Quercetin Dietary Supplement Ingredient Now GRAS Approved for Food and Beverages

Quercegen Pharmaceuticals LLC (Sudbury MA), a supplier of quercetin ingredients for the pharmaceutical and nutraceutical industries, announced that its QU995 quercetin dietary supplement ingredient has received GRAS status and can now be used in food and beverages. Read Quercegen’s comprehensive GRAS safety dossier submitted to FDA.

Quercetin is a natural polyphenolic antioxidant flavonoid found in many plants. It plays an important role in the inhibition of enzymes involved in free radical production. According to Quercegen, quercetin has been the subject of over 7000 research studies. Specifically, the company’s QU995 quercetin ingredient has been used in U.S. Department of Defense funded clinical trials in animals and humans since 2006, it says.

“Achieving GRAS status represents a major milestone for Quercegen Pharmaceuticals,” said CEO Gordon Brooks. “After many years of hard work and significant investment, we are delighted to be able to offer products with our highly purified, food-grade quercetin at levels of up to 500 mg per serving.” QU995 was developed together with Merck S.A. through a patented extraction and purification process.

Q-Force is Quercegen’s branded soft chews product and it contains the company’s patented Quercegen QB3C formula. QB3C is designed to improve the bioavailability of quercetin and adds vitamins B3 and C to the 99.5% pure quercetin. This stabilizes quercetin in water and boosts the natural bioavailability of quercetin in circulating plasma, thereby significantly enhancing its therapeutic benefits, says the company.

One of Quercegen’s affiliates, Quercegen Agronegocios, is the world’s largest producer of quercetin and operates a 3600-hectare farm in northern Brazil. It processes plant materials into crude rutin and quercetin for purification at its plant in Sao Luiz, and the resulting purified products are shipped around the world for inclusion in pharmaceuticals, dietary supplements, and food.

Notable Quercetin Studies

Among studies performed on quercetin, Quercegen cites a study on the effects of quercetin supplements on cold and flu symptoms.

“DARPA researchers have identified a very safe, natural antioxidant called quercetin and developed it into a new form that is now available to the military and the general public,” Quercegen quotes Dr. Tony Tether, director, Defense Advanced Research Projects Agency, in testimony submitted to the Subcommittee on Terrorism, Unconventional Threats, and Capabilities, House Armed Services Committee, United States House of Representatives, on March 13, 2008.

“Among quercetin’s many potential benefits is illness prevention,” Tether stated. “In a randomized, placebo-controlled study, quercetin helped prevent viral illnesses like colds and flu after physical exertion. Following a strenuous three-day exercise routine, 50% of the control group became ill with colds and flu, whereas only 5% of the quercetin-supplemented group did. This important immune-protective effect will help keep our warfighters healthy during training and deployment.”

“Quercetin exerts strong antioxidative, anti-inflammatory, anti-pathogenic, and immune regulatory effects in vitro and in animal-based studies,” the company also quotes David C. Nieman, DrPH, FACSM, director of the Human Performance Lab, North Carolina Research Campus, and professor at Appalachian State University, as saying. “Epidemiological data indicates reduced rates of cardiovascular disease and various types of cancer in groups self-selecting diets high in quercetin. Several recent supplementation studies in athletes have focused on quercetin’s potential influences as a countermeasure to postexercise inflammation, oxidative stress, and immune dysfunction in improving endurance performance and in reducing illness rates following periods of physiological stress.”