The U.S. Food and Drug Administration (FDA) has issued a draft guidance document explaining its authority to access and copy records related to cosmetic products under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This draft guidance, presented in a question-and-answer format, clarifies the Agencys current thinking on how key provisions of the law work in practice for cosmetics manufacturers, processors, and responsible persons.
Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), FDAs record access authority has been expanded. The Agency can now access adverse event reports during inspections, and also request manufacturing, distribution, quality, complaint, and safety substantiation records when it has reasonable belief a cosmetic product may pose serious adverse health consequences or death. These powers stem from Sections 605, 610, and the amended Section 704 of the FD&C Act.
The guidance outlines when and how FDA may exercise these authorities, the types of records covered, expectations for record retention and format, and protections for confidential commercial information. It also describes potential enforcement actions if firms refuse to comply. Industry stakeholders are invited to submit comments on the draft to help shape the final version