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Legislation Project: Federal
Food, Drug, and Cosmetic Act
Catherine DeMarco
Federal Food, Drug, and Cosmetic
Act of 1938
The Federal Food, Drug, and Cosmetic Act was passed by Congress in 1938 in reaction to
the growing public safety demands. Food adulteration continued to flourish because
judges could find no specific authority in the law for the standards of purity and content
which FDA had set up. Such products as "fruit" jams made with water, glucose, grass seed,
and artificial color undercut the market for honest products. The primary goal of the Act is to
protect the health and safety of the public by preventing deleterious, adulterated or
misbranded articles from entering interstate commerce. Under section 402(a)(4) of the
Act, a food product is deemed “adulterated” if, inter alia, the food was “prepared, packed,
or held under insanitary conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health.” A food product is also considered
“adulterated” if it bears or contains any poisonous or deleterious substance which may
render it injurious to health.
Federal Food, Drug, and
Cosmetic Act of 1938 cont.
The Act authorizes factory inspections and added injunctions to the enforcement tools at
the Food and Drug Administration's (FDA) disposal. Following hearings in the early
1950s, a series of laws addressing pesticide residues (1954), food additives (1958), and
color additives (1960) gave the FDA much tighter control over the growing list of
chemicals entering the food supply, putting the obligation on manufacturers to establish
their safety. The Act stands today as one of the primary means by which the federal
government enforces food and pharmaceutical safety standards.
In 1968, the Electronic Product Radiation Control provisions were added to the FD&C.
Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to
incorporate into FD&C regulations of effectiveness of previously marketed drugs. The
act has been amended many times, most recently to add requirements about
bioterrorism preparations.
The introduction of this act was influenced 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. It replaced
the earlier Pure Food and Drug Act of 1906.