CFSAN Constituent Update - FDA Reopens Comment Period on Draft Guidance for Industry: Fruit Juice and Vegetable Juice as Color Additives in Food

Center for Food Safety and Applied Nutrition

Constituent Update

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FDA Reopens Comment Period on Draft Guidance for Industry: Fruit Juice and Vegetable Juice as Color Additives in Food

February 28, 2017

The Food and Drug Administration is reopening the comment period on its draft guidance for industry: fruit juice and vegetable juice as color additives in food for 60 days to allow interested persons additional time to submit comments. The draft guidance, when finalized, will clarify when juices from fruits and vegetables may be used as color additives in food under existing authorizations without additional premarket review and approval from the agency under its color additive petition process.

Interested parties may submit comments by written letter or electronically starting March 1, 2017.

Additional information, including directions for filing comments and the final due date for comments, is available in the Federal Register notice announcing reopening of the comment period.

• Federal Register Notice Announcing Reopening of the Comment Period

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Original Constituent Update

December 13, 2016

In response to questions from food manufacturers, the U.S. Food and Drug Administration has issued draft guidance to clarify when juices from fruits and vegetables may be used as color additives for foods without additional premarket review and approval from the agency under its color additive petition process.

Color additives must be approved for use by the FDA and must be used only in compliance with the approved uses, specifications, and restrictions set out in FDA regulations. The authorization for the use of fruit and vegetable (21 CFR 73.250 and 21 CFR 73.260, respectively) as color additives in food are limited to the juice from certain fruit and vegetables and under certain conditions. The basis for these color additive regulations is that the fruit or vegetable from which the juice is made has been safely consumed as food. The fact that a plant material can be eaten does not necessarily mean that juice from such plant material meets the specifications of these regulations.

Manufacturers have asked the FDA about a variety of color additives made from plant materials. For example, in response to these inquiries, the FDA has advised that juice made from purple corn and black carrots can meet the specifications of the vegetable juice color additive regulation. We have also advised that juice made from safflower petal and hibiscus flower do not meet these specifications.

Manufacturers seeking to use plant materials that do not meet the specifications under the fruit and vegetable juice color additive regulations can submit color additive petitions with safety data for the FDA's review. In response to such petitions, the FDA has authorized color additives that are made from certain plant materials in separate color additive regulations.

Like all color additives in packaged foods, fruit juice and vegetable juice color additives must be declared in the ingredient label statement. 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."

The draft guidance will be available for public comment for 60 days starting December 14, 2016. The FDA will consider all comments before completing a final version.

To submit comments by mail, send to FDA at: Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852

All comments must include the agency name and docket number.

Additional Information:

• Federal Register Notice
• Draft Guidance
• 21 CFR 73.250 and 21 CFR 73.260
• Table of Previous Informal Opinions

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Additional Updates from the FDA Center for Food Safety and Applied Nutrition

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