Law Dictionary

Food, Drug, and Cosmetic Act (FDCA)

Law 21 U.S.C. § 301 et seq. (1938)
  1. prohibited interstate commerce in adulturated food products and hazardous or mislabeled household substances and strengthened the enforcement power of the Food and Drug Administration (FDA). The Act established new consumer product identification and quality standards and expanded the FDA's role in inspecting food and cosmetics and in testing and licensing drugs. It has been amended several times to broaden its coverage, which now includes medical devices, sanitation certification, labeling and anti-tampering requirements, and FDA oversight in drug marketing. These amendments often came in the wake of heavy lobbying, pro and con, by both consumer advocates and industry representatives.


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