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.)
MoCRA Check-In: Unknowns Include How US FDA Will Address Potentially Noncompliant Ingredients
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.
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Beauty industry insiders from trade associations and attorneys specializing in marketing law and/or cosmetics manufacturing look forward to a more business-friendly FTC in the US in 2025, while they expect industry to face an increasing number of challenges at the state level. Meanwhile, the EU beauty market is hopeful it will see reduced regulations this year.
Linda Katz, director of the Office of Cosmetics and Colors at the US Food and Drug Administration, is credited with leading efforts toward modernization of cosmetics regulations as she retires after 22 years at the helm.
FDA publishes the first proposed rule under the Modernization of Cosmetics Regulation Act – a testing method for detecting asbestos in talc-containing cosmetics.
Many small US and independent beauty brands are still unfamiliar with the Modernization of Cosmetics Regulation Act, as are owners of beauty brands based outside the US; the lack of education about the regulation is making many stakeholders at risk for non-compliance.
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FDA publishes the first proposed rule under the Modernization of Cosmetics Regulation Act – a testing method for detecting asbestos in talc-containing cosmetics.
The Washington State Department of Ecology publishes ‘Interim Policy on Lead in Cosmetics’ which provides safe harbor options for cosmetic products struggling with the 1ppm limit under the state’s Toxic Free Cosmetics Act, while the department gathers information under a newly opened rulemaking to ‘identify a feasible approach to regulating lead in cosmetic products.’
Many small US and independent beauty brands are still unfamiliar with the Modernization of Cosmetics Regulation Act, as are owners of beauty brands based outside the US; the lack of education about the regulation is making many stakeholders at risk for non-compliance.