On Aug. 7, 2023, the U.S. Food and Drug Administration (FDA) released draft guidance, “Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry,” which would require facilities that manufacture and process cosmetics to register and submit cosmetic product listings to the FDA. This guidance aims to formalize the FDA’s Voluntary Cosmetic Registration Program to ensure that cosmetic products sold in the United States are safe. Read on to understand what the draft guidance would require and what to expect if the draft guidance is adopted
Facilities That Are Required to Register
Under the draft guidance, some facilities manufacturing or processing cosmetics would be required to participate in the formalized program. However, other facilities would be exempt, including (i) small businesses with average gross annual U.S. sales of cosmetic products totaling less than $1 million for the preceding three-year period; and (ii) facilities subject to FDA regulation as a drug or device manufacturer whose cosmetic products already are subject to such FDA regulation.
Other facilities would also be exempt, including those that merely sell products such as salons, healthcare facilities such as hospitals, facilities that merely create or manufacture cosmetics for research, and those that are involved in a narrow capacity such as labeling, holding or repackaging. It is important that companies conduct a review of sales and develop policies and procedures for such review.
Registering With FDA
Only one person is required to register with the FDA as a “responsible person,” such as the owner or operator of a facility. Therefore, if a facility is contracted to manufacture or process cosmetics, the party contracting such services may register with the FDA, and the facility would not be required to register. The FDA’s Voluntary Cosmetic Registration Program will not transfer to the formal registration system once created. A responsible person would need to register with the FDA even if previously registered through the voluntary program. McGuireWoods recommends choosing a responsible person and devising a registration plan prior to finalization.
Submitting a Cosmetic Product Listing
The facility’s registration would need to provide a range of information, including the address and facility name, the products being manufactured or processed, and under which categories established by FDA in Appendix A in the draft guidance (beginning on page 12) the products would fall. The facility would also need to provide the FDA with all ingredients used and information about each ingredient, including fragrances, flavors and intended uses.
Other information about the company would be required, such as an overview of the company’s structure, Data Universal Numbering System (DUNS) number, webpage link(s), parent company name and contact information. Each submission will require an attestation of truthfulness, so companies must ensure that all information is correct, especially concerning product listings. The FDA has stated a responsible person and/or facility would not be required to pay a fee for registering or submitting a cosmetic product listing. It is highly likely that the FDA will require the submission of cosmetic product listings.
What to Expect
The draft guidance, if adopted, would not go into effect before Dec. 29, 2023. If it is adopted, any facility operating on Dec. 29, 2022, that would be required to register under the guidance, must do so within 60 days from the date the facility engaged in manufacturing or processing cosmetics. In the interim, the FDA has stated it is developing an electronic submission portal for facilities to register and submit cosmetic product listings. The FDA has also stated that the information provided to FDA will not be available for public disclosure, even in response to a request under the Freedom of Information Act, also known as a FOIA request. Facilities and responsible persons would also have an ongoing duty to provide updated information to the FDA if the draft guidance is adopted.
Companies should determine a course of action for registration, including developing policies and procedures for review of cosmetics sales. For private equity clients in this space, expect a more fulsome review of diligence and potential registration changes. The FDA is accepting comments online through Sept. 7, 2023.
McGuireWoods attorneys have experience with all levels of the cosmetics industry, from regulatory guidance to litigation. For more information about whether your facility would be required to register, or for assistance preparing submission of cosmetic product listings before Dec. 29, 2023, please contact one of the authors of this article.