FDA MoCRA Compliance Setup Package

Based on: MoCRA (21 U.S.C. §361 et seq.), FDA Final Guidance on Cosmetic Facility Registration and Product Listing

This one-time setup package helps ensure that cosmetic businesses comply with the mandatory requirements of the Modernization of Cosmetics Regulation Act (MoCRA) for lawful distribution of cosmetic products in the U.S. market. Services include FDA Cosmetic Facility Registration, U.S. Agent Representation, Responsible Person support, and Product Listing assistance.

Scope of Work

Information Gathering

Collect and assess required company information to determine registration applicability, including:

• Owner, operator, or agent in charge
• Legal facility name, physical address, and contact information
• Alternate firm names (if applicable)
• Parent company details (if applicable)
• Existing FDA Establishment Identifier (FEI)
• Responsible Person contact information
• List of activities conducted in the facility
• Any former names the firm was known by

Registration and Renewal Process

• Identify the applicable type of registration (initial, update, or biennial renewal)
• Confirm registration requirements and deadlines
• Prepare and submit registration using FDA’s Cosmetics Direct platform
• Monitor and verify registration status, including confirmation of updates or cancellations
• Provide guidance on the implications of non-registration, failure to renew, or failure to update required information

Electronic Registration (Cosmetics Direct)

• Enter accurate facility details into the FDA system, including:
- ∘ Facility name, address, and contact information
- ∘ U.S. Agent information (for foreign facilities)
- ∘ Product listing details if applicable
• Verify and confirm registration completion
• Maintain records of submission and track any follow-up or changes

Cosmetic Product Listing

• Collect product-specific information, including but not limited to:
- ∘ Brand and product name
- ∘ Responsible Person and facility information
- ∘ Cosmetic category and intended use
- ∘ Full ingredient list (with fragrance/allergen content if required)
• Review listing data for completeness and alignment with FDA Cosmetics Direct guidelines
• Identify any missing or non-compliant fields and request corrections as needed
• Submit listing electronically via Cosmetics Direct
• Confirm submission and provide the FDA-generated reference number(s)

Responsible Person Support

• Assist with identifying or designating the Responsible Person for MoCRA compliance
• Provide an overview of the Responsible Person’s responsibilities, including:
- ∘ Labeling requirements
- ∘ Safety substantiation
- ∘ Fragrance allergen disclosure (pending final rule)
- ∘ Serious adverse event reporting procedures

Product Classification & Jurisdiction Advisory

• Review product type to determine applicable regulatory classification (cosmetic, OTC drug, etc.)
• Prepare a summary report outlining FDA oversight and registration pathway

Compliance Monitoring & Notifications

• Set up tracking for biennial registration renewals and product listing updates
• Provide renewal reminders and advisory on updates to MoCRA requirements impacting the facility or Responsible Person

Deliverables

• FDA cosmetic facility registration confirmation
• U.S. Agent designation letter (for foreign facilities)
• FDA cosmetic product listing confirmation

Fees and Subscription Options

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.