Phage approved in food, why not as a therapeutic?

Abstract

Bacterial resistance is not only restricted to human infections but is also a major problem in food. With the marked decrease in produced antimicrobials, the world is now reassessing bacteriophages. In 2006, ListShield™ received the US FDA approval for using phage in food. Nevertheless, regulatory approval of phage-based therapeutics is still facing many challenges. This review highlights the use of bacteriophages as biocontrol agents in the food industry. It also focuses on the challenges still facing the regulatory approval of phage-based therapeutics and the proposed approaches to overcome such challenges.

Keywords:

• bacterial resistance
• bacteriophages
• food biocontrol products
• phage therapy

Financial & competing interests disclosure

W Sarhan and H Azzazy are authors of a patent application describing the use of nanofibers and phage for wound healing. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Key issues

• In 2011, the WHO has made the call ‘No action today, no cure tomorrow’ raising the need for immediate solutions against the serious problem of bacterial resistance.

• Phage holds a substantial antibacterial potential as a therapeutic and a bio-control agent in food.

• In 2006, US FDA approved the first phage product to be applied directly to ready-to-eat meat.

• Different challenges are still in the way for approval of phage therapy, such as: immunogenicity, pharmacokinetics, systemic side effects, narrow host range, bacterial resistance, manufacturing safety and efficacy, regulatory approval and patentability.

• The regulatory approval for phage consumption in food should motivate the pharmaceutical industry and scientific community for developing bacteriophage therapeutics.