Stratum said GRAS status meant Artinia, as it is called, would be available for use in energy and sports drinks, fruit juices and meal replacement drinks; milk products such as smoothies, yogurt and yogurt drinks, cereal and energy bars, breakfast cereals, pastas and other baked goods at up to 70mg/kg per day.
"Achieving GRAS approval is a major milestone and a testament to the rigorous and extensive scientific and technical information associated with ARTINIA," said Joseph L Evans, PhD, Stratum’s pharmacology manager.
A toxicology report on Artinia first appeared in July last year in the journal Food and Chemical Toxicology. It involved feeding chitin-glucan to healthy Wistar rats at dietary levels of 0, 1, 5 and 10 percent for 13 weeks.
No adverse effects were found, and the ingredient was “tolerated without any signs of toxicity.”
Novus International-owned Stratum launched Artinia in March last year in conjunction with its Belgian business partner Kitozyme. In addition to the above study, the ingredient was the subject of a six-week human intervention study in 2010 for which results are expected in the first quarter of this year.
The study investigated the ingredients ability to boost heart health and the body’s natural defense against oxidized low-density lipoprotein (LDL) cholesterol by boosting blood levels of super oxide dismutase and glutathione peroxidase.
In addition it looked into Artinia’s effects on other established biomarkers of glycemic control, inflammation and human safety
The patent-pending ingredient is produced from the chitin-glucan molecule obtained from the fungus Aspergillus niger.