FDA MoCRA Compliance Requirements: Step-by-Step for Foreign and Domestic Cosmetic Facilities
If your product's manufacturing facility has been listed in FDA and has FEI number, start with no. 3
1) Designate a US FDA Agent
Your US Agent is your official FDA contact, receives inspection notices and regulatory correspondence, and must be physically located in the United States. Foreign facilities only. All foreign cosmetic facilities must designate a US FDA Agent before facility registration can be completed. Domestic facilities do not require a US Agent.
2) Complete MoCRA Facility Registration and obtain an FEI Number
Complete MoCRA Facility RegistrationFacility registration is submitted through the FDA Cosmetics Direct portal. Asla Partners handles the entire submission for foreign and domestic facilities. Compliance was required by July 1, 2024 for facilities already in operation. If your facility is not yet registered, contact us to get into compliance. Facility registration must be renewed every two years.
A Facility Establishment Identifier (FEI) number is the FDA's unique identifier for your facility and is required for MoCRA facility registration through the Cosmetics Direct portal. The FEI number is assigned by the FDA. If your facility does not yet have one, or if you need to locate an existing FEI number before beginning registration, Asla Partners can assist with FEI number requests for both foreign and domestic cosmetic facilities.
3) Submit a Product Listing for Every Cosmetic Product
The responsible person must submit a product listing for each cosmetic product distributed in the United States through the FDA Cosmetics Direct portal. Listings include the product name, ingredient list, labeling, and responsible person information. One listing is required per product. Asla Partners handles individual and bulk product listing submissions for companies with large product catalogs.
4) Review Labels for MoCRA Compliance
Review Labels for MoCRA Compliance All cosmetic labels must comply with FDA labeling requirements, including ingredient declaration in descending order of predominance, required label elements, and permissible claims. Asla Partners offers cosmetic label compliance review for foreign and domestic companies.
The responsible person must maintain records demonstrating that each cosmetic product is safe for its intended use. These records are subject to FDA inspection. Asla Partners assists with safety substantiation file preparation.
MoCRA requires the responsible person to report serious adverse events to the FDA within 15 business days of receiving a report. Asla Partners assists with adverse event reporting for foreign and domestic responsible persons.
5) Update Product Listings Annually and Renew Facility Registration Every Two Years
Cosmetic product listings must be updated at least once per calendar year. Facility registration must be renewed biennially. Asla Partners tracks both deadlines and handles updates. You do not need to track renewal dates yourself.