June 26, 2022

Volume XII, Number 177

Advertisement
Advertisement

June 24, 2022

Subscribe to Latest Legal News and Analysis
Advertisement

FDA Denies Request to Exempt D-Tagatose from Added Sugar Labeling

  • In a letter dated May 18, 2022, FDA denied a citizen petition from Bonumose LLC which requested that the Agency (1) exempt D-tagatose from classification as an “Added Sugar” and (2) allow for the voluntary labeling of D-tagatose as a separate declaration under “Total Carbohydrates,” similar to the approach taken for sugar alcohols.

  • By way of background, FDA exercises enforcement discretion which allows allulose to be excluded from the “Total Sugars” and “Added Sugars” label declarations and allows the use of 0.4 kcal/g for allulose when determining “Calories.” See Guidance for Industry: The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.  FDA had also previously requested information on the kinds of sugars that are metabolized differently than traditional sugars, any distinct physiological effects caused by those sugars, and suggestions on how those sugars should be declared and accounted for on food labels. See 85 Fed. Reg. 66335 (Oct. 19, 2020).

  • FDA declined to exempt D-tagatose from classification as an added sugar primarily because its caloric contribution of 1.5 kcal/g was not negligible. FDA explained that the declaration of added sugars is intended to allow consumers to avoid calories that do not make a significant nutritional contribution (i.e., “empty calories”). Although 1.5 kcal/g is significantly less than the 4 kcal/g that most familiar sugars (e.g., sucrose) contribute, it is also significantly more than the 0.4 kcal/g that allulose contributes. FDA also noted that at the use levels indicated in Bonumose’s GRAS Notice for D-tagatose, D-tagatose could significantly contribute to a consumer’s intake of empty calories. However, the Agency did indicate that it would not object to the use of 1.5 kcal/g for D-tagatose when determining “Total Calories.”  Because FDA determined that it was appropriate to consider D-tagatose as an added sugar, it also declined to allow for voluntary labeling of D-tagatose in a manner similar to sugar alcohols.

  • FDA’s response is interesting because it focuses solely on the caloric issue to the exclusion of differences in the way that D-tagatose is metabolized and its physiological effects. FDA’s only comment on the latter points is to note that a health claim that D-tagatose may reduce the risk of dental caries is allowed under 21 CFR 101.80.

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 144
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement

About this Author

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...

202-434-4100
Advertisement
Advertisement
Advertisement