Transcript Federal Food, Drug, and Cosmetic Act 1938, 1954, 1958 (FFDCA)

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 Issues
Agency/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.