Contents

• We're Moving! October 4, 2004
  • CFSAN Office of Food Additive Safety and Office of Cosmetics and Colors Move to College Park, MD October 29, 2004
• Listing of Color Additives Subject to Certification; D&C Black No. 2: Final Rule July 28, 2004
  • Correction Federal Register, August 25, 2004
  • Confirmation of Effective Date Federal Register, October 8, 2004
• FDA Talk Paper: FDA Alerts Consumers About Adverse Events Associated with Permanent Makeup July 2, 2004
• Enforcement News Warning Letters, Recalls, Import Alerts and Refusals

Background

• Color Additives Fact Sheet - July 2001
• Q & A for Color Additives
• Color Additives: FDA's Regulatory Process and Historical Perspectives October/November 2003
  An overview of U.S. color additive laws, regulations, enforcement, the certification process, and the historical context.

U.S. Color Laws, Regulations, and Related Resources

• Summary of Color Additives Listed for Use in Foods, Drugs, Medical Devices and Cosmetics November 2000
• Regulations Related to Color Additives
• The Food, Drug, and Cosmetic Act, Chapter VII, Subchapter B -- Colors

Colors Subject to Certification

• Color Certification Reports (updated quarterly)
• Companies Requesting Color Certification Within the Last Two Years February 5, 2004

The Petition Process

• Questions about the Petition Process
• Guidance for Submitting Petitions and Notifications (Office of Food Additive Safety)
• Pending Color Additive Petitions
• "Dear Colleague" Letter on Improvements to the Food and Color Additive Petition Review Process October 5, 2000
• Color Additive Petitions: FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs or Cosmetics January 1997
• Environmental Assessment Technical Handbook ordering information

Compliance Resources

• Color Additive Status List (Investigations Operations Manual, Appendix A)
• Sampling Schedule for Color Containing Products/Color Additives (From FDA's Investigations Operations Manual)
• FDA Response to CTFA Request Regarding the Use of Abbreviated Labeling for Declaring Certified Color Additives in Cosmetics June 7, 1999
• Excerpts from the Compliance Policy Guides Manual -- From FDA's Office of Regulatory Affairs
  • Foreword
  • Introduction
  • 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 7127.03)
  • Sec 587.300 Color Additives (CPG 7127.03)

Color Additives for Specific Product Categories

• Color Additives and Cosmetics
• Color Additives and Foods
• Color Additives and Medical Devices
• Color Additives and Drugs

FDA Offices and Centers that Regulate Products with Color Additives

• Office of Food Additive Safety, Center for Food Safety and Applied Nutrition
• Office of Cosmetics and Colors, Center for Food Safety and Applied Nutrition
• Center for Devices and Radiological Health
• Center for Drug Evaluation and Research