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

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. My discussion here addresses this most recent update proposing Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products. (Also see "US FDA Provides Guidance On MoCRA Facility Registration 17 Weeks Before Deadline To Register" - HBW Insight, 8 August, 2023.) This is a very important update since it provides for the mandatory product listing and facility registration required by MoCRA