Cosmeticlawinfo database

The proposed rule would require manufacturers of talc-containing cosmetic products to test their products for asbestos using specific testing methods which contain both Polarized Light Microscopy (PLM) and Transmission Electron Microscopy/Energy Dispersive Spectroscopy/Selected Area Electron Diffraction (TEM/EDS/SAED) to test talc-containing cosmetic products for potential asbestos contamination. The proposed rule requires manufacturers to test representative samples of each batch or lot of talc-containing cosmetic product or on representative samples of each batch or lot of the talc ingredient used in the manufacture of cosmetic products. Further, manufacturers of talc-containing cosmetic products may rely on a certificate of analysis from the talc supplier if they qualify the supplier by establishing and maintaining the reliability of the supplier’s certificate of analysis by performing verification testing. The proposed rule also contains enforcement provisions. FDA proposes that failure to operate in compliance with the testing or recordkeeping provisions of the rule would render the talc-containing cosmetic product adulterated under 601(c) for the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 361(c)]. In addition, the proposed rule states if asbestos is present in a cosmetic product, or in talc used in a cosmetic product, that cosmetic product would be deemed adulterated under 601(a) of the FD&C Act [21 U.S.C. 361(a)]; and if asbestos is present in talc intended for use in a cosmetic, that talc is adulterated under 601(a) of the FD&C Act [21 U.S.C. 361(a)].