Last month, FDA issued a final rule to approve a new blue color additive made from butterfly pea flower (clitoria ternaea) for use in (1) alcoholic beverages, (2) sport and energy drinks, (3) flavored or carbonated water, (4) fruit drinks (including smoothies and grain drinks), (5) carbonated soft drinks (fruit-flavored or juice, ginger ale, and root beer), (6) fruit and vegetable juice, (7) nutritional beverages, (8) chewing gum, (9) teas, (10) coated nuts, (11) liquid coffee creamers (dairy and non-dairy), (12) ice cream and frozen dairy desserts, (13) hard candy, (14) dairy and non-dairy drinks, (15) fruit preparations in yogurts, and (16) soft candy, at levels consistent with good manufacturing practice (GMP). See 86 Fed. Reg. 49230 (Sep. 2, 2021). The principal coloring component of the new color additive is anthocyanins. The rule approving the new “butterfly pea flower extract” color additive is effective today (October 5, 2021).
FDA concluded that batch certification was not necessary to public health. As a reminder, while all color additives must be approved for their intended use, FDA may determine that, in addition, protection of the public health requires the Agency to analyze and certify a sample from each batch of the color additive (i.e, batch certification). See 21 CFR 71.20 (b). Color additives subject to batch certification are listed in 21 CFR, Parts 74 and 82, and color additives exempt from certification are listed in 21 CFR Part 73. The new color additive will be codified at 21 CFR 73.69.
Another blue color additive that is currently approved is spirulina at 21 CFR 73.530. Blue color additives derived from natural sources including jagua fruit pulp (Genipa americana) (filed July 31, 2020), gardenia (filed April 20, 2021), and unicellular red algae (Galdieria sulphuraria) (filed September 9, 2021) are also currently under review for use in food. See List of Food Additive and Color Additive Petitions.
Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...
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