Federal Food, Drug and Cosmetic FDC Act

The LBPPPA with its early amendments triggered parallel rulemaking setting lead limits in paint sold to the general public and banning sale of new furniture and toys painted with lead paint above an interim level of 0.5% Pb as solid content or dried paint film and an eventual level of 0.06% Pb. In March 1972, the U.S. FDA announced (37 FR 5229-5231 March 11, 1972) regulations under the Federal Hazardous Substances Act [2(f)(1)(A) 74 STAT. 372, 374 Part 191] and the Federal Food, Drug and Cosmetic (FDC) Act [ 701 e, f, g 52 Stat. 1055-56 and 70 Stat. 919 et seq.] for new sales. 

In its guidance document Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products, the US Food and Drug Administration (US Department of Health and Human Services, FDA, 1998) describes the introduction of an effectiveness requirement according to a standard of "substantial evidence" in the Federal Food, Drug, and Cosmetic Act (the FDC Act) of 1962 ... 

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