FDA rules tagatose must be classified as an added sugar

When used as a food ingredient, tagatose — a naturally occurring but rare sugar — will need to be disclosed on product labels as Added Sugars, the FDA ruled last week.

Sweetener maker Bonumose, which produces the sugar through a streamlined method using plant-based starches and enzymes, had petitioned the FDA to exempt the sweetener from the Added Sugars designation in 2018. The company argued the FDA should use its discretion to give tagatose a different designation because research has found that it does not increase risk for chronic disease and instead has been shown to have positive health effects, which conflicts with the rationale behind the Added Sugars labeling.

In its seven-page response, the FDA agrees with the health research submitted by Bonumose, but says tagatose has too many calories to be exempted from the label designation. Tagatose has 1.5 calories per gram, while allulose — another rare sugar that the FDA has exempted from the Added Sugars designation — has 0.4 calories or less per gram.

“We are not prepared to amend our regulations regarding the declaration of D-tagatose on Nutrition Facts labels at this time,” the ruling states.

The ruling could make it difficult for Bonumose to sell its new tagatose ingredient to U.S. manufacturers. The Virginia sweetener company had scaled up its tagatose production and was prepared to produce and market it this year. In general, today’s manufacturers are looking for sweeteners that are natural, close to the taste of sugar, low in calories, and that don’t add to a product’s sugar load as indicated on the Nutrition Facts label. Tagatose already met the first three criteria. It’s naturally found in small amounts in fruits, cacao and dairy. It’s 90% as sweet as sugar and has similar structural properties. and it has about a third of the calories of sugar.

If it needs to be included on labels as an “Added Sugar,” however, it may dissuade manufacturers from including it. Under the revamped Nutrition Facts panel, products must report the grams of additional sugars each serving of a product contains, as well as the percentage of the recommended daily intake of sugar a person will get from eating it. Considering tagatose is so similar to sugar in terms of sweetness value and structure, this number may not be much different.

A decision that ‘ignored the other health benefits’

Bonumose CEO Ed Rogers said he believes the decision was arbitrary and does not make sense.

“It just is an illogical decision and an inconsistent decision. And we think one that will ultimately be changed,” he said.

Rogers provided reasons that tagatose shouldn’t be labeled as an added sugar, and why it stands on its own as a beneficial food ingredient. Similar reasons — and scientific studies to back them up — were in Bonumose’s 2018 petition to the FDA.

Unlike most common sugars, tagatose doesn’t spike blood glucose levels. In fact, Rogers said, it can reduce blood sugar levels when consumed with other foods. It doesn’t cause tooth decay, and has been found to break up dental plaque. It also has prebiotic effects, feeding healthy gut bacteria with dietary fiber. And, Rogers said, those fibers are the entire reason tagatose has the caloric load that it does. Tagatose has been shown in studies to be as effective at managing hyperglycemia as diabetes drugs, as a toxin inhibitor for people with a gut pathogen, and can be used in a treatment for sickle cell anemia. It also can be used as a sweetener in toothpaste.

In its decision, the FDA didn’t contest any of this research and affirmed the health benefits of tagatose. In an email, an FDA spokesperson confirmed that the calories in tagatose was behind its decision.

“It just is an illogical decision and an inconsistent decision. And we think one that will ultimately be changed.”

“The Dietary Guidelines for Americans recommend that Americans limit calories from added sugars to less than 10 percent of total calories. In determining which sugars should be included in the declaration of Added Sugars on the label, a key consideration is whether the ingredient provides empty calories to the diet,” the email states.