MoCRA Cosmetics U.S. Agent
MoCRA facility registration and U.S. Agent support for cosmetics companies
CENIT helps foreign cosmetics facilities prepare MoCRA facility registration, designate a U.S. Agent, and coordinate separately scoped administrative product listing support without taking over the Responsible Person role.
U.S. Agent only
CENIT acts as the FDA communication contact for foreign facilities. CENIT does not act as Responsible Person at launch.
Product listings stay RP-owned
The Responsible Person remains responsible for product listings. CENIT can provide administrative listing support when separately scoped.
Drug-claim screening
Products with acne, anti-aging, hair-growth, or structure/function claims need manual review before CENIT proceeds.
Pricing
Launch pricing is per facility. Request a scope review before payment so CENIT can confirm U.S. Agent scope, Responsible Person boundaries, product listing volume, and any drug-claim risk.
Tier 1 – Initial MoCRA setup
For foreign cosmetics facilities starting MoCRA registration with CENIT as U.S. Agent.
- Initial facility registration support via FDA Cosmetics Direct
- CENIT U.S. Agent designation and consent handling
- Administrative setup review for client-provided facility information and U.S. Agent details
- Registration confirmation document and CENIT cover letter
Tier 2 – Annual agent
For ongoing U.S. Agent maintenance and renewal monitoring.
- Continued U.S. Agent role for FDA communications
- FDA correspondence forwarding within 24 business hours
- Biennial facility renewal support
- Annual confirmation letter for internal records
Additional product listing
For administrative product listing support based on Responsible Person-provided information.
- Product listing intake and formatting support when separately scoped
- Submission support for one additional product listing
- Annual update support for that product listing
- Manual review first during launch
Launch scope
| Included | Not included unless separately agreed |
|---|---|
| MoCRA facility registration support and U.S. Agent designation | Acting as Responsible Person or assuming RP obligations |
| Separately scoped administrative product listing support based on Responsible Person-provided information | Safety substantiation review, label review, claim substantiation, or ingredient legality review |
| FDA correspondence forwarding and biennial renewal monitoring | Serious adverse event reporting, recall coordination, GMP audits, or state-level cosmetics compliance |
| Manual review for potential drug-claim risk before submission | Drug, OTC, sunscreen, acne-treatment, hair-growth, or therapeutic product support |
How the process works
1. Confirm scope
CENIT confirms the products are cosmetics, not drugs, and that the client remains the Responsible Person.
2. Complete intake
The client provides facility details, FEI or D-U-N-S information, Responsible Person details, and product listing data.
3. Submit and maintain
CENIT supports administrative submission after review, confirmation delivery, correspondence forwarding, and renewal reminders.
Good fit
- Foreign cosmetics facility needing a U.S. Agent
- Skincare, fragrance, hair care, color cosmetics, or oral-care cosmetics without therapeutic claims
- Client can identify its Responsible Person and provide product listing data
Manual review first
- Anti-aging, acne, wrinkle prevention, hair growth, pain relief, or other drug-like claims
- Any active FDA enforcement action, recall, serious adverse event issue, or product classification uncertainty
- Any request for Responsible Person, safety substantiation, or label-claim review services
Important disclaimer
CENIT Consulting acts only as the U.S. Agent for FDA communications and as an administrative submitter for registration/listing information provided by the client. CENIT does not act as the Responsible Person and does not assume responsibility for product safety, label accuracy, claims, ingredient legality, adverse event reporting, or recall obligations.
MoCRA facility registration and product listing are not FDA approval, FDA certification, or product endorsement. FDA does not issue certificates for cosmetic facility registrations or product listings.
The client remains responsible for determining that its products are cosmetics under U.S. law and for maintaining safety substantiation and other MoCRA compliance records.