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U.S. Department of Health and Human Services


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Agency Response Letter GRAS Notice No. GRN 000098

CFSAN/Office of Food Additive Safety

April 4, 2002

Dr. Edward Iorio
Jedwards International
10 Furnace Brook Parkway
Quincy, MA 02169

Re: GRAS Notice No. GRN 000098

Dear Dr. Iorio:

The Food and Drug Administration (FDA) is responding to the notice, dated February 4, 2002, that you 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)). FDA received the notice on February 11, 2002, and designated it as GRAS Notice No. GRN 000098.

The subject of the notice is small planktivorous pelagic fish body oil. The notice informs FDA of the view of Jedwards International that small planktivorous pelagic fish body oil is GRAS, through scientific procedures, for use in food as described in 21 CFR 184.1472(a)(3) with respect to food categories and the level of use in those food categories.

In a letter dated March 25, 2002, you withdrew your GRAS notice. Given your letter, we ceased to evaluate your GRAS notice, effective March 25, 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 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