For Industry

Laws, Regulations, and Guidance


FDA regulates color additives under the authority of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act.

Regulations Related to Color Additives 

FDA-regulated products must comply with the color additive regulations; otherwise they are adulterated and/or misbranded. Color additive violations are common reasons for warning letters and import detentions.  

Guidance for Industry

Guidance documents contain nonbinding recommendations. 

Page Last Updated: 01/27/2015
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