Federal Food, Drug, and Cosmetic Act 1938, 1954, 1958

(FFDCA)By Catherine Cabot

Period 6

FFDCA

• The Draft Year was 1938• The Amendment Years were 1954 and

1958• This piece of legislation is national (U.S.)• THE FFDCA) is a set of laws passed by

Congress in 1938 giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.

FFDCA (continued)

• This act was introduced due to heavy influence by the death of more than 100 patients due to a sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a liquid form.

• THE FFDCA has nine chapters that cover the definitions of foods, drugs, etc.; prohibited acts and penalties; food; drugs and devices; cosmetics; general authority; imports and exports; and miscellaneous.

• For example, The FFDCA requires producers of food additives to demonstrate to a reasonable certainty that no harm will result from the intended use of an additive. If the FDA finds an additive to be safe the agency issues a regulation specifying the conditions under which the additive may be safely used.

FFDCA Environmental IssuesAgency/Group Responsible for Regulation and Enforcement

• The environmental issues include protection of human health and safety by preventing the harm that can come from such things as food additives, medicinal drugs and cosmetic products.

• The Food and Drug Admionistration (FDA) is responsible for the regulation and enforcement of the act.