H.R.4395 - Cosmetic Safety Amendments Act of 2012

To amend the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements for the registration of cosmetic product manufacturing establishments, the submission of cosmetic product and ingredient statements, and the reporting of serious and unexpected cosmetic product adverse events, and for other purposes. view all titles (2)

All Bill Titles

  • Official: To amend the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements for the registration of cosmetic product manufacturing establishments, the submission of cosmetic product and ingredient statements, and the reporting of serious and unexpected cosmetic product adverse events, and for other purposes. as introduced.
  • Short: Cosmetic Safety Amendments Act of 2012 as introduced.

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04/18/12
 
 
 
 
 
 
 

Official Summary

Cosmetic Safety Amendments Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to require the registration of every domestic and foreign establishment engaged in the manufacture of a cosmetic intended to be marketed in the United States with the Secretary of Health and Human Servi

Official Summary

Cosmetic Safety Amendments Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to require the registration of every domestic and foreign establishment engaged in the manufacture of a cosmetic intended to be marketed in the United States with the Secretary of Health and Human Services (HHS). Requires such manufacturers to submit to the Secretary:
(1) a cosmetic and ingredient statement for each manufactured cosmetic containing a unique registration number for the manufacturing establishment where the cosmetic is manufactured, the brand name for the cosmetic, the ingredients in the cosmetic, and contact information for individuals responsible for filing and maintaining the cosmetic and ingredient statement; and
(2) a report on any serious and unexpected adverse event allegedly associated with the use of a cosmetic product. Requires the Secretary to:
(1) establish good manufacturing practices for the manufacture, processing, filling, or packaging of cosmetics; and
(2) establish and maintain in the Center for Food Safety and Applied Nutrition of the Food and Drug Administration (FDA) an electronic National Cosmetic Regulatory Databank to hold information pertaining to the regulation of cosmetics. Grants the Secretary authority to review the findings of the Cosmetic Ingredient Review Expert Panel with respect to any cosmetic products. Authorizes the Secretary to:
(1) establish a tolerance level for a nonfunctional constituent in a cosmetic product,
(2) evaluate the safety of any ingredient in a cosmetic product, and
(3) obtain access to and copy records for determining whether a cosmetic product is adulterated and presents a threat of serious adverse health consequences or death to humans. Denies entry into the United States of a cosmetic product if:
(1) the importer does not present the unique cosmetic establishment registration number and the unique cosmetic and ingredient statement number, or
(2) either of such numbers is not correct.

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