Bill > HR4262

Introduced Session

Cosmetics Safety Enhancement Act of 2012 - Amends the the Federal Food, Drug, and Cosmetic Act to require the registration of cosmetic products and cosmetic manufacturing facilities, including, for each product: (1) a unique facility identifier, (2) every product's brand name, and (3) product ingredients. Sets registration fees. Requires a cosmetic manufacturer: (1) before the introduction into interstate commerce of a cosmetic product, to establish a file containing scientific evidence substantiating the product's safety; (2) to report any serious adverse event information received that is associated with the use of a cosmetic product; and (3) maintain records concerning any cosmetic product that may be adulterated, misbranded, or otherwise in violation of the Act, including all records relating to cosmetic product safety substantiation or relating to serious adverse event reports. Deems a cosmetic product adulterated if its manufacture, packing, or holding do not conform to current good manufacturing practice regulations. Provides each manufacturer with an opportunity to cease distribution and recall of a cosmetic product if it is determined that there is a reasonable probability that the product is adulterated and the use of, or exposure to, such product will cause serious adverse health consequences or death to humans. Permits the issuance of an order requiring a recall if there is not a voluntary recall of an adulterated product.

Committee Categories

John Dingell (D)*,  Frank Pallone (D), 

Referred to the Subcommittee on Health. (on 03/30/2012)

Official Document