Burlington, NJ, January 12, 2010 - Fuji Chemical Industry Co., Ltd., a Japanese pharmaceutical company and producer of premier natural astaxanthin, has attained GRAS (Generally Recognized As Safe) status for its AstaREAL® brand of astaxanthin for use as an ingredient in food and beverages. On January 6, 2010, Fuji received the official no-objection letter from the Food and Drug Administration (FDA) accepting Fuji's GRAS notification which was filed with the FDA on July 7, 2009. Prior to FDA notification a panel of experts convening in June 2009 independently determined that AstaREAL astaxanthin was Generally Recognized As Safe.
Mitsunori Nishida, president and CEO of Fuji Chemical said, "Achieving GRAS status fulfills one more milestone in Fuji's global development program of AstaREAL astaxanthin and opens the door for marketing astaxanthin as a food ingredient in the US as well as to increase greater global awareness of this magnificent material."
AstaREAL astaxanthin is a member of the carotenoid family of natural pigments closely related to beta carotene, lycopene and lutein. It is a powerful natural biological antioxidant found most abundantly in seafood. It is what gives the pink and red color to salmon, shrimp and lobster. However, animals as well as humans depend on their diet to obtain astaxanthin and other carotenoids since neither can produce it themselves. To provide a supply of natural astaxanthin to consumers throughout the world and to ensure maximum purity Fuji cultivates AstaREAL astaxanthin in fully enclosed state of the art bio-systems in Hawaii and Sweden.
Charles DePrince, president of Fuji Health Science, Inc., (Fuji Chemical's USA subsidiary) said, "As the world leader in natural astaxanthin production and research, Fuji demonstrates once again its commitment to quality and safety as its first priority. Fuji's enclosed systems have allowed much tighter specifications to be established as well as met on a consistent basis. Consequently, our GRAS notification includes specification for purity that is unique to AstaREAL."
AstaREAL astaxanthin has been marketed globally (including the US) for years as a dietary ingredient for use in supplements. Now as the first and only astaxanthin to attain GRAS status, AstaREAL is also permitted to be marketed as an ingredient in food and beverages within the US, expanding the potential market as well as the availability of astaxanthin to the consumer. Food categories for which astaxanthin is now allowed include baked goods, beverages, cereals, chewing gum, coffee, tea, dairy product analogs, frozen dairy desserts and mixes, hard candy, milk products, processed fruits and fruit juices, processed vegetables and vegetable juices and soft candy.
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