how are medical food regulated
Medical foods were regulated as drugs prior to 1972 according to Federal Food, Drug, and Cosmetic Act, 21 U.S.C.321(g)(1)(B). Orphan Drug Act, Pub. Law. 97-114 (1983) Congress amended Orphan Drug Act to formally define a medical food in 1988; reaffirmed in 1992, and again in 1996.