FDA accepts clinical research underlying GLUCODOWN® dietary fiber labeling

FDA provides that only forms of dietary fiber demonstrating a “beneficial physiological effect on human health”, can be declared on nutritional supplement product labels, as dietary fiber

GLUCODOWN®, manufactured by Glucose Health, is the leading functional tea beverage in the over-the-counter diabetic nutritional category, which encompasses the more than 100 million Americans estimated to be diabetic or pre-diabetic. Food and Drug Administration (“FDA”) regulations enacted in 2016, provide that only forms of dietary fiber demonstrating a “beneficial physiological effect on human health”, can be declared on nutritional supplement product labels, as dietary fiber.

More than two years ago, a citizen’s petition prepared by Archer Daniels Midland was submitted to the FDA on behalf of Fibersol®-2, the trade name of the dietary fiber in GLUCODOWN®.  The FDA concluded, “based on (its) careful review of the strength of scientific evidence” that Fibersol®-2 meets “our regulatory definition of dietary fiber” as established in 2016, in Title 21 CFR 101.9(c)(6)(i).

The result is GLUCODOWN® is the first instant tea mix in America, enriched with a form of soluble dietary fiber recommended by the Food & Drug Administration for inclusion in the aforementioned Title 21. More than 20 years of clinical research and 100 published studies establish the beneficial physiological impacts of the Fibersol®-2 soluble dietary fiber in GLUCODOWN®.

This body of scientific evidence establishes, in particular, beneficial impacts on: post-prandial blood sugar levels;glucose and lipids metabolism; and digestive health.

All products labeling on containers of GLUCODOWN® Peach, Lemon and Raspberry tea mixes reference these three functional impacts in a manner that is concise and measured, with appropriate cautionary statements for the benefit of all consumers.

Additionally, every GLUCODOWN® container provides a link www.glucodown.com/clinical-data to an informative product and educational website, where many of the relevant scientific studies have been compiled.