FDA's Cosmetics Direct Portal Now Open for MoCRA Submissions

The 2022 Modernization of Cosmetics Regulation Act requires cosmetics manufacturers update facility registrations and product listings by July

Cosmetics manufacturers can now use the Food and Drug Administration's (FDA) Cosmetics Direct online portal to submit product listings and facility registrations under the 2022 Modernization of Cosmetics Regulation Act (MoCRA). MoCRA requires any company that makes, sells, or distributes cosmetics within the U.S. to register their facilities and all cosmetic products by July 1, 2024. 

Since product listings must include the facility registration number for each facility where the products are manufactured, it is essential that facility registrations are carried out immediately to enable cosmetic product listings to meet the July deadline. 

Preparing MoCRA submissions for Cosmetics Direct

After a delay last fall, FDA launched the Cosmetics Direct portal in mid-December. To help cosmetics companies prepare for MoCRA submissions, FDA also released a 90-page user guide explaining how cosmetics makers can set up and manage their Cosmetics Direct accounts, prepare submissions, and troubleshoot submission issues.

FDA also released a Cosmetics Direct preview document last September demonstrating common validation failures that can occur during submission and explaining the Structured Product Listing (SPL) format that must be included as an XML zip file for all submissions. SPL is a document markup standard approved by the global standard Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.

By using Cosmetics Direct, cosmetic manufacturers will adopt the same digital filing process used by pharmaceutical manufacturers for FDA drug submissions. Respondents who use Cosmetics Direct can also access their previous entries and submissions.

Other MoCRA requirements and exemptions

MoCRA also imposes new adverse event reporting requirements, which took effect at the end of 2023; new labeling requirements for fragrance allergens, which need to be completed by Dec. 29 of this year; and new requirements for Cosmetic Good Manufacturing Practice (GMP), with a proposed ruling expected by the end of the year and final rule expected by the end of 2025.

Although MoCRA's requirements are sweeping, limited exemptions are available for small businesses, defined as manufacturers with annual revenues of less than $1 million USD. FDA has provided a decision tree tool for cosmetic producers to determine their exemption status. However, the small business exemption does not apply to manufacturers of products that come into contact with mucus membranes of the eye, injectables, or products intended for internal use or those that alter the appearance for more than 24 hours and cannot be removed by the consumer. 

In addition, manufacturers located outside the U.S. require a U.S. representative (Responsible Person) with a domestic address. Exponent can act in this capacity for international manufacturers.