MoCRA Update: Final Guidance and Launch of Electronic Submissions Portal

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.

Cosmetics Direct

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
Definitions
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 also details how the FDA will be utilizing the FDA Establishment Identifier (FEI) as the required facility registration number for product facility registrations. In order to complete both the facility registration and product listing, a company must first obtain an FEI by either searching FDA’s existing FEI database or by requesting a new FEI.

Individuals and companies may utilize the FEI Search Portal to confirm if a facility already has an FEI number.

Get MoCRA Compliant With the Help of a Customs Attorney

​​Diaz Trade Law attorneys have vast experience in assisting companies in complying with FDA regulations. Contact us at info@diaztradelaw.com for assistance submitting your product listing, facility registration, or for help assessing the impacts of MoCRA on your cosmetic products.

Read more about MoCRA requirements:

A New Era in Cosmetics Regulation: The Modernization of Cosmetic Regulations Act
FDA Issues Draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products

The post MoCRA Update: Final Guidance and Launch of Electronic Submissions Portal appeared first on Customs & International Trade Law Blog.

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