FDA Releases Draft Guidance regarding the Low Calorie Sweetener – Allulose

In particular, FDA announced that it will exercise enforcement discretion to allow (1) the exclusion of allulose from the “total sugars” and “added sugars” declarations in the Nutrition Facts Panel, and (2) the use of a general factor of 0.4 calories per gram allulose when determining the caloric contribution of allulose.  FDA will continue to view allulose as a carbohydrate that must be included in the declaration of Total Carbohydrates.  FDA’s determination is based on the agency’s review of information and data submitted in several citizen petitions regarding allulose, as well as FDA’s independent review of the scientific evidence related to allulose and metabolism, caloric value, and dental caries.  FDA states it will exercise enforcement discretion as described above pending the agency’s further review of these issues through rulemaking.  This enforcement discretion applies to both conventional foods and dietary supplements containing allulose.

While the agency has traditionally determined “total sugars” based on chemical structure, FDA explains that due to advances in food technology, some novel sugars may not contribute 4 kcal/g like other traditional sugars.  In light of this, FDA’s current thinking is that the agency should not only consider the chemical structure of sugars, but other factors such as the sugar’s association with dental caries, effect on blood glucose and insulin levels, and caloric contribution, when determining whether a sugar should be included in the declaration of “total sugars,” and by extension, “added sugars” declarations on the label.  The draft guidance signals that the agency may be willing to consider additional factors beyond the chemical structure of a sugar in assessing whether such sugar should be captured in “total sugars” and “added sugars” declarations.

FDA states it considers allulose to be a carbohydrate and it therefore must be included in the “total carbohydrate” declaration.  FDA determined that the “total carbohydrate” declaration captures many ingredients that may not have a significant caloric contribution, and that the calculation method for “total carbohydrate” declarations continues to be appropriate when applied to allulose.  More information can be found at the draft guidance.  See FDA Draft Guidance, The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels, April 2019.

Please let us know if you have any questions regarding FDA’s draft guidance.

Authored by Martin Hahn.