The cosmetic regulatory landscape has entered a new era. With the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) now actively enforced, 2025 represents a critical compliance milestone for cosmetic brands operating in or exporting to the United States. 

The FDA Cosmetics Act has fundamentally reshaped regulatory expectations introducing mandatory facility registration, product listing, adverse event reporting, safety substantiation, labelling updates, and upcoming cosmetic GMP (cGMP) requirements. Compliance is no longer a reactive exercise; it is a core business function tied directly to market access, brand reputation, and regulatory risk management. 

This in-depth guide from Maven Regulatory Solutions explains what cosmetic brands must know in 2025, outlines key FDA enforcement timelines, and provides a strategic framework to maintain MoCRA compliance efficiently. 

Briefly: Key FDA Cosmetic Compliance Updates for 2025 

• MoCRA facility registration & product listing now fully enforced 
• 15-business-day reporting for serious adverse events is mandatory 
• Cosmetic GMP (cGMP) final rule deadline: December 29, 2025 
• Responsible Person contacts details required on labels (effective Dec 29, 2024) 
• PFAS safety assessment obligations under active FDA evaluation 

MoCRA Overview: The Most Significant FDA Cosmetics Reform in Decades a Regulatory Turning Point 

The Modernization of Cosmetics Regulation Act of 2022 marks the most substantial overhaul of U.S. cosmetic regulations since the Federal Food, Drug, and Cosmetic Act of 1938. 

Under MoCRA, the FDA gained expanded authority to: 

• Oversee cosmetic manufacturing facilities 
• Enforce mandatory product listings 
• Require safety substantiation 
• Conduct inspections 
• Mandate recalls when products pose health risks 

What were once voluntary programs are now legally binding obligations with enforcement consequences. 

As of January 1, 2025: 

• 9,528 active cosmetic facility registrations 
• 589,762 active cosmetic product listings 

These figures highlight the scale of industry-wide compliance efforts already underway. 

FDA Enforcement Milestones Brands Cannot Ignore 

Facility Registration Under MoCRA Who Must Register? 

Any Responsible Person including manufacturers, packers, private-label owners, and distributors must ensure facility registration for cosmetics marketed in the U.S. 

This applies to: 

• Domestic and foreign manufacturers 
• Contract manufacturing organizations (CMOs) 
• Importers and private-label brands 

Small businesses and artisan brands are not exempt. 

Registration Process & Maintenance 

Facilities must submit Form FDA 5066 electronically (or via paper, if applicable). Required information includes: 

• Facility location and operations 
• Product categories manufactured or packed 
• Ownership details 

Ongoing Obligations 

• Annual renewal by December 31 
• Updates within 60 days of material changes 
• U.S. Agent designation for foreign facilities 

Non-Compliance Risks 

• Registration suspension 
• Import refusal 
• FDA enforcement actions 

Cosmetic Product Listing Requirements What Must Be Listed? 

Each marketed cosmetic product must be listed with: 

• Full ingredient disclosure 
• Product category and intended use 
• Responsible Person details 

Listings must reflect current formulations. Any ingredient or concentration change triggers an update. 

Annual Update & Lifecycle Management 

• New products: list within required timelines post-launch 
• Discontinued products: remove from active listings 
• Reformulated products: update ingredient data 

The FDA’s electronic portal supports bulk uploads, enabling efficient portfolio management for large brands. 

Adverse Event Reporting: 15-Day Compliance Rule Mandatory Reporting Obligations 

Responsible Persons must report serious adverse events to the FDA within 15 business days of becoming aware of them. 

Serious adverse events include: 

• Hospitalization 
• Life-threatening reactions 
• Permanent impairment or disability 

A copy of the product label must accompany each submission. 

Documentation & Record Retention 

Brands must maintain: 

• Consumer complaint records 
• Medical documentation (where available) 
• Investigation outcomes 
• Corrective actions 

Robust internal pharmacovigilance-style systems are now essential for cosmetic compliance. 

Cosmetic GMP (cGMP): Preparing for the December 2025 Deadline 

MoCRA requires the FDA to finalize cosmetic Good Manufacturing Practices (cGMP) by December 29, 2025. 

Expected Scope of cGMP Requirements 

While the final rule is pending, FDA guidance indicates alignment with established GMP principles: 

• Quality management systems 
• Personnel training 
• Facility hygiene & contamination control 
• Raw material qualification 
• Batch documentation & traceability 

Strategic Preparation Steps 

• Conduct GMP gap assessments 
• Develop SOPs and batch records 
• Implement supplier qualification programs 
• Train manufacturing personnel proactively 

Labelling & Safety Substantiation Requirements 

Mandatory Contact Information 

All cosmetic labels must display: 

• Responsible Person name 
• Physical address 
• Phone number or website 

Email alone is insufficient. 

Safety Substantiation & PFAS Focus 

Brands must maintain adequate safety substantiation for every cosmetic product. 

Safety data may include: 

• Toxicological assessments 
• Scientific literature 
• Supplier safety data 
• Product testing results 

PFAS (per- and polyfluoroalkyl substances) now require heightened scrutiny, with FDA-mandated safety evaluations continuing through December 29, 2025. 

Compliance Strategy: Best Practices for Cosmetic

Brands Build Internal Compliance Infrastructure 

• Cross-functional regulatory, quality, and legal teams 
• Centralized compliance tracking systems 
• Routine internal audits 

Leverage Digital Compliance Tools 

• Automated deadline reminders 
• Electronic adverse event tracking 
• Document management systems 

Risk-Based Compliance Planning 

Prioritize: 

1. Facility registration & listing accuracy 
2. Adverse event readiness 
3. GMP preparedness 

FDA Enforcement & Penalties 

Inspection Authority 

The FDA may conduct unannounced inspections of cosmetic facilities. Inspection readiness requires: 

• Immediate document access 
• Trained staff 
• Clear corrective action procedures 

Consequences of Non-Compliance 

• Warning letters 
• Product seizures 
• Import alerts 
• Mandatory recalls 
• Reputational damage 

 Outlook: What’s Next After 2025? 

• Continued FDA guidance updates 
• Increased enforcement activity 
• Greater alignment with international cosmetic regulations 
• Expanded focus on ingredient transparency and sustainability 

Conclusion: Turning Compliance into Competitive Advantage 

Cosmetic regulatory compliance in 2025 is no longer optional it is a strategic differentiator. Brands that invest early in MoCRA-aligned systems will benefit from: 

• Faster market access 
• Reduced enforcement risk 
• Stronger consumer trust 

The upcoming cosmetic GMP deadline is the next critical milestone. Early action today ensures operational stability tomorrow. 

Maven Regulatory Solutions supports cosmetic brands with end-to-end regulatory strategy, FDA compliance, and GMP readiness helping you stay compliant, confident, and competitive. 

Frequently Asked Questions (FAQs) 

1.Is MoCRA applicable to imported cosmetics? 

Yes. Foreign manufacturers must register facilities, designate a U.S. agent, and comply fully with MoCRA. 

2.Are small cosmetic brands exempt from FDA registration? 

No. MoCRA does not exempt small or artisan brands from registration and listing requirements. 

3.When will cosmetic GMPs become enforceable? 

The FDA’s final cosmetic GMP rule is expected by December 29, 2025. 

4.Do formulation changes require relisting? 

Yes. Any ingredient or concentration change requires a product listing update.