F.D.A. clears GRAS status of carotenoid ingredient

by Jeff Gelski
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BURLINGTON, N.J. — The Food and Drug Administration has no objection to the Generally Recognized As Safe (GRAS) status of the AstaReal brand of astaxanthin for use as an ingredient in food and beverages, according to an F.D.A. letter received by Fuji Chemical Industry Co., Ltd., a Japanese pharmaceutical company and producer of natural astaxanthin. Fuji Health Science, Inc., a marketing and sales subsidiary of Fuji Chemical Industry Co., is based in Burlington.

Astaxanthin is a member of the carotenoid family of natural pigments related to beta-carotene, lycopene and lutein. The natural biological antioxidant is found in seafood. It gives the pink and red color to salmon, shrimp and lobster.

“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 U.S. as well as to increase greater global awareness of this magnificent material,” said Mitsunori Nishida, president and chief executive officer of Fuji Chemical.

AstaReal astaxanthin for years has been marketed globally, including in the United States, as a dietary ingredient for use in supplements. Fuji Chemical Industry in July 2009 filed a GRAS notice inventory with the F.D.A. for the use of Haematococcus pluvialis extract containing astaxanthin esthers for use as an ingredient in baked foods, beverages, cereals, chewing gum, coffee and tea, dairy product analogs, frozen dairy desserts and mixes, hard candy, milk products, processed fruit and vegetables, processed vegetables and vegetable juices, and soft candy at use levels of 0.5 mg of astaxanthin per serving.

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