Enforcement Begins July 1 for FDA Cosmetics Filings

Dear Valued Customer,

As a result of the Modernization of Cosmetics Regulation Act of 2022, the U.S. Food and Drug Administration (FDA) announced the availability of various tools to meet the requirements of filing cosmetic facility registrations and cosmetic product listing that are required. Originally, this deadline for filing was required by the end of 2023. However, the FDA extended the deadline for enforcement of these required filings to July 1, 2024. The FDA has provided exemptions for small businesses and a decision tool to help importers determine if they are required to register a cosmetic product facility.

Options to File

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).

Complete FDA Paper Forms 5066 and 5067 which can be mailed or emailed Registration & Listing of Cosmetic Product Facilities and Products | FDA

FDA Resources

FDA Announces the Availability of Additional Submission Tools for Cosmetic Product Facility Registration and Cosmetic Product Listing | FDA

Modernization of Cosmetics Regulation Act of 2022 (MoCRA) | FDA

Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (December 2023) (fda.gov)

OCAC Descision Tool (fda.gov)

Cosmetics Direct | FDA

Thank you for being a Valued Customer. If you have any questions, please do not hesitate to contact your C.H. Robinson commercial representative for further information.

Sincerely,

C.H. Robinson