August 18, 2019

August 16, 2019

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FDA Allows Allulose to be Excluded From Sugar Declarations

  • On April 18, 2019, FDA released a draft guidance for industry entitled, “The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.” The guidance announces FDA’s intent to exercise enforcement discretion for the exclusion of allulose from the amount of “Total Sugars” and “Added Sugars” declared on the label and the use of a general factor of 0.4 calories per gram for allulose when determining “Calories” on the Nutrition and Supplemental Facts labels.

  • Allulose is a monosaccharide used as a sugar substitute in certain conventional foods and beverages. In a press statement, Dr. Susan Mayne, director of FDA’s Center for Food Safety and Applied Nutrition stated, “[t]he latest data suggests that allulose is different from other sugars in that it is not metabolized by the human body in the same way as table sugar. It has fewer calories, produces only negligible increases in blood glucose or insulin levels, and does not promote dental decay.”

  • As a result of FDA’s announcement, the Agency’s decision is likely to generate more interest in allulose as a sugar substitute given the increasing pressure on industry to reduce sugar and calories.

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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...

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