On June 25, 1938 President Franklin D. Roosevelt signed the Food, Drug, and Cosmetic Act 1938 . “The new law brought cosmetics and medical devices under control, and it required that drugs be labeled with adequate directions for safe use. Moreover, it mandated pre-market approval of all new drugs, such that a manufacturer would have to prove to FDA that a drug were safe before it could be sold.” [3] Taking over the 1906 Food and Drug Act.