FDA Cosmetic Updates: New Q&As for MoCRA Facility Registration, Product Listing; Delayed Timelines for GMPs and More

FDA continues to construct its regulatory program for cosmetic products, albeit at a slower pace than the congressional timelines provided in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). FDA has yet to provide explanatory guidance on several congressionally mandated items including fragrance allergen disclosures, product safety substantiation, and serious adverse event reporting. FDA’s Fall 2024 Unified Agenda published on December 15 provided some updated timelines ranging from late 2024 to late 2025. Days before, FDA also updated its Guidance on cosmetic facility registration and product listing.

The proposed rule for good manufacturing practices (GMPs) will be delayed until October 2025. FDA estimates closer publication dates for the proposed rules on fragrance allergen disclosures (January 2025) and asbestos testing methods for products containing talc (December 2024), although those timelines may be delayed further given the upcoming change in presidential administrations.  

FDA did issue Draft Guidance on one MoCRA topic, Registration and Listing of Cosmetic Product Facilities and Products, published in August 2023 and revised and finalized in December 2023. The Draft Guidance was intended to assist the cosmetic and personal care product industries with submitting their facility registrations and cosmetic product listings by detailing who is responsible for making the submissions, what information to include, and how and when to submit the information to FDA. In December 2023, FDA finalized the Draft Guidance and added Appendix B to provide frequently asked questions and answers.

Now, FDA has updated the Guidance again. This most recent version of the Guidance published on December 12 finalizes Appendix B, Questions 1–19, and adds three new questions and answers. 

The first new question (No. 20) provides information about the requirement that a foreign manufacturing establishment must have a U.S. Agent. The Guidance describes a U.S. Agent as an individual or business entity that maintains a US place of business and is physically present in the United States. The responsibilities of a U.S. Agent include assisting in communications between FDA and the foreign establishment (including the receipt of documents), responding to FDA questions about imported products, and assisting FDA in scheduling inspections of the foreign establishment. 

The second new question (No. 21) clarifies that, like food and drug manufacturing facilities, a cosmetic registered establishment may include multiple buildings that are in close proximity (within three miles of each other). In this case, where one FDA Establishment Identifier (FEI) is associated with multiple buildings, only one establishment registration would be required.

The third new question (No. 22) explains that the product listing requirement applies to free samples and gifts intended for consumers and not just cosmetics offered for retail sale. By contrast, if the free samples are provided for research and development purposes and are not intended for consumption by the consumer, then the samples do not need to be listed with FDA.

Finally, FDA expanded the types of eye-area products that disqualify an entity from claiming the small business exemption. Section 612 of MoCRA defined a “small business” to specifically exclude manufacturers of cosmetic products that “regularly come into contact with the mucus membrane of the eye under conditions of use that are customary or usual.” The December 2023 version of the Guidance described only eye makeup remover, a liquid or mucosal eyeliner, and a false eyelash adhesive as products that would regularly come into contact with the mucus membrane of the eye.

In the December 2024 version, FDA has arguably expanded this definition by adding eye shadow to that product list, stating that products that are “intended to be applied in the proximity of the eye” would be expected to regularly come into contact with the mucus membrane. Thus, eye shadow makers would not qualify for the small business exemption.

While one could argue that the typical application of eye shadow occurs above the eye and does not regularly touch the eye’s mucus membrane, FDA may be reacting to recent advertisements and social media videos that show eye shadow being applied under the eye like eye liner, and around the entirety of the eye—and in those cases the mucus membrane is likely to be touched. 

FDA has requested that the public provide comments on the additional three questions of the Guidance by January 13, 2025, which is not much time given the intervening year-end holidays.

KEY TAKEAWAYS

Now that FDA has worked through one year’s worth of industry registration and listing submissions, it has identified common questions that it has answered via the Guidance document. For new “responsible persons” that must submit facility registration and product listing information for the first time, the Guidance will provide useful instructions to address issues that come up when gathering the requested information and determining the correct details to submit to FDA. And since the product listing submissions are a biennial requirement, the FDA’s Q&A format will be instructive for all who have continuing compliance obligations under MoCRA. 

For MoCRA requirements that have no associated FDA guidance statements, like the requirement to have safety substantiation for each product and the requirement to submit serious adverse event reports to FDA, each affected member of the cosmetic industry must develop its own policies and procedures to manage compliance with the law and create recordkeeping strategies to document that compliance.

While FDA continues to take more time into 2025 to stand up its regulatory program under MoCRA—and awaits a new presidential administration and new FDA Director of the Office of Cosmetics and Colors—industry members should use this time to their advantage by devising internal procedures, contract terms, and vendor oversight standards that could be seen as industry-leading principles when FDA eventually engages in MoCRA enforcement actions.