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FDA In Brief: FDA allows the low-calorie sweetener allulose to be excluded from total and added sugars counts on Nutrition and Supplement Facts labels when used as an ingredient

April 17, 2019

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  Nathan Arnold
  301-796-6248

“Ensuring that consumers have current, science-based information is one of the key goals of our Nutrition Innovation Strategy. We want Americans to be able to easily determine the most relevant and useful information available when looking at Nutrition Facts and Supplement Facts labels. One of the several approaches we’ve taken to achieve this important goal is issuing new labeling guidances when we identify an area where further clarity is needed. Today, we’re taking such a step by issuing a draft guidance on the labeling of allulose, a sweetener that may be used as a substitute for certain sugars in foods, so that the information presented on Nutrition and Supplement Facts labels appropriately represents its unique properties,” said 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. As such, we’ve issued guidance today stating that we intend to exercise enforcement discretion to allow allulose to be excluded from the total and added sugars declarations on the Nutrition Facts and Supplement Facts labels when allulose is used as an ingredient. Allulose will still count towards the caloric value of the food on the label – but the guidance document issued today states our intent to exercise enforcement discretion to allow the use of a revised, lower calorie count. As with other ingredients, allulose must still be declared in the ingredient list. This is the first time the FDA has stated its intent to allow a sugar to not be included as part of the total or added sugars declarations on labels, a reflection of our flexible and science-based approach to food product labeling. This guidance is one of several that the FDA has already released or will soon be releasing to assist manufacturers in complying with new labeling requirements.”

Today, the U.S. Food and Drug Administration issued a draft guidance “The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels” to provide the current view on the declaration of calories, total carbohydrates, total sugars and added sugars for products that contain allulose on Nutrition and Supplement Facts labels. Allulose is a low-calorie sweetener that is naturally occurring in small amounts in wheat, some fruits, and a variety of other foods and can also be manufactured.

Under the FDA’s 2016 Nutrition Facts label rule, the amount of allulose needs to be counted towards the amount of total carbohydrates, total sugars and added sugars declared on the Nutrition and Supplement Facts labels. Additionally, under the 2016 Nutrition Facts label rule, allulose must be counted as four calories per gram of sweetener on Nutrition and Supplement Facts labels. This draft guidance states that the FDA intends to exercise enforcement discretion to allow manufacturers to exclude allulose from the amount declared in the total and added sugars declarations. Additionally, the guidance states that the FDA intends to exercise enforcement discretion to allow manufacturers to use 0.4 calories per gram of allulose when calculating the calories from allulose in a serving of a product. However, manufacturers must continue to include allulose in the total carbohydrates declaration.

The FDA plans to soon release additional guidance to help manufacturers in complying with new labeling requirements, including a guidance to address the declaration of added sugars on packages and containers of honey, maple syrup and certain cranberry products. In the meantime, the agency has addressed the unique properties of allulose in the draft guidance issued today.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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