Compliance & Enforcement

This section contains information on compliance with and enforcement of laws and related FDA regulations for cosmetics.

Warning Letters

• Warning Letters Related to Cosmetics
• What are FDA Warning Letters? – Regulatory Procedures Manual

Recalls & Alerts

• Recent FDA Recalls Related to Cosmetics -- Up-to-date cosmetics recall information
• FDA Recall Policy for Cosmetics
• Enforcement Reports: FDA’s Weekly Reports on Recalls
• Recalls, Market Withdrawals, and Safety Alerts -- All FDA-regulated Products
• Import Alerts Related to Cosmetics

Compliance Resources

• Cosmetics Compliance Program: Import and Domestic (PDF - 214KB) 
• CDER-CFSAN Agreement for Products That Purport to Be Cosmetics but Meet the Statutory Definition of a Drug
• Import Surveillance

Inspection Resources

• Inspection of Cosmetics
• Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist
• Draft Guidance for Industry: Cosmetic Good Manufacturing Practices
• Inspection Reference, Guides & Field Activities
• Information for Importers -- FAQs on importing cosmetics into the United States, and links to additional resources
• Import Surveillance -- Links to Import Refusals and Import Alerts Related to Cosmetics  

Adverse Event Reporting

If you’ve experienced a bad reaction to a cosmetic, FDA wants to know. Here is information on how to report a problem.

• Adverse Event Reporting
• MedWatch: The FDA Safety Information and Adverse Event Reporting Program 
• Webinar: How Consumers Can Report an Adverse Event or Serious Problem to FDA