Congress enacts the Modernization of Cosmetics Regulation Act of 2022
On 29 Dec 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was enacted as part of the Omnibus Appropriations Act of 2022, passed by the US Congress on 29 Dec 2022. MoCRA strengthens the US Food & Drug Administration (FDA) authority over cosmetic products. This represents the most significant expansion of the FDA’s authority over cosmetics since the original enactment of the Food & Drug Cosmetic Act of 1938 (FD&C Act). While most MoCRA will go into effect within one year (i.e., by 29 Dec 2023), a few items will be phased in over the next three years.
MoCRA covers the following areas:
- Introduction of facility registration and product listing
- Introduction and amendments to definitions. This includes “cosmetic product,” “adverse event,” “serious adverse event,” and “facility.”
- The addition of serious adverse event submissions
- Introduction of good manufacturing practices (GMP) for facilities (permits FDA to issue final regulations within three years)
- Introduction of safety substantiation for cosmetic products, including record retention
- Expansion of labeling requirements (takes effect in two years)
- Expansion on enforcement, mandatory recalls, recordkeeping, and record inspection
- New ingredient-specific requirements for talc-containing cosmetic products; and
- New requirements to assess the use, safety, and risks of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products.
The most immediate impact of this new legislation is the implementation of the Cosmetics Facility Registration and product listing. The FDA currently has a voluntary cosmetics registration program, which will transition to mandatory registration along with a provision to provide product details for all products out of the facility.
Under MoCRA, each manufacturing facility for cosmetic products must maintain a valid facility registration with FDA. Like the Food Facility Registration, there will also be a requirement for biennial renewal. Neither FDA nor the Act details the vehicle by which the facility registration will occur and/or if it will become an additional option in the current FDA United Registration and Listing System (FURLS) portal.
The Act states an existing facility currently in operation must register by 29 Dec 2023. Going forward, new facilities must register within 60 days of first engaging in the manufacturing or processing of a cosmetic product for distribution in the US. For contract manufacturers, MoCRA clarifies that the facility or any responsible person whose products are manufactured or processed at such facility may submit the registration for that facility.
Responsible persons must also maintain listings of their cosmetic products with the FDA, including each product’s name, type, ingredients (including fragrances, flavors, or colors), and facility of manufacture or processing. A responsible person must submit its product listing for currently marketed products by December 29, 2023, and for any new cosmetic product within 120 days of marketing such product.
Registration must occur on a per-facility basis, whereas listing must occur on a per-responsible person basis. Further, the processes are to operate on separate timelines, with registration renewals occurring every two years and listing updates occurring yearly.
Please note: FDA has not currently posted MoCRA to their website as of the date of this notice.
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