Under the Federal Food, Drug, and Cosmetic Act (Chapter VII, Section 721), color additives are subject to FDA approval before they may be used in food. In the approval process, the agency evaluates scientific data to ensure that a color additive is safe for its intended purposes. Any food that contains an unapproved color additive would be considered adulterated under U.S. law and would be subject to enforcement action to remove it from commerce.
The following resources are related to the use of color additives in FDA-regulated food products.
- FDA's Main Color Additives Page
- Color Additive Status List
- Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices
- Food and Color Additives Final Rules by Year
- Color Additive Questions & Answers for Consumers
- Consumer Update: How Safe are Color Additives?
- Consumer Information on Ingredients & Packaging
- Questions & Answers About 4-MEI
Guidance for Industry
- Guidance for Industry: Pre-Petition Consultations for Food Additives and Color Additives
- Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices
- Guidance for Industry: Preparing a Color Additive Petition for Submission to the Center for Food Safety and Applied Nutrition for Color Additives Used in or on Contact Lenses
- Guidance for Industry: Colored Sea Salt
- More Color Additive Guidance for Industry