Draft Guidance for Industry: Fruit Juice and Vegetable Juice as Color Additives in Food

CreateTime:2016-12-15 Count:507

Fruit juice and vegetable juice can be used under certain conditions as color additives in food under 21 CFR 73.250 (fruit juice) and 21 CFR 73.260 (vegetable juice). The color additive “fruit juice” is defined in § 73.250 as the juice expressed from mature varieties of fresh, edible fruits, or by the water infusion of the dried fruit. Similarly, the color additive “vegetable juice” is defined in § 73.260 as the juice expressed from mature varieties of fresh, edible vegetables, or by the water infusion of the dried vegetable.
The fact that plant material can be eaten does not necessarily mean that juice from such plant material meets the specifications of these regulations. This guidance is intended to help manufacturers determine whether a color additive derived from a plant material meets the specifications for fruit juice under § 73.250 or vegetable juice under § 73.260. This guidance, including our interpretation of the terms used in § 73.250 and § 73.260, is limited to these color additive regulations. This guidance does not address the use of fruit- or vegetable-derived color additives that are authorized under different color additive regulations or that are the subject of a color additive petition.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

Sources: FDA

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