As the additional period granted to cosmetics companies to comply with the new obligations instituted by the Modernization of Cosmetics Regulation Act (MoCRA), in particular the registration of establishments and listing of products, expires on 1 July 2024, the US Food & Drugs Administration (FDA) is reminding us of the tools it has made available for this purpose.
Firstly, the FDA summarises the main new features of the MoCRA.
MoCRA provided new authorities to FDA and requirements for industry including:
• Facility Registration: Cosmetic product manufacturers and processors must register their facilities with FDA, update their registration to reflect changes to their registration information within 60 days of any changes, and renew their registration every two years
• Product Listing: A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
“Responsible person” means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the Federal Food, Drug, and Cosmetic Act or section 4(a) of the Fair Packaging and Labeling Act.
Generally, a cosmetic product listing must include the facility registration number of each facility where the cosmetic product is manufactured or processed. Thus, it is important for facilities to register before the product listing is completed.
Exemptions
MoCRA exempts certain small businesses from facility registration and product listing requirements.
However, such exemptions do not apply to facilities that manufacture or process, or responsible persons for the following cosmetic products:
• Products that regularly come …
