U.S. Color Regulation Basics

• Color Additives Fact Sheet - July 2001
• Color Additives FDA Backgrounder - February 1990
• Color Additive Status List (Inspection Operations Manual, Appendix A)
• Summary of Color Additives Listed for Use in Foods, Drugs, Medical Devices and Cosmetics November 2000
• Import Detentions and Import Alerts Involving Color Additive Violations
• Regulations Related to Color Additives

Colors Subject to Certification

• Color Certification Reports (updated quarterly)
• Companies Requesting Color Certification Within the Last Two Years August 1, 2001

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

Color Additives for Specific Product Categories

• Color Additives and Cosmetics
  • Eye Products August 1, 2001
  • Hair Dye Products
  • Heading Off Hair Care Disasters: Use Caution With Relaxers and Dyes January - February 2001
  • Lead Acetate Used in Hair Dye Products October 7, 1998
  • Novelty Makeup September 25, 2001
  • Requests Regarding the Harmonization of Ingredient Nomenclature
  • Tanning Pills October 18, 2000
  • Tattoos and Permanent Makeup November 29, 2000
  • Temporary Tattoos and Henna/Mehndi April 18, 2001

• Color Additives and Foods
  • EAFUS: A Food Additive Database
  • Food Color Facts January 1993
  • Imported Foods - Food and Color Additives Compliance Program May 3, 2001
  • Toxicological Principles for the Safety of Food Ingredients (Redbook 2000) July 7, 2000
  • Toxicological Testing of Food Additives 1997

• Color Additives and Medical Devices
  • Illegal Promotion of Contact Lenses September 25, 1998
  • Color Additives for Medical Devices
  • Medical Glove Guidance Manual Draft Guidance: Color and Flavor Additives July 30, 1999
  • Color Additive Petitions (p. 11-19 of PMA Manual) (available in PDF)

• Color Additives and Drugs
  • Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use (21 CFR 201.20)

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