FDA MoCRA Services—Support at the Stage You Need
MoCRA requirements may involve product classification, U.S. Agent designation, an FEI number, facility registration, label review, product listing, and ongoing updates.
Asla Partners offers each service separately. If you have already completed part of the process, you can request support only for the remaining step.
1) Confirm Which MoCRA Requirements Apply
Before submitting a facility registration or product listing, confirm whether your product is regulated as a cosmetic, a drug, or both.
A product’s intended use, ingredients, marketing claims, and consumer expectations can affect its FDA classification. Products intended to treat or prevent disease or affect the structure or function of the body may be regulated as drugs, even when marketed as beauty or personal care products. Same applies for cosmetics products marketed as treatment or affect function of the body, may be regulated as drugs.
2) Identify the Responsible Person and Designate a U.S. Agent if Required
The Responsible Person is the manufacturer, packer, or distributor whose name appears on the cosmetic product label. A company located outside the United States may serve as the Responsible Person if it meets this definition.
The product label must include a domestic address, domestic telephone number, or electronic contact information through which the Responsible Person can receive adverse event reports.
A U.S. Agent is a separate role. A foreign cosmetic facility that is required to register with the FDA must designate a U.S. Agent located in the United States.
The U.S. Agent assists the FDA with communications involving the foreign facility, questions about products offered for U.S. import, inspection scheduling, and the delivery of FDA information or documents when the agency cannot promptly reach the facility.
If requested, Asla Partners can serve as the designated U.S. Agent for a foreign cosmetic facility. U.S. Agent service is purchased separately from facility registration and product listing services.
3) Obtain an FEI Number and Register the Cosmetic Facility
An FDA Establishment Identifier, or FEI number, is required before a cosmetic facility registration can be submitted. The FEI is assigned by the FDA and is associated with the facility’s physical location.
Facilities that manufacture or process cosmetic products for the U.S. market may be required to register through FDA Cosmetics Direct. A new facility generally must register within 60 days after first beginning the applicable manufacturing or processing activities.
Upon request, Asla Partners can assist with obtaining FEI number and facility registration.
4) Review the Cosmetic Label for U.S. FDA Requirements
FDA cosmetic facility registration and product listing do not replace the requirement to use a compliant U.S. product label.
Before printing the final packaging or submitting the product listing, Asla Partners can review the proposed label for applicable U.S. cosmetic labeling requirements. The review covers :
- Product identity
- Manufacturer, packer, or distributor information
- Adverse event contact information
- Required warnings and statements
- Product and marketing claims
- Claims that may cause the product to be regulated as a drug
- And more
5) Submit the FDA Cosmetic Product Listing
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. Asla Partners provide service of individual or bulk cosmetic product listings through FDA Cosmetics Direct.
6) Maintain Product Listings and Renew Facility Registration
MoCRA obligations continue after the initial submissions are completed.
Cosmetic product listings must be updated annually. This includes reporting relevant changes and updating a listing when a product has been discontinued.
Cosmetic facility registrations must be renewed every two years. Changes to required facility registration information generally must also be submitted to the FDA within 60 days.
Even after products has been listed, clients remain responsible for receiving and maintaining adverse event records and complying with other applicable FDA requirements.