FDA Withdraws Draft Guidance on Fruit and Vegetable Juices as Color Additives

FDA Withdraws Draft Guidance on Fruit and Vegetable Juices as Color Additives

FDA withdrew 2016 draft guidance on use of fruit and vegetable juices as color additives based on public comments with substantive technical concerns.

May 12, 2017

The Food and Drug Administration is withdrawing a 2016 draft guidance on the use of fruit juice and vegetable juice as color additives based on public comments that raised substantive technical concerns. The concerns include that the guidance promoted practices that may be inconsistent with current industry practices intended to enhance food safety.

Historically, the FDA has responded to industry questions on the use of vegetable juices and fruit juices as color additives on a case-by-case basis. Color additives used in food must be approved for use by FDA. FDA has authorized the use of juice from certain fruit and vegetables (21 CFR 73.250 and 21 CFR 73.260, respectively) as color additives in food. The draft guidance was developed to assist industry understanding whether plant-derived color additives meet the specifications in these regulations or require separate approval as color additives.

Although FDA is withdrawing this draft guidance, the regulations authorizing certain plant-derived color additives remain in place and the agency will continue to respond on a case-by-case basis to industry questions on these topics. In addition, FDA intends to continue evaluating information submitted to its docket and consulting with stakeholders in considering next steps.

Like all color additives in packaged foods, fruit juice and vegetable juice color additives must be declared in the ingredient label statement and must be safe under intended conditions of use. Fruit juice and vegetable juice when used as color additives in food may be declared as “Artificial Color,” “Artificial Color Added,” or “Color Added,” or by an equally informative term that makes clear that a color additive has been used in the food, such as “Colored with Fruit Juice” or “Vegetable Juice Color.” 

For more Information, see the December 2016 Federal Register Notice.