Agency Response Letter GRAS Notice No. GRN 000017
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CFSAN/Office of Premarket Approval
April 17, 2000
Lee B. Dexter
Lee Dexter & Associates
15704 Webberville Road
Austin, Texas 78724
Re: GRAS Notice No. GRN 000017
Dear Ms. Dexter:
The Food and Drug Administration (FDA) is responding to the notice, dated October 15, 1998, that you submitted on behalf of Larex, Incorporated (Larex) 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 March 11, 1999 and designated it as GRAS Notice No. GRN 000017.
The subject of the notice is arabinogalactan. The notice informs FDA of the view of Larex that arabinogalactan is GRAS, through scientific procedures, for a variety of technical effects in a number of food categories.
In a letter dated April 6, 2000, you informed FDA that Larex was withdrawing GRN 000017. According to your April 6 letter, Larex intends to resubmit a GRAS notice for arabinogalactan with a revised estimate of dietary exposure and a revised set of specifications. Given your letter, we ceased to evaluate Larex's GRAS notice, effective April 11, 2000, the date 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 Office of Premarket Approval's homepage on the World Wide Web.
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