MoCRA Cosmetics Facility Registration, Product Listing & Port Import Refusal Guide (2026)
Under the Modernization of Cosmetics Regulation Act (MoCRA), overseas cosmetics facilities must hold active FDA registration (FEI) and Responsible Person product listings, maintain written safety substantiation, and print adverse event reporting contacts on labels. Crucial warning: the FDA does NOT pre-approve cosmetics or issue pre-market 'compliance certificates' for foreign shipments—port surveillance checks digital listings and packaging claims in real time.
Intelligence vs. Legal Counsel Boundary: DWPERadar surfaces public FDA DWPE Import Alerts, OASIS detentions, Warning Letters (e.g., drug-claim misbranding or microbial adulteration), and FEI links; importers remain responsible for verifying active Cosmetics Direct FEI/listing submissions with their Responsible Person.
2026 Compliance Matrix & Detention Boundaries
| Control Area | 2026 Rule / Standard | Port Detention Trigger | Exclusion / Verification Limit |
|---|---|---|---|
| Facility Registration & Product Listing | Manufacturing facilities must maintain valid FEI registration and renew biennially alongside product ingredient listings. | Unregistered factories or discrepant shipper names fail PREDICT screening at LA/Long Beach and Newark ports. | MoCRA includes limited small-business exemptions only below statutory sales thresholds and never exempts sterile/eye-area products. |
| Cosmetic Puffery vs. Unapproved Drug Claims | Cosmetic copy is limited to cleansing, beautifying, and appearance modification without disease/structure-function claims. | Packaging mentioning 'treats eczema', 'acne cure', or 'cell regeneration' triggers UNAPPROVED_NEW_DRUG (§ 505(a)) holds. | Form FDA 766 bonded relabeling may cure drug-claim wording if formula lacks active API drugs, subject to FDA district authorization. |