FDA Launches Cosmetics Direct Portal for Electronic Registration and Listing

FDA Launches Cosmetics Direct Portal for Electronic Registration and Listing - MoCRA

On December 18, 2023, the U.S. Food and Drug Administration (FDA) announced the official launch of Cosmetics Direct, a new electronic submission portal designed to simplify the registration and listing process for cosmetic product facilities and products. This development follows requirements established by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

What is Cosmetics Direct?

Cosmetics Direct is a dedicated online platform that allows cosmetic businesses to electronically submit their product listings and facility registrations directly to the FDA. This portal offers a streamlined and user-friendly solution for meeting MoCRA’s new compliance requirements.

Key features of Cosmetics Direct include:

  • User-Friendly Data Entry Forms – Simplifies the process of entering facility and product details.
  • SPL Authoring Tool – Ensures submissions are compliant with Structured Product Labeling (SPL) standards.
  • Automatic Submission and Processing – Submissions are validated, saved, and transmitted directly to the FDA without the need to use the Electronic Submissions Gateway (ESG).

Additional Submission Options

In addition to Cosmetics Direct, the FDA is offering alternative submission methods:

  • SPL-Formatted Submissions via the Electronic Submissions Gateway (ESG) for those already familiar with the platform.
  • The FDA is also developing new SPL-X forms, which are expected to become available soon.
  • For businesses unable to submit electronically, the FDA is preparing paper forms as an additional option. These forms are also anticipated to be available in the near future.

Delayed Enforcement for Compliance

To give the cosmetic industry more time to meet these new requirements, the FDA has announced a six-month enforcement delay.

  • Although the original compliance deadline was December 29, 2023, the FDA will not enforce these requirements until July 1, 2024.

This delay applies to:

  • Cosmetic product facility registration for facilities that began manufacturing or processing products after December 29, 2022.
  • Cosmetic product listing for products first marketed after December 29, 2022.

Next Steps for Businesses

To stay compliant with MoCRA, cosmetic businesses are encouraged to:

  • Access the Cosmetics Direct portal at https://direct.fda.gov/ to begin the registration and listing process.
  • Stay informed about the upcoming release of SPL-X forms and paper submission options.
  • Use this extended timeline to prepare the required information and ensure submissions are accurate and complete.

Conclusion

The launch of Cosmetics Direct represents a significant step forward in improving the efficiency and accuracy of cosmetic product regulation. By encouraging electronic submissions, the FDA aims to streamline data management while providing businesses with a smoother path to compliance. With the enforcement delay extending the deadline to July 1, 2024, now is the ideal time for cosmetic product companies to prepare and submit their required information.

Back to blog