This is the first time the FDA has approved a bacteriophage-based product for use in food, and the additives could soon be hitting Europe, said John Vazzana, president and CEO of Baltimore-based Intralytix, the company behind the LMP-102 bacteriophage (bacteria eater).
Bacteriophages are the viral hit squads of the microscopic world, specifically targeting bacteria, rather than human, plant or animal cells. For every bacterium, there is a phage that likes to latch on to them, take over their life processes and ultimately kill the cell.
"We are using nature's own defenses against bacteria that are harmful to humans," Vazzana told FoodNavigator-USA.com.
And getting this view across to consumers will be key to gaining consumer acceptance of an additive that belongs to the virus family. This should also be helped by the additive being labeled as a 'phage', said Vazzana.
"Bacteriophages are the most ubiquitous life-form on the planet," he said. "They're everywhere - all over the body and in your stomach."
Since bacteriophages specifically target bacteria, they are safe for humans.
Indeed, a FDA memorandum dated June 3, 2005, reported that bacteriophage, LMP-102, was safe for use as a food additive in meat and poultry products, and the administration amended its food additive regulations on Friday, August 18, 2006 to "provide for the safe use of a bacteriophage preparation on ready-to-eat meat and poultry products as an antimicrobial agent against Listeria monocytogenes."
Recent analysis from Frost & Sullivan forecast that US demand for antimicrobials - chemicals used to wash equipment and foods to ensure they are free of food borne pathogens - would reach $215.8m in 2012, from $161.7m in 2005.
But increased food safety regulations and the cost of recalls due to contaminated foods are driving processors to search for better solutions to reduce pathogens in their plants.
According to the predictions that Intralytix have put together, said Vazzana, the "all-natural" LMP-102 phage "can be priced so that it will be competitive."
The viral additive consists of six individually purified phages in equal measure. The reason for incorporating six phages, says the Federal Register, is to minimize the possibility that Listeria develops resistance to the additive.
"Each phage is specific against various L. monocytogenes strains, including those strains known to be associated with foodborne illness," says the Federal Register (Vol. 71, pp. 47729-47732).
The individual phages are separately produced using L. monocytogenes hosts. As the phage multiplies it eventually destroys the host cell. The phages are then filtered using a series of membrane filtration steps. The mixture of phages is reported to be stored in a phosphate-buffered saline solution and used at levels of about one milliliter of solution per 500 sq. centimeters of food product surface area just prior to packaging.
"It is our intent to seek approval for additional food safety products effective against E. coli O157:H7 and Salmonella in the next 12 months," said Vazzana.
Moreover, he said that the FDA has "somewhat encouraged" Intralytix to push on with the bacteriophage that targets E. coli.
Despite the approval from the FDA for LMP-102, the ingredient must also comply with the Federal Meat Inspection Act and/or the Poultry Meat Inspection Act, both of which are administered by the USDA, before it can be used in ready-to-eat meat and poultry products.
"In particular, those statutes provide that the ingredient must be suitable for its intended use," states the Federal Register.
This last point is straight forward, said Vanazza, since the USDA has been actively involved and have "already had a team of people looking at this.
According to the Centers for Disease Control and Prevention, about 2,500 people become seriously ill every year from listeriosis, the Listeria infection in humans. Twenty per cent of these infections are fatal.