FDA Facility Registration & U.S. Agent Done Right.
As the world’s largest FDA cosmetic registration company with 30,000+ customers, our expert team will help you register your cosmetic facility for MoCRA compliance and serve as your US Agent as required for companies outside of the US.
Facility Registration: Get & Stay
FDA MoCRA Compliant
US Agent: When Communication
Speed & Accuracy Matters
If your company is outside of the US, FDA requires you to designate a US Agent for communication.
One Partner. One Plan. Zero Gaps.
Choose a solution that fits your business. Our tiered plans deliver FDA expertise, 24/7 support, and the critical services exporters need — so you stay confident and compliant at every stage.
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Cosmetic Establishment Registration
Required FDA registration for cosmetic facilities doing business in the U.S.
Registrar’s Cosmetic Establishment Registration Certificate
Printable certificate showing your establishment registration with FDA.
U.S. Agent and/or Authorizing Agent for FDA communications
Serve as your official U.S. contact for FDA notices and updates.
Cosmetic Product Listings
Submit accurate cosmetic product listings to the FDA.
Adverse Event Management software
Manage entire Adverse Event process per FDA requirements.
Serious Adverse Event Case Management
Medical assessment and documentation of Serious Adverse Events per FDA requirements.
Cosmetic Product Label Check
Review your product labels for FDA compliance.
California Ingredient Check Service
Review your product formula and identify California State compliance risks.
Onboarding session with FDA expert
Personalized session to set up and explain compliance services.
Online training for Regulatory/Quality Assurance professionals
Web-based training courses for your team.
FDA compliance consulting
One-on-one consulting with FDA compliance experts.
Unique Facility Identifier (UFI) / DUNS assistance
Guidance on obtaining or maintaining your facility’s FDA identifier.
FEI Assistance
Obtain and maintain your FDA Establishment Identifier (FEI) number.
24/7 live client support
Access to compliance experts anytime, anywhere.
RegistrarHub compliance center portal
Centralized online portal to manage all compliance needs.
Evaluate detention (Notice of Action) and recommend resolution
Expert review of FDA detentions with recommended next steps.
Active resolution of detained shipment charges with FDA
Direct engagement with FDA to clear detained shipments.
Compliance for
Brands
N/A
10 listings
per year
10 listings
per year
2 per year
10 products
per year
2 courses
per year
2 hours
per year
N/A
N/A
3 lines
per year
Compliance for
Manufacturers
N/A
N/A
N/A
N/A
N/A
2 courses
per year
2 hours
per year
3 lines
per year
Compliance for
Brands and Manufacturers
10 listings
per year
10 listings
per year
2 per year
10 products
per year
2 courses
per year
2 hours
per year
3 lines
per year
Easily Register Your
Cosmetic Facility and Designate US Agent Now.
Not Sure Which MoCRA
Regulations
Apply to You?
Watch our video all about the FDA MoCRA, or find out using our exclusive MoCRA Wizard. Answer a few short questions, and in less than two minutes, the MoCRA Wizard will show you exactly which FDA cosmetic requirements you must meet.
Get Expert Insights on MoCRA
Learn from our cosmetic experts on how to navigate FDA Product Listings under MoCRA.
Complete Adverse Events Guide
U.S. Responsible Person vs. EU Responsible Person
Hear From Our Industry Experts
Our webinars on cosmetic regulations unravel the complexities of the new FDA MoCRA.
Frequently Asked Questions
MoCRA is the Modernization of Cosmetics Regulation Act of 2022 and was signed into law on December 29th, 2022. MoCRA is the largest reform of existing cosmetic regulations in the United States in 84 years and establishes many new requirements, such as:
- Facility Registration
- Product Listings
- Good Manufacturing Practices (GMPs)
- Safety Substantiation
- New labeling requirements
- Adverse Event Reporting
- Record Keeping
Under MoCRA, the term “facility” includes any establishment that manufactures or processes cosmetic products distributed in the United States. Most facilities will need to register and comply with GMPs issued by FDA.
Find out which requirements your company will need to meet. Registrar Corp’s industry experts created the MoCRA Wizard to help companies determine which requirements they must meet. Answer a few short questions and in less than two minutes, know exactly which you’ll need to comply with and how we can help.
The term “responsible person” means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the cosmetic label.
The “responsible person” will be responsible for:
- Cosmetic product listings
- Adverse event reporting and record keeping
- Safety substantiation
- Labeling updates
- Recalls
- Fragrance allergen disclosures
Yes, small businesses will have more flexible and simplified requirements. FDA defines a small business as a business with average gross annual sales in the U.S. for the previous 3-year period of less than $1,000,000, adjusted for inflation. This does not apply to any responsible person or facility engaged in manufacturing cosmetic products that:
- Come into contact with eyes,
- Are injected,
- Are intended for internal use,
- Or alter the appearance for more than 24 hours under conditions of use that are customary or usual.
Wondering if you’re exempt? Find out if you’re exempt by answering a few questions using our MoCRA Wizard, developed by our industry experts to help you find out which, if any, requirements you must meet.
For existing facilities, facility registration and product listings are due by December 29, 2023. New facilities that manufacture or process cosmetic products for distribution in the U.S. must register within 60 days of marketing the product or 60 days after the deadline for existing facilities, whichever is later.
MoCRA allows for flexible listings where companies can submit a single listing for cosmetic products with identical formulations or formulations that only differ with respect to colors, fragrances or flavors, or quantity of contents.
In the Draft Guidance, FDA announced that Cosmetics Direct will be using the same electronic submission system as drugs, meaning all listings will need to be submitted through the Structure Product Labeling (SPL Format). The SPL will require to list all shades, fragrance and quantity variations.
Not sure where to start? Our industry professionals created a simple tool to help companies determine which requirements apply to them. Answer a few short questions and in less than two minutes, the MoCRA Wizard will show exactly which requirements you must meet to maintain FDA compliance.
By December 29, 2023, companies must provide electronic contact information in which a responsible person can receive adverse event reports.
Cosmetic products that contain fragrance allergens must update their label to list those allergens. For professional cosmetic products, labels must indicate a clear and prominent statement that the product is administered or used only by licensed professionals and is in conformity with the existing cosmetic labeling requirements.
Learn more about adverse event requirements and how we can help you comply.
Within 1 year: Professional cosmetics product labels must include all required information and state that only licensed professionals may use the product.
Within 2 years: Labels must include responsible person’s contact information for adverse reporting and must identify fragrance allergens determined by FDA.