June 17, 2018

June 15, 2018

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FDA Approves New Source of Omega-6 Fatty Acids for Dog Food

  • The Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) announced the approval of a variety of bioengineered safflower as a source of omega-6 fatty acids in dry adult dog food. The final rule amends Title 21 Code of Federal Regulations (C.F.R.) Part 573 (“Food Additives Permitted in Food and Drinking Water of Animals”) by adding 21 C.F.R. 573.492 to permit the use of the food additive gamma-linolenic acid (GLA) safflower oil containing an omega-6 fatty acid in animal food.

  • FDA took this action in response to a food additive petition submitted by Arcadia Biosciences, Inc. (Arcadia); the Agency announced the filing of Arcadia’s food additive petition on September 12, 2012 (77 FR 56175). In the petition, Arcadia requested that the food additive regulations be amended to permit the use of GLA safflower oil—which was bioengineered to contain a gene from the water mold Saprolegnia diclina responsible for production of GLA in the seed oil—for use in dry food for adult dogs.

  • FDA stated in the August 15, 2017 Federal Register (82 Fed. Reg. 38595) that it had concluded that the data submitted by Arcadia established “the safety and utility of GLA safflower oil as a source of omega-6 fatty acids in complete dry adult maintenance dog food…”

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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...