Regulatory Counsel

0910-AJ00 202410 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Good Manufacturing Practice for Cosmetic Product Facilities

The proposed rule, if finalized, would establish good manufacturing practices for cosmetic product facilities to help ensure the safety of cosmetic products.

]]> Section 3(f)(1) Significant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined No 21 CFR 711 21 U.S.C. 361 21 U.S.C. 364b 21 U.S.C. 364h-i 21 U.S.C. 371 Statutory NPRM 12/29/2024 Yes

This proposed rule, if finalized, would establish good manufacturing practices for cosmetic product facilities to help ensure the safety of cosmetic products by minimizing or preventing the distribution of cosmetic products that are unsafe due to contamination, mixups, deterioration, and adulteration during manufacturing or processing of the cosmetic product. The proposed requirements establish the key elements for governance and maintenance of control over the manufacturing and processing of a cosmetic product to help ensure that the public health is protected and that cosmetic products are not adulterated.

Cosmetic products and ingredients are not subject to FDA premarket approval, with the exception of certain color additives. Companies and individuals who manufacture or market cosmetics are responsible for ensuring that their products are safe and properly labeled. Cosmetic products that are contaminated, do not conform to a manufacturer’s established specifications, or have incorrect packaging, labeling, or labels, could be unsafe for consumers. Contamination, a common reason for cosmetic product recalls, can be introduced during manufacturing or processing of a cosmetic product and render cosmetic products injurious to health.

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FDA is issuing this rule under section 606 of the FD&C Act (21 U.S.C. 364b), which authorizes the establishment by regulation of good manufacturing practices for facilities. The legal authority for this rule also rests on section 601 of the FD&C Act (21 U.S.C. 361) regarding adulterated cosmetics and 701(a) of the FD&C Act (21 U.S.C. 371(a)), which authorizes the promulgation of regulations for the efficient enforcement of the FD&C Act. In addition, authority for certain aspects of this rule may be found in sections 612 and 613 of the FD&C Act (21 U.S.C. 364h and 364i).

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FDA will consider different options so that we minimize costs to industry; for example, delaying compliance for some affected entities.

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The proposed rule is expected to generate compliance costs on affected entities, such as one-time costs to read and understand the rule and costs to alter manufacturing or processing practices. Estimated benefits TBD.

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None.

]]> NPRM 10/00/2025 Undetermined Businesses Undetermined No Undetermined No No Iris Chen Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-3613 questionsaboutmocra@fda.hhs.gov Office of the Chief Scientist, 10903 New Hampshire Avenue, Silver Spring MD 20993