FDAbasics Offers Complete FDA Compliance and Registration Services for the Cosmetics Industry
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires any facility that manufactures or processes cosmetics for the US market to register with the FDA and submit a product listing for every cosmetic product distributed in the United States. This applies to both foreign and domestic facilities. Foreign facilities must also designate a US FDA Agent. There are no FDA government fees for MoCRA registration or product listing.
FDABasics handles MoCRA facility registration, FEI numbers, product listings, annual listing updates, and label compliance reviews for foreign manufacturers, domestic manufacturers, and private label companies. We have served clients in 100+ countries since 1995 and hold 5-star ratings on Trustpilot and Google. The FDA does not issue a Certificate of Registration. FDABasics provides one at no extra charge with every completed registration.
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Fill in the form for your registration type below and we will have your FDA registration number within 2 business days.
FDA MoCRA Compliance Requirements: Step-by-Step for Foreign and Domestic Cosmetic Facilities
Facility registration and product listing are two separate obligations under MoCRA. Both must be in place before your products are distributed in the United States. FDAbasics can help you at each step along the way.
Step 1: Designate a US FDA Agent Your US Agent is your official FDA contact, receives inspection notices and regulatory correspondence, and must be physically located in the United States. Foreign facilities only. All foreign cosmetic facilities must designate a US FDA Agent before facility registration can be completed. Domestic facilities do not require a US Agent.
Step 2: Obtain an FEI Number A Facility Establishment Identifier (FEI) number is the FDA's unique identifier for your facility and is required for MoCRA facility registration through the Cosmetics Direct portal. The FEI number is assigned by the FDA. If your facility does not yet have one, or if you need to locate an existing FEI number before beginning registration, FDABasics can assist with FEI number requests for both foreign and domestic cosmetic facilities.
Step 3: Complete MoCRA Facility Registration Facility registration is submitted through the FDA Cosmetics Direct portal. FDABasics handles the entire submission for foreign and domestic facilities. Compliance was required by July 1, 2024 for facilities already in operation. If your facility is not yet registered, contact us to get into compliance. Facility registration must be renewed every two years.
Step 4: Submit a Product Listing for Every Cosmetic Product The responsible person must submit a product listing for each cosmetic product distributed in the United States through the FDA Cosmetics Direct portal. Listings include the product name, ingredient list, labeling, and responsible person information. One listing is required per product. FDABasics handles individual and bulk product listing submissions for companies with large product catalogs.
Step 5: Review Labels for MoCRA Compliance All cosmetic labels must comply with FDA labeling requirements, including ingredient declaration in descending order of predominance, required label elements, and permissible claims. FDABasics offers cosmetic label compliance review for foreign and domestic companies.
Step 6: Maintain Safety Substantiation Records
The responsible person must maintain records demonstrating that each cosmetic product is safe for its intended use. These records are subject to FDA inspection. FDABasics assists with safety substantiation file preparation.
Step 7: Report Serious Adverse Events Within 15 Business Days
MoCRA requires the responsible person to report serious adverse events to the FDA within 15 business days of receiving a report. FDABasics assists with adverse event reporting for foreign and domestic responsible persons.
Step 8: Update Product Listings Annually and Renew Facility Registration Every Two Years
Cosmetic product listings must be updated at least once per calendar year. Facility registration must be renewed biennially. FDABasics tracks both deadlines and handles updates. You do not need to track renewal dates yourself.
Who Must Register
Under MoCRA, any facility that manufactures or processes cosmetic products for distribution in the United States must register with the FDA. The responsible person, the manufacturer, packer, or distributor whose name appears on the label, must also submit a product listing for each product. This applies to both foreign and domestic establishments.
Facility and company types that must comply include:
- Skin care manufacturers, foreign and domestic, including lotions, creams, serums, and sunscreens
- Hair care manufacturers including shampoos, conditioners, and hair dyes
- Color cosmetics manufacturers including foundations, lipsticks, and eyeshadows
- Fragrance manufacturers
- Nail product manufacturers
- Baby cosmetic product manufacturers
- Oral hygiene cosmetic products including toothpaste and mouthwash, where classified as cosmetic
- Private label cosmetic companies whose name appears on the product label
- Domestic contract manufacturers producing cosmetics for brand owners
Foreign facilities must designate a US FDA Agent before facility registration is complete. Domestic facilities do not require a US Agent.
If your product makes drug claims such as treating acne, preventing dandruff, or providing sun protection through an active ingredient, it may be regulated as a drug rather than a cosmetic and is subject to different registration requirements. Contact us before registering if you are unsure how your products are classified.
Renewal Dates and Deadlines
| Requirement | Frequency | Renewal Window | Deadline |
|---|---|---|---|
| MoCRA Facility Registration (foreign and domestic) | Every 2 years | Biennial, no fixed window | 2 years from original registration date |
| Cosmetic Product Listing Update | At least once per calendar year | Anytime during the calendar year | December 31 of each year |
| Serious Adverse Event Reporting | Per event | Upon receipt of a qualifying report | Within 15 business days of receiving the report |
| Safety Substantiation Records | Ongoing | Maintain continuously | Must be current at all times |
Our Services and Fees
| Service | Fee | Need to Know |
|---|---|---|
| US Agent Services | $299/yr or $250/yr for 2 years upfront | Required for all foreign cosmetic facilities |
| MoCRA Facility Registration (foreign) | $199 | Completed in 2 business days |
| MoCRA Facility Registration (domestic) | $299 | No US Agent required for domestic facilities |
| FEI Number Request | $99/facility | FDA-assigned identifier required for Cosmetics Direct registration |
| Cosmetic Product Listing (per product) | $199/product | Via FDA Cosmetics Direct portal |
| Annual Product Listing Update | Contact us for volume discounting | Per product, required at least annually |
| Cosmetic Label Compliance Review | $299/label | Ingredient list, format, and claims compliance |
Why Cosmetic Companies Choose FDABasics
FDABasics has helped foreign and domestic cosmetic companies with MoCRA compliance since the regulations came into effect. We handle facility registration, FEI numbers, product listings, annual renewals, and label reviews for manufacturers, private label companies, and responsible persons of all sizes.
- 30+ Years of FDA Regulatory Experience
- Facility Registration Completed in 2 Business Days
- Certificate of Registration Included at No Extra Charge
- Bulk Product Listing Services for High-SKU Companies
- 5-Star Rated on Trustpilot and Google
- Transparent, Competitive Fees with No Hidden Charges
- Proactive Biennial Renewal and Annual Listing Management
- US-Based Team Serving Manufacturers in 100+ Countries
- Strict Client Confidentiality
Frequently Asked Questions
What is MoCRA and does it apply to my cosmetic business?
MoCRA stands for the Modernization of Cosmetics Regulation Act of 2022, the most significant update to US cosmetic law in over 80 years. Under MoCRA, all facilities that manufacture or process cosmetics for the US market must register with the FDA. Foreign facilities must designate a US FDA Agent. The responsible person for each product must submit a product listing. MoCRA applies to both foreign and domestic manufacturers and to private label companies whose name appears on the product label.
Does MoCRA apply to domestic US cosmetic manufacturers?
Yes. MoCRA applies to any facility that manufactures or processes cosmetics for the US market, regardless of where the facility is located. Domestic facilities are subject to facility registration and product listing requirements just as foreign facilities are. The only difference is that domestic facilities do not need to designate a US FDA Agent.
I am a private label company. Do I need to register under MoCRA?
If your company's name appears on the cosmetic product label as the manufacturer, packer, or distributor, you are the responsible person under MoCRA and are required to submit product listings for those products. If you also operate or control the facility where the products are manufactured or processed, facility registration may also apply to you. Contact us to confirm your obligations based on your specific role in the supply chain.
Do I need to list every cosmetic product I sell in the US?
Yes. The responsible person must submit a product listing for each cosmetic product distributed in the United States. Listings must be updated at least annually. If you sell 50 products in the US, you need 50 separate product listings on file with the FDA. FDABasics handles bulk submissions for companies with large product catalogs.
Can the FDA inspect cosmetics manufacturers?
Yes. The FDA can and does inspect cosmetic manufacturing facilities to assure cosmetic product safety and to determine whether cosmetics are adulterated or misbranded under the FD&C Act or FPLA.
Get Started With Our Top Cosmetic Forms
- US Agent Form for Foreign Companies
- Cosmetic Facility Registration Form
- Cosmetic Product Listing Form
- Cosmetic Facility FEI Number Form