Virginia-based startup Bonumose has secured a preliminary victory in its battle with the US Food and Drug Administration (FDA) over the labeling of tagatose, a low-glycemic, tooth-friendly rare sugar with 92% of the sweetness of regular sugar but only 38% of the calories.
An attractive alternative to sucrose as it has bulk and sugar-like sweetness, tagatose is found naturally in a variety of foods but is produced on a commercial scale via a process typically starting with lactose (milk sugar) that gives it a price tag beyond the reach of most food manufacturers.
Bonumose, which uses maltodextrin as its source material, has patented an alternative low-cost production method it claims could catapult tagatose from a niche to a mainstream sweetener.
While interest in tagatose is high, however, the fact it counts as ‘added sugar’ on US food labels has been a stumbling block for food manufacturers, according to Bonumose, which has been locked in a battle with the FDA for years over how the sweetener is treated on the Nutrition Facts panel in the US.
Legal battle over tagatose labeling
The FDA has acknowledged the benefits of tagatose in multiple areas from improved glycemic control and prebiotic effects to reduced risk of dental caries. However, it has refused to exempt tagatose from ‘added sugar’ labeling on food labels, despite granting such a request for fellow rare sugar allulose in spring 2019, a decision blasted by Bonumose CEO Ed Rogers as “contradictory and illogical.”
The FDA has acknowledged that rare sugars such as tagatose do not have the “same effects in the body as traditional sugars.” However, in a response to Bonumose’s 2018 citizen petition calling for tagatose to be treated like allulose on food labels, the agency ultimately concluded that they should be treated differently because tagatose (1.5cals/g) has more calories than allulose (0.4cals/gram).
Bonumose responded with a lawsuit* arguing that forcing manufacturers to label tagatose as ‘added sugar’ compels misleading speech and violates their first amendment rights and that the FDA’s differing treatment of tagatose vs allulose was “arbitrary and capricious” and violates the Administrative Procedure Act.
Judge vacates FDA order denying Bonumose citizen petition
In a memorandum opinion seen by AgFunderNews, a court in the District of Columbia denied both parties’ motions for summary judgment on the First Amendment claim, but agreed that “the FDA acted arbitrarily and capriciously in denying Bonumose’s citizen petition.”
As a result, said Judge Randolph D. Moss, the court will “vacate the FDA’s May 18, 2022 denial order concerning Bonumose’s tagatose petition and will remand for further agency proceedings, but will not compel the FDA to reach any conclusion on remand.”
He added: “The agency never explains why the reduction of the risk of tooth decay was an important consideration in the allulose decision but was irrelevant in the tagatose decision… nor did it explain why control of glycemic levels plays second fiddle to caloric contributions.”
In short, he said, the FDA “never explained why the difference in caloric contribution between allulose and tagatose presented health consequences of sufficient magnitude to disregard the other health benefits of tagatose— that is, reduced risk of dental caries and improved glycemic control.”
What happens next?
The ruling does not mean that food manufacturers can immediately change the way tagatose is treated on US food labels, however, said Alliance for Natural Health USA general counsel Jonathan W. Emord, who represented Bonumose.
He told AgFunderNews: “The court reversed the agency decision and remanded it to the FDA for further proceedings. Those proceedings must be guided by the court’s decision, albeit Judge Moss did not dictate the outcome.
“Because mandatory labeling of sugars is compelled speech, there is a First Amendment component that requires prompt agency action,” he added.
“Moreover, as the court explained in its decision, the arguments for exception from sugars labeling reveal significant subclasses of the American population are being injured by FDA’s position… consequently, FDA must act promptly or risk court action to compel it to act.”
Bonumose CEO Ed Rogers told us: “We are immensely grateful for Jonathan’s excellent representation and for Judge Moss’ well-reasoned, detailed decision. More than six years after Bonumose filed its citizen petition, this is a victory for healthy children and adults, and for better-for-your food/beverage brands.”
An FDA sp0kesperson told AgFunderNews: “The agency is reviewing the decision and is not able to comment at this time.”
Tagatose application areas beverages, chocolates, snacks, confections, and retail
Bonumose, which has high-profile backers including Hershey and sugar refiner ASR Group, started manufacturing tagatose at a demo-scale plant in Virginia in late 2022.
“We’ve seen strong and broad interest, which waned somewhat following the FDA’s decision to label tagatose as added sugar,” said Jim Kappas, VP specialty ingredients at ASR Group, which started distributing the product in spring 2023 in a recent interview with AgFunderNews. “In recent months, however, there has been a resurgence of interest, in part due to shortcomings of other alternatives, and also due to Bonumose obtaining Nutra Strong prebiotic certification in March 2024.
“Categories of strong interest include the following, roughly in order of degree of interest: beverages, chocolates, snacks, confections, and retail, both tabletop and baking mixes. The key benefits driving interest are tagatose’s low glycemic index, color formation [it undergoes the Mailliard reaction], ease of handling [tagatose is free-flowing, due to its low hygroscopicity], and prebiotic effect [it increases short chain fatty acid production in the gut].”
According to Rogers at Bonumose, studies in humans and experimental models suggest that tagatose is fermented in the large intestine, where it increases levels of beneficial bacteria, and stimulates the production of beneficial short-chain fatty acids such as butyrate.
* The case is Bonumose vs The FDA, FDA commissioner Dr. Robert Calif, and the USA. 1:23-cv-00645 filed in the District of Columbia in March 2023.
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