In a recent Q&A with Citeline, Claudia Lewis provides guidance on how cosmetic companies can prepare for and respond to FDA-mandated recalls under MoCRA. The following is an excerpt:
Venable LLP attorney Claudia Lewis shares how MoCRA stakeholders can audit safety substantiation records, take steps toward GMP compliance and review labeling claims, while also preparing internal processes to enable a rapid response in the case of an FDA mandatory recall.
The US Food and Drug Administration recently published draft guidance on mandatory cosmetic recall provisions of the Federal Food, Drug and Cosmetic Act as amended through the 2022 passage of the Modernization of Cosmetics Regulation Act.
The guidance is intended to provide stakeholders insight on the agency’s approach to mandatory recalls, steps in the process, the expected response from a responsible person after a recall is issued, and examples of circumstances that the agency might consider as “serious adverse health consequences or death (SAHCOD).”
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