Modernization of Cosmetics Regulation Act (MoCRA): Reforming the FDA’s Cosmetics Industry Oversight

The U.S. Congress overhauled the U.S. Food & Drug Administration’s (FDA) oversight framework of the cosmetics industry with passage of the Modernization of Cosmetics Regulation Act (MoCRA). MoCRA represents the first major cosmetics update to the Food, Drug, & Cosmetics Act (FDCA) since 1938. MoCRA was a bipartisan effort led by Senators Murray (D-WA) and Burr (R-NC) and joined by Representatives Pallone (D-NJ) and McMorris Rodgers (R-WA). MoCRA passed as part of the consolidated appropriations package at the close of the 2022 legislative calendar and it was signed into law by President Biden on December 29, 2022.

The legislation was supported by industry and trade groups, as well as NGO stakeholders. It was the culmination of years of advocacy to enact enhanced facility and product registration, labeling, safety substantiation, adverse event reporting and good manufacturing practices in the cosmetics industry and to bring the U.S. in line with the more advanced regulatory regimes globally. MoCRA contains a comprehensive set of new requirements, directs the FDA to promulgate new rules and guidance for the cosmetics industry, bolsters the FDA’s enforcement authority and appropriates significant funds to the FDA for the multiyear implementation.

Cosmetics companies are preparing for the first set of compliance deadlines that come into effect on the one-year mark since MoCRA became law—December 29, 2023.

Businesses Covered

Businesses that manufacture or process cosmetics for distribution in the United States, including importers, are subject to MoCRA. There are specific exemptions to coverage. Cosmetics products that are also categorized as a drug under FDCA Chapter V are exempt from MoCRA. Certain small businesses (as defined under MoCRA) are exempt from the facility registration, product listing and good manufacturing practices requirements.

Adverse Event Reporting and Recordkeeping

Consistent with other industries regulated by the FDA, cosmetic companies must now maintain records of any health-related “adverse events” associated with their products for a period of six years (three years for small businesses). These records must be reported to the FDA within 15 business days of learning about the event. “Responsible persons,” such as manufacturers, packers, or distributors, must also provide any new and material medical information related to the adverse event for one year following the initial submission.

Facility Registration and Product Listing

Existing facilities must register with the FDA within one year of MoCRA’s enactment, while new facilities have 60 days from the commencement of operations. Responsible persons must also list each cosmetic product, along with its ingredients and manufacturing information, with the FDA. This requirement applies to both existing and new products, with specific deadlines for each. The FDA has issued draft Registration and Listing of Cosmetic Facilities and Products guidance, as well as draft guidance on the planned online submissions portal for registration, entitled Cosmetics Direct.

Good Manufacturing Practices (GMPs)

One of the significant changes introduced by MoCRA is the directive to the FDA to establish GMP regulations for cosmetic manufacturing and processing facilities. These regulations will be consistent with national and international standards and aim to ensure the safety and quality of cosmetic products. The FDA will issue a proposed rule within two years of MoCRA’s enactment, with a final rule to follow within three years. In the interim, the FDA has issued draft guidance for Cosmetic Good Manufacturing Practices.

Safety Substantiation

MoCRA emphasizes the importance of safety substantiation for cosmetic products. Responsible persons must ensure a product is “safe” and maintain records supporting the “adequate substantiation” of the safety of their products. This includes tests, studies, research, analyses or other evidence considered by qualified scientific experts to demonstrate the reasonable certainty that a cosmetic product is safe. The FDA may consider cumulative exposure to the product and its ingredients when determining safety.

Cosmetic Labeling and Fragrance Allergen Transparency

MoCRA introduces labeling requirements to enhance transparency and consumer awareness. Cosmetic product labels must include contact information for responsible persons to receive adverse event reports. Professional cosmetic products must include the same labeling information required for products sold to consumers and also state that only licensed professionals may use the product. Additionally, once the FDA issues a new fragrance allergen rule (draft rule due 6/29/2024), cosmetic labels will be required to identify each fragrance allergen present in the product.

Enforcement Authorities: Facility Suspension, Records Access and Mandatory Recalls

The FDA is now empowered to suspend the registration of a cosmetic facility if it determines that a product manufactured by that facility poses a reasonable probability of causing serious adverse health consequences. Once suspended, the facility cannot distribute any cosmetic products until its registration is reinstated. MoCRA also grants the FDA the authority to access company records related to cosmetic products when there is a reasonable belief that a product or its ingredients are adulterated and pose a threat of serious adverse health consequences.

MoCRA also granted the FDA mandatory recall authority where there is a reasonable probability that a cosmetic is adulterated or misbranded or “exposure to such cosmetic will cause serious adverse health consequences or death.” Congress appropriated $14.2M for FY 2023, $25.96M for FY 2024 and $41.89M annually for FY2025-2027 to the FDA to implement and enforce MoCRA.

Of note, the FDA was also directed to promulgate a rulemaking on the use of standardized testing methods to detect asbestos in talc-containing products (draft rule due by 6/29/2024) and to conduct an assessment and publicly report on the safety of PFAS use in cosmetics within three years of MoCRA enactment.

Key Takeaways for Cosmetics Company Compliance

The Modernization of Cosmetics Regulation Act brings about significant changes to the regulation of cosmetic products in the United States. By enhancing adverse event reporting, facility registration and product listing, GMPs, safety substantiation, and cosmetic labeling, MoCRA aims to improve consumer safety and raise the standards for the cosmetic industry.

To ensure compliance with MoCRA, cosmetic companies should be aware of the specific deadlines for each requirement. It is crucial for companies to review their operations, update their practices and implement any necessary changes to meet the new regulatory requirements.

Developing or updating a corporate compliance plan to include provisions for recordkeeping, registration, labeling, adverse events, recalls, safety, quality assurance, GMP alignment, internal audit and handling of confidential business information is an important step. It’s also prudent to follow the evolving global sustainability and ESG requirements for transparency, reporting and disclosures, as well as the rules governing environmental marketing claims, such as the FTC Green Guides, which cover the use of terms such as green, sustainable, recyclable, non-toxic and free of.

©2023 Verde Impact LLC. For more information on MoCRA and compliance with cosmetics industry regulations, contact Verde Impact @ info@verdeimpact.com.