FDA Issues Draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products

On August 7, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance to assist cosmetics companies submitting cosmetic product listings and cosmetic product facility registrations to the agency. The agency characterized the guidance as playing a critical role in helping to ensure the safety of cosmetic products that many consumers use day-to-day.

Background

The growth in the cosmetics industry over the last several years prompted Congress to pass the Modernization of Cosmetics Regulation Act (MoCRA). in 2022. MoCRA modernizes and strengthens cosmetics regulations in the United States and gives the FDA additional authority. Key MoCRA requirements include:

FDA registration for cosmetics facilities
Product listings for each cosmetic product
Adverse event reporting
Safety substantiation
Compliance with Good Manufacturing Practices (GMPs)
Fragrance allergen labeling

MoCRA also gives the FDA new records access and mandatory recall authority. To assist companies in their MoCRA compliance efforts, the FDA has published new guidance answering key questions and providing recommendations.

Draft Guidance

The draft guidance for industry describes MoCRA requirements for facility registration and product listings, as well as the exemptions for certain small businesses. The guidance explains:

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
When to make the submissions

The document also answers key questions such as what to do if a product is both a drug and a cosmetic product and whether there are fees to submit a registration or product listing. The guidance does not establish legally enforceable responsibilities. Rather, it describes the agency’s thinking on a topic and should be viewed as recommendations.

What Should Cosmetics Companies Do?

The guidance that has been issued is not finalized. The FDA will be accepting comments from industry and the public until September 7. Once finalized, cosmetics companies should carefully review the guidance and use it to further inform their MoCRA compliance strategy.

Diaz Trade Law attorneys have vast experience in assisting companies in complying with FDA regulations. Contact us at info@diaztradelaw.com for assistance submitting comments on the guidance or for help assessing the impacts of MoCRA on your cosmetic products.

FDA Issues Draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products