Agency Response Letter GRAS Notice No. GRN 000005
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CFSAN/Office of Premarket Approval
December 11, 1998
Mr. Martin J. Hahn
Hogan & Hartson L.L.P.
555 Thirteenth Street, NW
Washington, DC 20004-1109
Re: GRAS Notice No. GRN 000005
Docket No. 98S-0104
Dear Mr. Hahn:
This is in response to your letter dated November 9, 1998, concerning the notice that you submitted on behalf of Hawaii International Seafood, Inc. (Hawaii International), to the Food and Drug Administration (FDA) claiming that the use of tasteless smoke as a preservative to protect the taste, aroma, and color of red-meat seafoods such as tuna and salmon is generally recognized as safe (GRAS). FDA had designated this notice as GRAS Notice No. GRN 000005.
Your November 9, 1998, letter states that Hawaii International is in the process of preparing a new notice to FDA regarding tasteless smoke, that the new notice will not contain any confidential business information, and that it will clarify that the basis for the claim that the subject use of tasteless smoke is GRAS is through scientific procedures. In addition, your letter states that, given the intent of Hawaii International to submit a new notice, it is unnecessary for FDA to commit further resources to GRAS Notice No. GRN 000005.
Given your letter, FDA ceased to evaluate GRAS Notice No. GRN 000005, effective November 9, 1998, the date on which we received your letter. If Hawaii International wishes to have FDA consider a new notice regarding tasteless smoke, please be advised that the appropriate mechanism is for the firm to submit, in accordance with proposed § 170.36, a complete GRAS notice. FDA will assign a new file number to any new notice.
In accordance with proposed 21 CFR 170.36(f), a copy of this letter has been placed at the agency's Dockets Management Branch (Docket No. 98S-0104). As mentioned in our letter dated May 15, 1998, which acknowledged receipt of GRAS Notice No. GRN 000005, a copy of the information in GRAS Notice No. GRN 000005 that conforms to the information in proposed § 170.36(c)(1) is likewise available in Docket No. 98S-0103., letter acknowledging receipt of your conversion request, a copy of your conversion request is likewise available in Docket No. 98S-0103.
Linda S. Kahl, Ph.D.
Regulatory Policy Branch (HFS-206)
Division of Product Policy
Office of Premarket Approval
Center for Food Safety and Applied Nutrition