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