KANSAS CITY — Food companies increasingly have turned to allulose in their sugar-reduction efforts since the US Food and Drug Administration in 2019 exempted the “rare” sugar from being included as a carbohydrate, sugar or added sugar on the Nutrition Facts Label. Other non-traditional sugars could join allulose in receiving the exemption, but in some cases years of research might be needed.

The FDA in October 2020 asked for comments on sugars that are metabolized differently than conventional sugars, drawing interest from industry. Both General Mills, Inc., Minneapolis, and the Hershey Co., Hershey, Pa., commented.

Traditional sugars cause an increase in blood glucose and insulin levels, according to the FDA. They have 4 calories per gram and are associated with tooth decay. Some sugars, however, are metabolized differently and do not have all the same effects on the body as traditional sugars. The non-traditional sugars include “rare” sugars, which are so named because they are found in nature in small quantities.

“Due to their unique properties, rare sugars offer potential health benefits as part of an overall healthy diet pattern, including slower intestinal absorption rate, lower caloric contribution, improved glycemic response, prebiotic function and lower risk of tooth decay,” said Wendelyn Jones, PhD, executive director of the Institute for the Advancement of Food and Nutrition Sciences, a Washington-based non-profit organization. “However, the scientific literature does not contain a publication that highlights potential physiological benefits and describes the unique properties of several rare sugars within a single document. Thus, IAFNS funded work to develop a narrative overview summarizing the metabolic and physiological properties of uniquely metabolized sugars as compared to the primary monosaccharides and disaccharides in the diet to address this research gap.”

The research funded by the IAFNS was led by John L. Sievenpiper, MD, PhD, associate professor in the University of Toronto’s Department of Nutritional Sciences, and colleagues at the university. It was published Aug. 2 in Nutrition Reviews. Given the huge costs of conducting large, randomized trials, funding would need to be multisectoral, Dr. Sievenpiper’s team concluded. Governmental funding agencies, health associations like the American Heart Association, and the industry that produces and markets the sweeteners should be engaged, according to the researchers.

The length of the studies and the number of participants in them would depend on the primary outcomes of interest, according to the researchers. Trials aiming to find differences in longer-term intermediate outcomes such as body weight, cholesterol, blood pressure and glycemic control would require more than 100 participants over 3 to 12 months. Assessing differences in outcomes of clinical and public health importance such as diabetes, cardiovascular disease, cancer and death would require randomized trials involving thousands of participants over 3 to 10 years.

The evidence so far

After focusing on 50 studies, the researchers listed strengths and drawbacks of five selected rare sugars.

“Allulose and isomaltulose have the most evidence from randomized controlled trials to support their benefits compared to various other rare sugars,” Dr. Sievenpiper said. “Allulose, with almost no caloric content, has been shown to reduce the postprandial glycemic response to other co-ingested carbohydrates and contributes to weight loss. While isomaltulose, also known as Palatinose, has the same caloric content as sugar, it has been shown to have a low-glycemic index and improve insulin resistance, with possible benefits for individuals with type 2 diabetes.”

While L-arabinose has been shown to reduce glucose absorption in rodent studies, studies in humans will be needed to better understand the long-term effects of L-arabinose consumption on cardiometabolic outcomes. D-tagatose shows promise as an alternative sweetener, especially in individuals with type 2 diabetes. Trehalose has fewer clinical trials compared with other rare sugars and needs more long-term clinical and mechanistic studies.

General Mills lists its criteria

General Mills in its comments to the FDA proposed ingredients should be defined as rare carbohydrates when they meet the following criteria: chemically a sugar, meaning mono- and di-saccharides and excluding fiber or carbohydrates with three or more monomeric units; less than 4 calories per gram; low-cariogenic potential based on a pH of less than 5.7 of dental plaque; and elicits a lower glycemic or insulinemic response compared to traditional sugars.

Beneo, Inc., Parsippany, NJ, gave comments to the FDA on its Palatinose brand of isomaltulose. The slow release of glucose from Palatinose provides sustained and balanced energy while avoiding the typical sugar spike and crash, said Kyle Krause, product manager, functional fibers and carbohydrates, North America for Beneo. With a low-glycemic index of 32, Palatinose keeps insulin levels low.

“The beneficial effect of Palatinose on blood glucose levels and its corresponding insulin response have been demonstrated in various human clinical studies and in all groups of people, including those who are healthy, people with diabetes, during pregnancy, and those who have a normal weight or are overweight,” Mr. Krause said.

Palatinose has been shown to replace sucrose gram for gram in snacks, baked foods and other grain-based foods, he said. In chocolate, it contributes to a lower blood glucose response while also supporting sustained energy, and it is tooth-friendly.

Allulose in new products

The Hershey Co. in its comments to the FDA cited data from Innova Market Insights, Arnhem, The Netherlands, showing how allulose has increased in use since its exemption. While 20 new products in the United States contained allulose in the first half of 2019, 54 contained the sweetener in the second half of 2019. Those numbers grew to 86 in the first half of 2020 and 107 in the second half.

“We urge FDA to build on this experience and continue to expand opportunities for added sugars reduction by addressing the labeling of non-traditional sugars more broadly, as a category,” the Hershey Co. said.

Besides allulose, other non-traditional sugars that the FDA could explore are tagatose; isomaltulose; the monosaccharides sorbose, ribose, allose and L-arabinose; and the disaccharides trehalose and kojibiose, according to the Hershey Co. The company has partnered with ASR Group, West Palm Beach, Fla., to co-lead an equity investment in Bonumose, Inc., Abemarle County, Va., which is involved in rare sugars such as allulose and tagatose.

Top categories for new product innovation with allulose are tabletop sweeteners, frozen desserts (both dairy and non-dairy), dietary supplements, confectionery items and snack bars, said Christina Coles, senior associate marketing manager, sugar reduction and specialty sweeteners, for Ingredion, Inc., Westchester, Ill.

“Allulose is not typically used all by itself to replace the entire sugar content in a full sugar product,” said Didem Icoz, senior manager, sugar reduction and specialty sweeteners for Ingredion. “When using additional sugar reduction solutions, or a smaller amount of sugar in addition to the allulose, take all the ingredients in a formula into account when determining potential or perceived health advantages.”

Tate & Lyle, PLC, London, cited Mintel data showing the year 2020 had three times the number of product launches with allulose when compared to 2019.

“Popular applications for allulose are the nutrition bar, ice cream and bakery categories,” said Abigail Storms, head of global sweeteners for Tate & Lyle. “As more brands continue to innovate healthful and tasty products, we anticipate new product launches will span across eating occasions like breakfast and snacking.”

In the baking category, a challenge arises in reducing sugar, calories and carbohydrates to improve the nutritional profile while still maintaining the bulk and texture, she said.

“When used in baked goods at GRAS (Generally Recognized As Safe) inclusion rates, formulators can achieve meaningful sugar and calorie reduction and deliver on consumers’ taste expectations,” she said. “Allulose also works well in combination with other sugar reduction tools such as soluble corn fiber and stevia sweeteners. Using allulose in combination with other sweeteners can help formulators achieve deeper sugar reduction and can make great tasting grain-based foods with significantly reduced sugar and net carbs.”

In chocolate, developers may incorporate up to 25% of allulose to achieve significant sugar and calorie reduction.

“It can be combined with other low- or no-calorie ingredients such as soluble corn fiber and stevia sweeteners to make delicious and indulgent reduced-sugar and reduced-calorie chocolate confections,” Ms. Storms said.