FDA Publishes Two Key Guidance Documents on Cosmetics Facility Registration and Product Listing

January 26, 2024

The U.S. Food and Drug Administration (FDA) had a busy end of 2023 regarding cosmetics facility registration and product listing, which are now required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

In November 2023, FDA finalized an implementation guide for structured product labeling (SPL) that includes SPL authoring tools for cosmetics manufacturers that will be required to submit cosmetic product listings, of which FDA delayed enforcement until July 1, 2024. In December 2023, FDA published guidance for manufacturers on how to comply with the new registration and listing requirements.

While enforcement has been delayed, cosmetics manufacturers should register promptly to avoid violating the law.

Background on MoCRA and SPL

With its passage in 2022, MoCRA significantly expanded FDA’s authority to regulate cosmetics manufacturers. Section 607(a) of the Food, Drug, and Cosmetic Act (FDCA) requires owners or operators to register any facility that “engages in the manufacturing or processing of a cosmetic product for distribution in the United States,” and Section 607(c) requires those manufacturers to “list all cosmetics they manufacture for sale in the US.” Certain entities that label, relabel, package, repackage, hold and distribute cosmetics may be exempt, as are certain small businesses.

Voluntary registration and listing were accepted until March 2023, but mandatory registration and listing will be required through the new Cosmetics Direct portal in 2024, and information entered into the voluntary registration system will not be transferred to Cosmetics Direct. The portal has been available for registration and listing since mid-December 2023, but FDA indicated it will not enforce the requirements until July 1, 2024.

Similar to the requirements for drug manufacturers, cosmetics manufacturers will be required to list the products they manufacture and must submit the cosmetic labels in accordance with the SPL document markup standard adopted by FDA as a mechanism for exchanging product and facility information. The Cosmetics Direct portal “contains user friendly data entry forms, performs initial validations, creates and saves the SPL submission, and submits the SPL to FDA for internal processing….” FDA has made various user guides available for both Cosmetics Direct and the SPL protocol on the Cosmetics Direct information page.

Considerations for Manufacturers, Distributors and Labelers

As FDA expands and exercises its authority in the cosmetics industry, stakeholders should consider the following as they structure their MoCRA compliance plans.

  1. Broad Definition of Responsible Person. The FDCA defines a “responsible person” who must submit a product listing for each cosmetic product as an entity whose name appears on the label. Entities should perform an analysis to determine whether they are “responsible persons” under these updated regulations.
  2. Small-Business Exemption. Any business whose average gross annual sales in the U.S. of cosmetic products for the preceding three-year period is less than $1 million and that does not engage in manufacturing or processing certain cosmetics products is exempt from both registration and listing requirements. The exemption does not apply if the small business manufactures or processes cosmetics that come into contact with the mucus membrane of the eye, are injected, are intended for internal use or are intended to alter appearance for more than 24 hours.
  3. Other Exempt Entities. Certain other entities are exempt from registration and product listing requirements, including most salons or beauty shops, cosmetics retailers, hospitals and healthcare clinics, and manufacturers of cosmetics meant for use in research. Certain conditions may apply to these and other exceptions, so organizations should review the requirements carefully.
  4. Operational Convenience. Cosmetics facilities should use FDA’s SPL implementation guide as the primary reference guide when submitting registration information and product listing details through Cosmetics Direct. This will help organizations facilitate and streamline their submissions and ensure that they correctly submit product listings.

Compliance Going Forward

While the Dec. 29, 2023, registration and listing deadlines technically have expired for entities that were manufacturing cosmetics prior to Dec. 29, 2022, the deadline for manufacturers that started manufacturing after Dec. 29, 2022, is the later of Feb. 27, 2024, or 60 days after manufacturing activities first begin. However, FDA’s enforcement delay until July 1, 2024, provides manufacturers with a grace period; cosmetics facilities that are required to register but have not already done so should be sure to register promptly. For those that are newly manufacturing, there is still time to comply before the Feb. 27, 2024, deadline.

McGuireWoods tracks developments in the food, drug and device industry. If you have any questions about cosmetics facility registration or product listing, please contact one of the authors of this article.