FDA Published Draft Guidance on MoCRA Registration and Listing

FDA Published Draft Guidance on MoCRA Registration and Listing

November 9, 2023, Covington Alert

Originally posted, August 7, 2023; Updated September 18, 2023 and November 9, 2023.

November 9, 2023 Update — Yesterday, FDA announced that it “does not intend to enforce requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months,” meaning initial cosmetic product registration and listing activities now must be completed by July 1, 2024.  This means that a facility that manufactures or processes cosmetics must register within 60 days of first engaging in such activity, or by July 1, 2024, whichever is later.  Similarly, the Responsible Person for a cosmetic product must list its product with FDA within 120 days of first marketing the product in interstate commerce, or by July 1, 2024, whichever is later.

September 18, 2023 Update —Today, FDA published screenshots of its forthcoming electronic registration and listing platform, Cosmetics Direct, and published drafts of paper forms (registration; listing) that companies can use as an alternative to Cosmetics Direct. A Paperwork Reduction Act (PRA) notice invited stakeholders to submit comments on Cosmetics Direct and the new paper forms within 30 days. Finally, FDA launched its cosmetics registration and listing website, which outlines registration and listing requirements under MoCRA and provides related resources.

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Published on August 7, 2023 — Today, the United States Food and Drug Administration (“FDA”) published a draft guidance (“Draft Guidance”) on the new cosmetic product facility registration and cosmetic product lising requirements under the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”). To ensure they are reviewed before FDA begins work to finalize the draft guidance, comments should be submitted by September 7, 2023.

MoCRA requires the owners or operators of a “facility” (as defined in MoCRA) that manufactures or processes cosmetic products for U.S. distribution to register the facility with FDA, unless an exemption applies. For facilities that manufactured or processed cosmetic products for U.S. distribution as of December 29, 2022, and that are not exempt under MoCRA, the owners or operators of such facilities must register the relevant facilities with FDA by December 29, 2023. For facilities that began manufacturing or processing cosmetic products for U.S. distribution after December 29, 2022, and that are not exempt under MoCRA, the owner or operator of such facilities must register the relevant facilities with FDA within 60 days of first engaging in the activities or by February 27, 2024, whichever is later. All registrations must be renewed biennially. [See above for updates to this]

An exempt facility is one that qualifies as a small business under MoCRA, as well as a facility that is subject to registration with FDA as a drug or device establishment, unless such facility additionally manufactures or processes cosmetic products that are not also subject to FDA’s drug or device authorities. Note also that the MoCRA definition of “facility” itself includes a number of carve outs; most notably, an establishment that solely performs labeling, relabeling, packaging, repackaging, holding, and/or distributing of cosmetic products is not a “facility” subject to these requirements. Other carve outs to the definition of “facility” include establishments that manufacture or process cosmetic products that are solely for use in research or evaluation, including for production testing, and not offered for retail sale, and establishments that manufacture cosmetic ingredients but not cosmetic products.

The Draft Guidance notes that facilities that manufacture or process cosmetic products on behalf of one or more responsible persons (e.g., contract manufacturers) need only register once, and that a “Responsible Person”[1] for whom the facility manufacturers or processes products may choose to submit the registration on behalf of that facility. The Draft Guidance lists the categories of information to be included in the submission. If an FDA Establishment Identifier (FEI) is already assigned to the facility, the FEI must be included in the registration submission.

The Draft Guidance notes that obtaining an existing FEI should be the first step before preparing a submission. Before seeking a new FEI, companies should check the FEI Search Portal to see if they have an existing FEI. Companies without an FEI can obtain one by submitting a request to feiportal@fda.hhs.gov. The request should include the following information:

1. The legal name of the firm being registered.
2. Whether the submitter is representing the firm as an Agent (third party).
3. Any alternate firm names, including those used for "doing business as" purposes.
4. The physical address of the firm being registered.
5. The designated mailing address for the firm being registered.
6. The name and contact information of the designated contact person at the facility being registered.
7. A comprehensive list of activities conducted at this specific location (e.g., drug manufacturing, food packaging, etc.).
8. Any registration numbers associated with other FDA Centers, if applicable.
9. Any former names the firm was known by.
10. Any previous addresses linked to the firm.

The “Responsible Person” (as defined in MoCRA) for a cosmetic product marketed on December 29, 2022, must submit to FDA a cosmetic product listing by December 29, 2023. For a product first marketed after December 29, 2022, the Responsible Person must list the cosmetic product with FDA by 120 days after first marketing the product in interstate commerce, or within 120 days of December 29, 2023, whichever is later. [See above for updates to this]. Responsible Persons who qualify as small businesses are exempt from the listing requirements, as are cosmetic products that are also subject to FDA’s drug or device authorities. Appendix A of the Draft Guidance provides a list of cosmetic product categories and codes to be used in cosmetic product listings.

The Draft Guidance also explains that FDA will not make available for public disclosure the product listing number, brand names under which cosmetic products manufactured at a particular facility are sold, or the facility number of the facility where a cosmetic product is manufactured or processed, but will make all other information available consistent with the Freedom of Information Act, 5 U.S.C. § 552.

FDA is developing an electronic submission portal for submission of registration and listing information as well as a paper form as an alternative submission tool, all of which FDA expects to have available in October 2023. FDA strongly encourages electronic submission. FDA also separately published a Notice soliciting applications for up to nine participants in a voluntary pilot program to conduct user acceptance testing to help evaluate the electronic submission portal for cosmetic facility registration and cosmetic product listing. FDA plans to begin the pilot testing “on or about September 15.”

If you have any questions concerning the material discussed in this client alert, or more broadly about MoCRA implementation,[2] please contact the members of our Food, Drugs, and Devices practice.

[1] “Responsible Person” means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 364(4)) and in accordance with § 1453(A) of Title 15.

[2] For more information on MoCRA, please see our comprehensive client alert here: https://www.cov.com/en/news-and-insights/insights/2022/12/years-in-the-making-congress-modernizes-fdas-cosmetics-authorities.