Cosmetic Modernization Amendments of 2015
Cosmetic Modernization Amendments of 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to set forth provisions governing the Food and Drug Administration's (FDA's) regulation of cosmetics, including requiring the registration of manufacturing establishments and the submission of a cosmetic and ingredient statement for each cosmetic. The FDA must publish a list of registered establishments and a list of cosmetics and their ingredients.
Cosmetic manufacturers, packers, and distributors must report to the FDA any serious and unexpected adverse events likely caused by a cosmetic. Cosmetic labels must include contact information to report a serious adverse event.
The FDA may establish principles and standards for good manufacturing practices for cosmetics. A cosmetic may not be sold if it presents a significant risk of serious adverse health consequences because it was not manufactured in accordance with good manufacturing practices.
Certain ingredients are deemed safe for use in cosmetics unless restricted by the FDA. The FDA must establish a program to evaluate the safety of cosmetics and cosmetic ingredients.
The FDA must establish and maintain a National Cosmetic Regulatory Databank that contains submitted information on cosmetics. Confidential business and trade secret information may be disclosed only to state agencies that request this information for good cause.
The FDA may establish exemptions to requirements so that implementation and compliance is cost-effective.
Color additives that the FDA has not listed as suitable and safe but that are generally recognized as safe may be used in cosmetics.
States and local governments may not establish or continue in effect specified requirements relating to cosmetics.
Cosmetics may only be imported from registered establishments that have submitted a cosmetic and ingredient statement.Referred to the Subcommittee on Health.