FDA Issues Supplemental Response on the Labeling of D-tagatose on the Nutrition Facts Label

The US Food and Drug Administration (FDA) has issued a supplemental response to the citizen petition dated April 18, 2018, from Bonumose, Inc., regarding the percent Daily Value (%DV) declaration for added sugars for products containing D-tagatose. D-tagatose must be declared as an added sugar on the Nutrition Facts label, but it contains fewer calories than sucrose, or table sugar.

The FDA’s original response, issued May 18, 2022, indicated that the agency would not object to the use of 1.5 calories per gram (kcal/g) for D-tagatose when determining “Calories” on the Nutrition Facts label.

The FDA’s supplemental response states that it intends to exercise enforcement discretion if the added sugars %DV declaration on the Nutrition Facts label for products containing D-tagatose is adjusted based on a calorie contribution of 1.5 kcal (calories) per gram of the sweetener, rather than the 4 kcal/g that is the basis for the value in the regulations, pending future rulemaking.

The FDA has determined that it is premature to finalize an overarching strategy for calculating the %DV on the Nutrition Facts label for all sugars such as D-tagatose because many sugars metabolized differently than traditional sugars are in the early stages of development, and the agency has limited information at this time regarding the range or uniformity of the caloric values for these other sugars.

For More Information

Federal Register Notice for Sugars that Are Metabolized Differently Than Traditional Sugars

Sugars That Are Metabolized Differently Than Traditional Sugars

Docket Regarding D-tagatose and the Nutrition Facts Label