Agency Response Letter GRAS Notice No. GRN 000263
CFSAN/Office of Food Additive Safety
December 23, 2008
George Weston Foods, Ltd.
1 Braidwood Street
Enfield, NSW, 2136
Re: GRAS Notice No. GRN 000263
Dear Mr. Schutz:
The Food and Drug Administration (FDA) is responding to the notice, dated September 26, 2008, 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); the GRAS proposal). FDA received the notice on October 3, 2008, filed it on October 8, 2008, and designated it as GRAS Notice No. GRN 000263.
The subject of the notice is sweet lupin fiber. The notice informs FDA of the view of George Weston Foods, Ltd. that sweet lupin fiber is GRAS, through scientific procedures, for use as an ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, jams and jellies, processed fruits and fruit juices, and soft candy at levels ranging from 1 to 20 per cent.
In a letter dated December 10, 2008, you asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective December 16, 2008, the date that we received your letter.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000263, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying via the FDA home page at http://www.fda.gov. To view or obtain an electronic copy of the text of the letter, follow the hyperlinks from the "Food" topic to the "Food Ingredients and Packaging" section to the "Generally Recognized as Safe (GRAS)" page where the GRAS Inventory is listed.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
cc: Dr. John Hicks, Jr. DVM, MPH
Risk Management Division
Office of Policy and Program Development
Food Safety and Inspection Service
U.S. Department of Agriculture
1400 Independence Avenue., S.W., Room 3549, South Agriculture Building
Washington, DC 20250-3700