/>iKey Takeaways
- What Happened: The Food and Drug Administration (FDA) released new guidance regarding the registration and listing of cosmetic product facilities and products.
- Who’s Impacted: Cosmetic product manufacturers.
- What Should You Do: Companies should consider submitting comments on this guidance by January 13, 2025.
The Food and Drug Administration (FDA) has issued updated guidance on a key aspect of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), enacted in December 2022. MoCRA added new cosmetics provisions to the Federal Food, Drug, and Cosmetic Act, including cosmetic establishment registration and cosmetic product listing requirements. For more details on MoCRA, see here. Registration and listing were required by July 1, 2024.
In December 2023, FDA issued its final guidance on cosmetics product facility registrations and product listings; see our previous alert. That final guidance included information about Cosmetics Direct and a Frequently Asked Questions section with 19 FAQs. The December 2024 new guidance document expands on that final guidance by adding three new FAQs. FDA is requesting comments on the FAQs. 89 Fed. Reg. 100508 (Dec. 12, 2024).
The three new FAQs, listed on the last two pages of Appendix B, discuss the responsibilities of a U.S. Agent, when FDA Establishment Identifiers (FEIs) can be used for multiple buildings, and listings for free samples or gifts. First, FDA described the limited role that U.S Agents play by listing responsibilities that an agent generally would include. The responsibilities generally relate to facilitating communications between the FDA and the foreign establishment. Second, FDA clarified that an FEI may be used for multiple buildings that are part of the same establishment under certain circumstances. In order for multiple buildings to use the same FEI, they must be within 3 miles of each other, their activities must be closely related to the same business enterprise, they must be under the same supervision, and FDA must be able to inspect them during a single inspection. Finally, the guidance clarifies that, in most situations, free samples or gifts must have a product listing. The guidance details the limited situations in which this is not the case.
For those interested in commenting on the new guidance, parties should submit comments to the docket by January 13, 2025. As an additional reminder, the December 29, 2024 deadline has recently passed for the requirement for Responsible Persons to update their product labels with contact information.
