Formula maker Abbott steadfastly denies that his infant formula sickened four babies and killed two. The denial is despite the same dangerous bacteria that made the babies sick –Cronobacter sakazakii— found at the company’s formula plant in Sturgis, Michigan, which the Food and Drug Administration claims produced formula “under unsanitary conditions.” And at least one container of Abbott’s formula tested positive for the same Cronobacter sakazakii strain that infected one of the infants.
Still, Abbott claims that the link has not been confirmed and that the formula is not to blame. In a long twitter thread on May 13, the company made the blunt claim: “The formula of this plant did not cause these teething problems†
But that’s a bold and misleading claim, according to the Food and Drug Administration. In a press conference Monday night, agency officials thoroughly dismantled Abbott’s defenses.
The company’s staunch denial is likely to compound the frustration of American parents forced to navigate a dire shortage of infant and specialty formulas. The shortage is due in part to a recall of Abbott’s formulas and a closure of the Sturgis facility, which the FDA had identified numerous problems. Parents have seen empty shelves in store after store as they desperately try to secure food for their children, some of whom require specialized formulas due to metabolic conditions. Parents have faced purchase limits, rising prices and scams in places where there is availability. Even if parents can get the formula, Abbott’s denials can raise safety questions.
Abbott’s claims
Abbott’s defense is indeed questionable. In last week’s Twitter thread, the company reiterated that the link between its formulas and the four teething problems has not been confirmed — which is true. But the company suggested that huge data gaps somehow support the company’s claim that the formula is not the cause of disease.
Overall, the company states that little testing of the finished formula found no contamination before it left the factory. The contaminant found at the facility was present in “non-product contact areas”. In addition, the genetic sequencing of the strains found at the facility did not match the strains found in two of the sick babies (no genetic information was available for the other two babies).
Opened formula bottles from three out of four sick babies were tested, and only one tested positive for Cronobacter sakazakii† While the contamination in the container with one positive formula matched the voltage of C. sakazakii infected the child, it did not match the strains identified at the Sturgis facility. Finally, Abbott notes that the four sick babies all consumed different types of formula produced at the Sturgis plant, and that their illnesses occurred at different times in different states. It’s unclear why that matters, but Abbott concluded that contamination at the plant did not cause the diseases.
In Monday’s press conference, FDA officials called that reasoning almost nonsense. Most importantly, the lack of a genetic match is not proof that the formula is not the source of the child’s bacterial infections.
FDA response
C. sakazakii is not a notifiable disease in this country, Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, emphasized in the news conference. That means when cases do arise, outbreak investigations aren’t quickly launched and health officials aren’t jumping to collect bacterial isolates, begin genetic sequencing and identify clinical clusters as they do for other pathogens of concern. As a result, the FDA and the Centers for Disease Control and Prevention only have genetic sequences from two out of four sick babies. And overall, there are only about 238 genetic sequences of C. sakazakii strains in the CDC database, which is an extremely small number compared to other pathogens, such as: E coli, complicate genetic research.
“From the outset, we were limited in our ability to determine causally whether or not consumption of the product from the Abbott Sturgis plant was associated with these four cases,” Mayne said.
Mayne also pointed out that the FDA is isolating multiple tribes from C. sakazakii from the area at the Sturgis factory when they were testing, which was after the cases were identified. “There’s definitely a possibility that other strains that we didn’t detect at the time we were at the factory for the inspection could definitely be there.”
Frank Yiannas, the FDA’s Deputy Commissioner for Food Policy and Response, echoed the point, saying that the genetic data for C. sakazakii in this outbreak and is generally minimal. “It’s hard to read too much into that,” he said. He also emphasized that there was a diversity of strains in the plant — five different lineages — and noted that there are examples in the scientific literature of multi-strain outbreaks over time from a single source.
“The other thing we’ve heard emphasized quite a few times is that these products have been tested” and most of them tested negative for C. sakazakiisaid Yiannas. But that doesn’t make sense either. Some of the final batches of the formula are 400,000 to 500,000 pounds, but the final product testing plans only include a set of 30 samples of 10 grams each, together less than a pound, Yiannas said. “The chance of detecting low contamination levels through a final product testing plan — it’s almost never going to happen,” he said. “Some statisticians calculate that there is a 97 percent chance that you… will not find low levels of contamination with that type of sampling plan.”
Overall, he said, “over-reliance on finished product testing isn’t really the best way to ensure food safety; it’s really about process control.”
