Quick Answer: MoCRA requires certain cosmetic manufacturers and processors to register facilities with FDA and renew that registration every two years. The obligation concerns the facility—not an FDA approval of the product or factory. Brands should identify which site makes or processes the U.S.-market product and document who controls registration data.
Last reviewed: September 12, 2026
What is a cosmetic facility under MoCRA?
FDA defines a facility as an establishment, including an establishment of an importer, that manufactures or processes cosmetic products distributed in the United States. Facility registration is distinct from product listing. A responsible person lists marketed products; a person required to register handles the facility registration.
When is facility registration required?
FDA states that manufacturers and processors must register required cosmetic facilities and renew registration every two years. The appropriate answer depends on the actual activity, product classification, and whether an exemption applies. Do not rely on a sales brochure or registration number as evidence of approval.
| Question | Practical check |
|---|---|
| Which location makes or processes the cosmetic? | Map each facility involved in the U.S. supply chain. |
| Is the product a cosmetic-only product? | Review intended use and claims before assigning an FDA pathway. |
| Could a small-business exemption apply? | Check FDA’s current exemption information and exceptions by product type. |
| Who owns renewal control? | Name the organisation and contact responsible for the two-year cycle. |
Manufacturer and brand-owner responsibilities
| Manufacturer / processor | Brand owner / responsible person |
|---|---|
| Confirm facility role and provide accurate site information. | Confirm the name on the label and the product-listing role. |
| Maintain manufacturing and quality records appropriate to the arrangement. | Control final label, claims, market placement and product-change decisions. |
| Maintain a process for notifying relevant partners of facility changes. | Maintain product information and serious-adverse-event escalation process. |
A practical registration workflow
- Document product, claims, facility and label-named entity.
- Review FDA’s current facility-registration guidance and exemptions.
- Assemble correct establishment details and relevant contacts.
- Use FDA’s submission route, including Cosmetics Direct where appropriate.
- Set a controlled renewal date and change-control review.
Important limits of registration
FDA explains that a registration number does not indicate FDA approval of the facility or its cosmetic products. FDA also says it does not issue certificates or other documents verifying compliance for cosmetic facility registration. Avoid using facility registration as a promotional claim or substitute for product safety, claims review, or market-specific documentation.
Common errors to avoid
- Confusing a contract manufacturer’s facility obligation with the label entity’s product-listing obligation.
- Assuming every small business is exempt without assessing the product-specific exceptions.
- Missing a renewal date after a formula, supplier, or ownership change.
- Describing registration as an “FDA-approved factory” credential.
Official sources
| Source | Use |
|---|---|
| FDA Registration & Listing | Current FDA information on required registration, renewals, exemptions and submissions. |
| FDA MoCRA overview | FDA’s definition of facility and overview of MoCRA obligations. |
FAQ
Does facility registration mean FDA approved the manufacturer?
No. FDA states that registration is not a cosmetic approval programme and a registration number does not indicate approval.
How often is registration renewed?
FDA states that every person required to register must renew the registration every two years from the initial registration date.
Does a private-label brand register the factory?
Roles depend on the real arrangement. The facility registration and the responsible-person product listing are separate obligations and should be allocated in writing.
MOOYAM provides cosmetic OEM/ODM manufacturing and technical documentation support. Visit OEM/ODM or contact us.
Regulatory notice: Regulatory requirements may change. Verify current requirements with FDA or a qualified compliance professional before market placement.