FDA Launches Cosmetics Direct Portal and Issues Guidance on Facility Registration and Product Listing Under MoCRA

The U.S. Food and Drug Administration (FDA) recently launched Cosmetics Direct, an electronic submission portal for facility registration and product listing as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The portal offers user-friendly data entry forms, performs initial validations, and facilitates the submission of structured product labeling (SPL) to the FDA.

In conjunction with the portal launch, the FDA has released final guidance providing instructions for the submission process. This guidance outlines key information required for both facility registration and product listing, specifies responsible parties, and details when and how submissions should be made.

For facility registration, companies need to provide comprehensive details, including the owner/operator's name, facility name and address, contact information, U.S. agent details (for non-U.S. facilities), facility registration number (FEI), brand names, product categories, and more.

Product listing submissions entail information such as FEI of manufacturing facilities, responsible person details, cosmetic product names, categories, ingredient lists, submission type, and optional details like parent company name, label image, webpage link, Unique Ingredient Identiers (UNIIs), and more.

Before initiating the submission process, companies must obtain a facility registration number (FEI), which is also the FDA Establishment Identifier. This unique 7-to-10-digit identifier helps identify companies associated with FDA-regulated products. Companies can check for an existing FEI using the FEI Search Portal or request an FEI by providing necessary information to feiportal@fda.hhs.gov.

It's important to note that although the FDA has announced a delay in enforcing facility registration and product listing requirements until July 1, 2024, the Cosmetics Direct portal is now accessible for companies opting to submit this information electronically. This enforcement delay does not affect other provisions of MoCRA, such as reporting serious adverse events and maintaining records supporting the safety of cosmetic products, which took effect on December 29, 2023.

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