FDA Enforcement Trends: What Cosmetics Companies Should Expect in 2026
- Bustos Law Group
- Sep 23, 2025
- 5 min read
Updated: Nov 21, 2025
The FDA's enforcement landscape for cosmetics is rapidly evolving as MoCRA implementation matures and new regulatory priorities emerge.
Based on current enforcement patterns and regulatory developments, here are the key trends cosmetics companies should prepare for in 2026.
1. Aggressive MoCRA Compliance Enforcement
What's Coming: The FDA's grace period for MoCRA compliance is ending. Expect systematic enforcement actions against unregistered facilities and unlisted products starting in early 2026.
The Evidence: Recent enforcement patterns show the FDA is building comprehensive databases of non-compliant companies. The agency has been conducting "soft enforcement" through educational outreach, but this approach is shifting toward formal enforcement actions.
What Companies Should Expect:
Targeted inspections of facilities that missed registration deadlines
Warning letters specifically citing MoCRA violations
Import alerts for products from unregistered foreign facilities
Facility registration suspensions for serious safety violations
Preparation Strategy: Complete facility registration and product listing immediately. The FDA is prioritizing companies that demonstrate good faith FDA compliance efforts over those that ignore requirements entirely.
2. Enhanced Digital Marketing Surveillance
What's Coming: The FDA is dramatically expanding its monitoring of social media, e-commerce platforms, and digital marketing for cosmetic drug claims and safety violations.
The Evidence: Recent warning letters increasingly cite Instagram posts, TikTok videos, and Amazon product listings as evidence of violations. The agency has invested heavily in digital surveillance technology and artificial intelligence tools to monitor online marketing.
What Companies Should Expect:
Automated screening of social media content for drug claims
Enforcement actions based on influencer and affiliate marketing content
Increased scrutiny of customer reviews and testimonials
Cross-platform monitoring linking products to marketing claims
Preparation Strategy: Audit all digital marketing content, including influencer partnerships and customer-generated content. Implement social media compliance training and monitoring systems.
3. Serious Adverse Event Reporting Crackdowns
What's Coming: The FDA launched its public adverse event reporting dashboard in September 2025, signaling increased focus on cosmetic safety reporting. Expect aggressive enforcement of the 15-day reporting requirement.
The Evidence: The new dashboard allows real-time public access to adverse event reports, creating transparency that will drive enforcement priorities. Companies failing to report serious adverse events face significant penalties under MoCRA.
What Companies Should Expect:
Systematic audits of adverse event reporting compliance
Warning letters for late or incomplete adverse event reports
Public scrutiny through the adverse event dashboard
Increased liability exposure from unreported safety issues
Preparation Strategy: Implement robust adverse event monitoring and reporting systems. Train customer service teams to identify and escalate potential serious adverse events immediately.
4. Manufacturing Quality System Enforcement
What's Coming: The FDA is developing Good Manufacturing Practice (GMP) regulations for cosmetics, expected to be finalized in 2026. Early enforcement will target facilities with obvious quality system failures.
The Evidence: Recent warning letters like Sombra Cosmetics (December 2024) show the FDA is already applying drug GMP standards to cosmetics facilities when safety issues arise. The agency is building enforcement precedents before formal cosmetic GMP rules take effect.
What Companies Should Expect:
Increased facility inspections focusing on manufacturing controls
Warning letters citing inadequate quality systems
Enforcement actions for contamination and safety failures
Requirements for process validation and equipment qualification
Preparation Strategy: Begin implementing pharmaceutical-style quality systems now. Focus on water system validation, process controls, and contamination prevention.
5. International Supply Chain Enforcement
What's Coming: The FDA is strengthening coordination with international regulatory authorities and expanding oversight of foreign cosmetics manufacturers.
The Evidence: Recent enforcement actions increasingly target foreign facilities and import violations. The agency has expanded its international inspection program and is sharing enforcement data with EU and other regulatory authorities.
What Companies Should Expect:
Increased inspections of foreign manufacturing facilities
Import alerts for facilities with compliance violations
Enhanced screening of imported cosmetics at ports
Coordination between FDA and foreign regulatory authorities
Preparation Strategy: Audit all foreign suppliers and contract manufacturers. Ensure international facilities meet US registration and compliance requirements.
6. Color Additive and Ingredient Safety Focus
What's Coming: The FDA is intensifying enforcement around color additives and ingredient safety, particularly for products marketed to children and sensitive populations.
The Evidence: Recent warning letters consistently cite color additive violations and unapproved ingredients. The agency is paying special attention to products with safety concerns for vulnerable populations.
What Companies Should Expect:
Systematic review of color additive compliance
Enforcement actions for unapproved or misused color additives
Increased scrutiny of products marketed to children
Safety substantiation requirements for novel ingredients
Preparation Strategy: Conduct comprehensive ingredient safety reviews. Verify all color additives are approved for their specific uses and concentrations.
7. E-commerce Platform Enforcement
What's Coming: The FDA is working directly with major e-commerce platforms to remove non-compliant cosmetics and enforce registration requirements.
The Evidence: Amazon, eBay, and other platforms have begun requiring FDA registration information from cosmetics sellers. The agency is leveraging platform cooperation to enforce compliance at scale.
What Companies Should Expect:
Platform-based compliance verification requirements
Automatic removal of products from unregistered facilities
Enhanced screening of new product listings
Coordination between FDA and platform enforcement teams
Preparation Strategy: Ensure all e-commerce listings include accurate registration information. Prepare for platform-specific compliance verification processes.
8. Private Label and Contract Manufacturing Scrutiny
What's Coming: The FDA is clarifying enforcement responsibilities in private label and contract manufacturing relationships, with increased accountability for brand owners.
The Evidence: Recent guidance emphasizes that brand owners cannot transfer compliance responsibility to manufacturers. Enforcement actions increasingly target both parties in private label arrangements.
What Companies Should Expect:
Joint enforcement actions against brand owners and manufacturers
Increased scrutiny of quality agreements and compliance coordination
Requirements for brand owner oversight of manufacturing operations
Enforcement actions for inadequate supplier verification
Preparation Strategy: Strengthen quality agreements with contract manufacturers. Implement robust supplier verification and oversight programs.
9. State-Federal Enforcement Coordination
What's Coming: The FDA is coordinating more closely with state regulatory authorities, creating multi-jurisdictional enforcement actions.
The Evidence: Recent enforcement patterns show coordination between FDA and state authorities, particularly for companies with multi-state operations or safety violations.
What Companies Should Expect:
Simultaneous federal and state enforcement actions
Shared enforcement databases and intelligence
Coordinated inspection and investigation activities
Multi-jurisdictional consent decrees and settlements
Preparation Strategy: Ensure FDA compliance with both federal and state requirements. Monitor state regulatory developments that may influence federal enforcement.
10. Technology-Driven Enforcement
What's Coming: The FDA is implementing artificial intelligence and data analytics to identify compliance violations and prioritize enforcement actions.
The Evidence: The agency has invested heavily in technology systems for regulatory surveillance and enforcement targeting. Recent enforcement actions show sophisticated data analysis and pattern recognition.
What Companies Should Expect:
Automated identification of compliance violations
Predictive enforcement targeting based on risk factors
Real-time monitoring of product safety and marketing claims
Data-driven prioritization of inspection and enforcement activities
Preparation Strategy: Implement compliance technology systems that can demonstrate systematic compliance management. Prepare for data-driven enforcement approaches.
Preparing for 2026: Action Items
Immediate Priorities:
Complete MoCRA facility registration and product listing
Implement adverse event reporting systems
Audit digital marketing content for compliance
Strengthen quality management systems
Verify international supplier compliance
Strategic Investments:
Compliance technology and monitoring systems
Professional regulatory expertise and legal counsel
Quality system upgrades and validation programs
Staff training and competency development
Supplier verification and oversight programs
Risk Management:
Conduct comprehensive compliance audits
Develop enforcement response protocols
Strengthen insurance coverage for regulatory risks
Create crisis communication and management plans
Establish relationships with regulatory experts
The Bottom Line
In 2026, FDA enforcement will be more systematic, technology-driven, and comprehensive than ever before.
Companies that proactively address compliance gaps and invest in robust regulatory programs will gain competitive advantages, while those that ignore evolving requirements face significant enforcement risks.
The transition from voluntary to mandatory cosmetics regulation is complete. Success in 2026 requires treating cosmetics compliance as a strategic business priority, not an optional regulatory exercise.
Companies that embrace this new regulatory reality and invest in comprehensive compliance programs will be best positioned for long-term success in the evolving cosmetics marketplace. If you need to know more about new regulations, subscribe to our newsletter.