i- As we have previously blogged, in 2022 FDA denied a petition from Bonumose LLC which requested that the agency exempt D-tagatose from declaration as an added sugar. The petition argued that D-tagatose contributes less calories than traditional sugars (1.5 calories/g vs. 4 calories/g) and is not associated with the same health outcomes as traditional sugars (i.e., mono- and disaccharides, such as glucose, fructose, lactose, and sucrose), but FDA declined in part because even 1.5 calories/g could contribute non-negligible levels of what the Agency deemed empty calories.
- Last month, FDA issued a supplemental response in which it indicated that it would exercise enforcement discretion in regard to the % daily value (DV) declaration of added sugars in products containing D-tagatose if the % DV calculation is based on a 1.5 calories/g contribution of D-tagatose. The DV for added sugars is 10% of total calories based on a 2000 calories diet (200 calories), which is 50 g for traditional sugars which metabolize at 4 calories/g.
- The supplemental response represents only a minor change as the 2022 response indicated that the agency would not object to the use of 1.5 calories/g in the calculation of calories. FDA has maintained its position that D-tagatose should be included in the added sugars declaration.
- The supplement was issued in response to an ongoing lawsuit challenging the response to the petition (Bonumose v. FDA, Civ. Action No. 23-645 (D.D.C.).
FDA Supplements Response to D-Tagatose Petition
Wednesday, January 3, 2024
