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U.S. Department of Health and Human Services

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Agency Response Letter GRAS Notice No. GRN 000172

CFSAN/Office of Food Additive Safety

October 31, 2005

Jianhua Zhu
BioNeutra, Inc.
#132, Advanced Technology Center
Edmonton Research Park
9650-20th Ave., N.W., Edmonton
Alberta T6N 1G1, CANADA

Re: GRAS Notice No. GRN 000172

Dear Dr. Zhu:

The Food and Drug Administration (FDA) is responding to the notice, dated June 6, 2005, 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 the notice on June 20, 2005, filed it on June 21, 2005, and designated it as GRAS Notice No. GRN 000172.

The subject of the notice is isomalto-oligosaccharide. The notice informs FDA of the view of BioNeutra that isomalto-oligosaccharide is GRAS, through scientific procedures, for use as a low-calorie sweetener in a variety of food products, except meat and poultry, at a level of up to 30 grams per day.

In an e-mail dated October 17, 2005, you withdrew your notice with the understanding that BioNeutra may, in the future, submit another GRAS notice for the use of isomalto-oligosaccharide. Given your e-mail, we ceased to evaluate your GRAS notice, effective October 17, 2005, the date that we received your e-mail.

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 homepage of the Office of Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).

Sincerely,
Antonia Mattia, Ph.D.
Director
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition