Troubling Practices of the FDA – Part 1

by Susan Williams

This August, the FDA approved a spray known as LM-102, which consists of six bacteria-killing viruses that will be used on ready-to-eat meat and poultry products.

These viruses, known as bacteriophages, can kill the Listeria monocytogenes bacteria, which can cause a serious infection known as listeriosis. The Centers for Disease Control and Prevention (CDC) estimates that approximately 2,500 Americans become seriously ill with listeriosis each year, and 500 of those victims eventually die. Most of those who become ill are pregnant women, the elderly with compromised immunity, and small children.

This bacteriophage spray, marketed as a food additive, is designed to be sprayed on ready-to-eat meat products such as cold cuts, hot dogs, sausages, and chicken right before they are packaged. The FDA claims that the bacteriophages are prepared in such a way that they only attack strains of the Listeria bacterium, and do not harm human or plant cells.

In spite of these assurances, many consumers are understandably worried. Some feel that this will lead to poorer hygiene and quality control among meat vendors, who will depend on the spray to cover their errors. "Listeria is a small problem in the grand scale of things to be worried about when it comes to our food supply. The real problem is that they let slaughterhouses use infected, diseased animals. There's little oversight," asserts Mike N., a consumer and health activist from Weston, Wisconsin.

Others worry about resistant strains of Listeria developing, or mutations of the viruses contained in the spray, which could then become harmful to humans. Félix d'Herelle, a French-Canadian microbiologist and one of the first to discover bacteriophages, co-authored a 1924 book titled "Immunity in Natural Infectious Disease". The book specifically addresses "Adaptation and the Bacteriophage", explaining various studies by the authors that show the bacteriophage and the bacterium that is being attacked both undergo an adaptation process. d'Herelle comments, "

The bacteriophage adapts itself to a more and more vigorous attack against the bacterium, and the bacterium accustoms itself to resist this attack." He continues, "The proofs are then multiple: The bacteriophage possesses the power of adaptation... of assimilation. It possesses likewise the two corollaries of these powers; the faculties of multiplication and variability.... The bacterium does not remain passive before the attack of the bacteriophage. It is capable of resistance. It is even able, when the conditions for it are favorable, to acquire a complete immunity."

Lytic phages, like the ones that the FDA has determined are contained in the LM- 102 spray, function basically in this manner: In short, the bacteriophage attaches to the surface of the much larger bacteria. Once attached, the bacteriophage injects DNA into the bacterium. This viral DNA instructs the bacterium to produce masses of new viruses. When so many of these new viruses are produced that the bacterium cannot hold anymore, the bacterium bursts (lysis) and dies. This then requires the viruses to find new host cells.

Bacteria produce poisons known as "endotoxins" in an effort to defend themselves. When the bacteria rupture and die, these endotoxins are released. The FDA ruling remarks that Listeriolysin O (LLO), one of the main endotoxins of L. monocytogenes, “may potentially be present as a residue in this food additive after the manufacturing process.” Yet the agency speculates that any residual LLO “does not present a toxicological concern” for three reasons: that it is “likely to be inactivated by the cholesterol” in treated meat; is “likely to be inactivated by the low pH…within the human stomach.”; and is “expected to be rapidly and irreversibly degraded by proteolytic enzymes that may be presented in the diet or in the stomach.”

Neither the FDA nor Intralytix, the manufacturer, provided data which would support any of these conclusions. In fact, the FDA stated in Reference 1 of the Final Rule that “no studies were performed at lower pH levels that are more consistent with that of the gastric environment.”

Another issue with bacteriophages is that they irritate the body's immune system. "They provoke allergy, asthma, autoimmune problems, and elevate cholesterol. They also interfere with the healthy function of cells lining the digestive tract.

Researchers have demonstrated that the presence of bacterial endotoxins can start cancer in the colon," explained Byron J. Richards, the Founder and Director of Wellness Resources and a Board-Certified Clinical Nutritionist. "Additionally, the human immune system reacts directly to viral phages. Thus, a person who eats a lot of processed deli meat is certain to evoke an immune reaction to the viruses.... How can the FDA approve a food additive that it knows can induce a variety of human immune responses?"

The Food and Water Watch Organization (FWW) has filed a stay of action and a formal evidentiary public hearing on this matter, with the intent of revoking the FDA's approval of this substance.

"The regulatory change FDA has promulgated is based on numerous arbitrary and capricious analytical failures and should be revoked. Due to significant shortcomings and factual misrepresentations in the Final Rule, potential risks to public health posed by FDA’s decision have not been sufficiently examined," said Wenonah Hauter, Executive Director of FWW. "USDA has failed to enact stringent hygiene and testing regulations for Listeria even after years of regulatory delay. FDA's quick fix virus 'treatment' at the end of the production line can't make up for failures in sanitation or inadequate testing at food processing plants.”

FWW has criticized the FDA for ignoring its own regulations requiring extensive safety screening and testing protocols before treatments like this new virus solution can be legalized. For example, the agency has not studied whether the viruses could cause genetic damage, organ malfunction, blood disorders or other problems in people who consume them. FWW also asserts that approval was based on woefully inadequate human testing, and that many key points were based purely on conjecture.

Food & Water Watch also criticized the agency for failing to provide the information it used to evaluate safety and efficacy in a timely manner. "It is outrageous that the agency was so slow in releasing key documents used to support its decision – some of which aren’t available even as the comment period closes," charged Hauter.

Additionally, the only studies conducted using the approved substance, LM-102, were performed by the manufacturer, Intralytix, were not published in peerreviewed journals, and therefore were not reviewed by independent scientists.

Furthermore, Intralytix does not guarantee that the bacteriophage spray will completely eliminate the L. monocytogenes bacteria. "There are other methods available which are more effective in reducing the amount of bacteria, and carry far fewer potential unintended consequences than bacteriophages," suggested Hauter. "A few examples include surface-treating hot dogs with a mixture of pressurized steam and hot water at 121° C, (Journal of Food Protection, March 2005) and dipping hot dogs in liquid smoke and heating them for 1 minute at 165° F (Institute of Food Technologists Annual Meeting, July 2004, Las Vegas)."

Consumers will not be informed as to which meat or poultry products have been treated with the LM-102 substance. However, organic products will not be treated with the spray.

Intralytix, the Baltimore-based manufacturer, is planning to seek FDA approval for another bacteriophage spray aimed at killing E. coli bacteria.