FDA Clarifies Applicability of Color Additive Regulations for Vegetable and Fruit Juice

In response to questions from food manufacturers, the U.S. Food and Drug Administration has issued draft guidance to clarify when juices from fruits and vegetables may be used as color additives for foods without additional premarket review and approval from the agency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

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