Federal Food, Drug, and Cosmetic Act 1938, 1954, 1958 (FFDCA) By, Lauren Levy
FFDCA • The Draft year for the FFDCA was 1938 • The Amendment years were 1954 and 1958 • The piece of legislation was national • The introduction of this act was influenced by the death of 100+ patients due to a sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a liquid form • Replaced Pure Food and Drug Act of 1906.
FFDCA (Description of Function) • FFDCA is a set of laws passed by Congress in giving authority to the Food and Drug Administration (FDA) [Agency Responsible for Regulation] to oversee the safety of food, drugs, and cosmetics. • In 1968, the Electronic Product Radiation Control provisions were added to the FD&C • FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs.
FFDCA (Environmental Issues/ Agency Responsible for Regulation and Enforcement) • FFDCA governs the establishment of pesticide tolerances for food and feed products. - A tolerance is the maximum level of pesticide residues allowed in or on human food and animal feed. • FFDCA requires producers of food additives to demonstrate to a reasonable certainty that no harm will result from the intended use of an additive to humans • Main Environmental Issue: Human Safety