As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of posts diving into each aspect of MoCRA. Here, we will introduce the FDA’s online portal, FDA Direct, and show how it can be used for complying with MoCRA’s Facility Registration and Cosmetic Listing requirements.
The FDA previously announced that facility registration and cosmetic listing required under MoCRA could be completed online. The FDA’s online portal, FDA Direct, is now live and available for use.
Facility Registration
FDA Direct allows owners and operators of facilities producing cosmetic products to Register New Facilities, Amend Facility Registrations, or comply with Renewal Requirements. A New Facility Registration can be created using the Cosmetic Product Facility Registration form in the Cosmetic Registration and Listing section.
Users should be prepared to provide a Facility Name, Facility DUNS Number (optional), information about the Facility including Facility contact information, and a Facility FEI Number (existing FEI numbers can be found and new FEI numbers can be requested here.)
Next, information can be entered about the produced cosmetics including Brand Names, Responsible Persons, and Product Categories. Multiple Brand Names can be listed for each facility. Once all required information has been submitted, the facility registration can be submitted to the FDA for validation and processing.
Cosmetic Product Listing
FDA Direct can also be used to comply with MoCRA’s requirements that marketed cosmetic products be listed with the FDA. Users will find the Cosmetic Product Listing Home Page where they can view any previous submissions and submit new Cosmetic Product Listings.
New Product Listings can be created from a blank form and will require information including FEI Numbers for each facility where the product is produced, information on the Responsible Person, the label name of the product, applicable cosmetic category(ies) for the product, the Product Listing Number (if any previously assigned), and a list of ingredients including any fragrances, flavors, or colors as required under 701.3 of title 21, Code of Federal Regulations (or any successor regulations).
Alternatively, New Product Listings can be created by uploading FDA accepted SPL files previously created, useful for bulk submissions.
Husch Blackwell’s attorneys are available to consult with clients on a range of issues involving the new MoCRA requirements. Do not hesitate to reach out to our team for further guidance, and stay tuned for additional MoCRA posts on our blog.