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U.S. Department of Health and Human Services

Food

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Agency Response Letter GRAS Notice No. GRN 000001

CFSAN/Office of Premarket Approval

November 25, 1998

Mr. Mark W. Empie
Archer Daniels Midland Company
Box 1470
Decatur, IL 62525

Re: GRAS Notice No. GRN 000001
Docket No. 98S-0104

Dear Mr. Empie:

This is in response to your letter dated November 2, 1998 concerning notice of Archer Daniels Midland Company (ADM) to the Food and Drug Administration (FDA) claiming that the use of soy isoflavones as a micronutrient in performance bars, mature adult meal replacements, and "healthy" beverages at a level of 25 mg soy isoflavone extract per serving is generally recognized as safe (GRAS). FDA had designated this notice as GRAS Notice No. GRN 000001. Your November 2, 1998, letter requests that FDA commit no further resources to the review of GRAS Notice No. GRN 000001 while ADM is in the process of incorporating additional information to update the file.

Given your request, FDA ceased to evaluate GRAS Notice No. GRN 000001, effective November 3, 1998, the date on which we received your letter. If you wish to have FDA consider additional information that you submit regarding soy isoflavones, please be advised that the appropriate mechanism is for ADM to submit, in accordance with proposed § 170.36, a complete GRAS notice. FDA will assign a new file number to any new notice regarding soy isoflavones.

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 March 5, 1998, which acknowledged receipt of your GRAS notice, a copy of the information in your notice that conforms to the information in proposed § 170.36(c)(1) is likewise available in Docket No. 98S-0103.

Sincerely,
   
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

cc:  Mr. Gary Yingling
McKenna and Cuneo
1900 K Street, N.W.
Washington, DC 20006-1108