Phospha E receives GRAS for use in foods
Phospha E vitamin E ingredient has been self-affirmed as GRAS
(generally recognized as safe), which will soon open the door for
its use in foods and beverages in the US.
Phospha E is a patented derivative of vitamin E that is said to have superior properties compared to its parent molecule. Phosphagenics said it has been shown to be better absorbed than vitamin E, both orally and through the skin, to lower cholesterol and triglycerides, prevent the formation of plaque in heart arteries, as well as having unique anti-inflammatory properties. Until now, the company has been selling Phospha E for use in dietary supplements and medical foods. However, the company has self-affirmed the ingredient as GRAS after an independent panel of food safety experts evaluated data related to the use of Phospha E in breakfast cereals, juice beverages and table fats. Phosphagenics said it is preparing a GRAS notification to inform the US Food and Drug Administration (FDA) of the self-affirmation. If FDA has no objection, the ingredient will be available for use by the US food industry. Phospha E is currently sold internationally as a dietary supplement by NBTY Inc under the name of Ester-E and is marketed worldwide in the personal care market as Vital ET by ISP Corporation. "GRAS status extends the permitted use of Phospha E beyond the nutritional supplement market and into the substantial US food industry, and represents a tremendous commercial opportunity for Phosphagenics," said Harry Rosen, Phosphagenics' president and CEO. In January 2007 Phosphagenics entered into an agreement with Nestlé for the firm to license the product for use in nutritional products aimed at metabolic syndrome, a cluster of health conditions that increase the risk of type 2 diabetes and heart disease. In October 2007, Nestle and Phosphagenics said they will begin human clinical trials for to establish the efficacy of Phospha E in the management of metabolic syndrome. The companies had said that Nestle would fund the clinical trial and would be granted a worldwide exclusive license for the use of Phospha E in medical foods, while Phosphagenics would manufacture and supply Phospha E to Nestle.
