Allulose: FDA updates view on nature and value

Silver Spring / MD. (fda) The U.S. Food and Drug Administration (FDA) on 17 April, 2019, issued a draft guidance to provide its current view on the declaration of carbohydrates, total sugars and added sugars for products that contain allulose, a sweetener, on the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 The draft guidance also provides FDA’s current view on calculating the caloric value of allulose. The guidance is designed to assist manufacturers in complying with the Nutrition Facts label requirements.

0.4 calories per gram instead of 4 calories

FDA 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 The draft guidance also advises manufacturers of its intent to exercise enforcement discretion regarding the use of 4 calories per gram of sweetener to calculate the caloric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.

Allulose is different from other sugars

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. FDA 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 This draft guidance conveys FDA’s current thinking regarding allulose.

FDA will soon release other guidance documents regarding FDA’s current views on the Nutrition Facts label requirements. As an example, FDA will finalize its draft guidance on declaring added sugars on honey, maple syrup and certain cranberry products.

Comments on the draft guidance should be submitted within 60 days after publication in the Federal Register of the notice announcing the availability of the guidance to ensure that they are considered before work begins on the final guidance. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2019-D-0725.

For Additional Information please see the Federal Register Notice and the Draft Guidance for Industry: The Declaration of the Amount of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.

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FDA allows allulose to be excluded from total and added sugars counts on Nutrition and Supplement Facts labels when used as ingredient

«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 now 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 now 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.»

On 17 April, 2019, 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 now.