Food, Drug and Cosmetic Act
- Food, Drug and Cosmetic Act
-
Food, Drug and Cosmetic Act (FDCA/FD&C Act)
USA
The FDCA authorizes the FDA to, among other things:
• Inspect products already on the market.
• Regulate companies' manufacturing practices.
• Evaluate new drugs, medical devices and food additives for safety and effectiveness before companies can market them to the public.
• Recall or seize, or both, products it determines are unsafe or not FDCA-compliant.
• Issue standards for product labeling and other marketing communications, such as:
o the nutritional information found on food packaging; and
o the side effects and drug interactions listed on pharmaceutical labels.
(21 U.S.C. §§ 341-350f, 351-360ccc2, 371-379dd24.)
The FDCA does not regulate tobacco products or the medical use of approved drugs for unapproved purposes, which is also known as off-label use.
For more information about the Federal Food, Drug and Cosmetic Act, see Practice Note, Advertising: Overview: The Food, Drug and Cosmetic Act (www.practicallaw.com/2-501-2799).
The full text of the FDCA is available on the FDA's website.
Practical Law Dictionary. Glossary of UK, US and international legal terms.
www.practicallaw.com.
2010.
Look at other dictionaries:
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