Aussie Vitamin E Ingredient Determined GRAS

Phosphagenics Limited, Melbourne, Australia, has announced that an independent panel of food-safety experts unanimously concluded that the company’s patented Phospha E® is GRAS for use in breakfast cereals, juice beverages and table fats.

Phosphagenics claims Phospha E, a derivative of vitamin E, enables greater vitamin E absorption and activity. The company notes that in preclinical studies, Phospha E, when given orally, has been shown to lower blood cholesterol and triglyceride levels, inhibit the formation of arterial plaques, and suppress the main inflammatory pathways involved in metabolic syndrome.

The company is preparing a GRAS notification to inform FDA of the expert panel’s conclusion. If FDA has no further comment, GRAS designation allows manufacturers to produce and sell foods that include Phospha E in the U.S. food industry.

“GRAS status extends the permitted use of Phospha E beyond the nutritional-supplement market and into the substantial U.S. food industry, and represents a tremendous commercial opportunity for Phosphagenics,” said Harry Rosen, president and CEO, Phosphagenics.

In April 2006, Phosphagenics and Nestlé Nutrition, a unit of Nestlé S.A., entered into a research agreement to develop Phospha E for use in nutritional products that target the prevention and treatment of metabolic syndrome.

As noted on the Phosphagenics website, a phase 2 clinical trial of Phospha E, fully funded by Nestlé Nutrition, is currently underway.