FDA Announces the Availability of Additional Submission Tools for Cosmetic Product Facility Registration and Cosmetic Product Listing
Cosmetics Constituent Update
January 8, 2024
Today the U.S. Food and Drug Administration (FDA) announced the availability of SPL Xforms, a Structured Product Labeling (SPL) authoring tool for cosmetic product facility registration and cosmetic product listing mandated by the Modernization of Cosmetics Regulation Act of 2022 (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).
Today FDA also announced the availability of Form FDA 5066 and Form FDA 5067 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.
Delayed Enforcement
On November 8, 2023, FDA issued guidance on its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements under the FD&C Act as amended by MoCRA for six months to help ensure that industry has sufficient time to submit such facility registration and product listing information.
FDA does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements.
In addition, FDA does not intend to enforce the registration requirement for owners or operators of facilities that first engaged in manufacturing or processing a cosmetic product after December 29, 2022, or the listing requirement for cosmetic products first marketed after December 29, 2022, until July 1, 2024.
Related Resources
- Cosmetics Direct
- For assistance with validation errors in the Cosmetics Direct electronic submission portal, contact cosmeticsdirect@fda.hhs.gov
- For general questions regarding cosmetic product facility registration and cosmetic product listing, contact eRLC@fda.hhs.gov
- Electronic Submissions Gateway
- For technical assistance with ESG, contact ESGHelpDesk@fda.hhs.gov
- Structured Product Labeling Resources
- Structured Product Labeling (SPL) Implementation Guide with Validation Procedures
- Visit SPL Xforms for troubleshooting help and other advisories
- For questions on FDA SPL Xforms, contact SPL@fda.hhs.gov
- Registration & Listing of Cosmetic Product Facilities and Products
Additional Information
- Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products
- FDA Announces Launch of Cosmetics Direct for Electronic Registration and Listing of Cosmetic Product Facilities and Products
- Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing