In December of 2022, the Modernization of Cosmetics Regulation Act (MCRA) was passed. The MCRA amends the Federal Food Drug and Cosmetic Act, creating several new requirements for manufacturers, processors, and importers of cosmetics.
Below are some of the new requirements and how soon after enactment of the MCRA (December 29, 2022) they will take effect:
- Facility Registration
- Currently, cosmetic facility registration is voluntary. However, under this new legislation, cosmetic manufacturer registration will be mandatory.
- Cosmetic manufacturers must register within one year of enactment.
- Registrations will need to be renewed every two years.
- Product Listing
- Currently, cosmetic product listing is voluntary. However, under this new legislation, cosmetic product listing will be mandatory.
- Manufacturers will need to submit an annual listing to FDA for each of their cosmetic products beginning one year from enactment.
- Good Manufacturing Practices (GMPs)
- Currently, FDA provides GMP guidelines for the manufacturing of cosmetics. Under the MCRA, FDA will establish mandatory GMPs for cosmetics.
- New Labeling Requirements
- Cosmetic labels will need to bear a US domestic phone or mailing address through which the responsible person (the manufacturer, packer, distributor, or retailer identified on the drug label) can receive consumer adverse event reports. This will be required within three years of enactment.
- Labels will be required to declare fragrance allergens within 18 months from enactment.
- There will be new labeling requirements for professional-use only cosmetics.
- PFAS Recommendations
- FDA will assess the safety and risks of perfluoroalkyl and polyfluoroalkyl substances (PFAS) use in cosmetics within 3 years of enactment.
- Product safety record keeping requirements.
- New legislation for talc-containing products.
- FDA now has mandatory recall authority for cosmetics.
The will be other new requirements imposed by the MCRA as well. This email address is being protected from spambots. You need JavaScript enabled to view it. for more information!