Key Takeaways

• What Happened: The U.S. Food and Drug Administration (FDA) released Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products, providing more information on the newly required cosmetic product facility registrations and product listings to FDA.

• Who’s Impacted: Cosmetic product manufacturers.

• What Should You Do: Review the guidance and provide comments by September 7, 2023; be prepared to register your facilities and list your products in October 2023.

As described in our previous alert, Congress enacted the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) in December 2022. MoCRA amended the Federal Food, Drug, and Cosmetic Act (FFDCA) to add several new provisions, including a requirement for manufacturers and processors of cosmetic products to register their facilities with the Food and Drug Administration (FDA) and submit product lists to FDA. FFDCA § 607. According to MoCRA, every person who owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the U.S. must register with FDA starting on December 29, 2023. FFDCA § 607(a)(1)(A). Additionally, the responsible person for each cosmetic product sold in the U.S. must submit a cosmetic product listing to the FDA starting on December 29, 2023. FFDCA § 607(c)(2). A responsible person, as defined in FFDCA section 604(4), means “the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.”

FDA released draft guidance to provide more information on the process of submitting cosmetic product facility registrations and product listings to FDA. The guidance document mainly addresses:

• The statutory requirement to submit cosmetic product facility registrations and product listings;

• Definitions;

• Who is responsible for making the submissions;

• What information to include in the submissions;

• How to make the submissions; and

• When to make the submissions.

FDA had a Voluntary Cosmetic Registration Program prior to MoCRA that it phased out in anticipation of a new mandatory system. Information from this past system will not be carried over, so even if you submitted information before, you must do so again when the new system is live. FDA intends for the new submission portal, which will be used for both facility and product registration, to be available starting in October 2023. This gives regulated parties two months to register before the December 29 statutory deadline. The only exemptions to facility and product registration are for small businesses- as defined in the guidance document- and cosmetics that are also drugs or devices (and are therefore covered under FFDCA Chapter V). While a paper version of registration will be available, FDA recommends using its online portal.

On August 7, FDA published a notice announcing the availability of the draft guidance and soliciting comments on it. The comment deadline ends on September 7, 2023.