MoCRA facility registration
FDA submission preparation using client-supplied facility information, with registration confirmation after FDA processing.
MoCRA Cosmetics U.S. FDA Agent
MoCRA facility registration and U.S. Agent support for cosmetics companies
CENIT helps foreign cosmetics facilities prepare MoCRA facility registration and designate a U.S. Agent without taking over the Responsible Person role. Product listing support is scoped and quoted separately unless separately agreed.
Payment starts your CENIT onboarding. CENIT confirms the details before any FDA filing or action.
U.S. FDA Agent Services
Need Food Facility or Medical Device support?
This page is for MoCRA Cosmetics U.S. FDA Agent support. If your company needs Food Facility Registration or Medical Device / IVD U.S. FDA Agent support, use the dedicated service pages below.
Scope
MoCRA administration for cosmetics market access
The Year 1 MoCRA base fee covers MoCRA facility registration administration and the U.S. Agent role for one facility. Product listing support is scoped and quoted separately unless separately agreed. The Responsible Person remains responsible for product safety, labeling, substantiation, adverse event reporting, and recall decisions.
U.S. Agent designation
CENIT confirms and accepts the U.S. Agent role after fit confirmation, authorization, and agreement acceptance.
Product listing assistance
Product listing support is handled separately using information supplied and confirmed by the client or Responsible Person.
FDA communication routing
FDA communications addressed to CENIT as U.S. Agent are routed to the client contact on record.
Facility maintenance and listing updates
Applicable facility-registration maintenance is included with the continuing U.S. Agent service. Product-listing submissions, annual updates, and renewals remain separate unless expressly included in writing.
Confirmation records
Registration and listing confirmations are delivered after FDA processing is complete.
Boundaries
MoCRA filings are not FDA approval
Facility registration and product listing are administrative filings. MoCRA filings are not FDA approval, certification, or endorsement of any cosmetic product.
Included in the base service
- MoCRA facility registration administration.
- U.S. Agent designation and FDA communication routing.
- Applicable facility-registration maintenance during the active U.S. Agent service.
Not included by default
- CENIT does not act as the Responsible Person or assume Responsible Person duties.
- Safety substantiation, formula review, label review, or claim review.
- Serious adverse event reporting or recall coordination.
- Drug, OTC, sunscreen, acne, hair-growth, or therapeutic claim support.
Product listing support is available only as a separately scoped add-on or where separately agreed.
Is this you?
One cosmetics facility. Standard cosmetic products. No open FDA enforcement issue. No claims that the product treats disease, prevents disease, affects body structure/function, treats acne, regrows hair, or provides sunscreen/SPF protection. You know who the Responsible Person is.
If your product uses claims such as anti-aging, wrinkle reduction, firming, collagen support, repair, therapeutic benefit, or before/after performance claims, contact CENIT before paying so we can confirm the right path.
Before paying, contact CENIT if your business may qualify for MoCRA's small-business exemption. Eligibility depends on inflation-adjusted average annual U.S. gross sales of cosmetic products during the preceding three-year period and on product type. The exemption does not apply to certain products that regularly contact the eye's mucous membrane, are injected, are intended for internal use, or are intended to alter appearance for more than 24 hours where customary removal is not part of use.
If any of that does not match, contact CENIT before paying. CENIT will confirm whether the standard payment path fits or whether a custom quote is needed.
Check if this fitsPayment starts your CENIT onboarding. CENIT confirms your details match this page before any FDA filing or action. If something does not match and CENIT cannot proceed under this page scope, CENIT will contact you and refund your payment in full.
CENIT does not act as the Responsible Person. The Responsible Person remains responsible for product safety, safety substantiation, labels, claims, ingredients, adverse event reporting, recall obligations, records, and product listing accuracy. See the exclusion list above for items that require separate scope or written agreement.
Pricing
MoCRA U.S. Agent onboarding for one facility
Price is per facility. Year 1 onboarding is charged at checkout. Annual continuation begins after the first year unless terminated or separately changed.
Onboarding for one facility
US$449 due nowUS$449 is due now for one cosmetics facility. The annual continuation is US$299/year and starts 12 months after checkout unless terminated or separately changed.
Start MoCRA U.S. Agent onboardingAfter the first year
US$299 / yearAnnual continuation starts 12 months after checkout and continues yearly unless the service is terminated or separately changed. This rate applies from year two. It is not available as the first purchase.
Product listings or broader scope
QuotedProduct listings, broader scope, and multiple or complex facilities are not self-serve at launch. Contact CENIT before paying if your request includes product listings, multiple or complex facilities, or broader scope. CENIT will confirm whether the standard payment path fits or whether a custom quote is needed. Product-listing submissions, annual updates, and renewals are not included in the US$299 annual continuation unless expressly agreed in writing.
Request a listings quotePayment starts your CENIT onboarding. CENIT confirms your details match this page before any FDA filing or action. If something does not match and CENIT cannot proceed under this page scope, CENIT will contact you and refund your payment in full.
FDA does not currently charge a user fee for MoCRA facility registration or product listing. CENIT's fee covers administrative service and the U.S. Agent role.
Process
Check, pay, submission support
The sequence keeps FDA filing work behind fit confirmation, Responsible Person confirmation, authorization, and required intake information.
Check your fit
Confirm your facility and product match the one-facility scope before paying.
Pay and complete intake
If your request matches the one-facility scope, pay directly and complete the intake form that follows. If you are not sure, contact CENIT before paying.
Submission support
Once you have paid and completed intake, CENIT handles the agreed submission support and delivers your confirmation.
Next step
Check your fit, then pay
If your request matches the one-facility scope, start onboarding from the pricing section. If you have product listings to scope, multiple facilities, drug-like claims, Responsible Person uncertainty, or an enforcement issue, contact CENIT first.