FDA MoCRA Cosmetic Registration: Complete Compliance Guide for Cosmetic Brands | XPRO America
The U.S. cosmetic regulatory landscape has undergone the most significant transformation in decades with the implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). For cosmetic manufacturers, brand owners, private-label companies, and foreign exporters targeting the United States market, FDA MoCRA Cosmetic Registration is no longer optional—it is a legal requirement.
This article explains MoCRA in detail, outlines who must comply, what registrations are required, deadlines, penalties for non-compliance, and how XPRO America helps cosmetic companies achieve fast, accurate, and risk-free FDA MoCRA compliance.
What Is MoCRA and Why It Matters?
MoCRA significantly expands the authority of the U.S. Food and Drug Administration over cosmetic products sold in the United States. Unlike the earlier voluntary cosmetic registration system (VCRP), MoCRA makes facility registration and product listing mandatory.
- Cosmetic manufacturers
- Brand owners
- Contract manufacturers
- Private-label sellers
- Foreign cosmetic exporters selling in the USA
If your cosmetic products enter U.S. commerce, MoCRA compliance is required regardless of whether you are based in the U.S. or overseas.
Who Must Register Under FDA MoCRA?
1. Cosmetic Facility Registration
Every facility that manufactures or processes cosmetic products for U.S. distribution must register with the FDA under MoCRA.
This includes:
- U.S.-based cosmetic manufacturing facilities
- Foreign cosmetic manufacturing facilities
- Contract and third-party manufacturers
Important: Foreign facilities must appoint a U.S. Agent, a role professionally handled by XPRO America.
2. Cosmetic Product Listing
Each cosmetic product must be listed with the FDA and linked to its registered facility.
Product listing includes:
- Product name and brand
- Cosmetic category
- Ingredients (including fragrances and colors)
- Responsible Person details
Failure to list products accurately can result in FDA enforcement action.
Key FDA MoCRA Compliance Requirements
✔ Facility Registration
- Mandatory for all cosmetic manufacturers and processors
- Requires renewal every two years
- FDA assigns a unique Facility Registration Number
✔ Product Listing
- Required for each cosmetic product sold in the U.S.
- Updates mandatory for formulation or label changes
✔ Responsible Person Designation
- A U.S.-based Responsible Person must be designated
- Responsible for compliance, adverse event reporting, and recalls
✔ Adverse Event Reporting
- Serious adverse events must be reported to FDA within 15 business days
- Records must be maintained for up to 6 years
✔ Safety Substantiation
- Companies must maintain evidence supporting product safety
- FDA can request documentation at any time
MoCRA Compliance Deadlines
- Existing cosmetic facilities: Registration required by FDA deadlines
- New facilities: Registration before U.S. market entry
- Product listings: Must be submitted after facility registration
Missing deadlines can lead to:
- Product detention at U.S. ports
- Import alerts
- Forced product recalls
- Legal penalties
Penalties for MoCRA Non-Compliance
The FDA now has expanded enforcement authority under MoCRA, including:
- Mandatory recalls
- Facility suspension
- Import refusals
- Public warning letters
- Permanent market bans
For cosmetic brands, even a single compliance failure can disrupt U.S. distribution, damage brand reputation, and cause significant financial loss.
Why Choose XPRO America for FDA MoCRA Cosmetic Registration?
XPRO America is a specialized FDA compliance consultancy providing end-to-end MoCRA solutions for cosmetic companies worldwide.
Our MoCRA Services Include:
- FDA Cosmetic Facility Registration
- FDA Cosmetic Product Listing
- U.S. Agent Services for Foreign Manufacturers
- Responsible Person Representation
- Ingredient & Label Compliance Review
- Adverse Event Reporting Systems
- Ongoing FDA Compliance Support
We ensure 100% accuracy, fast processing, and proactive regulatory risk management.
FDA MoCRA for Foreign Cosmetic Manufacturers
Foreign cosmetic companies face additional challenges:
- Mandatory U.S. Agent appointment
- Language and regulatory interpretation barriers
- Higher risk of import refusals
XPRO America acts as your authorized U.S. compliance partner, ensuring seamless communication with the FDA and uninterrupted U.S. market access.
MoCRA vs Old FDA Cosmetic Regulations
| Aspect | Before MoCRA | After MoCRA |
|---|---|---|
| Facility Registration | Voluntary | Mandatory |
| Product Listing | Voluntary | Mandatory |
| FDA Recall Authority | Limited | Mandatory Recall Power |
| Adverse Event Reporting | Minimal | Strict & Enforced |
| Safety Documentation | Not Enforced | Required |
MoCRA represents a new era of cosmetic regulation, aligning cosmetics closer to drug and medical device oversight.
Common MoCRA Compliance Mistakes
- Assuming distributors handle FDA registration
- Listing products without registered facilities
- Using incorrect ingredient nomenclature
- Failing to update product listings after reformulation
- Missing adverse event reporting deadlines
XPRO America prevents these costly mistakes through structured compliance workflows.
How Long Does FDA MoCRA Registration Take?
With XPRO America, typical timelines are:
- Facility Registration: 3–5 business days
- Product Listing: 2–4 business days
- U.S. Agent Setup: Immediate
Delays usually occur when companies attempt self-registration without regulatory expertise.
Future FDA Enforcement Under MoCRA
The FDA has clearly stated that MoCRA enforcement will increase progressively. Cosmetic brands should expect:
- Increased FDA audits
- Data verification checks
- Import surveillance
- Label and ingredient scrutiny
Early compliance is the safest and most cost-effective strategy.
Get FDA MoCRA Compliant with XPRO America
FDA MoCRA Cosmetic Registration is not just a legal formality—it is a critical market access requirement. Whether you are launching a new cosmetic brand or managing a global product portfolio, XPRO America ensures your compliance is accurate, timely, and audit-ready.
Partner with XPRO America today to secure your U.S. cosmetic market presence with confidence.
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