Additionally, FDA Finalizes Labeling Guidance for Low-Calorie Sugar Allulose

October 16, 2020

 Media Inquiries

 Nathan Arnold
 301-796-6248

The following quote is attributed to Susan Mayne, Ph.D., director of FDA’s Center for Food Safety and Applied Nutrition:

“Last year the FDA stated that we intend to exercise enforcement discretion for a sugar, allulose, to be excluded from the total and added sugars declarations on the new Nutrition Facts label, although it must still be included in the amount of total carbohydrates. The draft guidance was based on our commitment to taking a science-based approach to food product labeling decisions. Today, we are pleased to finalize this guidance and to provide additional information to manufacturers that use allulose as an ingredient.

The FDA is committed to providing information to manufacturers regarding the new Nutrition Facts label, which is why today we are also seeking information on certain sugars and sweeteners that are metabolized differently than other traditional sugars. We know that some manufacturers are looking for ways to reformulate their products to reduce the sugar content, while still providing products that meet consumer preferences. The use of sugars and sweeteners that provide fewer calories, that are not associated with dental cavities, and that result in a lower glycemic and insulinemic response than other sugars could be one way for industry to make products that help consumers meet dietary recommendations to limit added sugars intake.

We welcome input on these sugars. Our goal is to provide information on food labels that is meaningful to consumers, providing them the information that they need to make informed decisions about their food choices and health – and information that is also based in the latest nutritional science."

Additional Information

• Today, the U.S. Food and Drug Administration is taking two actions regarding labeling of certain sugars and sweeteners on the revised Nutrition Facts label. The new label requires additional information about added sugars, among other changes.
• First, the FDA is issuing a final guidance that includes information on the declaration of total carbohydrate, total sugars, added sugars and calories on the Nutrition Facts label for products that contain allulose. Allulose is naturally occurring in small amounts in wheat, some fruits and a variety of other foods and can also be manufactured. The final guidance states our intent to exercise enforcement discretion for 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 carbohydrate declaration, which is measured in grams on the label, and list it as an ingredient.
• Additionally, the FDA is issuing a Request for Information to receive information about sugars like D-tagatose and isomaltulose, which are metabolized differently than traditional sugars, e.g., table sugar. These sweeteners meet the definition of a sugar but do not have the same effects in the body as sucrose. While traditional sugar increases blood glucose and insulin levels after being consumed and has four calories per gram, non-traditional sugars, in some cases, provide fewer calories, lead to lower blood glucose and insulin levels after a meal relative to traditional sugars and/or may not cause cavities. These sugars do not include high-intensity sweeteners, such as aspartame, which are not sugars and contribute only a few or no calories when added to food.

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.