Findings

Congress finds the following: (1) Homeopathic drug products have a long history of use in the United States and are prepared according to methods different from other drugs regulated under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). (2) Federal regulatory oversight of homeopathic drug products has been implemented through mechanisms other than premarket approval, reflecting the distinct characteristics, methods of preparation, risk profile, and patterns of use of such products. (3) A clear statutory framework consistent with the historical regulatory treatment of homeopathic drug products will promote safety, quality, and access, ensure consistent regulation, and reduce uncertainty.