The Food and Drug Administration issued draft guidance last week to explain its current position on allulose, a low-calorie sweetener, and allow enforcement discretion for certain declarations in the Nutrition and Supplement Facts label. According to the guidance, FDA will allow manufacturers to exclude the sweetener from the total and added sugars declarations, but they must continue to include it in the total carbohydrates declaration.

Allulose occurs naturally in small amounts in wheat, some fruits and a variety of other foods, and is approved for use in dairy foods. It also can be manufactured. FDA said its determination and draft guidance is based on the agency’s review of data from Tate & Lyle, an IDFA Gold Business Partner, and other companies that submitted citizen petitions regarding allulose, as well as an independent review of scientific evidence. 

According to Susan Mayne, Ph.D., director of FDA’s Center for Food Safety and Applied Nutrition, “The latest data suggests that allulose is different from other sugars in that it is not metabolized by the human body in the same way as table sugar. It has fewer calories, produces only negligible increases in blood glucose or insulin levels and does not promote dental decay.”

Allulose will still count towards the caloric value of the food on the label, Mayne said, but the agency will allow the use of a revised, lower calorie count. FDA intends to exercise the enforcement discretion in the guidance pending a further review through rulemaking. 

2016 Requirements
Under the FDA’s 2016 Nutrition Facts label rule, the amount of allulose must be counted in the amount of total carbohydrates, total sugars and added sugars declared on the Nutrition Facts labels. Although the 2016 rule also requires allulose to be counted as four calories per gram of sweetener, the recent guidance states that FDA will exercise enforcement discretion to allow manufacturers to use 0.4 calories per gram of allulose when calculating the calories in a serving.

“According to consumer research, listing an ingredient that contributes virtually no calories as a ‘sugar’ and an ‘added sugar’ is confusing to buyers who read the labels,” said Cary Frye, IDFA senior vice president of regulatory affairs. “We believe this enforcement discretion will help consumers to learn the true nutritional profile of products containing allulose, including dairy products.”

For more details, read “The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.”

Members with questions may contact Frye at cfrye@idfa.org.