On August 7, 2023, the FDA issued draft guidance for Registration and Listing of Cosmetic Product Facilities and Products to assist cosmetics companies in submitting cosmetic product facility registrations and cosmetic product listings, including ingredients, to the FDA.
The proposal outlines the statutory obligations, responsible parties, required information, submission procedures, and deadlines, and is open for consultation until September 7, 2023.
In line with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), published on December 29, 2022, which introduced section 607 of the FD&C Act, this guidance establishes requirements for cosmetic product facility registration and listing.
Any facility manufacturing or processing cosmetic products for the US market, except:
Anyone manufacturing, packaging, or distributing cosmetics, except:
Note: One submission can cover multiple cosmetics with identical or different formulations
Optional Information Requested by the FDA:
The FDA will not disclose product listing and facility registration numbers, or brand names under a facility registrion. All other information will be publicly disclosed.
If a cosmetic is also a drug/medical device:
In anticipation of the forthcoming FDA guidance on cosmetic product facility registration and listing, companies should proactively review and understand the new requirements, evaluate current practices, identify responsible personnel, and gather essential information. We also recommend any stakeholders with a vested interest in registration and listing of cosmetic product facilities and products submit their comments to the FDA before the September 7, 2023 deadline for comments.
To ensure seamless compliance with the new regulations, dicentra, can offer you tailored services to guide you through these changes. From comprehensive regulatory analysis and documentation review to submission preparation and ongoing compliance support, dicentra’s expertise streamlines the process, helping companies meet the deadlines and navigate the evolving regulatory landscape. Prepare confidently for the new FDA guidance by partnering with dicentra. Contact dicentra today.
This article provides a supplemental review of the FDA’s Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products and is not a substitute for reading the complete draft guidance document.