FDA Issues Final Guidance Document on MoCRA Requirements for Cosmetic Facility Registration and Cosmetic Product Listing, Also Opens Electronic Portal for Submissions

On December 18, 2023, the U.S. Food and Drug Administration (FDA) made two announcements concerning the cosmetic facility registration and cosmetic product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). First, the Agency launched its “Cosmetics Direct” electronic submissions portal to receive cosmetic facility registration and product listing information. Second, FDA released its final guidance on the information to be included with registration and listing submissions. As noted in a compliance policy issued on November 8, 2023, the Agency is not enforcing the facility registration or product listing requirements until July 1, 2024. Nevertheless, companies should begin taking steps to comply with the new provisions. The December 18 developments are discussed in more detail below.

“Cosmetics Direct” Electronic Portal

As discussed in FDA’s announcement, the Cosmetics Direct electronic portal is now open for companies to submit facility registration, product listing, and labeling information. The Agency describes the portal as a “Structured Product Labeling (SPL) authoring tool, for cosmetic product facility registration and cosmetic product listing, that contains user friendly data entry forms, performs initial validations, creates and saves the SPL submission, and submits the SPL to FDA for internal processing.” SPL is the format to be used for the submission of cosmetic labeling information. A detailed User’s Guide to Cosmetics Direct is also available. In general, each party that wishes to make submissions through the portal will need to set up an account.

Final Guidance of Cosmetic Facility Registration and Product Listing

In its December 18 Constituent Update, FDA announced it has issued a final guidance document entitled “Registration and Listing of Cosmetic Product Facilities and Products” intended to provide further information about (1) who is responsible for making the registration and listing submissions; (2) what information to include; (3) how to submit; (4) when to submit; and (5) certain exemptions to the registration and listing requirements. The Final Guidance also discusses some optional details that FDA requests companies to include with the submissions. A few important points are noted below:

• A cosmetic manufacturer will need to submit its facility registration number with its initial registration. The Agency will use the FDA Establishment Identifier (FEI) number as the facility registration number. The Final 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. Final Guidance, Section III.C.1. (footnote 5).
• A cosmetic facility’s registration is required to include: (1) the name of the owner/operator of the facility; (2) the facility’s physical address and information for a contact person; (3) a list of all brand names of the cosmetic products manufactured or processed at the facility; (4) the responsible person for each cosmetic product; and (5) the product category or categories into which each product falls (based on the options listed in the Appendix A to the Final Guidance). Final Guidance, Section III.C.1.
• FDA asks that companies include the following optional information in their facility registrations: (1) the parent company name (if there is one); (2) the facility’s Data Universal Numbering System (DUNS) number (a unique nine-digit identification number provided by Dun & Bradstreet (D&B)); and (3) additional contact information for persons associated with the registration. Final Guidance, Section III.C.1.
• The listing for each cosmetic product is required to include (1) the facility registration number of each facility where the cosmetic product is manufactured or processed; (2) the name and contact number of the responsible person, along with the name of the cosmetic product as it appears on the label; (3) information for the product category or categories that cover it (as described in Appendix A of the Final Guidance); and (4) a list of ingredients in the cosmetic product (including fragrances, flavors, or colors). 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. Final Guidance, Section III.C.2.
• FDA asks that companies include the following optional information in their product listings: (1) the parent company name (if there is one); (2) the type of business as stated on the label (e.g., manufacturer, packer, or distributor); (3) an image of the product label (such as a .jpeg file); (4) a product webpage link; (5) whether the cosmetic product is for professional use only; (6) the responsible person DUNS number for the address listed on the product label; (7) Unique Ingredient Identifiers (UNIIs)[1]; and (8) additional contact information for persons associated with the listing. Final Guidance, Section III.C.2.
• 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. Final Guidance, Section III.D. MoCRA does not require that cosmetic facility registration numbers be protected from disclosure, so it appears that FDA may make those available (similar to what the Agency does with registration numbers for drug and medical device establishments (but not food facilities)).
• The Final Guidance includes a “frequently asked questions” (FAQs) section in Appendix B that is being distributed “for comment purposes only” and is, therefore, essentially a draft version. However, these FAQs provide further insight into how FDA is interpreting certain provisions of the registration and listing requirements and are, therefore, worth reviewing.

As you probably know, MoCRA (enacted on December 29, 2022) 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 or listing requirements, or any other provisions of MoCRA, please feel free to contact Partner Frederick Stearns (stearns@khlaw.com) or your existing contact at Keller and Heckman LLP.

[1] UNIIs are part of FDA’s “Global Substance Registration System” and are designed to ensure consistent identification of chemical substances. FDA offers a UNII Search Service, which has information on over 143,000 substances.