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Tagatose, a low-calorie, natural sweetener with EU-approved health claims, is now exempt from added sugar labelling in the US – a move that could see uptake scale significantly.
The US Food and Drug Administration (FDA) outlined the exemption in a letter of enforcement discretion addressed to the CEO of Virginia-based tagatose manufacturer Bonumose. The startup has been campaigning for several years for such an exemption.

Tagatose is found naturally in a variety of foods, including some dairy products, whole wheat, and various fruits, and is produced commercially via a multi-step enzymatic process. It is 90% as sweet as sugar but much lower in calories, containing 1.5 calories per gram.
In the EU, the ingredient has two approved EU health claims for contributing to tooth mineralisation and inducing a lower blood glucose spike than table sugar – two aspects recognised by the FDA in its letter to Bonumose.
Speaking to Ingredients Network, Edwin Rogers, CEO of Bonumose, said the decision indicates an FDA leadership that has “common sense, sincerity, and a desire for action to solve solvable diet-related diseases”.
“There are a lot of promising solutions to reducing sugar, and a lot of bad solutions,” Rogers said, adding that Bonomuse believes its tagatose could be “one of the most important sugar alternatives going forward”.
This is largely to do with its versatility as a sugar alternative and the scalability of Bonomuse's production method, he said.
Tagatose comes “really close” to matching the sweetness, taste, flavour, bulking and other properties of sucrose, Rogers said, making it suitable for all categories. Some of the best opportunities for its wider commercial use, though, are in chocolate, ready-to-eat cereal, ice cream, yoghurt and other confections, he said.
“Now the focus is all about scaling,” the CEO said.
Bonumose's proprietary method, which uses enzymes to create tagatose from plant-derived ingredients, gives good scalability promise, he said, not only because it is low-cost but also because it can be done locally.
The startup's method relies on existing food ingredient value chains and farmer-grown crops, which means scaling can happen in the US, he explained, instead of relying on China where around 90% of sugar alternatives currently come from.
“Food and beverage companies can reformulate with tagatose to reduce sugar and add prebiotic fibre benefits whilst maintaining sugar-like taste and texture and not confusing consumers with contradictory messages,” he said.
Marion Nestle, Paulette Goddard professor of nutrition, food studies and public health at New York University, Emerita, said that the tagatose exemption from sugar labelling will see companies “immediately start using more of it” but added that this is not necessarily a good idea.
“Tagatose is one of those things that marks products as ultra-processed,” Nestle said. “It's a naturally occurring sugar, sweet, but poorly absorbed, used in place of sugar to present fewer calories and less risk for tooth decay.”
The US-based non-profit, Center for Science in the Public Interest (CSPI), had shared findings from a study indicating tagatose is “poorly absorbed by the body”, she said, and also cited reports on the ingredient being linked to gastrointestinal effects when consumed in excess amounts.
Health Canada, Food Standards Australia New Zealand, and the World Health Organization (WHO), however, had not raised concerns over the use of tagatose in foods, according to the CSPI.
“A zero calorie, safe replacement for sugar is the holy grail of the food industry. They keep trying,” Nestle said.
Rogers said Bonumose will certainly continue to use its enzyme technology to develop other rare sugars and push ahead with scaling tagatose in the bid to widen access to sugar alternatives. “We think rare sugar production is important to the national interest,” he said.
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