Cosmetic Registration and Listing Coming into Effect (Reminder)

Trade Update • June 18, 2024

ffective July 1, 2024, cosmetic manufacturers and processors will be required to register their facilities with the U.S. Food and Drug Administration (FDA) and submit product listings and facility registrations to the FDA. This applies to a broad range of products, including makeup, nail polish, shaving creams, perfumes, cleansers, haircare products, moisturizers, and other skincare items.

Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938.

Under MoCRA, cosmetic product manufacturers and processors must register their facilities with the FDA, update content within 60 days of any changes, and renew their registrations every two years. In addition, each marketed cosmetic product (including its ingredients) must be listed with the FDA and updates must be provided annually.

Exemptions

MoCRA exempts certain small businesses from facility registration and product listing requirements. However, such exemptions do not apply to facilities that manufacture or process, or responsible persons for, the following cosmetic products:

• Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use.
• Products that are injected.
• Products that are intended for internal use.
• Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.

Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices.

Submission Tools for Cosmetic Facility Registration and Product Listing

The FDA has made available SPL Xforms, a Structured Product Labeling (SPL) authoring tool for cosmetic product facility registration and cosmetic product listing mandated by the MoCRA.

Xforms is one option of creating an SPL file with cosmetic product facility registration and cosmetic product listing information. FDA is also accepting cosmetic product facility registrations and cosmetic product listings via the electronic submission options below:

• Cosmetics Direct, an FDA Structured Product Labeling (SPL) authoring tool and electronic submission portal at https://direct.fda.gov/, and
• SPL-formatted submissions through the Electronic Submissions Gateway (ESG).

Form FDA 5066 and Form FDA 5067 is also available as an additional submission tool for providing cosmetic product facility registration and cosmetic product listing information to FDA. These paper forms are available at Registration & Listing of Cosmetic Product Facilities and Products.

Completed paper forms can be mailed to FDA’s Registration and Listing of Cosmetic Product Facilities and Products Program at: Food and Drug Administration, Office of Cosmetics and Colors, Registration and Listing of Cosmetic Product Facilities and Products Program, 5001 Campus Drive, CPK1, Room 1B-046, College Park, MD 20740-3835 or emailed to RLC-PaperSubmissions@fda.hhs.gov.

While electronic submission is not required, FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency.

Questions or concerns about if your products are affected please contact us.