In a recent ruling, the FDA has determined that tagatose, a naturally occurring but uncommon sugar, must be listed as Added Sugars on product labels when used as a food ingredient. Bonumose, a sweetener manufacturer that produces tagatose through a streamlined method utilizing plant-based starches and enzymes, had sought an exemption for tagatose from the Added Sugars label designation in 2018. The company argued that the FDA should consider a different classification for tagatose, citing research indicating it does not elevate the risk of chronic diseases and may even offer health benefits, which contradicts the rationale for Added Sugars labeling.
In its seven-page response, the FDA acknowledged the health studies provided by Bonumose but stated that tagatose contains too many calories to qualify for exemption. Tagatose has 1.5 calories per gram, whereas allulose—a different rare sugar that the FDA has exempted from the Added Sugars designation—contains 0.4 calories or less per gram. The FDA concluded, “We are not prepared to amend our regulations regarding the declaration of D-tagatose on Nutrition Facts labels at this time.” This ruling could pose challenges for Bonumose in marketing its new tagatose ingredient to U.S. manufacturers, as the company was gearing up to produce and promote it this year.
Today’s manufacturers are increasingly in search of sweeteners that are natural, closely mimic the taste of sugar, are low in calories, and do not contribute to the sugar load indicated on Nutrition Facts labels. Tagatose meets the first three criteria; it is naturally found in small quantities in fruits, cocoa, and dairy, is 90% as sweet as sugar, and contains about one-third of the calories of sugar. However, if it must be labeled as an “Added Sugar,” it may deter manufacturers from using it.
Under the revised Nutrition Facts panel, products must disclose the grams of added sugars per serving and the percentage of the daily recommended sugar intake from that product. Given that tagatose is similar to sugar in sweetness and structure, the reported grams may not differ significantly. Bonumose’s CEO, Ed Rogers, criticized the decision as arbitrary and illogical, asserting that it ignores the health benefits of tagatose. He pointed out that unlike most common sugars, tagatose does not cause spikes in blood glucose levels and can even lower them when consumed with other foods. Additionally, it does not promote tooth decay and may help reduce dental plaque while providing prebiotic benefits that nourish healthy gut bacteria.
The FDA did not dispute any of the health research presented by Bonumose but emphasized that the caloric content of tagatose influenced its decision. The Dietary Guidelines for Americans recommend limiting calories from added sugars to less than 10% of total caloric intake. The FDA’s rationale was that the “empty calories” from tagatose could accumulate throughout the day, complicating efforts to meet nutrient needs within calorie limits. Rogers contended that this reasoning was flawed as it overlooked the significant health benefits of tagatose.
Despite the FDA’s ruling, Rogers noted that some manufacturers have expressed a willingness to proceed with their tagatose-sweetened product plans regardless of the FDA’s classification. Furthermore, Bonumose is exploring opportunities to launch tagatose in other countries where labeling laws view it differently from sucrose-related sweeteners. The company has been collaborating with over 50 manufacturers on tagatose launches and maintains a notable partnership with Hershey, which supports tagatose and funds Bonumose’s new R&D center.
Additionally, Rogers mentioned that while tagatose is categorized as a sugar, there is room for marketing campaigns and label claims to highlight its unique benefits. Bonumose may also submit new information to the FDA, as the agency indicated that a new petition could be considered if fresh evidence becomes available. Rogers expressed frustration over the lengthy process leading to an “incomprehensible” decision, suggesting that it hinders innovation while negatively impacting consumers.
In light of the FDA’s decision, there remains a potential conflict of interest concerning the influence of high fructose corn syrup producers versus health-focused innovations like tagatose. Bonumose’s press release raised concerns about possible bias within the FDA, citing internal documents that may suggest favoritism towards industrial corn sweetener manufacturers. While Bonumose has the capability to produce allulose, Rogers emphasized that tagatose is superior in terms of health benefits.
In summary, Bonumose continues to advocate for tagatose as a beneficial food ingredient, emphasizing its advantages for consumers. The company aims to educate the market about tagatose while exploring opportunities in regions with more favorable labeling laws, all the while promoting the sweetener’s unique properties, such as its effectiveness in managing blood sugar levels and its role in supporting gut health.
Moreover, the conversation around tagatose and its classification is crucial in the broader context of innovative sweeteners. As consumers increasingly seek healthier options, the emergence of alternatives like lifetime liquid calcium magnesium citrate highlights the demand for ingredients that offer both health benefits and versatility in food applications.