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MoCRA Check-In: Unknowns Include How US FDA Will Address Potentially Noncompliant Ingredients

 
• By John Bailey

If the FDA reviews companies’ product information submitted under the Modernization of Cosmetics Regulations Act of 2022, which is due by 29 December 2023, and denies product listings deemed noncompliant, that could place products containing unapproved color additives and certain drug active ingredients, for example, in violation of the law.

MoCRA Check-In
• Source: Shutterstock

Since my last progress report in June, several important steps have taken place as we move toward the implementation date for the Modernization of Cosmetics Regulations of 2022 (MoCRA). Before getting into these steps, it’s important to highlight what happens on 29 December 2023. On this date, the cosmetic industry, including ingredient suppliers, will become subject to this new law. This includes (1) product listing and facility registration, (2) reporting to FDA of serious adverse events associated with a product, and (3) mandatory safety substantiation for cosmetic products. (Requirements for (1) labeling, (2) good manufacturing practices, (3) fragrance allergen labeling, (4) talc-related rule, and (5) PFAS in cosmetics rule go into effect later.) Just for perspective, 29 December 2023 is not far away and companies should be taking steps now to comply with these new requirements. (Also see "Attorneys On Modernized Cosmetic Regulations And New Litigation Risks" - HBW Insight, 12 January, 2023.)

Since MoCRA was enacted, FDA has posted only four updates on their website, the most recent on 7 August....

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