The US Food and Drug Administration (FDA) has exempted low-cal sweetener tagatose from ‘added sugar’ labeling requirements on US food labels following a lengthy campaign by Virginia-based startup Bonumose to get the agency to change its position.
While interest in tagatose is high, the fact it counts as ‘added sugar’ on US food labels has been a stumbling block for food manufacturers, according to Bonumose, which has been locked in a battle with the FDA for years over how the sweetener is treated on the Nutrition Facts panel in the US.
Bonumose, which has developed a lower-cost production method, says food manufacturers are far more likely to use tagatose—which is almost as sweet as sugar but only has 38% of the calories—if it does not count as ‘added sugar’ on food labels.
Judge reverses ‘arbitrary and capricious’ FDA decision
The FDA has acknowledged the benefits of tagatose in areas from improved glycemic control to reduced risk of dental caries. However, it denied a request from Bonumose to exempt tagatose from ‘added sugar’ labeling in 2022, despite granting such a request for fellow rare sugar allulose.
Bonumose hit back with a lawsuit, and in 2024, a court agreed that the FDA had acted arbitrarily and capriciously in denying Bonumose’s petition.
In a letter of enforcement discretion just published on its website (but dated Nov. 2025), the FDA says it will “exercise enforcement discretion with respect to the exclusion of D-tagatose from the declarations of ‘added sugars’ and ‘total sugars’ on the Nutrition Facts label.”
It also recognized its caloric value as 1.5 cals/gram (vs 4 cals/g for regular sugar) and acknowledged its non-cariogenic and low-glycemic credentials.
Move has ‘sparked tremendous market interest,’ says ASR Group
Welcoming the news, Bonumose CEO Ed Rogers said: “What I have noticed is a tremendous amount of interest in using tagatose specifically because of its health benefits, not just as a benign replacement for traditional sugars.”
He added: “You can imagine the confusion caused when tagatose is touted for its health benefits yet had to be counted under added sugars on nutrition facts panels. Consumers are already suspicious enough, and that mixed message would have kept tagatose effectively off the market.”
Bonumose investor and distribution partner ASR Group said the FDA’s about-face had “sparked tremendous market interest,” while Bonumose said it is “focused on increasing tagatose production capacity by orders of magnitude over what exists at the Virginia demo plant.”
The firm, whose backers also include Hershey, started manufacturing tagatose at a demo-scale plant in Virginia in late 2022 and signed a cooperation agreement with Roquette to “enhance the scalability” of the sweetener in 2024.
Tagatose production
An attractive alternative to sucrose as it has bulk and sugar-like sweetness, tagatose is found naturally in a variety of foods but is produced on a commercial scale via a process typically starting with lactose (milk sugar) that gives it a price tag beyond the reach of most food manufacturers.
Bonumose, which uses maltodextrin as its source material, has patented an alternative low-cost production method it claims could catapult tagatose from a niche to a mainstream sweetener.
“The FDA’s decision impacts tagatose potential and interest across a number of food and beverage categories,” said Jim Kappas, VP specialty ingredients at ASR Group, which started distributing tagatose in spring 2023. The key benefits driving interest are tagatose’s low glycemic index, color formation (it undergoes the Mailliard reaction), ease of handling (tagatose is free-flowing, due to its low hygroscopicity), and prebiotic effect (it increases short chain fatty acid production in the gut), he said.
According to Bonumose, studies in humans and experimental models suggest that tagatose is fermented in the large intestine, where it increases levels of beneficial bacteria, and stimulates the production of beneficial short-chain fatty acids such as butyrate.
