Original source
Draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products | FDA
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Instrument: Draft Guidance. Agency: U.S. Food and Drug Administration (FDA). Scope: Cosmetic product facilities and products subject to MoCRA registration and listing requirements. Key points: The draft guidance describes the FDA’s current thinking on how to comply with registration and listing obligations under MoCRA. It includes details on who must register, what information to submit, and how to update listings. The comment period is open; the deadline is not specified in the available material. The guidance is not final and does not impose binding requirements.
The FDA has issued a draft guidance on registration and listing requirements for cosmetic product facilities and products under the Modernization of Cosmetics Regulation Act (MoCRA). This draft guidance outlines the proposed procedures and information requirements for facility registration and product listing. Stakeholders have an opportunity to submit comments before the guidance is finalized.
Official text
English translation — the official-language text prevails
The U.S. Food and Drug Administration has issued a draft guidance for industry entitled ‘Registration and Listing of Cosmetic Product Facilities and Products.’ This draft guidance, when finalized, will represent the FDA’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.