Draft Guidance for Industry: The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels
Submit Comments by 06/17/2019
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2019-D-0725
- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Nutrition and Food Labeling
This guidance is intended to provide our current view on the declaration of allulose on Nutrition and Supplement Facts labels as well as on the caloric content of allulose. This guidance also is intended to advise manufacturers of our intent to exercise enforcement discretion for the exclusion of allulose from the amount of “Total Sugars” and “Added Sugars” declared on the label and the use of a general factor of 0.4 calories per gram for allulose when determining “Calories” on the Nutrition and Supplement Facts labels pending review of the issues in a rulemaking.
In arriving at our decision to consider the exercise of our enforcement discretion, we considered data and information provided in citizen petitions and other information submitted to us. We received a citizen petition requesting the exemption of allulose from the declaration of “Total Carbohydrate,” “Total Sugars,” and “Added Sugars” on the Nutrition Facts label (Docket Number FDA-2015-P-1201) (Ref. 1). We also considered a citizen petition requesting the use of a general factor for caloric value of allulose of 0.4 calories per gram (kcal/g) (Docket Number FDA-2016-P-2030) (Ref. 3), and another a citizen petition requesting the use of a general factor for caloric value of allulose of 0.2 kcal/g (Docket Number FDA-2017-P-1463) (Ref. 4). We considered these citizen petitions (as well as comments submitted to the dockets for these citizen petitions) in conjunction with comments to a proposed rule titled “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (79 FR 11880, March 3, 2014) (hereafter referred to as “the proposed rule”). We also conducted an independent review of the scientific evidence related to allulose and metabolism, caloric value, and dental caries.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.
Calories per gram or kilocalories per gram (kcal/g) has been defined as the amount of heat energy needed to raise the temperature of a kilogram of water 1oC (determined at 14.5oC to 15.5oC) and is the unit that has been traditionally used for expressing the energy value of foods (Ref.2).