FDA MoCRA Cosmetic Facility Registration
Administrative Registration & Listing Facilitation (MoCRA-Compliant)
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires cosmetic manufacturers and processors to register their facilities and list products with the U.S. Food and Drug Administration (FDA).
Consultare Inc. Group provides administrative assistance for FDA Cosmetic Facility Registration and Product Listing submissions, ensuring accurate data entry and coordination through FDA’s Cosmetics Direct system.
All services are facilitative and administrative only, strictly aligned with FDA requirements.
Scope of Work
1. Registration Eligibility Assessment
- We review client-provided information to:
- • Determine applicability of FDA Cosmetic Facility Registration
- • Identify whether submission is:
- • Initial registration
- • Update
- • Biennial renewal
2. Information Collection & Organization
- We collect and organize required facility information, including:
- • Owner, operator, or agent in charge
- • Legal facility name and address
- • Contact details
- • Parent company (if applicable)
- • Existing FDA Establishment Identifier (FEI), if available
- • Responsible Person details
- • Facility activities
- Important:
- All information is submitted as provided by the Client.
- We do not verify or certify accuracy.
3. Electronic Registration (Cosmetics Direct)
- We provide administrative assistance to:
- • Enter facility data into FDA Cosmetics Direct
- • Include U.S. Agent details (if separately designated)
- • Submit registration or updates
- • Confirm submission and maintain records
4. Cosmetic Product Listing Facilitation
- We assist in organizing and submitting product listing data, including:
- • Product name and brand
- • Responsible Person details
- • Cosmetic category and intended use
- • Ingredient information (as provided)
- We:
- • Review for completeness and format alignment
- • Identify missing fields
- • Submit via Cosmetics Direct
- • Provide FDA reference numbers upon submission
5. Responsible Person Overview (Guidance Only)
- We provide a high-level overview of Responsible Person obligations under MoCRA, including:
- • Labeling requirements
- • Safety substantiation expectations
- • Adverse event reporting requirements
- • Fragrance allergen disclosure (pending rules)
- Note:
- We do not act as the Responsible Person or perform these functions.
6. Submission Confirmation & Records
- Upon completion, we provide:
- • Confirmation of registration submission
- • FDA-issued registration acknowledgment (if available)
- • Product listing confirmation numbers
- • Internal submission records
7. Updates, Renewals & Cancellations (Optional)
- Where separately contracted, we may assist with:
- • Biennial facility registration renewal
- • Product listing updates
- • Registration updates or cancellation
- Services are provided on a per-submission basis only.
Important Service Limitations
- Our services are strictly limited to registration and listing facilitation.
- We do not:
- • Act as U.S. Agent (separate service required)
- • Act as Responsible Person
- • Apply for FDA Establishment Identifier (FEI)
- • Perform safety substantiation or GMP compliance
- • Conduct labeling reviews
- • Provide legal or regulatory advice
- • Guarantee FDA acceptance or compliance outcomes
- The Client remains fully responsible for:
- • Regulatory compliance
- • Product safety
- • Adverse event reporting
- • Accuracy of all submitted information
Pricing Structure
| Service / Option | Fee |
|---|---|
|
[Initial Registration] FDA Cosmetic Facility Registration and Listing Facilitation Assistance (Initial Registration) Submission for up to 1 facility and 1 cosmetic product SKU listing |
$300.00 (one-time) |
|
[Initial Registration Optional Add-on] FDA Cosmetic Product Listing Registration (for additional product listings) |
|
| 1 additional SKU | $110.00 (one-time) |
| Up to 5 SKUs | $528.00 (one-time) |
| Up to 10 SKUs | $1,000.00 (one-time) |
| Up to 15 SKUs | $1,425.00 (one-time) |
| 20 SKUs and above | Custom Quote |
|
[Update/Renewal] FDA Cosmetic Facility Registration and Listing Update / Renewal Assistance (Update/Renewal Facilitation - one-time submission) Submission for up to 1 facility and 1 cosmetic product SKU listing |
$250.00 per year |
|
(Update/Renewal Optional Add-on) FDA Cosmetic Product Listing Update / Renewal (one-time update/renewal submission for additional product listings) |
|
| 1 additional SKU | $60.00 per year |
| Up to 5 SKUs | $275.00 per year |
| Up to 10 SKUs | $525.00 per year |
| Up to 15 SKUs | $725.00 per year |
| 20 SKUs and above | Custom Quote |
| Optional Add-Ons | Fee |
|---|---|
| U.S. Agent Representation (required for foreign facilities) | $199 per year |
| Product Label Review | starts at $750 for 1 SKU |
| Importer of Record (IOR) Services | starts at $399 per shipment |
Ideal For:
- • U.S. and foreign cosmetic manufacturers
- • Private label brands and contract manufacturers
- • Brand owners and Responsible Persons
- • Companies preparing for FDA inspection readiness
Important Regulatory Notes:
- • Cosmetic facility registration is mandatory under MoCRA
- • Registration must be renewed biennially (even-numbered years)
- • Product listing is required for each marketed cosmetic product
- • Updates must be submitted within 120 days of changes
- • Foreign facilities must designate a U.S. Agent (separate service)
- Failure to comply may result in:
- • Import refusal
- • Product holds
- • FDA enforcement actions
- Ideal For:
- • U.S. or foreign cosmetic manufacturers entering the U.S. market
- • Contract manufacturers or private label brands
- • Importers, brand owners, and Responsible Persons
- • Companies needing MoCRA-aligned documentation for FDA inspection readiness
- Disclaimer
- Consultare Inc. Group provides administrative registration and listing assistance only.
- We:
- • Do not assume regulatory responsibility
- • Do not guarantee FDA acceptance or approval
- • Do not certify compliance
- All regulatory obligations remain solely with the Client.
FDA Cosmetic Facility Registration + U.S. Agent Representation + FDA Establishment Identifier (FEI) + DUNS Processing (includes 1 cosmetic product listing)
Fee (USD): $790.00 per facility (one-time)
(Add-on) Additional Cosmetic Product Listing
Fee (USD): $150.00/product per year
FDA MoCRA Renewal – Facility + Agent + Listing Update
Fee (USD): $320.00 (annual)
Ideal For:
• U.S. or foreign cosmetic manufacturers entering the U.S. market
• Contract manufacturers or private label brands
• Importers, brand owners, and Responsible Persons
• Companies needing MoCRA-aligned documentation for FDA inspection readiness
Important Notes:
• Facility registration and establishment identifier number are mandatory for all manufacturers and processors of cosmetic products sold in the U.S.
• A U.S. Agent is required for foreign facilities.
• A Responsible Person must be designated per product to handle labeling compliance and adverse event reporting.
• Product listing is required for every cosmetic marketed in the U.S. and must be updated annually or within 120 days of changes.
• Failure to comply with MoCRA requirements may result in import refusals, market holds, or enforcement actions.
