FDA Final Guidance on Cosmetic Facility Registration and Product Listing: Take Two

As we have reported extensively since its enactment, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) imposed extensive new requirements related to cosmetic products marketed in the United States. Among its many provisions, MoCRA imposes requirements for annual cosmetic product facility registration and cosmetic product listing.

We provided an overview of the facility registration and product listing requirements here and here, and additionally covered the previous 2023 final guidance and launch of the Cosmetics Direct portal here. As explained previously, Cosmetics Direct serves as the electronic submission portal to facilitate submissions of facility registrations and product listings.

Aside from minor word changes, the 2024 final guidance differs from the 2023 final guidance in few respects. Indeed, the only substantive changes appear in Appendix B, which covers frequently asked questions and answers about cosmetic facility registrations and cosmetic product listing submissions.

The material updates to Appendix B are as follows:

• In both the 2023 and 2024 final guidance, Question three provides details regarding the definition of “responsible person” and notes that, under MoCRA, cosmetic products must bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may be a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product.” Both guidances additionally recommended that “firms consider when selecting electronic contact information, such as an email address or a website (whether foreign or domestic), how they can best respond to these reports and meet maintenance, inspection, and reporting requirements under [the FDCA].” Notably, the 2024 final guidance now adds the following additional thought from the FDA: “For example, a fax number or QR code is unlikely to facilitate reporting due to potential limitations in accessibility for all consumers.”
• The 2024 final guidance adds Question 20, which notes that the responsibilities of a US agent are limited and generally include only the items enumerated in the guidance. Among other things, these responsibilities include assisting the FDA in communications with foreign establishments, assisting the FDA with scheduling inspections of foreign establishments, and responding to questions regarding imported products.
• The 2024 final guidance adds Question 21, which addresses whether multiple buildings that are in close proximity to one another (i.e., within three miles) be associated with one FDA Establishment Identifier (FEI) number, or whether two FEI numbers are needed. Here, the FDA notes that a cosmetic product facility may include multiple buildings that are part of the same establishment. Furthermore, multiple buildings with different physical addresses that are within three miles of one another are generally considered one establishment with one FEI number if:
  • Their activities are closely related to the same business enterprise.
  • They are under the supervision of the same local management.
  • They are capable of being inspected by the FDA during a single inspection.

The 2024 guidance provides further instruction on how to register a cosmetic product facility with multiple buildings that are associated with the same FEI number.

• The 2024 final guidance adds Question 22, which states that, generally, a product listing must be submitted for free samples or gifts. The FDA notes that, while the definition of “facility” under MoCRA includes exemptions for venues where cosmetic product samples are provided free of charge, the requirement to submit a listing nonetheless still applies to such products. However, the guidance makes clear that the FDA does not expect the listing requirement to apply to “samples that are provided within the industry for purposes of research and development or product development and not intended for consumption by the consumer.”

Notably, the 2024 final guidance states that Questions 20-22 in Appendix B are being distributed for comment purposes only. Comments should be submitted by January 13, 2025, to ensure that the FDA considers them before the agency begins work on the final version of this section.

ArentFox Schiff will continue to closely monitor additional updates on MoCRA compliance.

If you are interested in more information about MoCRA, would like guidance on complying with these new requirements, or would like assistance preparing a comment on Questions 20-22 in Appendix B, please contact ArentFox Schiff’s Food, Drug, Medical Device & Cosmetic group.