As facilities registered under MoCRA in early 2024 begin reaching their two-year renewal deadlines, the FDA has announced updates to the Cosmetics Direct electronic submission portal to support biennial registration renewals.
These updates include improved status visibility, automated renewal reminders, and updated guidance materials.
But beyond the technical improvements, 2026 marks an important operational milestone: many cosmetic facilities that registered in early 2024 must now prepare for their first biennial renewal.
This article explains what has changed—and more importantly, what cosmetic facilities need to verify before renewing their MoCRA registration.
What did the FDA update?
The FDA updated the Cosmetics Direct portal and related materials to improve clarity and usability.
Key updates include:
- Display of facility registration status and renewal date within the portal
- Automated biennial renewal reminder notifications
- Updated user guides and tutorials
- Clarified renewal submission instructions
More than 14,000 cosmetic facilities are currently registered with the FDA.
These updates are designed to facilitate compliance—but they do not change the legal obligation to renew every two years.
Reminder: MoCRA biennial renewal is mandatory
Under Section 607(a)(2) of the FD&C Act, any facility required to register must renew its registration every two years.
Renewal is based on the anniversary date of the initial registration—not on a fixed calendar cycle.
For example:
- If the initial registration was submitted on February 20, 2024
- The renewal deadline will be February 20, 2026
Facilities may submit renewal earlier if desired.
It is important to note that renewal timelines for cosmetic facilities may differ from those applicable to other FDA-regulated establishments.
Who is concerned?
The renewal requirement applies to:
- U.S.-based cosmetic manufacturers and processors
- Facilities manufacturing or processing cosmetics for U.S. distribution
- Foreign companies operating facilities that manufacture or process cosmetics for the U.S. market
Each facility has its own renewal timeline. Companies operating multiple facilities must track renewal dates individually.
What cosmetic facilities should check before renewal
Before submitting a biennial renewal, facilities should verify:
- The correct renewal date for each facility
- Registration status in the Cosmetics Direct portal
- Whether any information has changed since the last submission
- Whether to use Biennial Renewal (with changes) or Abbreviated Renewal (no changes)
- That responsible contacts are accurate and monitored
- That internal responsibility for renewal submission is clearly assigned
- That confirmation records are properly archived
The FDA provides an abbreviated renewal option when no changes have occurred—but it is only appropriate if registration information remains fully accurate.
Common mistakes during MoCRA renewal
Based on early implementation experience, common issues include:
- Assuming renewal follows a calendar year rather than an anniversary date
- Overlooking individual renewal dates for multi-facility organizations
- Selecting abbreviated renewal even though information has changed
- Failing to update changes within required timeframes
- Relying solely on automated reminders
- Confusing MoCRA renewal with other FDA establishment registration cycles
Proactive tracking remains essential, even with improved portal functionality.
What happens if renewal is not submitted?
Failure to renew facility registration may result in:
- Non-compliance with Section 607 renewal requirements
- Increased regulatory exposure during FDA inspections or inquiries
- Operational disruptions requiring urgent corrective action
Maintaining accurate and active registration status is a core MoCRA compliance obligation.
Conclusion
The FDA’s portal updates reflect the transition from initial MoCRA implementation to ongoing regulatory maintenance.
For cosmetic facilities, 2026 is not simply an administrative step—it is the first real compliance test of MoCRA’s biennial renewal framework.
Facilities should review their registration data, verify renewal timelines, and assign internal ownership well in advance of their anniversary date.
Going further
If you would like support reviewing your MoCRA facility registration or preparing for biennial renewal, our regulatory team can assist.
You can also subscribe to our cosmetics regulatory newsletter to stay informed about FDA and MoCRA developments.
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As facilities registered under MoCRA in early 2024 begin reaching their two-year renewal deadlines, the FDA has announced updates to the Cosmetics Direct electronic submission portal to support biennial registration renewals.
These updates include improved status visibility, automated renewal reminders, and updated guidance materials.
But beyond the technical improvements, 2026 marks an important operational milestone: many cosmetic facilities that registered in early 2024 must now prepare for their first biennial renewal.
This article explains what has changed—and more importantly, what cosmetic facilities need to verify before renewing their MoCRA registration.
What did the FDA update?
The FDA updated the Cosmetics Direct portal and related materials to improve clarity and usability.
Key updates include:
- Display of facility registration status and renewal date within the portal
- Automated biennial renewal reminder notifications
- Updated user guides and tutorials
- Clarified renewal submission instructions
More than 14,000 cosmetic facilities are currently registered with the FDA.
These updates are designed to facilitate compliance—but they do not change the legal obligation to renew every two years.
Reminder: MoCRA biennial renewal is mandatory
Under Section 607(a)(2) of the FD&C Act, any facility required to register must renew its registration every two years.
Renewal is based on the anniversary date of the initial registration—not on a fixed calendar cycle.
For example:
- If the initial registration was submitted on February 20, 2024
- The renewal deadline will be February 20, 2026
Facilities may submit renewal earlier if desired.
It is important to note that renewal timelines for cosmetic facilities may differ from those applicable to other FDA-regulated establishments.
Who is concerned?
The renewal requirement applies to:
- U.S.-based cosmetic manufacturers and processors
- Facilities manufacturing or processing cosmetics for U.S. distribution
- Foreign companies operating facilities that manufacture or process cosmetics for the U.S. market
Each facility has its own renewal timeline. Companies operating multiple facilities must track renewal dates individually.
What cosmetic facilities should check before renewal
Before submitting a biennial renewal, facilities should verify:
- The correct renewal date for each facility
- Registration status in the Cosmetics Direct portal
- Whether any information has changed since the last submission
- Whether to use Biennial Renewal (with changes) or Abbreviated Renewal (no changes)
- That responsible contacts are accurate and monitored
- That internal responsibility for renewal submission is clearly assigned
- That confirmation records are properly archived
The FDA provides an abbreviated renewal option when no changes have occurred—but it is only appropriate if registration information remains fully accurate.
Common mistakes during MoCRA renewal
Based on early implementation experience, common issues include:
- Assuming renewal follows a calendar year rather than an anniversary date
- Overlooking individual renewal dates for multi-facility organizations
- Selecting abbreviated renewal even though information has changed
- Failing to update changes within required timeframes
- Relying solely on automated reminders
- Confusing MoCRA renewal with other FDA establishment registration cycles
Proactive tracking remains essential, even with improved portal functionality.
What happens if renewal is not submitted?
Failure to renew facility registration may result in:
- Non-compliance with Section 607 renewal requirements
- Increased regulatory exposure during FDA inspections or inquiries
- Operational disruptions requiring urgent corrective action
Maintaining accurate and active registration status is a core MoCRA compliance obligation.
Conclusion
The FDA’s portal updates reflect the transition from initial MoCRA implementation to ongoing regulatory maintenance.
For cosmetic facilities, 2026 is not simply an administrative step—it is the first real compliance test of MoCRA’s biennial renewal framework.
Facilities should review their registration data, verify renewal timelines, and assign internal ownership well in advance of their anniversary date.
Going further
If you would like support reviewing your MoCRA facility registration or preparing for biennial renewal, our regulatory team can assist.
You can also subscribe to our cosmetics regulatory newsletter to stay informed about FDA and MoCRA developments.
