Intralytix obtains FDA, FSIS regulatory clearance for bacteriophage-based product against E. coli

Intralytix, Inc. announced today that it has completed regulatory clearance from both the Food and Drug Administration (FDA) and the United States Department of Agriculture's Food Safety and Inspection Service (FSIS) for its phage-based EcoShield™ food safety product, effective against E. coli O157:H7.

“permitting use of this product by the ground beef industry.”

Previously, Intralytix had obtained FDA clearance of EcoShield in the form of a "Food Contact Notification" or FCN, specific for the use of EcoShield on red meat parts and trim intended to be ground. The FDA has designated the FCN clearance for this phage-based product as FCN No. 1018. Data submitted as part of Intralytix's FCN application showed that EcoShield reduces E. coli O157:H7 in ground meat by more than 95%.

Most recently, the FSIS has issued its "no objection" letter allowing the use of EcoShield when applied to red meat parts and trim that will be ground. "The FSIS's letter completes the regulatory process," noted John Woloszyn, Intralytix's CEO, "permitting use of this product by the ground beef industry." "We expect EcoShield will become a very important tool to make ground red meat safer," he added. Both the FDA and the FSIS will treat EcoShield as a processing aid when applied in this manner.

Escherichia coli (abbreviated as E. coli) O157:H7 is a Shiga toxin producing strain of E. coli (or STEC). It is the most commonly identified STEC in North America, causing severe stomach cramps, diarrhea, vomiting and urinary tract infections. E. coli O157:H7 can be borne by meats, fruits, vegetables and certain dairy products. While normally a surface contaminant, the pathogen becomes internalized when meat is ground.

Bacteriophages (or phages) are nature's way of destroying bacteria. A bacteriophage is a virus that is harmless to humans, animals and plants, but is very effective in killing bacteria. "Phages provide an all-natural, nontoxic, safe and effective means for significantly reducing or eliminating disease-causing bacteria that are sometimes present on foods," stated Mr. Woloszyn. He also noted that the company's Chief Scientist, Dr. Alexander Sulakvelidze, will be making a presentation on EcoShield and the company's phage technology at the Institute of Food Technologists' (IFT's) Annual Meeting in New Orleans this weekend.

Intralytix has developed bacteriophage-based products that target some of the deadliest foodborne bacterial pathogens, including Listeria monocytogenes (ListShield™) and now, E. coli O157:H7. Similar phage-containing food safety products active against other foodborne bacterial pathogens are in the early- to-late developmental stages.