Last week, the FDA announced that tagatose—a naturally occurring yet uncommon sugar—must be labeled as Added Sugars when used as a food ingredient. Bonumose, a sweetener manufacturer that produces tagatose through a simplified process utilizing plant-based starches and enzymes, had requested an exemption from this designation in 2018. The company argued that the FDA should consider tagatose differently, citing research indicating that it does not elevate chronic disease risk and actually offers health benefits, which contradicts the rationale for the Added Sugars label.
In its seven-page response, the FDA acknowledged the health benefits presented by Bonumose but determined that tagatose contains too many calories to qualify for exemption from the Added Sugars label. Tagatose has 1.5 calories per gram, contrasting with allulose, another rare sugar exempted by the FDA, which has 0.4 calories per gram or less. The ruling stated, “We are not prepared to amend our regulations regarding the declaration of D-tagatose on Nutrition Facts labels at this time.” This decision could pose challenges for Bonumose in marketing its new tagatose ingredient to U.S. manufacturers, especially since they had scaled up production and were ready to launch it this year. Manufacturers today generally seek natural sweeteners that closely mimic the taste of sugar, are low in calories, and do not increase the sugar content as indicated on Nutrition Facts labels. Tagatose meets the first three criteria, as it is naturally found in small amounts in fruits, cacao, and dairy, is 90% as sweet as sugar, and has about one-third of the calories of traditional sugars. However, if it must be categorized as an “Added Sugar,” manufacturers may hesitate to incorporate it.
Under the revised Nutrition Facts panel, products must disclose the grams of added sugars per serving and the percentage of the recommended daily sugar intake. Given the similarities in sweetness and structure between tagatose and sugar, this disclosure may not differ significantly. Bonumose’s CEO, Ed Rogers, criticized the decision as arbitrary and illogical, asserting, “We think one that will ultimately be changed.” He provided reasons why tagatose should not be classified as an added sugar and emphasized its merits as a beneficial food ingredient. Similar arguments, supported by scientific studies, were part of Bonumose’s 2018 petition to the FDA.
Unlike most sugars, tagatose does not cause spikes in blood glucose levels; in fact, it can lower blood sugar when consumed with other foods. It does not contribute to tooth decay and has been shown to break down dental plaque. Additionally, it has prebiotic effects, nourishing healthy gut bacteria with dietary fiber. Rogers noted that the fibers in tagatose account for its caloric content. Studies have demonstrated that tagatose can effectively manage hyperglycemia, serve as a toxin inhibitor for individuals with gut pathogens, and even be used in treatments for sickle cell anemia. It is also suitable as a sweetener in toothpaste.
The FDA did not dispute any of the research findings and affirmed tagatose’s health benefits in its decision. An FDA spokesperson clarified that the caloric content of tagatose influenced the ruling. “The Dietary Guidelines for Americans recommend that Americans limit calories from added sugars to less than 10 percent of total calories. A key consideration in determining which sugars should be included in the declaration of Added Sugars is whether the ingredient contributes empty calories to the diet,” the spokesperson stated. According to the FDA, the higher caloric content of tagatose compared to allulose could lead to significant cumulative caloric intake throughout the day, making it harder for consumers to meet nutrient needs within calorie limits. Rogers argued that this reasoning was arbitrary since it overlooked the health benefits of tagatose.
He expressed confusion over how the FDA could acknowledge the advantages of tagatose while basing its decision solely on calorie counts, especially given that tagatose has a significantly lower caloric load than traditional sugars. “It would be extremely helpful if the FDA allowed consumers to understand that tagatose is not like regular sugar,” Rogers said, finding it perplexing that the FDA has chosen to withhold this information from consumers. The FDA’s draft decision on allulose indicated that while caloric contribution is important, the department should also take into account other factors, including associations with dental caries and effects on blood glucose and insulin levels, when considering labeling sweeteners as added sugars.
Following the ruling, Bonumose issued a press release accusing the FDA of favoring high fructose corn syrup producers over consumers by suppressing truthful information about tagatose. However, by press time, the release was removed. The statement included many of the arguments Bonumose had previously made in its petition to the FDA and highlighted the similarities between tagatose and allulose. The FDA exempted allulose from added sugar labeling in 2019, recognizing its different metabolism from sucrose and its significantly lower caloric contribution. Since then, allulose has gained considerable popularity, with manufacturers struggling to keep up with demand.
Bonumose’s press release also contained allegations against the FDA, suggesting that the decision regarding tagatose “could have been ghost-written by high fructose corn syrup (HFCS) lobbyists.” It pointed out that most allulose in the market is derived from fructose produced by HFCS companies through a complex and costly process reliant on HFCS production. Additionally, the release claimed that internal FDA documents obtained through a Freedom of Information Act request indicated a potential bias against health-focused innovations in favor of industrial corn sweetener producers. In an interview, Rogers refrained from elaborating on the alleged bias at the FDA mentioned in the press release, stating, “That’s not something I want to go into now,” but confirmed that they possess documents suggesting potential bias, which they plan to reveal at the appropriate time.
An FDA spokesperson noted that they were unaware of the specific documents referenced by Bonumose. “Our decision regarding their petition was based on the evidence presented to us by Bonumose,” the spokesperson stated. Rogers indicated that while Bonumose is considering various actions regarding what it perceives as bias at the FDA, nothing is off the table. He emphasized that this decision only affects how tagatose is classified on Nutrition Facts labels. Tagatose still holds a generally recognized as safe status and can be used in products.
Bonumose has been collaborating with over 50 manufacturers on tagatose launches and intends to continue these efforts. The company has a notable partnership with Hershey, which is financing Bonumose’s new R&D center and has openly supported the use of tagatose. Some manufacturers have already expressed their intention to proceed with plans for tagatose-sweetened products despite the FDA’s ruling. There is also the possibility of focusing on tagatose launches in other countries, as labeling laws abroad do not classify tagatose in the same category as sucrose-related sweeteners. Rogers mentioned that there is global interest in the sweetener.
Moreover, he acknowledged that Bonumose and manufacturers may need to work harder to communicate the benefits of tagatose. While it is categorized as a sugar, there are opportunities for marketing campaigns and label claims that can highlight its advantages. Rogers stated that they could also provide more information to the FDA, although they believe they have already supplied sufficient data from Bonumose’s 2018 petition. The FDA mentioned that if new information emerges, a new petition concerning tagatose can be submitted.
“It certainly makes things confusing for other companies and for us to wait four years only to receive a decision that is incomprehensible,” Rogers commented. He added that this situation would likely require more time and financial resources, ultimately harming consumers. In 2020, after the FDA exempted allulose from added sugar labeling, it sought comments on how to best address similar sweeteners—those metabolized differently than traditional sugars—on product labels. Thirty-one companies and individuals, including Bonumose, submitted their comments to the docket. As of now, no decisions or proposals have been made regarding this matter, and the FDA did not comment on whether regulatory actions would follow.
Rogers speculated that Bonumose, which specializes in producing a variety of rare natural sugars for ingredient use, might adjust its focus for the time being. “Maybe it’s a bit ironic: We can also make allulose,” he noted. “We can produce allulose in a more streamlined process than other companies, but we believe tagatose is the superior option.” Additionally, he pointed out that tagatose could be an excellent complement to products like nutricost calcium citrate powder, which is often marketed for its health benefits.