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FDA Withdraws Draft Guidance on Use of Certain Fruit Juice and Vegetable Juice as Color Additives

  • As previously covered on this blog, in December 2016, FDA announced the publication of Draft Guidance on “Fruit Juice and Vegetable Juice as Color Additives in Food” to assist manufacturers in determining whether a color additive derived from a particular plant material meets the specifications for fruit juice under § 73.250 or vegetable juice under § 73.260.  The issuance of this draft guidance followed numerous inquiries submitted to FDA over the years regarding whether certain color additives made from various plant materials would meet the specifications in the fruit juice or vegetable juice color additive regulations.  The Agency was initially slated to accept comments on the Draft Guidance through February 13, 2017, and subsequently reopened the comment period through May 1, 2017.

  • On May 12, 2017, FDA announced the withdrawal of the 2016 Draft Guidance based on comments received that raised substantive technical concerns.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.  In particular, Archer Daniels Midland Company (ADM) contended that the Draft Guidance did not reflect current industry practices as it appeared to set into motion a premarket consultation process.  And the Grocery Manufacturers Association (GMA) expressed concerns that the Draft Guidance’s focus on “minimal processing” would preclude the use of a number of existing industry practices for making safe colors from fruit and vegetable juices.

  • Although FDA is withdrawing this draft guidance, the Agency notes that the regulations authorizing certain plant-derived color additives remain in place and that the Agency will continue its practice of responding on a case-by-case basis to industry questions on these topics.  At the same time, the Agency intends to continue evaluating information submitted to its docket and consulting with stakeholders to consider next steps.

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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...