The Modernization of Cosmetics Regulation Act (MoCRA) introduced mandatory cosmetic facility registration with the US FDA, but registration is not a one-time obligation. To remain compliant, cosmetic manufacturers and processors must complete a biennial cosmetic facility registration renewal—a renewal that occurs every two years.
This renewal process ensures that the US FDA maintains accurate and current information about facilities involved in cosmetic manufacturing and processing. Missing or delaying renewal can place a facility in a non-compliant status, leading to regulatory and commercial consequences.
XPRO America operates as a professional US FDA Consultancy, helping cosmetic companies manage biennial renewal obligations and maintain uninterrupted regulatory compliance.
Why Biennial Renewal Exists
MoCRA established biennial renewal to ensure that facility information remains current and reliable.
Biennial renewal allows the US FDA to:
- Confirm active manufacturing and processing locations
- Verify ownership and operational details
- Maintain updated contact information
- Support inspections and enforcement actions
Without regular renewal, facility data quickly becomes outdated, weakening regulatory oversight.
Who Must Complete Biennial Renewal
Biennial cosmetic facility registration renewal applies to:
- Domestic cosmetic manufacturers
- Domestic cosmetic processors
- Foreign cosmetic manufacturers exporting to the United States
- Foreign cosmetic processors exporting to the United States
If a facility is required to register under MoCRA, it is also required to renew its registration every two years.
Renewal Frequency and Timing
Cosmetic facility registration must be renewed every two years according to the US FDA renewal cycle.
Key timing principles:
- Registration must remain active at all times
- Renewal must be completed within the designated renewal window
- Failure to renew by the deadline results in an inactive registration
An inactive registration is treated as non-compliance.
Where Biennial Renewal Is Submitted
All renewals are submitted electronically through the US FDA’s Cosmetics Direct system.
Paper submissions are not accepted.
XPRO America manages electronic renewal submissions and confirmation tracking for clients.
Information Reviewed During Renewal
During biennial renewal, companies must review and confirm or update:
- Facility legal name
- Physical address
- Mailing address (if different)
- Contact person information
- Type of cosmetic activities performed
- Cosmetic product categories handled
- US Agent information (for foreign facilities)
Even if no changes exist, confirmation of accuracy is required.
Updating Changes During Renewal
If any facility information has changed since the last registration, updates must be submitted during renewal.
Common updates include:
- Ownership change
- Facility relocation
- New processing activities
- Updated contact information
Timely updates are critical to maintain compliance.
US Agent Requirement for Foreign Facilities
Foreign cosmetic facilities must continue to maintain a designated US Agent.
The US Agent:
- Acts as domestic contact for the US FDA
- Receives regulatory communications
- Facilitates information exchange
XPRO America provides US Agent services as part of its US FDA Consultancy offerings.
Relationship Between Renewal and Product Listing
Cosmetic product listing depends on valid facility registration.
If a facility registration expires:
- Associated product listings may be considered non-compliant
- New product listings may be rejected
- Existing products may face regulatory scrutiny
Maintaining active registration protects product listing status.
Consequences of Missing Biennial Renewal
Failure to complete biennial cosmetic facility registration renewal may result in:
- US FDA warning letters
- Import refusals
- Import alerts
- Mandatory recalls
- Business interruption
Renewal is essential for uninterrupted market access.
Common Renewal Mistakes
- Missing renewal deadline
- Failing to update changed information
- Incorrect facility details
- Expired US Agent designation
- Assuming product listing renewal replaces facility renewal
These errors increase compliance risk.
Best Practices for Renewal Compliance
- Track renewal deadlines internally
- Conduct annual facility information reviews
- Maintain centralized compliance records
- Assign renewal responsibility
- Work with an experienced US FDA Consultancy
XPRO America implements renewal tracking systems for clients.
Business Advantages of Timely Renewal
Companies that maintain timely renewal benefit from:
- Continuous regulatory compliance
- Faster product listing approvals
- Reduced import delays
- Stronger distributor confidence
- Lower enforcement risk
Renewal supports long-term operational stability.
How XPRO America Supports Biennial Renewal
XPRO America operates as a trusted US FDA Consultancy providing:
- Renewal deadline monitoring
- Facility information review
- Cosmetics Direct renewal submissions
- US Agent services
- Compliance status confirmation
- Regulatory correspondence support
For professional assistance with biennial cosmetic facility registration renewal, contact support@xproamerica.com.
Key Insight
Biennial cosmetic facility registration renewal is a core MoCRA obligation that protects a company’s ability to manufacture and distribute cosmetics in the United States. Companies that treat renewal as a strategic compliance activity reduce regulatory risk and ensure uninterrupted market access.
With guidance from XPRO America, cosmetic facilities can complete biennial renewals accurately and remain fully aligned with US FDA expectations.
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