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CFSAN/Office of Food Additive Safety
September 13, 2006
Clyde A. Takegushi, Ph.D.
Executive Vice President
Phoenix Regulatory Associates, LTD.
21525 Ridgetop Circle
Sterling, VA 20166
Re: GRAS Notice No. GRN 000171
Dear Dr. Takegushi:
The Food and Drug Administration (FDA) is providing additional information relevant to the notice dated June 6, 2005, that Dr. Douglas Ware submitted on behalf of Nutrition Physiology Corporation (NPC) 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 this notice on June 9, 2005, filed it on June 10, 2005, and designated it as GRN No. 000171. In a letter dated December 7, 2005, FDA informed NPC that the agency had no questions at that time regarding the conclusion of NPC that the subject of the notice is GRAS under the intended conditions of use.
On July 24, 2006, the FDA subsequently received a supplement to GRN 000171, dated July 20, 2004. This supplement informed FDA that NPC had determined that their use of the lactic acid bacteria mixture, which was the subject of GRAS Notice GRN 000171, in ready-to-eat meat products is GRAS. The supplement reflected NPC's conclusion that the additional use would not significantly increase consumer exposure to the lactic acid bacteria mixture that was the subject of G RN 000171. NPC based their determination on information submitted in the original GRAS Notice as well as information they submitted in the supplement.
Based on the information provided by NPC in GRN 000171, the supplement dated July 20, 2006, and other information available to FDA, the agency has no questions at this time regarding NPC's conclusion that the LAB mixture consisting of L. acidophilus (NP35, NP51), L. lactis (NP7), and P. acidilactici (NP3), is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of this LAB mixture. As always, it is the continuing responsibility of NPC to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.
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 the 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).
Edmundo Garcia Jr.
Consumer Safety Officer
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition