Intralytix Receives FDA Regulatory Clearance for Expanded Use in Red Meat for Phage-Based Salmonella Technology

Columbia, Maryland, USA - November 19, 2019. Intralytix, Inc. announced today that its food safety product, SalmoFresh™, has been granted a supplement to its GRAS (Generally Recognized As Safe) recognized status from the Food and Drug Administration (FDA), which expands the use of SalmoFresh™ to ready-to-eat and raw red meat carcasses, subprimals and trimmings.

This GRAS notice (GRN 000435) broadens the existing antimicrobial use of SalmoFresh™, which can also be used to treat poultry products, fish, shellfish and fresh and processed fruits and vegetables.

SalmoFresh™ is a non-chemical antimicrobial preparation for controlling the foodborne bacterial pathogen Salmonella. The active ingredients of SalmoFresh™ are naturally occurring lytic bacteriophages that selectively and specifically kill Salmonella enterica strains, including (but not limited to) strains belonging to the most common / highly pathogenic serotypes Typhimurium, Enteritidis, Heidelberg, Newport, Hadar, Kentucky, Thompson, Georgia, Agona, Grampian, Senftenberg, Alachua, Infantis, Reading, and Schwarzengrund.

SalmoFresh™ is the industry's best choice for eliminating or significantly reducing contamination of food with S. enterica, because it is:

• FDA affirmed as GRAS (GRN 000435)
• FSIS-listed as safe and suitable for use in the production of ready-to-eat (RTE) poultry and red meat and on raw poultry and red meat, including carcasses, subprimals, and trimmings as a processing aid with no labeling requirements (FSIS Directive 7120.1)
• Health Canada approved for use on fish, shellfish, and fresh and processed fruits and vegetables or on ready-to-eat poultry products prior to slicing and on raw poultry prior to grinding or after grinding (iLONO)
• National Food Service of Israel approved as a as a food processing aid for the treatment of fish, shellfish, fresh and processed fruits and vegetables and poultry immediately before or after grinding, and on ready to eat products before slicing (Ref: 70275202)
• Certified both Kosher and Halal
• OMRI-listed ("organic")
• Requires no labeling ("clean label")
• Contains no additives or preservatives
• Cost effective
• Effective under a wide range of food storage conditions (e.g., 2°C-42°C)
• All natural and not genetically modified (non-GM)
• Has no effect on organoleptic properties (including taste, appearance, and smell) of foods

For product inquires or to place an order, email Intralytix at sales@intralytix.com or call 1-877-ITXPHAGE (489-7424) and select option 1.