Virginia-based startup Bonumose has achieved a significant milestone in its ongoing dispute with the US Food and Drug Administration (FDA) over the labeling of tagatose. This low-glycemic, tooth-friendly rare sugar, which boasts 92% of the sweetness of regular sugar but only 38% of the calories, has been a focal point of contention due to its classification as ‘added sugar’ on US food labels. The FDA’s rigid stance has long been a stumbling block for food manufacturers eager to embrace tagatose as a mainstream sweetener.
Tagatose, naturally found in various foods, offers an attractive alternative to sucrose due to its bulk and sugar-like sweetness. However, its commercial production, typically starting with lactose (milk sugar), has been prohibitively expensive for most food manufacturers. Bonumose has disrupted this paradigm by patenting a low-cost production method using maltodextrin, potentially transforming tagatose from a niche product into a widespread sweetener. Despite the high interest in tagatose, its ‘added sugar’ label has deterred many food manufacturers, prompting Bonumose to engage in a protracted legal battle with the FDA.
The FDA has acknowledged the benefits of tagatose, including improved glycemic control, prebiotic effects, and a reduced risk of dental caries. However, the agency has steadfastly refused to exempt tagatose from ‘added sugar’ labeling, a decision it made for another rare sugar, allulose, in 2019. This inconsistency has been a point of contention for Bonumose CEO Ed Rogers, who has criticized the FDA’s stance as “contradictory and illogical.”
In response to Bonumose’s 2018 citizen petition, the FDA argued that tagatose, with its 1.5 calories per gram, has more calories than allulose, which contains only 0.4 calories per gram. This caloric difference, according to the FDA, justified the different labeling treatments. Bonumose countered with a lawsuit, claiming that the FDA’s decision forced manufacturers to engage in misleading speech, violating their First Amendment rights, and that the agency’s differing treatment of tagatose and allulose was “arbitrary and capricious,” thus violating the Administrative Procedure Act.
In a recent development, a court in the District of Columbia has vacated the FDA’s order denying Bonumose’s citizen petition. Judge Randolph D. Moss noted that the FDA had acted “arbitrarily and capriciously” in its decision-making process. The court will remand the case for further agency proceedings but will not compel the FDA to reach a specific conclusion. Judge Moss highlighted the FDA’s failure to explain why the reduction of tooth decay risk was a significant factor in the allulose decision but not in the tagatose decision. Additionally, the FDA did not justify why glycemic control was less important than caloric contribution in the case of tagatose.
This ruling does not immediately change how tagatose is treated on US food labels. However, it does mandate that the FDA re-evaluate its decision, guided by the court’s findings. Jonathan W. Emord, general counsel for the Alliance for Natural Health USA, who represented Bonumose, emphasized the urgency for prompt agency action due to the First Amendment implications and the potential harm to significant subclasses of the American population.
Bonumose CEO Ed Rogers expressed gratitude for the legal representation and the court’s detailed decision, viewing it as a victory for healthier food options. The startup, backed by prominent investors like Hershey and ASR Group, began manufacturing tagatose at a demo-scale plant in Virginia in late 2022. Despite initial setbacks following the FDA’s labeling decision, interest in tagatose has resurged, partly due to the shortcomings of other sweeteners and Bonumose’s recent Nutra Strong prebiotic certification.
Jim Kappas, VP of specialty ingredients at ASR Group, noted strong interest in tagatose across various categories, including beverages, chocolates, snacks, confections, and retail products. Tagatose’s low glycemic index, ease of handling, and prebiotic effects are driving this interest. Studies suggest that tagatose is fermented in the large intestine, increasing levels of beneficial bacteria and stimulating the production of short-chain fatty acids like butyrate.
The case, Bonumose vs The FDA, FDA commissioner Dr. Robert Calif, and the USA, filed in the District of Columbia, marks a pivotal moment in the ongoing debate over sugar labeling and the future of rare sugars in the food industry.