Agency Response Letter
GRAS Notice No. GRN 000171

Douglas R. Ware, Ph.D., President
Nutrition Physiology Corporation
11358 Woods Bay Lane
Indianapolis, IN 46236

Re: GRAS Notice No. GRN 000171

Dear Dr. Ware:

The Food and Drug Administration (FDA) is responding to the notice, dated June 6, 2005, that you 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.

The subject of the notice is lactic acid bacteria mixture (LAB mixture) consisting of Lactobacillus acidophilus (NP35, NP51), Lactobacillus lactis (NP7), and Pediococcus acidilactici (NP3). The notice informs FDA of the view of NPC that this LAB mixture is GRAS, through scientific procedures, for use to control growth of pathogenic bacteria in fresh chopped/ground, whole muscle cuts, and carcasses of meat and poultry at use levels between 106 to 108 colony forming units of lactobacilli per gram of product.

NPC described the identity and method of manufacture of the LAB mixture. NPC provides specifications for their LAB mixture and described standard procedures for production of the LAB mixture strains and strain maintenance. In its evaluation of safety of the LAB mixture, NPC relied on both published and unpublished information. NPC states that there is a long history of safe use of the species used in the LAB mixture in traditional food products and that their LAB mixture consists of non-pathogenic strains. NPC notes that lactic acid bacteria consumed in food are not known to be associated with infections.

Use in Meat and Poultry Products

During its evaluation of GRN 000171, FDA consulted with the Labeling and Consumer Protection Staff of the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA). Under the Federal Meat Inspection Act and the Poultry Products Inspection Act, FSIS is responsible for determining the efficacy and suitability of food ingredients in meat and poultry products as well as prescribing safe conditions of use. Suitability relates to the effectiveness of the ingredient in performing the intended purpose of use and the assurance that the conditions of use will not result in an adulterated product, or one that misleads consumers.

FSIS requested that FDA advise NPC to seek regulatory guidance from FSIS, Labeling and Consumer Protection Staff, about the use of the LAB mixture in meat and poultry products. NPC should direct such an inquiry to Dr. Robert Post, Director, Labeling and Consumer Protection Staff, Office of Policy, Program, and Employee Development, Food Safety and Inspection Service, 1400 Independence Ave., S.W., Suite 602, Annex, Washington, DC 20250-3700. The telephone number for that office is (202) 205-0279 and the telefax number is (202) 205-3625.

Based on the information provided by NPC in GRN 000171 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 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,

Laura M. Tarantino, Ph.D.
Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

cc: Dr. Robert Post, Director
Labeling and Consumer Protection Staff
Office of Policy, Program and Employee Development
Food Safety and Inspection Service
1400 Independence Ave., SW, Suite 602, Annex
Washington, DC 20250-3700