May 19, 2019

May 17, 2019

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FDA Accepts Qualified Health Claim Petition for Yogurt and the Reduced Risk of Diabetes

  • FDA has accepted a qualified health claim petition submitted by Danone North America on the ability of yogurt to reduce the risk of type 2 diabetes.  FDA is accepting comments on the petition until June 11, 2019.

  • Danone is requesting FDA’s consideration of the following qualified claims: (1) “Eating yogurt regularly may reduce the risk of type 2 diabetes.  FDA has concluded there is limited information supporting this claim;” or (2) “Eating yogurt regularly may reduce the risk of type 2 diabetes according to limited scientific evidence.”

  • Danone has requested the claim only for yogurts meeting the standards of identity under 21 C.F.R. §§ 131.200 (“Yogurt”), 131.203(“Lowfat yogurt”), and 131.206 (“Nonfat yogurt”).  Thus, non-dairy yogurts will not be eligible to make the claim if the petition is successful.

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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...