On December 29, 2022, President Joe Biden signed into law the Modernization of Cosmetics Regulation Act 2022 (MoCRA), marking a significant overhaul in U.S. cosmetics regulation not seen since the passing of the Federal Food, Drug, and Cosmetic Act in 1938. This transformative act, set to take effect on December 29, 2023, with some labeling requirements delayed until December 29, 2024, brings forth a redefinition of regulatory roles and a suite of new compliance requirements. Under MoCRA, the concept of a 'Facility' encompasses any establishment, whether within the U.S. or abroad, that engages in the manufacturing or processing of cosmetic products for the U.S. market. This definition specifically excludes entities such as beauty salons, pharmacies, and research laboratories. Additionally, MoCRA introduces the role of the 'Responsible Person', identifying them as the manufacturer, packer, or distributor whose name is on the cosmetic product's label, regardless of their geographic location.
A central feature of MoCRA is the requirement for Facility Registration. Facilities, including those based outside the U.S., are mandated to register with the FDA, the latter needing a U.S. agent for the process. This registration is not a one-time requirement but needs bi-annual renewal, starting from December 29, 2023. Alongside this, the Act requires the Responsible Person to list every cosmetic product sold in the U.S. on the FDA Cosmetics Direct portal. For new products, this listing should occur within 120 days of entering the U.S. market. MoCRA also touches upon Cosmetic Labeling & Fragrance Allergens. While it retains most of the current labeling rules, it introduces new requirements for products used professionally and those containing fragrance allergens, with a compliance deadline of December 29, 2024. Another critical aspect is Safety Substantiation. Responsible Persons are obligated to provide proof of product safety, adhering to a compliance deadline of December 29, 2023. The Act stipulates detailed procedures for Adverse Events Reporting, including the mandatory reporting of serious adverse events within 15 business days. In the realm of manufacturing, Good Manufacturing Practice (GMP) standards are set to be enforced, with the FDA expected to release the final regulations by December 29, 2025. Furthermore, MoCRA empowers the FDA with enhanced authority to suspend facility registrations, access records, and issue product recalls for safety reasons.
MoCRA also addresses specific concerns such as the Talc Rule and PFAS Report. It mandates standardized testing methods for detecting asbestos in talc-containing cosmetics and assessments of per- and polyfluoroalkyl substances (PFAS) in cosmetics, with final regulations and reports due in 2024 and 2025, respectively. Lastly, the Act provides a Small Business Exemption for businesses with annual sales under $1 million. While exempt from certain stipulations, these businesses must still adhere to labeling, safety substantiation, and adverse event reporting standards. In essence, MoCRA represents a comprehensive and modernized update to U.S. cosmetic regulations, significantly emphasizing product safety, transparency, and industry-standard compliance.
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