FDA publishes draft guidance detailing agency authority over cosmetic records

By Xiaolu Wang, Esq.

In January, the FDA released a draft guidance clarifying its authority to access cosmetics-related records under the Federal Food, Drug, and Cosmetic Act, following expanded enforcement powers established under the Modernization of Cosmetics Regulation Act (MoCRA).

The guidance outlines the circumstances under which FDA may access and copy records related to adverse events, inspections, and potentially adulterated cosmetic products — and highlights the types of situations that may trigger increased regulatory scrutiny.

This AgencyIQ analysis examines what the draft guidance signals about FDA’s evolving oversight approach, the potential compliance implications for cosmetic and chemical manufacturers, and key considerations teams should be watching as the guidance moves forward.

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