FDA rejects request to exempt tagatose from added sugars labeling in decision Bonumose criticized as ‘contradictory and illogical’

A rare non-cariogenic, low glycemic sugar with 92% the sweetness of sucrose, but only 38% of the calories (1.5 cal/g), tagatose is found naturally in a variety of foods, but is produced in commercial scale via a complex process usually starting with lactose (milk sugar) which gives it a price beyond the reach of most food manufacturers.

bonumose— which has patented an alternative, low-cost production method it claims could propel tagatose from a niche to a mainstream sweetener — is one of many companies including Unilever, Hershey and General Millswho urged the FDA to rethink how tagatose is labeled.

Confidence levels were high that changes could be on the way for tagatose after the FDA exempted allulose, another rare sugar, from labeling as total and added sugars in spring 2019(a move that sparked renewed interest in the sweetener) and subsequently released a request for comment on whether it should also rethink its approach to labeling other sugars that are metabolized differently from sucrose.

In its request for comment, the FDA said it was aware that rare sugars such as tagatose do not have the “same effects on the body as traditional sugars” and added only the sugars which “provided fewer calories, which are not associated with dental caries, and lead to a lower glycemic and insulin response than other sugars”could help manufacturers better meet consumer needs.

However, in a letter* sent to Bonumose this week in response to his citizen petition​calling for tagatose to be treated like allulose on food labels, the FDA said they should be treated differently because tagatose’s caloric contribution”is significantly higher than allulose​.”

FDA: calorie contribution of tagatose “is significantly higher than that of allulose”

Bonumose has been recognized by the FDA to provide evidence supporting the benefits of tagatose in several areas, from improved glycemic control and prebiotic effects to reduced risk of dental caries. However, he says, the calories formed “the basis of our decision here​.”

At 1.5 calories per gram, tagatose contains significantly fewer calories than sucrose (4 calories/gram), but significantly more than allulose (0.4 cal/gram), the FDA said: “The amount of empty calories in the diet provided by D-tagatose could be significantly higher than the amount provided by, for example, allulose or non-nutritive sweeteners.”

The FDA does not refer to other rare sugars in its letter, but its decision probably does not bode well for those hoping for a change in the labeling of isomaltulosegiven that it contains the same number of calories per gram as sucrose (4cal/g) despite its non-glycemic and tooth-friendly qualities.

Bonumose has developed a production processfor tagatose (which is usually made from lactose) “with extremely high yield, completely plant-based and low cost,” says CEO Ed Rogers: “It starts with starch, then maltodextrin and we can go straight to tagatose.”

The process, he claims, could lower the price below that of most sugar alcohols, and potentially even achieve cost parity with HFCS-55 if produced at scale.

Bonumose: “These calories are not empty calories, despite what the letter says”

Ed Rogers, CEO of Bonumose, which is preparing to start production of tagatose at a new facility in Virginia this summer, told FoodNavigator-USA that, “These calories are not “empty calories”, despite what the letter says. »

In a press release attacking the FDA “convoluted, contradictory and illogical letter“,Bonumose wrote:Tagatose has health benefits. Not only does tagatose not cause tooth decay, it even breaks up plaque, which means tagatose is suitable for toothpastes and mouthwashes, and has long been recognized by US and EU law for a health claim. dental.

As for blood sugar, she said:Not only does tagatose not raise blood sugar, it also has the effect of moderating sugar spikes caused by other ingredients, and under European law can carry a blood sugar lowering claim.

Finally, he noted:Tagatose feeds beneficial bacteria in the gut, making it healthy for the gut microbiome. In fact, the only calories present in tagatose are primarily due to tagatose acting as a soluble dietary fiber** in the large intestine.

Hershey — which invested in Bonumose last year through its arm C7 Ventures and is working with the company to develop better products for you — didn’t immediately respond to a request for comment, but expressed support for the changes. labeling, with R&D and Regulatory Affairs Director Dr. Amy Preston noting in a blog postLast year : “We also advocated for the rare sugar, tagatose, to benefit from the same exemption ​[as allulose].

* The FDA also denied a request by Bonumose to change regulations to allow voluntary reporting of “beneficial sugars” (defined by Bonumose as ketone monosaccharides with beneficial physiological effects) on a separate line of the Nutrition Facts panel. “Some sugars can be metabolized differently than traditional sugars that are not ketone monosaccharides,” said the FDA. “Therefore, defining a carbohydrate class in this way may exclude some sugars that are metabolized differently from traditional sugars.”

**According to Bonumose, there is evidence that tagatose has prebiotic effects, including inducing the production of the short-chain fatty acid butyrate and stimulating the growth of beneficial bacteria in the large intestine. However, his citizen petitionurging the FDA to classify tagatose as a dietary fiber was refusedlast summer.

Tagatose is an attractive alternative to sugar because it has a bulky, sugar-like sweetness with fewer calories and negligible impact on blood sugar, says Bonumose CEO Ed Rogers: “He is the closest thing to being a direct replacement for sugar in large-scale food production equipment.

Hershey and Unileversupported calls for tagatose to be exempted from added and total sugars labeling, although the Center for Science in the Public Interest said it was concerned about whether sugars metabolized differently than sucrose could cause digestive problems.

“We are concerned that D-tagatose, tested only in healthy adults in small studies, may also cause gastrointestinal effects at sufficient doses in some people, especially children who use tagatose (again , they are estimated to have higher exposures than adult users, on a body weight basis) and those with IBS.”

Rachel J. Bradford