U.S. Markets closed

FDA Accepts Clinical Research Underlying GLUCODOWN® Dietary Fiber Labeling

BENTONVILLE, Ark., March 13, 2019 /PRNewswire/ -- GLUCODOWN®, manufactured by Glucose Health, Inc. (GLUC), is the leading functional tea beverage in the over-the-counter diabetic nutritional retail category, which encompasses the more than 100 million Americans estimated to be diabetic or pre-diabetic.1 Food and Drug Administration ("FDA") regulations2 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).3

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:

  1. post-prandial blood sugar levels;
  2. glucose and lipids metabolism; and,
  3. digestive health.

All product 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.

First distributed online in partnership with Amazon in the third quarter of 2018, GLUCODOWN® Raspberry Tea Mix quickly achieved the status of an Amazon's No. 1 new product release – for the entire iced tea category (including all regular, diet and ready-to-drink iced teas).  Both Amazon and brick & mortar sales of GLUCODOWN® Peach, Lemon and Raspberry tea mixes are currently being supported by television commercials running on Hallmark and Game Show Network as well as weekly Facebook advertising. Additional advertising campaigns, expanding to national talk radio, are planned in the coming weeks.

About Glucose Health, Inc. (GLUC)

Glucose Health, Inc. is a publicly-traded company with the ticker symbol (GLUC). GLUCODOWN® is an innovative functional tea beverage which serves the fast-growing over-the-counter diabetic nutritional retail category.  GLUCODOWN® Peach, Lemon and Raspberry tea mixes are sold online and in pharmacies in all 50 States and are proudly made in Arkansas and Minnesota. For the GLUCODOWN® Amazon storefront click here

1Centers for Disease Control and Prevention, National Diabetes Statistics Report, 2017

2Nutrition and Supplement Facts Label Final Rule on May 27, 2016.

3https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm610111.htm

 

Cision

View original content:http://www.prnewswire.com/news-releases/fda-accepts-clinical-research-underlying-glucodown-dietary-fiber-labeling-300811477.html