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  1. CFSAN Constituent Updates

FDA Seeks Input on Nutrition Labeling for Certain Sugars and Issues Final Guidance on Allulose

Constituent Update

October 16, 2020

The U.S. Food and Drug Administration is taking two actions regarding the labeling of certain sugars on the Nutrition and Supplement Facts label. The FDA is issuing a Request for Information to receive information about the nutrition labeling of sugars that are metabolized differently than traditional sugars. The FDA also is issuing a final guidance regarding one of these sugars that are metabolized differently, allulose. The guidance addresses both the declaration of allulose on Nutrition Facts and Supplement Facts labels and the caloric content of allulose for use in nutrition labeling.

The Nutrition Facts label on foods and beverages lists the number or amount of calories, total carbohydrates, total sugars and added sugars, in addition to other information.  The sugars that many consumers are most familiar with, like sucrose or “table sugar,” cause an increase in blood glucose and insulin levels after they are consumed, have 4 calories per gram, and are associated with tooth decay.   Some sugars, such as allulose, D-tagatose, and isomaltulose, are metabolized differently than traditional sugars and do not have all of the same effects in the body as traditional sugars. Because of the different effects that these sugars can have, the FDA has received multiple requests from industry to treat certain sugars that are metabolized differently than traditional sugars as distinct for the purpose of nutrition labeling.  For example, the FDA has been asked to exempt allulose from being included as a carbohydrate, sugar, or added sugar on the Nutrition Facts label and for the number of calories be lower than the 4 calories per gram that is used for traditional sugars.
 
The FDA issued a draft guidance regarding one sugar that is metabolized differently—allulose—last year and is now finalizing that guidance.  The FDA is advising manufacturers that it intends to exercise enforcement discretion regarding the requirement that allulose be included in the amount of total sugars and added sugars declared on the Nutrition Facts label, pending review of the issues in a rulemaking. However, allulose still must be included in the amount of total carbohydrates. The final guidance also advises manufacturers of the FDA’s intent to exercise enforcement discretion for the use of 0.4 calories per gram for allulose when determining calories on the Nutrition and Supplement Facts labels.
 
Submit written comments on the Request for Information to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD.  Submit comments electronically, including attachments, to https://www.regulations.gov.  Electronic comments must be submitted on or before 60 days after the date of publication in the Federal Register; comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
 
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