Cosmetic companies did not expect to be impacted so heavily by the 4155-page, 1.7 trillion-dollar omnibus spending bill enacted by Congress for this year. Within this bill is the Modernization of Cosmetics Regulations Act of 2022 (MoCRA). While firmer regulatory grasp bythe FDA over cosmetics has been anticipated for some time, its inclusion within the spending bill was a surprise. MoCRA is a law that will alter the way the cosmetics industry is regulated by massively increasing FDA oversight and creating novel requirements for cosmetics manufacturers. This is important because the cosmetics and “cosmeceutical” industry traditionally has not been heavily regulated by the FDA, which until now stepped in only when it found “probable cause” for investigation.
This new law will require manufacturers of cosmetic products to register with the FDA. The primary party responsible for registration will be the party whose name appears on the cosmetics label, regardless of whether they are the importer, manufacturer, distributor, or packer. The deadline for initial registration is December 31, 2023, and parties must re-register every two years. The registration process is unfamiliar territory for most cosmetics manufacturers. The “registration must include brands, product categories, and product listing, including ingredients, fragrances, and colors, but not formulas or recipes[1]”; there are additional requirements for registration that will necessitate consulting with legal counsel to ensure compliance.
Additionally, it is anticipated that by the close of 2024, the FDA will issue several new documents for the cosmetics industry, such as new GMPs to help guide the manufacturing process for cosmetics. It will also issue a proposed rule regarding the identification of allergens in cosmetics and new regulations for testing for asbestos in cosmetics, among several other anticipated rules. With this increased oversight, the FDA will now require adverse event reporting for cosmetics, necessitating that manufacturers maintain records rigorously in case of FDA audits.
New rules around recalls may give manufacturers of these products reason to consult with legal counsel to better understand their new duties and should alert cosmetics manufacturers to the heightened importance of auditing their suppliers. Contracts with suppliers may need to be revamped, considering the new requirements and manufacturers should consider conducting internal audits of their existing agreements. It would be prudent for manufacturers of cosmetics to obtain assistance from outside legal counsel regarding FDA requirements under MoCRA. Any failure in compliance with these new requirements can allow the FDA to prohibit manufacturers from conducting business in the United States.
[1] A Facelift for Cosmetics: Modernization of Cosmetics Regulations Act of 2022 | News & Events | Clark Hill PLC
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