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Last month the United States Food and Drug Administration (“FDA”) issued its final guidance (“Guidance”) for the industry on cosmetic product facility registrations and product listings, as required by the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”). The <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-registration-and-listing-cosmetic-product-facilities-and-products" target="_blank" rel="noreferrer noopener">Guidance </a>provides recommendations and instructions for industry on how to submit facility registrations and product listings to the FDA. This Guidance follows draft guidance the FDA published in August 2023, including a new FAQ section, which the FDA seeks comments on by January 18, 2024.

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Along with publishing the Guidance, the FDA announced the new electronic submission portal, <a href="https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products/cosmetics-direct" target="_blank" rel="noreferrer noopener">Cosmetics Direct</a>. The goal of this portal is to help streamline submission of registration and product listing information required under Section 607 of the Federal Food, Drug and Cosmetic Act (“FDCA”). The Guidance also noted that paper forms were being developed as an additional submission tool. On January 8, 2024, the FDA announced that Form FDA 5066 and Form FDA 5067 were available as an additional submission tool for providing cosmetic product facility registration and listing information to the FDA. The paper forms are available <a href="https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products/cosmetics-direct" target="_blank" rel="noreferrer noopener">here</a>. In its January 8, 2024 announcement, the FDA also noted the availability of its <a href="https://www.fda.gov/industry/structured-product-labeling-resources/spl-xforms" target="_blank" rel="noreferrer noopener">SPL Xforms</a>, a <a href="https://www.fda.gov/industry/fda-data-standards-advisory-board/structured-product-labeling-resources" target="_blank" rel="noreferrer noopener">Structured Product Labeling</a> (“SPL”) tool for cosmetic facility registration and listing.

Key takeaways from the Guidance and draft FAQ page:

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What Definitions Will Apply? The Guidance will apply the same definitions as listed in Section 607 of the FDCA. The definitions are included for Contract Manufacturer, Cosmetic Product, Duns Number, Facility, FEI, Manufacturing or Processing of a Cosmetic Product, Operator, Owner, Responsible Person and Small Business.

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Who Registers a Facility and Submits Product Listing Information Under Section 607 of the FDCA? Every person who owns or operates a facility that engages in manufacturing or processing of a cosmetic product for distribution in the U.S. to register each facility and submit a cosmetic product listing (subject to limited exceptions).

Is Information Submitted under Section 607 of the FDCA for Facility Registration and Listing Available for Public Disclosure? No. The FDA will not disclose information on the brand names under which cosmetic products are manufactured or processed at a facility or facility registration numbers associated with a particular product listing. However, all other information from a cosmetic product listing and facility registration could be disclosed under a Freedom of Information Act Request (“FOIA”)

How Do You Submit Registration and Product Listing Information Required under Section 607 of the FDCA? Cosmetics Direct is an electronic submission portal. Submission through the portal is strongly encouraged by the FDA.

When Must You Register and List Under Section 607 of the FD&amp;C Act? In November 2023, the FDA announced its intent to delay enforcement of the requirements for cosmetic product facility registration and listings – the FDA does not intend to enforce the requirements regarding registration and listing until July 1, 2024, in an effort to provide industry time to comply with the new requirements.

Is there a Fee to Submit a Registration or Product Listing Under Section 607 of the FDCA? No, there is no fee.

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Firms that manufacture, pack, or distribute cosmetic products should review MoCRA and consult legal counsel to help determine what actions may need to be taken to confirm compliance. Please reach out to any BakerHostetler team member for assistance.

FDA Issues Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products