American River Nutrition’s DeltaGold receives FDA GRAS status
Vitamin E product is derived from the rainforest annatto plant
The US Food and Drug Administration (FDA) has awarded Generally Recognised as Safe (GRAS) status to American River Nutrition for the company’s DeltaGold vitamin E tocotrienol ingredient, which is derived from the annatto plant.
AIBMR Life Sciences, a scientific and regulatory consulting firm, prepared the notification.
DeltaGold has been self-determined as GRAS since 2010 after a review of safety and toxicology data by an independent expert panel chaired by a former FDA and EPA toxicologist. The FDA GRAS status lends further support to the ingredient’s safety, and allows manufacturers to add DeltaGold to a variety of foods and beverages, including baked goods, cereals, milk products, nutritional bars, nuts, and fats and oils, among others.
Vitamin E is a family of eight separate but related molecules: four tocopherols (alpha, beta, gamma, delta) and four tocotrienols (alpha, beta, gamma, delta). While alpha-tocopherol is found in most multivitamins and is supplemented in foods, a growing base of evidence suggests that this popular vitamin E interferes with the uptake and function of tocotrienols.
American River Nutrition claims DeltaGold is the only tocopherol-free source of tocotrienol, and contains the highest amount of delta- and gamma-tocotrienols that is commercially available.
'This is the first time a tocopherol-free tocotrienol product has received FDA GRAS status,' said Barrie Tan, Founder and President of American River Nutrition.
'The product is uniquely derived from the rainforest annatto plant. With GRAS status, DeltaGold can branch into new product categories.'
