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U.S. Department of Health and Human Services

Food

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Agency Response Letter GRAS Notice No. GRN 000097

CFSAN/Office of Food Additive Safety

July 10, 2002

Anthony L. Young
Piper Rudnick
1200 Nineteenth Street, N.W.
Washington, D.C. 20036-2412

Re: GRAS Notice No. GRN 000097

Dear Mr. Young:

The Food and Drug Administration (FDA) is responding to the notice, dated January 15, 2002, that Clover Corporation Ltd. (Clover) submitted 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); the GRAS proposal). FDA received the notice on January 16, 2002, filed it on January 25, 2002, and designated it as GRAS Notice No. GRN 000097.

The subject of the notice is tuna oil. The notice informs FDA of the view of Clover that tuna oil is GRAS, through scientific procedures, for use as a direct food ingredient in traditional foods with intended use levels that are the same as those listed for menhaden oil (21 CFR 172.1472(a)(3)).

In a letter dated June 24, 2002, you asked that FDA cease to evaluate Clover's notice while Clover prepares a revised notice to reduce the maximum amounts of tuna oil to be used in the foods listed in 21 CFR 184.1472(a)(3). Given your request, we ceased to evaluate Clover's GRAS notice, effective June 24, 2002, the date that we received your letter.

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 Clover's 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).

 

 

Sincerely,

Linda S. Kahl, Ph.D.
Division of Biotech and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition