FD&C Act

Food, Drug and Cosmetic Act (FDCA/FD&C Act)

USA

The federal statute giving the Food and Drug Administration (FDA) the authority to monitor and regulate the safety of food, drugs and cosmetics.

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.