FDA Issues Draft Guidance Document on MoCRA Requirements for Cosmetic Facility Registration and Cosmetic Product Listing
On August 7, 2023, FDA issued a Constituent Update and Draft Guidance document entitled “Registration and Listing of Cosmetic Product Facilities and Products” intended to provide further information about the upcoming cosmetic facility registration and cosmetic product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). At this point, the Agency expects the electronic portal for submitting registration and product listing information to be available for use in October 2023.
The Draft Guidance provides more detail about the specific information (mostly unsurprising) that will need to be included with facility registration and cosmetic product submissions, along with some optional details that FDA intends to request. A few important points are noted below:
- A cosmetic manufacturer will need to submit its facility registration number with its initial registration. The Agency intends to use the FDA Establishment Identifier (FEI) number as the facility registration number. The Draft Guidance includes information about how to determine if a facility already has an FEI or how to request one if no such number has previously been assigned. Draft Guidance, Section II.C.1. (footnote 3).
- A cosmetic facility’s registration will need to include: (1) a list of all brand names of the cosmetic products manufactured or processed at the facility; (2) the responsible person for each cosmetic product; and (3) the product category or categories into which each product falls (based on the options listed in the Appendix to the Draft Guidance). Draft Guidance, Section II.C.1.
- The listing for each cosmetic product will also need to include the product category or categories that cover it. To ensure consistency between facility registrations and product listings, responsible persons and manufacturers should communicate with each other to make sure they agree on the categorization of the cosmetic products. Draft Guidance, Section II.C.1.
- FDA confirmed that, for cosmetic facilities in operation as of December 29, 2022, the deadline for registration is December 29, 2023. For cosmetic facilities that began operations after December 29, 2022, the registration deadline is 60 days after starting operations or February 27, 2024, whichever is later. Draft Guidance, Section II.F.1.a.
- FDA confirmed that, for cosmetic products marketed as of December 29, 2022, the deadline for product listing is December 29, 2023. For cosmetic products first marketed after December 29, 2022, the listing deadline is 120 days after first marketing the product or 120 days after December 29, 2023 (i.e., April 24, 2023), whichever is later. Draft Guidance, Section II.F.2.a.
- FDA “intends to make relevant information from cosmetic product facility registration and listing available to the public to the extent permitted by law.” However, the Agency will not release; (1) product brand names submitted with facility registration forms; (2) facility registration numbers included on cosmetic product listing forms; or (3) product listing numbers assigned during the submission process. Draft Guidance, Section II.D. MoCRA does not require that cosmetic facility registration numbers be protected from disclosure, so it appears that FDA will make those available (similar to what the Agency does with registration numbers for drug and medical device establishments (but not food facilities)).
As you probably know, MoCRA dramatically expanded the regulatory requirements for cosmetic products and gave FDA greater authority over them. The facility registration and cosmetic product listing provisions are among several new requirements that will come into effect over the next one to three years. If you have any questions about the registration, listing requirements, or any other provisions of MoCRA, please feel free to contact Partner Frederick Stearns (email@example.com) or your existing contact at Keller and Heckman LLP.