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U.S. Department of Health and Human Services

Food

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Agency Response Letter GRAS Notice No. GRN 000036

CFSAN/Office of Premarket Approval

April 26, 2000

Robert E. Yates, Jr.
President
Vancol Industries, Inc.
1700 E. 68th Avenue
Denver, CO 80229

Re: GRAS Notice No. GRN 000036

Dear Mr. Yates:

The Food and Drug Administration (FDA) is responding to the notice, dated December 20, 1999, 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 your notice on January 3, 2000 and designated it as GRAS Notice No. GRN 000036.

The subjects of your notice are chromium picolinate, Ginkgo biloba leaf extract, and Panax ginseng root extract. The notice informs FDA of the view of Vancol Industries, Inc. that chromium picolinate, Ginkgo biloba leaf extract, and Panax ginseng root extract are GRAS, through scientific procedures, for use as ingredients in a non-carbonated beverage or tea.

In a letter dated April 10, 2000, you asked to withdraw your notice. Given your request, we ceased to evaluate your GRAS notice, effective April 10, 2000, the date we received your letter by telefax. In a letter dated April 14, 2000, we mistakenly informed you that we ceased to evaluate your GRAS notice effective April 10, 1999.

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 Office of Premarket Approval's homepage on the World Wide Web.

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