Despite multiple rejected attempts, Virginia-based alt-sweetener startup Bonumose will keep working to “compel and convince” the FDA to reconsider a regulation that mandates that its proprietary alt-sweetener, tagatose, be labeled under total or added sugar counts on Nutrition Facts Panels (NFPs), said the company’s CEO Ed Rogers. According to Rogers, Bonumose’s plant-based sugar substitute behaves like a dietary fiber rather than an “empty calorie” sweetener.
In 2018, the company submitted a citizen petition requesting that tagatose be added to the exemption list after the agency issued draft guidance that allowed allulose, another rare alt-sweetener with similar nutritionals, to be exempt from NFP sugar counts. Allulose’s exemption marked the first time a sweetener was allowed to be excluded from the sugars list.
The following year, Bonumose submitted a second petition arguing that tagatose instead should be labeled as a dietary fiber. The company said it included “reams of data” in the petition showing that the ingredient acts like a prebiotic, “feeds good gut bacteria, and contributes to gut health,” when digested. However, the FDA rejected that petition in June 2020, acknowledging the benefits and behavior of the ingredient when digested, but basing its rejection solely on the chemical makeup of tagatose, stating that a monosaccharide cannot be considered a fiber.
By late 2020, the agency finalized its guidance on allulose’s exemption and issued a Request For Information to show the difference in how tagatose is metabolized. Bonumose, Hershey, Unilever, General Mills, Center for Science in the Public Interest, and several others, subsequently submitted public comments in support of tagatose.
After four years of waiting, the FDA rejected Bonumose’s 2018 sugar-related citizen petition last week. The company disagreed, calling the decision “a convoluted, contradictory, and illogical letter that could have been ghost-written by high fructose corn syrup (HFCS) lobbyists.”
“At first [the FDA] ignored our requests for dialogue, would not even respond to our phone calls or emails, and later would say only that they were ‘working on it,’ and then made a decision without giving Bonumose a chance to refute FDA’s factual and logical mistakes,” Rogers said.
Bonumose said the agency recognized tagatose’s positive health benefits in the letter, but said the agency cited the ingredient’s calorie count as the sole reason for its rejection. Tagatose contains 1.5 calories per gram, which is 1.1 calories per gram higher than allulose’s 0.4. According to Roger’s those calories are not empty calories, like the FDA claims in its rejection letter, but rather contribute to the ingredient’s gut-support benefits.
“Tagatose, like soluble fiber, feeds good gut bacteria that produce short chain fatty acids (SCFAs) that are beneficial for gut health and overall health,” Rogers said. “Those SCFAs have caloric value. The caloric value of tagatose is due to it being a prebiotic, fiber-like nutrient, not empty at all. We wonder if the FDA considers fiber’s calories to be ‘empty calories,’ too.”
What is Tagatose?
Tagatose is typically derived from dairy and naturally forms when milk is heated, creating an ingredient with a similar texture, sweetness and appearance to table sugar. However, despite being a functionally equivalent ingredient to table sugar in food and beverage products, tagatose has not previously been produced at a scale that would make it cost-efficient for industry-wide use because, when derived from dairy, it only produces extremely small quantities.
When Bonumose was founded in 2016, it set out with the goal of producing tagatose, among other alternative sweeteners, at a more affordable price point. It soon developed a lower-cost, patented process that can create tagatose from entirely plant-based materials.
In the past, Tagatose has also been most commonly used in the dental industry and has been proven to treat and prevent many common oral diseases. It has long been recognized for its dental claims under both U.S. and European law.
The rare sugar, both in its dairy and plant-based form, has a glycemic index of three, which is significantly lower than sucrose at 68 and glucose at 100, according to Bonumose. Under European law, the ingredient can carry a blood glucose lowering claim as it has also been shown to moderate blood glucose levels.
Last year, Bonumose secured an investment from both The Hershey Company and America Sugar Refining (ASR) Group, parent of Domino Specialty Ingredients, to accelerate its production goal and began building its nearly $28 million, 36,000 square foot production plant in Virginia. The facility will expand Bonumose’s R&D capabilities as it looks to develop new alt-sweeteners and has the potential to help lower the cost of tagatose below that of sugar alcohols, creating cost-parity with high fructose corn syrup (HFCS-55), according to the company. Rogers said the facility will be ready to produce tagatose at a commercial scale within weeks.
“We believe this will be the largest tagatose plant, by capacity, in the world,” said Rogers. “Other companies, mainly in China, make tagatose from lactose (milk sugar), which is a more complicated and expensive process. Bonumose has global patents on its tagatose process, and also can make allulose in a better way than third parties, as well as many other rare, healthy monosaccharides.”
What does this FDA ruling mean?
Roger’s said the notice from the FDA has compelled the company to devote additional resources to achieving an “accurate tagatose description” and called the decision a “disservice to consumers,” but said otherwise it would carry on “business as usual. He said due to the company’s global presence, the decision won’t hinder tagatose production or adoption by food companies, but stated he believes the decision was influenced by the corn industry rather than the findings of the FDA.
Rogers claims to have viewed internal FDA documents (via the Freedom of Information Act) that “indicate a potential FDA bias against health-focused innovation and in favor of industrial corn sweetener producers.” He declined to share these documents with NOSH at this time.
“Tagatose’s attractiveness as a great-tasting, lower-cost sugar replacement with positive health benefits of course makes entrenched corn sweetener companies nervous,” he said “And tagatose’s potential to make some high-priced pharmaceuticals obsolete must make the FDA and drug companies nervous, too.”
Aside from tagatose, Bonumose also aims to develop and produce other sweeteners, including allulose, D-allose and D-mannose, in addition to exploring applications for the ingredient in pet food, dietary supplements and crop protection. However, according to Rogers “this is not over” and he will continue to fight for accurate tagatose labeling alongside and with the full support of its investment partners. The Hershey Company, for example, has stated that sugar-reduction is a core part of it’s growth strategy, citing both its investment in Bonumose and FDA advocacy in support of those efforts.
“If the FDA actually cared about human health, it would encourage, not discourage, the broad adoption of tagatose,” Rogers said. “Early in Bonumose’s history the communist government-owned Chinese Academy of Sciences tried to steal our invention and claim it as its own, and we beat them. Now we will fight the FDA’s folly, and we believe the FDA will not be successful in suppressing the tagatose truth for too long.”
The Corn Refiners Association declined to comment for this story.