Compliance & Enforcement of Color Additives

Resources for FDA compliance staff and news about enforcement action related to color additives. For additional information, see Color Additive Laws, Regulations, and Guidance.

Compliance Resources

• Color Additive Status List
• FDA's Investigations Operations Manual
• Untitled Letter Citing Regulatory Status of Mica-Based pearlescent pigments when used in cosmetics February 5, 2007
• Excerpts from the Compliance Policy Guidance Manual -- From FDA's Office of Regulatory Affairs  
  • Sec 500.425 Colorants in Paper and Paperboard for Use with Food (CPG 7117.10)
  • Sec 587.100 Label Declaration of Artificial Color (CPG 7127.01)
  • Sec 587.200 Uncertified or Delisted Colors in Foods for Export - (e.g., FD&C Red #2) (CPG 7127.02)
  • Sec 587.300 Color Additives (CPG 7127.03)

Enforcement News

• Warning & Untitled Letters to Industry Citing Color Additive Violations
• Import Alerts & Refusals Involving Color Additive Violations
• Color Additive Enforcement News