The Modernization of Cosmetics Regulation Act (MoCRA) was enacted on December 29, 2022, as part of the 2023 Omnibus Bill. By the end of this year, US manufacturers, packers, and distributors of cosmetics will be required to comply with new legal requirements under MoCRA. The new cosmetic law MoCRA sets federal standards for cosmetic business registration, product listing, recordkeeping, adverse event reporting, safety substantiation, GMP, recalls, etc.
These provisions create significant new authorities for the FDA and, for the first time since the FDCA was enacted in 1938, enhance the FDA’s regulatory oversight of cosmetics. Despite MoCRA not including a premarket approval requirement for cosmetics, it does create new obligations for the cosmetics industry. Several key provisions are outlined below:
Mandatory recall authority
The FDA is granted the authority to order a mandatory recall or a cosmetic product if it determined that the cosmetic product was likely to cause serious adverse health consequences or death.
Mandatory allergen labeling
The FDA is required to determine by regulation fragrance allergens that must be disclosed on a cosmetic label.
Current GMP practice for cosmetics
The FDA must issue mandatory current good manufacturing practice (GMP) regulations for cosmetics that are consistent with national and international standards.
Owners and operators of facilities that manufacture, or process cosmetic products must register with the FDA and renew such registration biennially. However, facilities that only perform activities related to the labeling, relabeling, packaging, repackaging, holding and/or distributing of cosmetic products will not be required to register.
“Responsible persons” (i.e., manufacturers, packers, or distributors of a cosmetic product whose name appears on the label, as set forth under the Fair Packaging and Labeling Act) are required to list with the FDA each cosmetic product, including its ingredients and information about where the cosmetic product is manufactured, and update cosmetic product labels to include contact information through which the responsible person can receive adverse event reports.
Mandatory adverse event reporting
Where a consumer has been harmed by a product, manufacturers are required to report this to FDA no later than 15 days after receiving the report and maintain all records related to serious adverse events for a minimum of six years.
MoCRA gives certain exemptions to small businesses with gross sales of less than $1 million. For example, while small businesses will still be required to maintain records of adverse events, they only will be required to maintain these records for three years, rather than six.
Responsible persons will be required to maintain records supporting “adequate substantiation” that the cosmetic product is safe. Cosmetic products that do not have adequate safety substantiation will be considered adulterated under a newly created adulteration provision within the FDCA.
The main actions that businesses should be taking right now are reviewing their procedures for adverse event reporting and for safety substantiation. Both requirements come into effect at the end of 2023.
Customers must have confidence that their product will be produced and distributed to the same standard as they would, and that trust begins with product quality and safety.