Under the Federal Food, Drug, and Cosmetic Act (Chapter VII, section 721), color additives, except for coal tar hair dyes, is subject to FDA approval before they may be used in food, drugs, or cosmetics, or in medical devices that come in contact with the bodies of people or animals for a significant period of time. The following resources are related to the use of color additives in FDA-regulated products.

Information on Specific Color Additives

• Letter to Additive Manufacturers on Certification of Irradiated Colors
• FD&C Red No. 3
• Titanium Dioxide

Color Additive Inventories

• Summary of Color Additives Listed for Use in the United States in Food, Drugs, Cosmetics, and Medical Devices
• More Color Additive Inventories

Color Additives in Specific Products

Color Additive Petitions

• Preparing a Color Additive Petition for Color Additives Used in or on Contact Lenses
• More Resources on Color Additive Petitions

Color Certification

• Quarterly Reports on the Certification of Color Additives
• Companies Requesting Color Certification Within the Last Two Years
• More Resources on Color Certification  

Compliance & Enforcement

• Color Additives Status List
• Warning & Untitled Letters
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• More Resources on Compliance & Enforcement

Laws, Regulations, and Guidance

Science & Research