FDA Finalizes Guidance on MoCRA Registration and Listing; Announces Cosmetic Guidance Documents Under Development

FDA Finalizes Guidance on MoCRA Registration and Listing; Announces Cosmetic Guidance Documents Under Development

December 19, 2023, Covington Alert

Yesterday, the United States Food and Drug Administration (“FDA”) published a final guidance (“Guidance”) on the new cosmetic product facility registration and cosmetic product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) (see our prior alerts here and here). The Guidance finalizes draft guidance that FDA released in August and adds a draft FAQ appendix on which FDA has requested comment. While FDA will accept comments on any guidance document at any time, it has requested comment on the FAQs in the next 30 days. In addition, FDA’s Office of the Chief Scientist (“OCS”), which is leading MoCRA implementation for FDA, published a list of guidance documents it intends to publish, in draft or final form, by the end of 2024. The list includes several guidances relevant to cosmetics, including anticipated guidance documents on mandatory recall and records access.

Highlights from the Guidance and draft FAQs include:

• The Cosmetics Direct portal for cosmetic product facility registration and product listing is live. Companies may also register and list using the Electronic Submissions Gateway or forthcoming paper forms.
• FDA confirms that registration and listing is only required for cosmetic products, which importantly FDA clarifies only means “the final formulation of cosmetic ingredients (including a final formulation that includes a single ingredient),” including “final formulations” that have not yet been packaged. This clarification further refines the statutory definition of “cosmetic product” to make clear it does not include intermediate ingredients or combinations of ingredients that are not a “final formulation.”
• FDA also explains that the listing requirements only apply to cosmetic products “that are marketed for users (e.g., consumers or professional use).”
• FDA defines “manufacturing or processing of a cosmetic product” to mean “engaging in the making of any cosmetic product by chemical, physical, biological, or other procedures, including manipulation, sampling, testing, or control procedures applied to the product.” Based on this definition, FDA explains that a laboratory that performs cosmetic product batch release testing needs to register as a cosmetic product facility, but that a laboratory that performs research and development testing on cosmetic products does not.
• In response to a Freedom of Information Act (“FOIA”) request, FDA explains that it will not disclose information on the brand names under which cosmetic products manufactured or processed at a facility or facility registration numbers associated with a particular product listing. But all other information from a cosmetic product listing and facility registration could be disclosed under FOIA, and FDA intends to make relevant cosmetic product facility registration and listing information available to the public.

If you have any questions concerning the material discussed in this client alert, or more broadly about MoCRA implementation,[1] please contact the members of our Food, Drug, and Devices practice.

[1] For more information on MoCRA, please see our comprehensive client alert here: https://www.cov.com/en/news-and-insights/insights/2022/12/years-in-the-making-congress-modernizes-fdas-cosmetics-authorities.