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On Friday 15 September 2023, the FDA issued a draft guidance shedding light on the much-anticipated MoCRA registration and listing requirements. The guidance, titled “Registration and Listing of Cosmetic Product Facilities and Products” gives an overview of the process. In addition to the guidance document, the FDA also published an 81 slide draft of screen shots of COSMETICS DIRECT, the program which will be used to electronically submit information to the agency. Paper submissions (Form 5066 Registration of Product Facility and Form 5067 Cosmetic Product Listing) are allowed, but industry is highly encouraged to submit registration and listing information electronically via the Cosmetics Direct portal. For anyone familiar with CDER Direct (drug submissions to the FDA), the new cosmetic portal will look very similar. The fields are different as they are tailored to cosmetic submissions, but the program appears as though it will function the same way.

The guidance document reiterates the regulatory changes and requirements brought about by MoCRA. It is presented in a Q & A format, articulating which entities are responsible for submitting information, and what information they must submit. The agency presents both required and requested information. Public disclosure of this information is also addressed.

As previously announced, registrations and product listings of entities that were engaged in cosmetic manufacturing, processing and/or distribution on 29 December 2022 are required by regulation to submit their information no later than 29 December 2023. For those that engage after 29 December 2022, information must be submitted to the FDA within 60 days of first engaging in cosmetic processes or by 27 February 2024, whichever is later.

Do remember that a cosmetic product that is also a drug, such as make up or lip balm which includes a sunscreen ingredient, are not subject to product listing requirement. The registration and listing obligation of these products falls under CDER. A facility that manufactures / processes both cosmetics and cosmetic-drug combination products will require both a drug establishment registration and a cosmetic facility registration.

Appendix A of the guidance document articulates all cosmetic product categories and codes.

The agency is seeking comments through its draft portal or paper submissions. See the Federal Register Vol 88, No 179 notice for instructions on how to submit a comment. The Registration & Listing of Cosmetic Product Facilities and Products website will offer information on the program as it evolves.

If you have questions on this guidance, more broadly on the MoCRA requirements, or need assistance with registration and listing , please contact Victoria Pankovich (vpankovich@easconsultinggroup.com) at EAS Consulting Group.

Posted in FDA and USDA Regulatory Update.