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US FDA was ‘wrong’ to deem tagatose calorie content ‘significantly higher’ than allulose, says Bonumose CEO

The US Food and Drug Administration (FDA) was “wrong” to deem tagatose’s calorie content contribution “significantly higher” than allulose because the difference between the two sugar substitutes is less than between tagatose and sucrose, said Edwin Rogers, chief executive of tagatose manufacturer Bonumose.

The Virginia-based ingredients company recently petitioned the US regulator to exempt the rare sugar from total and added sugars in the Nutrition Facts panel, but late last month the FDA rejected the request. 

This was despite the fact that the FDA did permit the Nutrition Facts label waiver for another rare sugar, allulose, in 2019, and put out an open invite for comments on whether nutrition labels should reflect that some sugars are metabolised “differently than traditional sugars.” 

Food giants including Unilever, Tate & Lyle, Hershey and General Mills responded, advocating for nutrition labels to distinguish between traditional and differently-metabolised sugars including tagatose. 

Nevertheless, in its May response to Bonumose, the FDA rejected its attempt to exempt tagatose – a sugar that is 90% as sweet as sucrose but with just 38% of the calories, a low glycaemic index and no “fake or weird tasting” profile, according to the company’s website.

In the letter, the FDA said tagatose’s caloric contribution of 1.5 kcal/g is “significantly higher” than allulose.

FDA ‘wrong’ to deem tagatose’s calories ‘empty’

“We think the FDA is wrong,” Rogers told Ingredients Network. “Tagatose has 62% fewer calories than sucrose. Allulose has 90% fewer calories than sucrose. It is true that tagatose has 1.1 more calories per gram than allulose, but tagatose has 2.5 fewer calories than sucrose. If 1.1 calories per gram is ‘significantly higher,’ how is 2.5 calories per gram not ‘significantly lower’?”

In its response, the FDA also “somehow mistook” tagatose’s calories as “empty,” Rogers claimed.

The FDA stated in its letter that tagatose has 1.5 calories per gram, compared to 4 calories per gram for sugar, more than 2 calories per gram for most sugar alcohols, 2 calories per gram for non-digestible carbohydrates (e.g., soluble fibre), and 0.4 calories per gram for allulose. 

“But tagatose has calories for the same reason soluble fibre does: because it feeds the good gut bacteria in the large intestine, leading to a healthy gut,” said Rogers. 

He added that Bonumose’s evidence was “voluminous” in support of the nutrition label sugars exemption, stressing: “Tagatose does not spike blood glucose or insulin, does not cause dental cavities, is low calorie, is associated with positive health outcomes, and more accurately should be counted under ‘fibre’ grams, not ‘sugar’ grams.”

Public health will be hurt by FDA decision, says CEO

Rogers said the decision could mean that, in the short-term, Bonumose may put more focus on selling tagatose for uses “where the FDA’s decision is irrelevant,” for instance in regions outside of the US or in non-food industries.

“Until the FDA’s decision is corrected, it will be the US consumer that is hurt the most, and indirectly, US public health,” he warned. 

Meanwhile, Bonumose is “continuing on plan,” he said. “We will have to devote more resources to informing consumers and food companies of the benefits of tagatose, and to achieving the right labelling for tagatose. 

Bonumose’s message to consumers: ‘Trust your gut, not bureaucracy’

“Tagatose is nearly a drop-in replacement for regular sugar; yet, has positive health benefits. The FDA's label does not alter the fundamental goodness of tagatose.”

Asked if Bonumose could try another petition, however, Rogers replied: “We are not disclosing our next steps at this time.” 

He went on to issue a plea to consumers. “Regrettably, I do not think the FDA listens to innovative, young companies that have the ability to disrupt established power structures within food and medicine. Tagatose can be a big part of the food-as-medicine solution to pervasive diet-related health problems. 

“That is good news for consumers but frightening to others. Our message to consumers: ‘trust your gut, not bureaucracy.’”