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.
In its decision, the FDA says that because the "empty calories" of tagatose are so much greater than what a consumer takes in when eating something with allulose, small amounts of tagatose calories could "add up throughout the day and contribute to the diet in a way that makes it difficult to meet nutrient needs within calorie limits."
"That is the reason they gave, but doing so we believe was arbitrary because it ignored the other health benefits," Rogers said.
He said he can't understand how the FDA can affirm the benefits of tagatose and make its decision solely on calorie counts, especially when the caloric load of tagatose is so much less than that of more traditional sugar sweeteners.
"It would be extremely helpful if the FDA would allow consumers to understand that tagatose is not like regular sugar," Rogers said. "Why the FDA has chosen to deny that information to consumers is a little perplexing."
In its draft decision on allulose, the FDA says a sweetener's caloric contribution is important, but the department should also consider "other evidence including their association with dental caries, their effect on blood glucose and insulin levels" in deciding whether to label sweeteners as added sugars.
Conflicts of interest?
After the decision was issued, Bonumose issued a scathing press release accusing the FDA of siding "with high fructose corn syrup producers and against consumers, by suppressing truthful information about tagatose." By press time, Bonumose had taken the release down.
The release contained many of the arguments Bonumose made in its initial petition to the FDA four years ago, as well as comparing tagatose to allulose. The FDA decided in 2019 to exempt allulose from added sugar labeling because it is metabolized differently than sucrose and contributes significantly fewer calories. Since this designation, allulose has been vastly popular, with manufacturers struggling at one point to meet demand.
But Bonumose's press release also made some accusations against the FDA. It stated the decision on tagatose "could have been ghost-written by high fructose corn syrup (HFCS) lobbyists," and brings out the point that most allulose today "is made from fructose by HFCS companies in a complicated and costly process that relies upon HFCS production." And, the press release says, internal FDA documents received through a Freedom of Information Act request "indicate a potential FDA bias against health-focused innovation and in favor of industrial corn sweetener producers."
In an interview, Rogers did not go into detail about the potential bias at the FDA referenced in the press release.
"That's not something I want to go into now," he said. "But yes, we have documents that we received from a FOIA request that indicate a potential bias, and we will bring those out at the appropriate time."
In an email, an FDA spokesperson did not know which documents Bonumose might be referring to.
"There were many statements made in Bonumose’s press release, however our decision related to their petition was based on the evidence that was presented to us by Bonumose," the department's spokesperson said.
Rogers said that in terms of action Bonumose may take about what it calls bias at the FDA, nothing is off the table.
Rogers said it is important to note this decision only relates to how tagatose is classified on a Nutrition Facts label. Tagatose still has generally recognized as safe status, and can be used in products.
Bonumose has been working with more than 50 manufacturers on tagatose launches, Rogers said, and the company will continue. Bonumose has a high-profile partnership with Hershey, which is funding the company's new R&D center and which has been vocal in its support for tagatose.
Rogers said some manufacturers have already said they don't care about the FDA's ruling and they will continue with their tagatose-sweetened product plans.
There's also the possibility of concentrating on tagatose launches in other countries. Labeling laws elsewhere look at tagatose differently, not putting it in the same classification as sucrose-related sweeteners. Rogers said he has heard interest in the sweetener from potential customers worldwide.
There also may be more onus on Bonumose and manufacturers to get the message out about the benefits of tagatose, Rogers said. While it counts as a sugar, there can be marketing campaigns and label claims that can try to communicate what it does.
Rogers said they can also try to provide more information to the FDA, though he says they should have enough from Bonumose's 2018 petition. And, the FDA said in an email, if there is new information available, a new petition about tagatose can be submitted.
"It certainly makes things confusing for other companies and for us to have to wait four years and then get to get a decision which is incomprehensible," Rogers said. "And I guess it's just going to take more time and more money. Meanwhile, consumers are being harmed."
In 2020, after the FDA exempted allulose from added sugar labeling, it sought comments on how to best address similar sweeteners — metabolized differently that traditional sugars — on package labels. Thirty-one companies and individuals, including Bonumose, added their comments to the docket. To date, nothing has been decided or proposed. The FDA did not comment on whether a regulatory action would be coming from this docket.
Rogers said maybe Bonumose — which specializes in making an array of rare natural sugars scalable for ingredient use — will also change its focus for the time being.
"Maybe it's a bit ironic: We can also make allulose," Rogers said. "We can make allulose in a more streamlined process than other companies can make allulose. But we just think tagatose is the better of the two."