U.S. FDA Cosmetics MoCRA: Facility Registration and Product Listing Review
MoCRA introduced new U.S. cosmetic compliance requirements for registration, listing, and record maintenance. For cross-border sellers, brands, and contract manufacturers, the key is not simply to obtain a number. The key is to confirm whether facility, Responsible Person, product formula, label, and FDA submission information correspond to the same sales version.
Pre-Listing Checklist
| Item | Review focus | Common risk |
|---|---|---|
| Facility registration | Confirm whether the facility manufacturing or processing cosmetics needs registration and information maintenance | Facility name, address, role, or contract-manufacturing relationship is unclear |
| Product listing | Review Responsible Person, product name, category, ingredients, and sales version | Listing information does not match actual label or formula |
| U.S. agent | For foreign facilities, review U.S. agent information and communication process | Agent information is missing, expired, or unable to respond to FDA contact |
| Label and ingredient files | Organize INCI, warnings, net quantity, responsible party, and directions for use | English label, packaging, and submission records use inconsistent versions |
| Record maintenance | Prepare adverse event, serious adverse event, safety substantiation, and change records | Batch, complaint, or version-tracking files are missing |
Claim Boundaries
- State which product, formula version, packaging version, and Responsible Person the FDA-related records apply to.
- Do not present facility registration or product listing as an official performance evaluation.
- After formula, label, facility, or responsible-party changes, review submission information again.
- E-commerce pages, packaging, manuals, and advertising assets should use compliant and restrained FDA-related wording.
Green Ark's Recommendation
Green Ark (Shenzhen) Certification Co., Ltd. recommends building a checklist that links facility registration, product listing, U.S. agent, label files, and record maintenance. U.S. FDA cosmetic-related wording is suitable for customer-facing pages only when submission information and sales version are consistent.
