In a significant milestone for the cosmetics industry, the U.S. Food and Drug Administration (FDA) has witnessed the enactment of a groundbreaking legislation known as the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). After an 80-year interval since the last substantial amendment, this comprehensive regulatory framework introduces new FDA registration and listing requirements, labeling rules, enforcement authority, and good manufacturing practices (GMP) obligations for cosmetic manufacturers. Incorporated within the Food and Drug Omnibus Reform Act of 2022 (FDORA) as part of the Consolidated Appropriations Act, 2023, MoCRA aligns the FDA's authority over the cosmetics sector with other regulated categories, such as drugs, devices, and foods. This article delves into the essential provisions of MoCRA and emphasizes the importance of compliance for cosmetic manufacturers in preparation for its implementation on December 29, 2023.

The new MoCRA requirements are:

Registration and Listing Requirements:

Under MoCRA, the cosmetic industry faces novel obligations concerning facility registration and product listing with the FDA. Existing facilities engaged in the manufacture or processing of cosmetic products for distribution in the U.S. must complete the registration process by December 29, 2023. New facilities that initiate cosmetic product manufacturing after the law's effective date have 60 days to register upon commencing operations, with subsequent biennial renewals required.

Similarly, cosmetic product manufacturers must provide the FDA with listing information for each product, including an ingredient list and the manufacturer's name and place of business on the label. Existing cosmetic products must comply with this requirement by December 29, 2023, while new products launched after the enactment date have 120 days from the commencement of interstate commerce to submit their listings, with annual updates mandated thereafter.

Adverse Events—Recordkeeping and Reporting:

MoCRA introduces recordkeeping and reporting mandates for adverse events related to cosmetic products. Manufacturers must maintain records of all health-related adverse events for six years (or three years for small businesses) and report any serious adverse event to the FDA within 15 business days of receiving relevant information. The scope of "serious adverse events" has been expanded to encompass significant disfigurement, persistent rashes, severe burns, substantial hair loss, or significant alterations of appearance. Additionally, cosmetic product manufacturers must grant the FDA access to relevant records when the agency reasonably believes a product poses a threat of serious adverse health consequences.

Labeling, Safety, and GMP:

MoCRA also addresses safety substantiation for cosmetics products, necessitating manufacturers to maintain records demonstrating adequate substantiation of U.S. safety standards. Defined as tests, studies, research, analyses, or other evidence supported by qualified scientific experts, this substantiation ensures the reasonable certainty of a cosmetic product's safety.

Regarding fragrance allergens disclosures, both consumer and professional cosmetics products must list each included fragrance allergen. Professionals are defined as state-licensed individuals practicing cosmetology, nail care, barbering, or esthetics. The FDA will issue regulations specifying substances considered fragrance allergens within 18 months of MoCRA's enactment.

Furthermore, MoCRA mandates the FDA to issue binding regulations governing GMP for cosmetic manufacturers by December 29, 2025. These regulations will empower the FDA to inspect cosmetic manufacturing facilities for GMP compliance, with specific provisions catering to small businesses.

Enforcement of MoCRA:

MoCRA preempts state and local laws that differ from its provisions related to cosmetic product registration, listing, GMP, records, recalls, adverse event reporting, and safety substantiation. However, it allows states to regulate ingredient usage or reporting, provided such requirements were in effect at the time of MoCRA's enactment.

The FDA possesses mandatory recall authority for adulterated, misbranded, or potentially harmful cosmetic products that could cause serious adverse health consequences or death. Manufacturers receive an opportunity for voluntary recall before the FDA intervenes. Facility suspension may occur if the FDA reasonably believes a cosmetic product poses serious adverse health consequences.

Additional MoCRA Provisions:

MoCRA extends guidance to small businesses, which are exempt from specific requirements of GMP and registration and product listing based on average gross annual sales criteria in the United States. To protect trade secrets and confidential commercial information, the FDA is required to implement effective procedures during MoCRA enforcement.

Recognizing the concerns of animal testing, MoCRA emphasizes the phasing out of such testing for cosmetics products, except for specific allowances. The funding allocated for conducting MoCRA-related activities in fiscal years 2023 to 2027 will facilitate the implementation and enforcement of these critical regulatory changes.

Conclusion:

The Modernization of Cosmetics Regulation Act of 2022 marks a momentous shift in the FDA's oversight of the cosmetics industry. With a comprehensive framework that includes registration, listing, adverse event reporting, safety substantiation, and GMP requirements, MoCRA sets a new standard for cosmetic manufacturers. As the act comes into effect on December 29, 2023, it is imperative for cosmetic businesses to promptly undertake necessary compliance measures to ensure adherence to the new regulatory landscape. By doing so, they can embrace the opportunities and challenges presented by MoCRA while fostering consumer confidence in the safety and efficacy of their products.