewed (not approved) by the FDA prior to their marketing. The FDA is not authorized to approve dietary supplements for safety and effectiveness.