Agency Response Letter GRAS Notice No. GRN 000409
CFSAN/Office of Food Additive Safety
January 26, 2012
Christopher Wahl, MD, MBA
141 Avenue du President Kennedy
5th Floor, UQAM-Biological Sciences Building
Montreal, Quebec, CANADA
Re: GRAS Notice No. GRN 000409
Dear Dr. Wahl:
The Food and Drug Administration (FDA) is responding to the notice, dated October 12, 2011, 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 18, 2011, filed it on October 18, 2011, and designated it as GRAS Notice No. GRN 000409.
The subject of the notice is Lactobacillus reuteri strain NCIMB 30242. The notice informs FDA of the view of Micropharma Ltd. that L. reuteri strain NCIMB 30242 is GRAS, through scientific procedures, for use as a food ingredient in food and beverages.
In a letter dated December 22, 2011, you withdrew your notice. Given your letter, we ceased to evaluate your GRAS notice, effective January 10, 2012, 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 000409, 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 at www.fda.gov/grasnoticeinventory.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition