When Sugars are Not Counted as Sugars: FDA Clarifies Nutrition Facts Labeling Requirements for Allulose 

October, 2020 - David Longinotti

Key Points

  • The FDA will exercise enforcement discretion when Nutrition and Supplement Facts Labels (a) exclude allulose from Total Sugars and Added Sugars declarations, and (b) use as low as 0.4 kcal/g for allulose calorie count; but allulose must be included as a Total Carbohydrate.

Allulose is a basic form of carbohydrate that is naturally occurring in a variety of sweet foods, such as raisins, maple syrup, and brown sugar. Allulose is absorbed by the body, but not metabolized and is nearly calorie-free. The new FDA Guidance,1 issued on Oct.19, 2020, clarifies how allulose may be declared on Nutrition and Supplement Facts labels. The guidance provides insight on an issue left unresolved in both the Nutrition Labeling and Education Act2 and subsequent rulemaking.3 The guidance provides that the FDA will exercise enforcement discretion when reviewing labels with the following declarations:

  • The label excludes allulose from Total Sugars.
  • The label excludes allulose from Added Sugars.
  • A caloric value for allulose is shown as low as 0.4 kcal/g.

The guidance also provides that allulose must be declared in the ingredient statement and included as a Total Carbohydrate.

The FDA also recently posted a constituent update requesting information about nutrition labeling of sugars that are metabolized differently from traditional sugars.4 It is possible that future guidance will provide similar clarity on other non-metabolized sugars.                                                                                                                                                                                                                   

1 The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels: Guidance for Industry (October 2020), Docket No. FDA-2019-D-0725.

2 21 U.S.C. 343 (Misbranded Food)

3 21 CFR 101 (Food Labeling: Revision of the Nutrition and Supplement Facts Labels, May 27, 2016).

4 Constituent Update: FDA Seeks Input on Nutrition Labeling for Certain Sugars and Issues Final Guidance on Allulose



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