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CFSAN/Office of Food Additive Safety
June 12, 2002
John E. Dore, Ph.D.
73-4460 Queen Kaahumanu Hwy, #102
Kailua-Kona, HI 96740
Re: GRAS Notice No. GRN 000101
Dear Dr. Dore:
The Food and Drug Administration (FDA) is responding to the notice, dated March 8, 2002, that R. Todd Lorentz, Ph.D., submitted on behalf of Cyanotech Corporation and Earthrise Nutritionals in accordance with the agency's proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS)). FDA received the notice on March 19, 2002, and designated it as GRAS Notice No. GRN 000101.
The subject of the notice is Spirulina. The notice informs FDA of the view of Cyanotech Corporation and Earthrise Nutritionals that Spirulina is GRAS, through scientific procedures, for use as an ingredient in foods such as bars, powdered nutritional drink mixes, and as a condiment in salads and pasta, at levels ranging from 0.5 to 3 grams per serving size.
In a letter dated May 28, 2002, you asked that FDA cease to evaluate your notice while you clarify and prepare additional information for a new notice. Given your request, we ceased to evaluate your GRAS notice, effective May 28, 2002, the date that we received your letter. In a letter dated May 30, 2002, we mistakenly informed you that we received your letter on March 28, 2002.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter, as well as a copy of the information in your notice that conforms to the information in proposed 21 CFR 170.36(c)(1), is available for public review and copying on the homepage of the Office of Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).
Linda S. Kahl, Ph.D.
Division of Biotech and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition