Agency Response Letter GRAS Notice No. GRN 000051
CFSAN/Office of Premarket Approval*
February 28, 2001
Melvin S. Drozen
Keller and Heckman L.L.P
1001 G Street, N.W.
Suite 500 West
Washington, D.C. 20001
Re: GRAS Notice No. GRN 000051
Dear Mr. Drozen:
The Food and Drug Administration (FDA) is responding to the notice, dated June 20, 2000, that you submitted on behalf of B.F. Goodrich 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 June 23, 2000 and designated it as GRAS Notice No. GRN 000051.
The subject of the notice is cassia gum. The notice informs FDA of the view of B.F. Goodrich that cassia gum is GRAS, through scientific procedures, for use as a stabilizer in food in general.
In a letter dated February 27, 2001, you informed FDA that B.F. Goodrich is withdrawing GRN 000051 from consideration by FDA. B.F. Goodrich is taking this action with the understanding that B.F. Goodrich may, in the future, submit another GRAS notice or make another appropriate submission for cassia gum. Given your February 27 letter, we ceased to evaluate GRN 000051 effective February 27, 2001, 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 Office of Premarket Approval's homepage on the Internet (at http://www.cfsan.fda.gov/~lrd/foodadd.html).
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
* The Office of Premarket Approval became the Office of Food Additive Safety on June 18, 2001.