Thanks to outdated and inflexible regulations, America’s infant formula supply remains frustratingly cribbed. In August, the Food and Drug Administration issued warning letters to three infant formula manufacturers alleging inadequate “process controls … designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment.”
This regulatory ramp-up is beginning to feel like the 2022 Abbott recall crisis when a major production facility closed due to unproven agency accusations that Abbott’s formula was contaminated. While the risk of contamination with bacteria such as Cronobacter sakazakii should be taken seriously, there are low-cost alternatives to costly inspections and closures that the FDA refuses to allow. Biotechnological innovation can make foods such as infant formula far safer, but only if regulators allow and embrace greater innovation.
Deadly pathogens such as Salmonella and Cronobacter have been killing people for as long as people have been tilling crops and preparing food. Inspection technology has improved considerably since the dawn of the 20th century, but it is a costly and difficult endeavor to inspect millions of packages of foodstuffs.
Fortunately, there are living organisms called “bacteriophages” that can be cheaply injected into foods and destroy deadly contaminants. These phages were originally used in World War II to treat soldiers’ many infections, but research in the 1990s concluded that phage cocktails could work wonders when applied to the food supply.
Biotechnology company Intralytix made history in 2006 when the FDA approved its phage-based product ListShield to eliminate Listeria monocytogenes, which kills about 200 Americans per year. However, the FDA’s approval was not a green light for all phage cocktail producers looking to bring their products onto the market. The agency made strict stipulations in the ListShield approval that hampered new and promising applications of biotechnology. According to the FDA, only a type of phages known as “lytic phages” were safe for human consumption; “lysogenic (otherwise known as ‘temperate’) phages, as opposed to those that are lytic, have the capacity to integrate into the host genome and may facilitate the transfer of toxin or drug resistance genes between bacterial cells.”
This assertion is contradicted by more recent evidence showing that lysogenic phages can be safely used for food-safety purposes. One 2021 study by Rice University researchers found that “virulent mutants of temperate phages which have lost the capacity to enter lysogeny through mutations or indels (genomic insertions or deletions) have similar propagation dynamics and behavior to lytic phages.” This is important because, without the “capacity to enter lysogeny,” these supposedly harmful phages cannot pose harm to humans.
Yet, manufacturers hoping to bring temperate phage products to market are effectively stymied by FDA regulations from 2006. Even older agency rules pose issues for phage manufacturers. The FDA mandates that infant formula producers have safeguards in place to “ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment,” and phages are almost certainly considered “microorganisms.”
Without the FDA updating these byzantine regulations, infant formula products with phage cocktails run the risk of being branded as “adulterated” by regulators and pulled from the market.
The FDA should realize the error of its ways and relax regulations to permit greater innovation in food safety. Families should not be forced to suffer through more agonizing recalls and formula shortages.
