In 1938, the Federal Food, Drug, and Cosmetic Act was passed by Congress, giving the FDA authority to set food safety standards.
It would expand FDA authority, require registration of food manufacturers and processors, regulate crop cultivation and harvesting and other measures.
Legislation in 1997 would have given the FDA authority to regulate all compounding pharmacies, but that legislation was partially overturned by a 2002 Supreme Court decision.
Specific provisions in the law governing small-farm and farmer's markets provide for FDA authority:
In 1998, Harkin introduced the first comprehensive, bipartisan bill to give the FDA authority to regulate tobacco and was an original cosponsor of the legislation that passed today.
-Response: The FSMA gives the FDA authority to issue mandatory recalls for all food products.
This law, though extensively amended in subsequent years, remains the central foundation of FDA regulatory authority to the present day.
Individual members of Congress cited the thalidomide incident in lending their support to expansion of FDA authority.
The 1962 Kefauver-Harris Amendment to the FD&C act represented a "revolution" in FDA regulatory authority.
Unlicensed blood products used within the boundaries of a state are not unusual, and these products are subject to general regulations from other FDA legal authorities.