MoCRA Countdown: U.S. FDA's New Cosmetic Portal Nears Launch

On November 1, 2023, the U.S. Food and Drug Administration (FDA) disclosed the latest progress and forthcoming initiatives regarding the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), specifically focusing on cosmetic product facility registration and product listing.

1. Final Guidance on Cosmetic Product Facility Registration and Product Listing Imminent

After the public consultation of the draft guideline, which was initially unveiled on August 7, 2023, the FDA received over 40 comments and suggestions. Currently the feedbacks are under evaluation, among which the valuable ones will be incorporated.

The FDA aims to finalize the guidance promptly. Once released, this comprehensive document will provide detailed instructions for companies in completing factory registration and product listing. Stakeholders are encouraged to stay proactive in their preparations, including reviewing the documents provided by the FDA, and collecting the necessary information for seamless completion of facility registrations and product listings.

For additional details and insights, interested parties can refer to the following resources:

• U.S. FDA Allows Delay in Enforcement of Cosmetic Facility Registration and Product Listing

• US Consults on Electronic Portal and Paper Forms for Cosmetic Facility Registration and Product Listing

• How to Conduct Cosmetic Product Facility Registration in the U.S.?

• How to Conduct Cosmetic Product Listing in the U.S.?

2. Imminent Launch of the New Electronic Submission Portal

In September 2023, the FDA initiated a public consultation on the draft electronic submission portal, named Cosmetics Direct, along with paper forms (Forms FDA 5066 and 5067). October 2023 witnessed the release of FDA Guidance on Structured Product Labeling (SPL) related to cosmetics. Once the FDA begins accepting data, for cosmetic product facility registrations and product listings, industry users can transmit SPL-formatted submissions through the FDA's Electronic Submission Gateway (ESG), or leverage SPL authoring software like Xforms. The electronic method is strongly recommended for its efficiency and expediency.

The FDA has confirmed it will announce the launch date of factory registration and product listing in the coming weeks, signaling the imminent introduction of the new submission system.

ChemLinked advises companies to stay vigilant for updates on electronic and paper submission templates (Forms FDA 5066 and 5067), and will timely keep stakeholders informed with the latest content.