MoCRA Cosmetic Facility Registration Fee — What You Actually Pay
This page explains the full cost structure of MoCRA compliance — what FDA charges (nothing), what FDA Registration Assistance charges, what each service includes, and what the full annual cost looks like for a cosmetic brand with multiple products.
Complete MoCRA Cost Breakdown
There are two distinct cost components in MoCRA compliance. Understanding who charges what prevents confusion and unexpected expenses:
| MoCRA Requirement | Who Charges It | Amount | Frequency |
|---|---|---|---|
| FDA Cosmetic Facility Registration | FDA (federal government) | $0 — Free | Government fee: $0. Required annually. FDA Registration Assistance manages the full process. |
| FDA Cosmetic Product Listing | FDA (federal government) | $0 — Free | Government fee: $0. Required per product sold in the U.S. FDA Registration Assistance prepares and submits. |
| Facility Registration Service Fee | FDA Registration Assistance | $849 / year | Annual — includes U.S. Agent, registration preparation, submission, annual renewal |
| Product Listing Service Fee | FDA Registration Assistance | $200 / product | Per product — covers preparation, INCI verification, submission, and update support |
Example total cost for a cosmetic brand with one facility and five products: $849 (facility registration) + 5 × $200 (product listings) = $1,849 in the first year. Annual renewal thereafter: $849 (facility renewal) + $200 per any new or reformulated product added.
What Each Service Includes
Facility Registration — $849/year
Covers: preparation and submission of the MoCRA Cosmetic Facility Registration through Cosmetics Direct; U.S. Agent designation for foreign facilities (required under MoCRA for all foreign manufacturing facilities); annual renewal management so the registration never lapses; facility record updates when information changes; and ongoing compliance guidance related to the registration.
Product Listing — $200/product
Covers: preparation and submission of the Cosmetic Product Listing with FDA; verification that all ingredients are listed using correct INCI (International Nomenclature of Cosmetic Ingredients) names; confirmation of product category and responsible person information; linkage to the registered manufacturing facility; and update support when formulations change or the listing requires amendment.
What Is NOT Included in the Service Fees
The FDA Registration Assistance MoCRA service fees cover facility registration, U.S. Agent designation, product listing, and ongoing management. The following are separate obligations that the responsible person must address independently:
Safety Substantiation
MoCRA requires the responsible person to maintain adequate safety substantiation for each cosmetic product. This documentation must be developed and maintained by the brand or their safety assessor. FDA does not charge for safety substantiation, but developing it may involve laboratory testing, formulation review, and toxicological assessment costs depending on the product and ingredients.
Serious Adverse Event Reporting (CSCAR)
MoCRA requires the responsible person to report serious adverse events to FDA within 15 business days of receiving a report. FDA does not charge for adverse event submissions. However, the responsible person must have internal processes to receive, evaluate, and report adverse event information. FDA Registration Assistance can advise on CSCAR obligations as part of ongoing compliance support.
Which Cosmetic Companies Need to Register and List Products
MoCRA cosmetic facility registration requirements are established under the Modernization of Cosmetics Regulation Act of 2022. The requirements apply broadly to anyone in the cosmetics supply chain who manufactures or processes cosmetics for U.S. distribution:
Domestic Manufacturers
U.S.-based facilities that manufacture or process any cosmetic product distributed in the United States must register under MoCRA and list each product. Domestic facilities do not need a U.S. Agent but must renew their registration annually.
Foreign Manufacturers
Foreign facilities that manufacture or process cosmetic products for U.S. distribution must register under MoCRA and designate a U.S. Agent with a physical U.S. address. FDA Registration Assistance serves as U.S. Agent for foreign cosmetic facilities in 135+ countries.
Contract Manufacturers
Contract manufacturers producing cosmetics for third-party brands must register the manufacturing facility. The brand owner (responsible person) must ensure the manufacturing facility is registered and that each product sold under the brand is listed. If the brand owner's name appears on the label, the brand owner is the responsible person.
Private Label Brands
Private label brand owners whose name appears on the cosmetic product label are the responsible person under MoCRA. They must ensure the contract manufacturing facility is registered, each product is listed, safety substantiation is maintained, and adverse events are reported. FDA Registration Assistance helps private label brands establish complete MoCRA compliance.
Importers
U.S. importers of cosmetic products from foreign manufacturers must ensure the foreign manufacturing facility is MoCRA-registered before importing. Imported cosmetic products from unregistered foreign facilities may be detained or refused at U.S. ports of entry under FDA's enforcement authority.
Hair Care, Fragrance & Skincare Brands
MoCRA applies to all cosmetic product categories — skincare, hair care, fragrance, color cosmetics, nail products, body care, and personal care. The same registration and listing requirements apply regardless of the cosmetic category. OTC drug products (anti-dandruff shampoos, sunscreens) require Drug Establishment Registration instead of MoCRA registration for the drug product.
MoCRA Is an Annual Compliance Obligation — Not a One-Time Filing
A common misconception is that MoCRA registration is a one-time submission. It is not. MoCRA creates ongoing annual compliance obligations that must be maintained throughout the life of the business:
Annual Registration Renewal
MoCRA cosmetic facility registrations must be renewed annually. Unlike FDA Food Facility Registration (which renews every two years), MoCRA renewals are required every year. Missing the annual renewal results in the registration lapsing, which affects the facility's MoCRA compliance status and can affect product listings associated with it. FDA Registration Assistance tracks and manages annual renewals for all facilities it serves.
Product Listing Updates
Product listings must be updated whenever the formulation changes (ingredients added, removed, or substituted); the product name changes; the responsible person changes; the manufacturing facility changes; or the product is discontinued. Allowing a product listing to fall out of sync with the actual product being sold is a compliance concern under MoCRA.
New Product Listings
Each new cosmetic product introduced to the U.S. market must be listed with FDA within 120 days of first being marketed. Companies launching new products throughout the year should have a process for timely listing submissions. The $200 per product listing fee applies to each new product added.
Safety Substantiation Maintenance
Safety substantiation records must be maintained and kept current. If a product is reformulated, the existing safety substantiation may need to be reviewed and updated to reflect the new formulation. Safety records must be available to FDA upon request during inspections.
Ready to Register Your Cosmetic Facility Under MoCRA?
FDA Registration Assistance provides complete MoCRA compliance — $849/year for Cosmetic Facility Registration including U.S. Agent designation and annual renewal management, and $200 per product listing with INCI verification and ongoing update support. FDA itself charges $0.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333. 1,000+ clients. 135+ countries. 15+ years of FDA regulatory experience.
Frequently Asked Questions — MoCRA Cosmetic Facility Registration Fee
1. Does FDA charge a fee for MoCRA cosmetic facility registration?
No. FDA does not charge a government filing fee for MoCRA cosmetic facility registration or cosmetic product listings. Both carry a $0 government fee from FDA. The costs come from the service fees charged by a compliance firm to prepare, submit, and manage the submissions correctly on your behalf.
2. How much does MoCRA cosmetic facility registration cost through FDA Registration Assistance?
FDA Registration Assistance charges $849 per year for MoCRA Cosmetic Facility Registration. This covers registration preparation and submission, U.S. Agent designation for foreign facilities, annual renewal management, and ongoing compliance support. FDA itself charges $0.
3. How much does a cosmetic product listing cost?
FDA Registration Assistance charges $200 per cosmetic product listing. Each cosmetic product sold in the United States must be individually listed with FDA. The $200 covers preparation, INCI ingredient verification, submission with FDA, and ongoing update support. FDA charges $0 for the listing itself.
4. Who needs MoCRA cosmetic facility registration?
Any facility that manufactures or processes cosmetic products for U.S. distribution — domestic manufacturers, foreign manufacturers, contract manufacturers. Private label brand owners must ensure their manufacturing facility is registered. Foreign facilities must also designate a U.S. Agent.
5. Do foreign cosmetic companies need a U.S. Agent for MoCRA registration?
Yes. Foreign cosmetic facilities registering under MoCRA must designate a U.S. Agent with a physical U.S. address. FDA Registration Assistance provides U.S. Agent services as part of its $849/year MoCRA facility registration service.
6. How often does MoCRA cosmetic facility registration need to be renewed?
MoCRA cosmetic facility registration must be renewed annually — every year. This is different from FDA Food Facility Registration which renews every two years. FDA Registration Assistance manages annual renewals for all facilities it serves and ensures the registration never lapses.
7. What is included in a cosmetic product listing under MoCRA?
Each product listing must include: the product name as it appears on the label; the cosmetic product category; the name and address of the responsible person; the FDA registration number of the manufacturing facility; and the complete ingredient list using INCI names. Listings must be updated when formulations change, product names change, or the responsible person or facility changes.
8. What is the Cosmetics Direct portal?
Cosmetics Direct is FDA's official registration and listing management system for MoCRA cosmetic compliance. It is the system FDA uses to receive all facility registrations and product listings. FDA Registration Assistance handles all submissions on behalf of cosmetic companies — clients do not need to create accounts or navigate the system themselves.
9. What is the "responsible person" under MoCRA?
The responsible person is the manufacturer, packer, or distributor whose name appears on the cosmetic product label under 21 CFR Part 701.12. The responsible person is accountable for product listing, safety substantiation, and serious adverse event reporting. For private label products, the brand owner is typically the responsible person.
10. What is safety substantiation and does it have a cost?
Safety substantiation is MoCRA's requirement to maintain adequate evidence that each cosmetic product is safe for its intended use. This documentation must be maintained by the responsible person and made available to FDA upon request. FDA does not charge for safety substantiation. Developing it may involve laboratory testing, formulation review, and toxicological assessment depending on the product.
11. What is CSCAR and does it cost anything?
CSCAR refers to MoCRA's serious adverse event reporting requirement — the responsible person must report serious adverse events associated with cosmetic products to FDA within 15 business days. Annual aggregate safety reports are also required. FDA does not charge a fee for adverse event submissions. The cost is operational — building the internal process to receive, evaluate, and report adverse events.
12. Can FDA Registration Assistance handle multiple product listings?
Yes. FDA Registration Assistance handles cosmetic product listings for companies with any number of products. The service fee is $200 per individual product listing. Each cosmetic product sold in the United States must be individually listed regardless of similarity to other products in the range.
13. Do private label cosmetic brands need MoCRA registration?
Yes. The private label brand owner whose name appears on the label is the responsible person and must ensure the manufacturing facility is registered and each product is listed. FDA Registration Assistance helps private label brands manage all MoCRA obligations including coordinating with contract manufacturers on facility registration status.
14. What happens if a cosmetic facility is not registered under MoCRA?
Operating without MoCRA registration when required is a prohibited act under the FDCA as amended by MoCRA. FDA can issue warning letters, refuse imported products at the port, and seek injunctions. Imported cosmetics from unregistered foreign facilities may be detained or refused entry at U.S. ports of entry.
15. Does the product listing need to be updated when a formulation changes?
Yes. Product listings must be updated when formulations change, product names change, the responsible person changes, the manufacturing facility changes, or a product is discontinued. A product listing that doesn't reflect the current product being sold is a compliance concern. The update service fee through FDA Registration Assistance applies when amendment submissions are needed.
16. Is MoCRA cosmetic facility registration the same as product approval?
No. MoCRA registration and product listing are not FDA approval. Registration enters the facility into FDA's cosmetic regulatory system. Product listing puts product information on file with FDA. Neither is FDA review or endorsement. Cosmetic products do not require FDA pre-market approval — they require registration, listing, safety substantiation, and labeling compliance.
17. What is the difference between MoCRA facility registration and food facility registration?
MoCRA cosmetic facility registration covers cosmetic manufacturing facilities and is managed annually, $849/year through FDA Registration Assistance. FDA Food Facility Registration covers food manufacturing facilities and is submitted through FURLS — renewed every two years, $858 complete service. A facility manufacturing both food and cosmetics may need both registrations.
18. Do hair care brands need MoCRA registration?
Yes. Shampoos, conditioners, styling products, hair color, and other cosmetic hair care products are subject to MoCRA facility registration and product listing. Anti-dandruff shampoos classified as OTC drugs require Drug Establishment Registration in addition to or instead of MoCRA registration for the drug product category.
19. Do fragrance and perfume brands need MoCRA registration?
Yes. Fragrances, perfumes, colognes, and body sprays are cosmetic products subject to MoCRA. The product listing must include all ingredients using INCI names — MoCRA does not create a fragrance ingredient disclosure exemption for the product listing (though consumer label ingredient disclosure has its own rules).
20. What is the INCI ingredient list and why is it required?
INCI — International Nomenclature of Cosmetic Ingredients — is the standardized naming system required for cosmetic ingredient declarations under 21 CFR Part 701.3. MoCRA product listings require INCI names for all ingredients. Using trade names or brand names instead of INCI names in the product listing is a submission error that FDA Registration Assistance catches during preparation.
21. Can the same facility registration cover multiple brands?
Yes. A single MoCRA facility registration covers all cosmetic products manufactured at that facility regardless of how many brands are produced there. Each product sold in the United States — across all brands from that facility — must be individually listed at $200 per product. The $849/year facility fee is per physical facility, not per brand.
22. What is the deadline for MoCRA compliance for existing facilities?
Initial MoCRA registration deadlines have passed — December 29, 2023 for facilities operating before that date. New facilities must register within 60 days of beginning cosmetic manufacturing for U.S. distribution. New products must be listed within 120 days of first being marketed. Facilities not yet registered should register as soon as possible to achieve compliance.
23. What if I have both a cosmetic and a food product line?
If your facility manufactures both cosmetic and food products, you may need both MoCRA cosmetic facility registration ($849/year) and FDA Food Facility Registration ($858 complete service). Both registrations are required independently for the applicable product categories. FDA Registration Assistance can manage both programs for companies with multi-category product portfolios.
24. How do I get started with MoCRA compliance through FDA Registration Assistance?
Contact FDA Registration Assistance at info@fdaregistrationassistance.com or call +1 (928) 275-8333. Provide your facility location, the brands and products you manufacture or sell in the United States, and any existing FDA registration information.
25. Why should cosmetic companies choose FDA Registration Assistance for MoCRA compliance?
FDA Registration Assistance provides a complete MoCRA compliance solution — $849/year for facility registration with U.S. Agent designation and annual renewal management, and $200 per cosmetic product listing with INCI ingredient verification and ongoing update support. The firm serves 1,000+ clients across 135+ countries with 15+ years of combined regulatory experience, providing direct access to experienced regulatory specialists.
