The U.S. Food and Drug Administration (FDA) has issued a draft guidance to provide its current view on the declaration of carbohydrates, total sugars, and added sugars for products that contain allulose, a sweetener, on the Nutrition Facts label. The agency is advising manufacturers that it intends to exercise enforcement discretion regarding the requirement that the sweetener allulose be included in the amount of “total sugars” and “added sugars” on the Nutrition Facts label. However, allulose still must be included in the amount of “total carbohydrates.”

The draft guidance also advises manufacturers of its intent to exercise enforcement discretion regarding the use of 4 calories per gram of sweetener to calculate the caloric contribution of allulose and instead, allow manufacturers to use a caloric value of 0.4 calories per gram to calculate the caloric contribution of allulose.

Allulose is a low-calorie sweetener that is naturally occurring in small amounts in wheat, fruits such as raisins and dried figs, and in other sweet foods such as brown sugar and molasses. It can also be manufactured. While allulose has a chemical structure similar to other sugars, it is not metabolized by the body in the same way as most sugars and does not contribute the same number of calories.

Under FDA’s 2016 Nutrition Facts label rule, allulose must be included in declarations for “total carbohydrates,” “total sugars,” and “added sugars.” Current requirements also require allulose to be counted as 4 calories per gram of the sweetener. However, FDA stated in the final rule that additional time was needed to fully consider the science as to whether allulose should be excluded from these requirements. The agency has received several petitions related, in part, to whether allulose should be exempt from being included as a carbohydrate, sugar, or added sugar and to the caloric value of allulose. This draft guidance conveys FDA’s current thinking regarding allulose.

Comments on the draft guidance can be submitted within 60 days after publication in the Federal Register.

Draft guidance

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