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FDA’s MoCRA Cosmetics Portal is Open: A Game-Changer for Industry Compliance

Date: 12/19/2023

mocra cosmetics portal open

FDA’s MoCRA Cosmetics Portal is Open!

  • Cosmetics Constituent Update: December 18, 2023

In a significant move, the U.S. Food and Drug Administration (FDA) has unveiled the Cosmetics Direct electronic submission portal, revolutionizing the registration and listing of cosmetic product facilities and products. This initiative is following the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).


  • Introducing Cosmetics Direct: A Dedicated Platform

The Cosmetics Direct portal, now accessible to the industry, serves as a dedicated space for electronic submissions related to cosmetic product facility registration and cosmetic product listing. Industry professionals can access the portal at https://direct.fda.gov/.

Cosmetics Direct introduces an FDA Structured Product Labeling (SPL) authoring tool designed for cosmetic product facility registration and cosmetic product listing. With user-friendly data entry forms, the platform streamlines the entire submission process, creating, validating, saving, submitting, processing, and automatically transmitting SPL submissions to the FDA. Notably, this process does not require the use of the Electronic Submissions Gateway (ESG).


  • Encouraging Efficiency with Electronic Submissions

The FDA strongly encourages the use of electronic submissions through Cosmetics Direct to enhance efficiency and streamline the submission and management of data for the agency.

As an alternative, the FDA is accepting cosmetic product facility registration and cosmetic product listing submissions through SPL-formatted submissions via the ESG. Additionally, the FDA is in the process of developing SPL-X forms, expected to be available soon.

This strategic move ensures that the industry has ample time to comply with the new requirements, emphasizing the FDA's commitment to supporting a seamless transition towards enhanced regulatory practices.


Stay tuned for further updates as the FDA continues to drive advancements in the cosmetics industry with innovative solutions like Cosmetics Direct. As the leading company in FDA compliance on a global scale, we possess the expertise to effectively fulfill MoCRA requirements well before the statutory deadline of December 29, 2023, and well into the future.


<Become MoCRA Compliant Today: https://www.provisionfda.com/cosmetics>


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