GPA’s First NutraStrong™ Certified Ingredient Just Got a Long-Overdue Regulatory Win
Late last year, the FDA issued an announcement with significant implications for prebiotics and the broader functional foods and beverages sector.
The announcement: The FDA has issued a letter of enforcement discretion exempting tagatose from “added sugars” and “total sugars” declarations on the Nutrition Facts label, and has formally set its caloric value at 1.5 cal/gram.
In 2022, the FDA denied tagatose the same labeling treatment granted to allulose, even though it acknowledged that tagatose does not behave like a conventional sugar in the body. A federal court later described this decision as “arbitrary and capricious.” The enforcement discretion letter is now in effect.
This ruling resolves a labeling issue that essentially conflicted with the scientific evidence. Tagatose is fermented in the large intestine, where it increases beneficial bacteria and stimulates production of short-chain fatty acids such as butyrate. Labeling it as an “added sugar” misinformed consumers about its actual effects.
GPA’s connection to tagatose runs deeper than this ruling. Tagatose was the first ingredient ever to earn NutraStrong™ Prebiotic Verified certification, a program built specifically to validate science-backed prebiotic ingredients. Under GPA’s Standards of Evidence, tagatose is recognized as a novel prebiotic with a developing but meaningful clinical foundation. We are pleased with the FDA decision, viewing it as a move that ensures labeling aligns with current evidence.
For formulators and brands, this change creates new opportunities. A functional ingredient with prebiotic activity, a low glycemic index, and sweetness comparable to sugar can now be used without labeling that undermines its positioning.
GPA will continue to monitor how this development influences formulation trends, consumer communication, and the regulatory landscape.
