FDA and FISIS have authorized the use of Bacteriophage-based product against E. coli.

Intralytix Inc. has developed a new phage-based product, designated EcoShield™, which is effective against E. coli O157:H7.

This company 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.

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. Data submitted as part of Intralytix's FCN application showed that EcoShield reduces E. coli O157:H7 in ground meat by more than 95%. EcoShield™ is 100% natural, and it does not contain preservatives or any known, potentially allergenic substances. 

The product is highly effective in reducing contamination of various foods (e.g., ground beef, fruits, vegetables, etc.) with E. coli O157:H7, thus providing a much-needed modality for significantly reducing or eliminating contamination of various food products with the bacterium.

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, permitting use of this product by the ground beef industry. EcoShield will become a very important tool to make ground red meat safer.

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. 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.

SOURCE: http://www.news-medical.net/news/20110615/Intralytix-obtains-FDA-FSIS-regulatory-clearance-for-bacteriophage-based-product-against-E-coli.aspx?page=2

Fernando Fuentes