Cyanotech and Earthrise Nutritionals Announce United States-Grown Spirulina Completes FDA Generally Recognized as Safe --GRAS-- Notification Process.Business Editors/Health/Medical Writers KAILUA KONA, Hawaii--(BUSINESS WIRE)--Nov. 10, 2003 Cyanotech Corporation (Nasdaq:CYAN), a world leader in producing high-value natural products from microalgae, and Earthrise earth·rise n. The rising of the earth above the horizon as seen from the moon. Nutritionals, Inc. (Petaluma, CA), today jointly announced that the US Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has no questions about the companies' determination that Spirulina spirulina Any cyanobacteria in the genus Spirulina. A traditional food source in parts of Africa and Mexico, spirulina is an exceptionally rich source of vitamins, minerals, and protein, and one of the few nonanimal sources of vitamin B12. is Generally Recognized as Safe Generally Recognized as Safe (GRAS) is a United States of America Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food (GRAS GRAS - A public domain graph-oriented database system for software engineering applications from RWTH Aachen. ) for addition to a variety of foods. Spirulina is a dried form of the common blue-green microalgae (Cyanobacteria cyanobacteria (sī'ənōbăktĭr`ēə, sī-ăn'ō–) or blue-green algae, photosynthetic bacteria that contain chlorophyll. ), Arthrospira platensis. Cultivated in the United States by Cyanotech and Earthrise, Spirulina is marketed as a nutritional supplement and is noted for its content of fatty acids, vitamins, beta-carotene, zeaxanthin, phycocyanin phy·co·cy·a·nin n. A blue phycobilin occurring especially in the cells of cyanobacteria. Noun 1. phycocyanin - blue pigment in algae and vegetable protein. In March 2003, Cyanotech and Earthrise submitted a joint notice to the FDA reporting their determination, through scientific procedures, that the Spirulina cultivated by both companies is GRAS for addition to a variety of foods. Conclusion of the notification procedure (by the FDA's written response) provides assurance to food manufacturers and consumers that the FDA has had an opportunity to review the safety evaluation of Spirulina for its intended use in specialty food bars, powdered nutritional drink mixes, snacks such as popcorn, and as a condiment in salads and pasta. Speaking on behalf of both companies were John E. Dore, Ph.D., Scientific Director for Cyanotech and Amha Belay, Ph.D., Scientific Director for Earthrise. "We are gratified grat·i·fy tr.v. grat·i·fied, grat·i·fy·ing, grat·i·fies 1. To please or satisfy: His achievement gratified his father. See Synonyms at please. 2. that the FDA had no objection to our GRAS determination for Spirulina. This added safety assurance is a benefit we are pleased to offer our customers in the functional food and dietary supplement markets and it paves the way for Spirulina's use in other food products." About Cyanotech Cyanotech Corporation, a world leader in microalgae technology, produces high-value natural products from microalgae and is the world's largest commercial producer of natural astaxanthin (pronounced "asta-zan-thin") from microalgae. Products include BioAstin(R) natural astaxanthin, a powerful antioxidant with expanding application as a human nutraceutical; NatuRose(R) natural astaxanthin for the aquaculture aquaculture, the raising and harvesting of fresh- and saltwater plants and animals. The most economically important form of aquaculture is fish farming, an industry that accounts for an ever increasing share of world fisheries production. and animal feed industries; Spirulina Pacifica(R), a nutrient-rich dietary supplement; and phycobiliproteins, which are fluorescent pigments used in the immunological diagnostics market. Spirulina Pacifica and BioAstin are sold directly online through the Company's website, www.nutrex-hawaii.com, as well as through resellers worldwide in over 30 countries. Technical information for the Company's phycobiliprotein products is available at www.phycobiliprotein.com. Corporate and product information is available at www.cyanotech.com. "Safe Harbor" Statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 - Cyanotech Except for statements of historical fact, the statements in this press release are forward-looking. Such statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include, but are not limited to, general economic conditions, forecasts of sales in future periods, changes in sales levels to our largest customers, weather patterns, risks associated with the acceptance of new products, competition, foreign exchange fluctuations, government regulation, and other factors more fully detailed in the Company's recent Form 10-Q and annual form 10-K filings with the Securities and Exchange Commission. |
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