A comprehensive review of the safety, toxicology and proposed usage by an independent scientific panel was found to support the GRAS status of the ingredient at an 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," said Frank Jaksch, CEO of ChromaDex.
"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 ingredient, recently hailed by Frost & Sullivan as the 2010 North American Health Ingredients Most Promising Ingredient of the Year, can now expand beyond supplements, where it has recently been incorporated in more than 20 nutraceutical products.
“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,” said William Spengler, President, ChromaDex.
“Based on a scientific foundation, we are seeking to establish a leadership role for pTeroPure in the rapidly growing market for health and wellness.”
Pterostilbene is chemically related to resveratrol, and reportedly holds promise for improving cardiovascular health, glucose levels, and cognitive function.
Comparing pterostilbene to resveratrol, the former is claimed to be metabolized at a slower rate in the body giving it more opportunity to be absorbed into the blood stream.
Research on the properties and potential of pterostilbene has been conducted by a group of scientists at the University of Mississippi and the ARS – a scientific research arm of the US Department of Agriculture.
ChromaDex has licensed patents from the University of Mississippi and the USDA related to cholesterol control, diabetes, and oxidative stress.
The University of Mississippi is also the site of the first human clinical trial to evaluate pTeroPure 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.