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FDA outlines MOCRA-driven changes to cosmetics oversight and rulemaking deadlines
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Summary
FDA officials summarized new authorities in the Modernization of Cosmetics Regulation Act (MOCRA), including requirements for good manufacturing practices, expanded labeling duties, records access, and new rulemaking deadlines; draft guidances on records access and mandatory recalls are open for comment.
Elizabeth Petro, Branch Chief of the Cosmetics Regulatory Activities Branch at the Food and Drug Administration, summarized the expansion of FDA authority under the Modernization of Cosmetics Regulation Act (MOCRA) and the agency’s near-term rulemaking priorities.
Petro said MOCRA, enacted Dec. 29, 2022, expands FDA’s tools to protect public health and directs the agency to issue good manufacturing practice (GMP) regulations. “MOCRA directs FDA that these regulations should be consistent to the extent practicable and appropriate with national and international standards,” Petro said, noting a congressionally directed deadline for a final GMP rule no later than Dec. 29, 2025.
She reviewed new labeling requirements that are already in effect or phasing in under MOCRA: professional‑use products must carry a clear statement that they are to be administered only by licensed professionals (effective Dec. 29, 2023), and all cosmetic product labels must include contact information for the responsible person to receive adverse‑event reports (effective Dec. 29, 2024). Petro also said MOCRA directs FDA to develop regulations for disclosing fragrance allergens on labels.
On record access and recalls, Petro said FDA’s inspection authority was expanded by MOCRA and that the agency issued a draft guidance, "FDA Records Access Authority for Cosmetic Products," on Jan. 21, 2026, seeking public comment. She also noted a draft guidance on mandatory cosmetics recalls published in December 2025 and invited comment. “If FDA determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and the use or exposure will cause serious adverse health consequences or death, FDA has the authority to order a mandatory recall,” Petro said.
Petro discussed MOCRA exemptions for certain smaller businesses and product types, and she highlighted the agencys’ continuing work on asbestos testing in talc‑containing products — a proposed rule published Dec. 27, 2024 was later withdrawn on Nov. 25, 2025, and FDA said it will issue a new proposed rule to meet statutory obligations.
The agency is soliciting public feedback on draft guidance documents via Regulations.gov and plans to publish slides and related resources on its MOCRA webpage.
