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ChromaDex Corp. announced that an independent scientific panel of experts supports the GRAS (generally recognized as safe) status of its ingredient pTeroPure. pTeroPure is an ultra-pure formulation of the naturally occurring compound pterostilbene, found in blueberries. pTeroPure has the potential to impact heart health by supporting cholesterol and blood pressure while providing additional benefits related to cognitive function and healthy aging. By achieving GRAS status, ChromaDex can now expand pTeroPure into the food and beverage industry, moving beyond the supplement industry where it has recently been incorporated in more than 20 nutraceutical products.
Following a comprehensive review of the safety, toxicology and proposed usage, an independent panel of experts reached a unanimous decision that pTeroPure is safe for use in food and beverage products. GRAS is a U.S. Food and Drug Administration (FDA) designation that an ingredient in food is considered safe by experts. The Allowable Daily Intake (ADI) for pTeroPure is up to 30mg/kg (or 1.89 grams) per day for food use and intake.
"The industry experts from the American Institute for Biosocial and Medical Research, including former U.S. Department of Agriculture and FDA staffers, all agreed that pTeroPure merits this designation," remarked Frank Jaksch, CEO of ChromaDex, Inc. "Their acceptance of GRAS for pTeroPure is a testament to the extensive scientific research for pterostilbene in general and the exceptional technical information that demonstrates the safety of pTeroPure in particular."
The first human clinical trial to evaluate pTeroPure is currently underway at the University of Mississippi to evaluate the compound in patients with lipid (cholesterol) disorders. The primary outcome includes standard lipid laboratory markers (HDL, LDL and triglycerides), and secondary endpoints include blood pressure, markers of oxidative stress, and safety. ChromaDex holds exclusive worldwide patent rights for pterostilbene based on technology licensed from the University of Mississippi and the USDA.
William Spengler, President, ChromaDex, Inc. states, "Achieving GRAS status for pTeroPure provides a significant new commercial opportunity for the Company to enter the multi-billion dollar market segment for natural food and beverage ingredients. Based on a scientific foundation, we are seeking to establish a leadership role for pTeroPure in the rapidly growing market for health and wellness."
pTeroPure was recently named the 2010 North American Most Promising Ingredient of the Year by the prestigious independent research company, Frost & Sullivan. Capitalizing on the diverse potential applications of the product, ChromaDex is also developing pTeroPure for the skincare and pharmaceutical markets.