Did you Know… No Powdered Baby Formula is Sterile?

T. Robert Hill is the founder of the Hill Boren Law Firm in Jackson, TN and began practicing law in 1969. The firm serves 1,000 clients annually, generating millions of dollars in personal injury, worker’s compensation and medical malpractice awards and judgments.

http://www.hillboren.com

No matter what the brand – soy or milk, high end or low end, generic or name brand – all powdered infant formula products contain levels of bacteria that, when ingested, have permanently injured and killed babies. These bacteria include salmonella, e. coli, and, the most dangerous to infants, Enterobacter Sakazakii (now known as Cronobacter). Cronobacter infection has been connected to numerous serious infant injuries and deaths over the last twenty years.

While these incidents do not happen often, the industry has refused to put a simple, factual warning on the label that would alert purchasers of the formula to the small, but potentially deadly, possibility that the use of the unsterile powdered formula could lead to serious injuries or even death. Warning labels are put on many medications for the safety of the public. Yet in the case of powdered infant formula, even doctors and hospitals that prescribe and use the formula are still unaware of the potential danger. Many healthcare providers are in fact unaware that the product is not sterile.

While most healthy, full-term infants have adequate protection from Cronobacter and other bacteria through a fully developed immune system, newborns, immune-compromised infants and low birth-weight babies do not. These infants’ compromised immune systems do not have the ability to defend against these types of bacteria. Many powdered infant formulas are specifically designed, manufactured and marketed for premature and low birth weight children, particularly powdered human breast milk fortifiers. Pre-term or otherwise immune-compromised infants are most at risk for infection.

While labels do show the proper method for mixing powdered formula, manufacturers have refused to place warnings on their labels regarding the possible consequences of unsafe or improper reconstitution of powdered infant formula. Even if Cronobacter is dormant in the can, it can be triggered by improper use of the formula (such as failing to boil the water or sterilize the nipples used to deliver the formula to the baby’s mouth). Practically speaking, very few people, who are not warned of inherent dangers in food products, follow instructions on the label of a commonly used product “to the T,” but rarely are the stakes this high, which is why more must be done to warn consumers.

So why is infant formula powder not made commercially sterile? The reason is simple: it is impossible to sterilize powdered formula during the manufacturing process. Powdered infant formula is mixed and spray-dried in open air settings that allow for contamination from the environment. Liquid formula can be boiled or pasteurized prior to packaging, eliminating harmful bacteria. Bacteria ends up in cans of powdered infant formula despite alleged compliance with woefully inadequate FDA oversight and enforcement.

Sadly, this dirty little secret remains so because the number of reported incidents is low. Also, the ability and knowledge available to identify the actual source of the catastrophic injury to the baby is scarce. In all likelihood, the number of confirmed infections is grossly underestimated due to the unavailability of information regarding the bacteria and its link to powdered infant formula. On the other hand, profits derived from marketing these products to hospitals and parents are enormous.

While there is only a small number of babies who will get sick from contaminated powdered infant formula, even fewer of them will seek recovery for some of the damages the baby and the family have suffered. Manufacturers have decided that a warning on the label would alarm a majority of physicians, health care professionals and parents who use and/or recommend these products on an ever-increasing basis.

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