**01/10/2024 Update: FDA issued a final guidance on Registration and Listing of Cosmetic Product Facilities and Products on December 18, 2023. The final guidance remains largely unchanged from the draft guidance discussed below, but includes several additional details. Of note, the guidance:
- Reflects FDA’s compliance policy as noted below in the 11/8/2023 Update. Specifically, the agency does not intend to enforce registration and listing requirements until July 1, 2024.
- Provides information regarding the newly developed electronic submissions portal for submitting registration and listing information and the availability of paper forms.
- Clarifies that a U.S. agent is required for registration of a foreign facility.
- Provides instructions for obtaining an FDA Establishment Identifier (FEI) for entities that do not already have one for purposes of submitting a facility registration number.
- Includes a new Appendix B with an FAQ section for comment purposes only that provides potentially useful information. Among other things, FDA proposes to clarify that FDA currently only expects facilities to register if they manufacture or process final formulations of cosmetics ingredients, and not those that only manufacture or process cosmetic ingredients; a laboratory that only performs batch release testing must register as such testing would be considered part of manufacturing and processing. In addition, for purposes of determining whether a facility qualifies as a small business exempt from registration and listing requirements, FDA provides proposed examples of products that regularly come into contact with the mucus membrane of the eye and that are intended to alter appearance for more than 24 hours.
**11/8/2023 Update: FDA issued a compliance policy regarding cosmetic facility registration and product listing requirements, stating its intent to delay enforcement of both requirements for 6 months, until July 1, 2024. The policy indicates that FDA will still be ready to accept registration and listing information by the statutory deadline of December 29, 2023, and encourages companies to meet this deadline if they are able to do so.
**9/20/2023 Update: FDA has published drafts of Form FDA 5066, “Registration of Cosmetic Product Facility,” and Form FDA 5067, “Cosmetic Product Listing,” as well as draft screenshots of the electronic system for submission for public comment. Comments are due by October 18, 2023. See https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products.
As we discussed in our prior KKB Alert of January 6, 2023, President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) at the end of last year. MoCRA’s numerous provisions included those establishing requirements for cosmetic product facility registration and product listing.[1] FDA has now published a draft guidance detailing recommendations and instructions for complying with these requirements. FDA recommends submitting comments by September 7, 2023.
We summarize some of the key points below.
Facility Registration
Registration requirements apply to all facilities engaged in manufacturing or processing a cosmetic product for distribution in the United States with two exceptions. First, “small businesses”[2] that do not engage in the manufacturing or processing of certain categories of cosmetic products (e.g., those that regularly come into contact with the mucous membrane of the eye or that are injected) are exempt. Second, facilities that manufacture only drug/cosmetic combination products (and no products that qualify solely as cosmetics) are exempt.[3] Contract manufacturers need register only once, even if they manufacture products on behalf of multiple customers, and the responsible person[4] for a brand of cosmetics may submit facility registration information for (and in lieu of submission of that information by) its contract manufacturer. Facility registration must be renewed biennially and registrations must be amended within 60 days of any changes to the information required for registration.
Information required for a complete facility registration includes: the name of the owner or operator of the facility, the facility’s name and address, and contact information; the facility registration number[5]; the brand names of products manufactured or processed at the facility; the category or categories of products manufactured or processed at the facility; and the submission type (e.g., initial, renewal, etc.). FDA will not publicly disclose brand name information associated with a particular facility’s registration. Before starting the registration process, the registrant must obtain an FDA Establishment Identifier (FEI) or identify any existing FEI that FDA may already have for the facility. For more information on how to request an FEI number or determine if a facility already has one, refer to the FEI Search Portal.
All existing cosmetic facilities in operation as of December 29, 2022, must register by December 29, 2023, and all facilities that commenced operations requiring registration thereafter must register within 60 days of first engaging in manufacturing/processing activities or by February 27, 2024, whichever is later.
Product Listing
Product listing is required for each cosmetic product on the U.S. market, unless one of the above-described exceptions applies. The product listing cannot be submitted without first registering the facility. Product listings must be updated annually, including updates that the product was discontinued.
Information required for a complete listing includes: the name and contact information of the responsible person; the name of the cosmetic product; the facility registration number(s); the applicable cosmetic category (or categories); an ingredients list; any previous product listing number assigned to the product; and the submission type. FDA will not publicly disclose product listing numbers or facility registration numbers included as part of product listings.
All existing cosmetic products on the U.S. market as of December 29, 2022, must be listed by December 29, 2023, and all cosmetic products first marketed after December 29, 2022, must be listed within 120 days of entering interstate commerce or within 120 days of December 29, 2023, whichever is later.
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FDA intends on making a new electronic submission portal available in October 2023 and strongly encourages electronic submissions using structured product labeling (SPL) format.[6] There is no fee associated with registration or listing. Importantly, FDA states that previous submissions to the voluntary cosmetic registration program will not satisfy MoCRA’s registration and listing requirements.[7]
We will continue to monitor FDA’s ongoing implementation of MoCRA and provide updates here.
[1] See generally 21 U.S.C. § 364c.
[2] Small businesses” have average gross annual U.S. sales of cosmetics for the previous 3-year period of less than $1,000,000 (adjusted for inflation). See 21 U.S.C. § 364h.
[3] These facilities are presumably in compliance with separate over-the-counter drug registration and listing requirements.
[4] The “responsible person” is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label. 21 U.S.C. § 364(4).
[5] The facility registration number is the same as the FDA Establishment Identifier (FEI).
[6] FDA is soliciting applications from cosmetic manufacturers to participate in a voluntary pilot program of the new electronic submission portal. Applications are due by August 22, 2023. See https://public-inspection.federalregister.gov/2023-16772.pdf.
[7] See 21 C.F.R. Parts 710 and 720.