Cosmetics Direct includes the required registration and listing submission information in a standard electronic format to help users organize their registration and listing submissions to include the information needed for FDA.

Continuing its implementation of the Modernization of Cosmetics Regulation Act (MoCRA), and following on the heels of FDA’s Draft Guidance on Facility Registration and Product Listing (previously discussed on our blog), on September 15, 2023, FDA announced its newly developed draft electronic submission portal, Cosmetics Direct, to assist persons submitting cosmetic product facility registrations and product listings under newly added Section 607 of the federal Food, Drug and Cosmetic Act.

Draft screenshots of the electronic system, including example submissions, are available for review and comments, along with an interim Federal Register notice announcing the new system.

What’s New

Cosmetics Direct includes the required registration and listing submission information in a standard electronic format to help users organize their registration and listing submissions to include the information needed for FDA. Cosmetics Direct also is intended to give users access to prior registrations and listing submissions.

Cosmetics Direct can be accessed through the Welcome to FDA Direct webpage, which will provide short background information about Cosmetics Direct. New users will need to create an account.

Users who intend to submit information about cosmetics and drugs may create a functional joint account with Cosmetics Direct and CDER Direct, FDA’s portal for drug submissions, which is intended to streamline the submission process.

Notable system features include:

• Users will be able to create initial submissions using blank forms or importing an FDA-accepted SPL stored in a valid XML zip file. SPL (structured product labeling) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information. Importing an existing facility registration or cosmetic product listing SPL will be beneficial for bulk submission.
• By selecting a country outside the U.S. as a facility location, users will be prompted to identify U.S. agent contact information.
• Users will be prompted to sign a confirmation statement attesting to the veracity of the information submitted, as well as additional contact information for any authorized agents submitting the information.
• Users will be prompted to save and validate any new submissions, be able to view the status of registrations and listings, and be notified if the system detects any errors through a validation failure message. The system will provide a list of errors that require fixing before resubmitting.
• Users may also upload and submit existing facility registration or cosmetic product listing SPL, and have the option to clone successfully submitted SPLs as starting points.
• Users will be able to view the status and details of all submissions on the Cosmetics Direct homepage.

FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency; however, those who wish to submit paper forms still have the option to do so via FDA Forms 5066 and 5067.

As of March 2023, FDA discontinued use of Forms FDA 2511, 2512 and 2512a, previously used for voluntary registration activities, and stopped accepting new submissions to the Voluntary Cosmetic Registration Program.

Takeaways

FDA’s announcement of Cosmetics Direct comes on the heels of its recent draft guidance for facility registration and product listing, clarifying, among other things, who must register and list, when they must do so and what must be submitted.

FDA has stated that it expects its new portal to begin accepting submissions sometime in October, in advance of the December 29, 2023, statutory deadline for facility registration and product listing.

For More Information

If you have any questions about this Alert, please contact Alyson Walker Lotman, Frederick R. Ball, Robert Kum, Kelly A. Bonner, Coleen W. Hill, Anne A. Gruner, any of the attorneys in our Fashion, Retail and Consumer Branded Products Industry Group or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.