Despite the death of two infants in December, the FDA recently reported that there is no need to recall Enfamil, a popular infant formula brand. Reuters reports that U.S. health officials said that after testing, “no trace of potentially deadly bacteria” was found in sealed Enfamil cans. Based on these findings, a recall was deemed unnecessary.
This announcement comes after two major retailers, including Walmart, removed certain packs of this formula from thousands of Missouri stores following the first death of an infant from that state. A second infant death occurred later in Florida. However, the New York Times called this preemptive move by the retailers “highly unusual” due to the fact that authorities had not yet determined that this formula was to blame for the death.
Nevertheless, such actions by the retailers could be explained by last September’s listeria outbreak traced to cantaloupes sold by Jensen Farms in Colorado. In what would become the deadliest listeria outbreak ever, 30 deaths and 146 infections across 28 states were reported. Add to that a current listeria outbreak, which involves nine different brands of cheese and brings back memories of the tainted cantaloupes, and food safety has been an undeniably large concern for safety experts and the public for the last six months. With these startling food recalls hitting the news throughout the second half of 2011, the actions taken by retailers following the deaths of these infants are more understandable.
However, safety officials did find the actions of these retailers overly hasty, as the maker of this formula was cleared of blame for the deaths despite the fact that both children had consumed the product. Furthermore, personal injury and product liability attorney, Bill Marler, explains in the Reuters report that proving this particular formula was responsible for the deaths would be difficult. According to the news source, this case resembles a similar 2009 case where no traces of the bacteria known as Cronobacter were found in sealed cans of the product in question. That case, again involving Mead Johnson as the defendant, was prosecuted by Marler but dismissed.
Marler sees a similar outcome for prosecutors who attempt to take action against the maker of this baby formula. According to the news source, the prosecution lacks the “smoking gun” evidence of contamination found in unopened cans of the formula.
Despite his assurances that finding Enfamil liable for the deaths would be difficult, Marler recently described the dangers of powdered infant formulas in his blog. He explains that according to the U. S. Food and Drug Administration, “powdered infant formulas are not commercially sterile products.” Although they are “heat-treated during processing,” Marler points out that these powders do not receive the required high temperatures sustained over a long period which are used in liquid formulas to make them commercially sterile.
Although these products can never be considered completely sterile, Marler goes on to note several risk reduction techniques. First, he explains that the FDA recommends “powdered infant formulas not be used in neonatal intensive care settings unless there is no alternative available.” Other ways Marler identifies to reduce the risk of infection among infants, who are highly susceptible to bacteria, include following procedures to minimize microbial growth and preparing only “a small amount of reconstituted formula for each feeding to reduce the quantity and time that formula is held at room temperature for consumption.” Although Cronobacter was found in an open container of the formula and another bottle of nursery water and infant formula, it was suggested this contamination may have occurred after the formula packages had been opened.
Despite FDA reassurances that Enfamil remains safe, the damage to consumer confidence in the brand has been done. Reuters points out this negative publicity may have already cost the company “one cycle of new parents, who might feed their children formula for about a year.” According to another report, though shares have begun to recover since Enfamil was cleared of responsibility in the infant deaths, it may take time for company shares to recover the 10 percent they have lost since being pulled from the shelves of retailers in December. Add to that lingering food safety concerns from notable 2011 recalls and it is easy to see how FDA attempts to clear this product may falter.