Checked on 2026-07-20. Source basis: official FDA MoCRA materials, plus marketplace-document boundaries. No listing, approval, certification, customs, traffic or timing promise.
MoCRA places facility registration, product listings, adverse-event handling and safety substantiation into the responsible company's compliance file. Cross-border beauty sellers should align FDA requirements, marketplace documents and product records without describing registration as FDA product approval.
Separate the MoCRA file into four workstreams
- Facility registration and renewal responsibilities.
- Product listings tied to ingredients and responsible persons.
- Adverse-event intake, assessment, reporting and record retention.
- Safety substantiation supported by literature, assessment or testing records.
Do not describe registration as FDA approval
Cosmetic products generally do not need FDA premarket approval, except for specific items such as color additives. Public-facing wording should distinguish registration, listing, safety substantiation and labeling compliance.
Service boundary
绿色方舟(深圳)认证有限公司 can help beauty sellers review MoCRA registration, product listing, label documents and safety-substantiation files. This does not promise marketplace review, import release or regulatory outcomes.