The Food and Drug Administration said it will use enforcement discretion to allow allulose, a rare sugar, to be excluded from the total sugars declaration and added sugars declaration on the Nutrition Facts Label when allulose is used as an ingredient, according to draft guidance issued by the F.D.A. on April 17.
The F.D.A. previously had said allulose counted in determining the amount of total sugars and added sugars in a product and that it had four calories per gram. The draft guidance also said the F.D.A. will use enforcement discretion to allow manufacturers to use 0.4 calories per gram of allulose when calculating the calories from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.
The draft guidance, which may be found here, may lead to the increased use of allulose as a way to reduce the amount of sugar, including added sugar, in food and beverage products.
“The latest data suggest that allulose is different from other sugars in that it is not metabolized by the human body in the same way as table sugar,” said Susan Mayne, Ph.D., director of the F.D.A.’s Center for Food Safety and Applied Nutrition. “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 toward 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 F.D.A. 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.”
The F.D.A. said it received citizen petitions to change the labeling of allulose from Tate & Lyle, P.L.C. and Food Lawyers. Matsutani Chemical Industry Co. Ltd. also submitted results from a clinical trial that assessed the impact of allulose consumption on dental plaque. Rare sugars are monosaccharides existing in small quantities in nature, according to Matsutani Chemical Industry Co. Ltd.
The F.D.A. will accept comments on the draft guidance within 60 days of publication in the Federal Register. Electronic comments may be submitted at www.regulations.gov. Written comments may be submitted 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.
The F.D.A. will begin enforcing the mandatory declaration of added sugars on the Nutrition Facts Label on Jan. 1, 2020. Added sugars are sugars that either are added during the processing of foods, or are packaged as such, and include sugars (free, mono- and disaccharides), sugars from syrups and honey, and sugars from concentrated fruit or vegetable juices that are in excess of what would be expected from the same volume of 100% fruit or vegetable juice of the same type.