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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US FDA has not developed an implementation plan for the Modernization of Cosmetics Regulation Act, nor a strategic workforce plan to support MoCRA rollout, the US Government Accountability Office says in a 6 December report to Congressional requesters.
Companies have concerns about how the FDA will respond if struggles to obtain data, or hiccups in the cosmetic product facility registration or listing process, lead to errors or deadline misses under the Modernization of Cosmetics Regulations Act. Attorneys from Duane Morris and Covington & Burling provide views on FDA’s related draft guidance, key challenges facing industry, and how the agency may proceed.
FDA announces plans to make submission portal available in October for meeting registration deadlines for facilities and product listings under Modernization of Cosmetics Regulation Act. Guidance also provides more specifics on data that should be submitted to agency.