On December 18, 2023, the U.S. Food and Drug Administration (FDA) launched Cosmetics Direct, an electronic submission portal for product listing and facility registration required under the Modernization of Cosmetics Regulation Act (MoCRA). The agency also issued final guidance with recommendations to assist companies and individuals submitting facility registration and product listing information to the FDA.
The Cosmetics Direct portal is dedicated exclusively to cosmetic product facility registration and cosmetic product listing electronic submissions to FDA. The portal is an FDA Structured Product Labeling (SPL) authoring tool that contains user friendly data entry forms, performs initial validations, creates and saves the SPL submission, and submits the SPL to FDA for internal processing.
Along with the launch of the portal, the agency also released a portal user guide. The guide provides helpful information on creating submissions through the portal including:
- Managing accounts and subaccounts
- How to check submission information and statuses
- Step-by-step instructions for new registrations
- Instructions for amending registrations
While the agency prefers electronic submissions, individuals and companies may also submit paper forms which will be offered soon.
Final MoCRA Guidance
The final guidance provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA. The guidance document explains several frequently asked questions including:
- The statutory requirement to submit cosmetic product facility registrations and product listings
- Who is responsible for making the submissions
- What information to include in the submissions
- How to make the submissions
- When to make the submissions
The guidance […]