Abbott insists that its infant formulas are not to blame for the deaths of two babies. The company denied thatCronobacter sakazakii was found at its formula factory in Michigan, which the FDA alleges was producing formula.
Abbott argues that the link hasn't been confirmed and that its formula isn't to blame. The formula from this plant did not cause these infant illnesses according to the company.
According to the Food and Drug Administration, that is not true. Agency officials dismantled Abbott's defense in a press conference Monday evening.
US parents are forced to navigate a dire shortage of infant and specialty formulas because of the company's denial. The FDA determined that there had been many problems with Abbott's Sturgis facility, which led to a recall of Abbott's formulas. Parents have seen empty shelves at store after store as they desperately tried to get sustenance for their children, some of whom need specialized formulas due to their metabolism. In places where there is availability, parents have faced purchasing limits, escalating prices, and scam. Abbott's denials may raise safety questions even if parents can get the formula.
Abbott's defense is questionable. The link between its formulas and the four infant illnesses has not been confirmed, according to the company. The company suggested that there were huge data gaps that supported the company's assertion that its formula is not the cause of illnesses.
AdvertisementThe company argues that there was no evidence ofcontamination before it left its factory. The facility was found to be contaminated with Clostridium perfringens, and the strains found in the facility did not match the strains found in two of the sick infants.
Only one of the four sick infants tested positive for Cronobacter sakazakii. The strain of C. sakazakii found in the positive formula container did not match the strain found in the Sturgis facility. Abbott notes that the four sick infants all consumed different types of formula produced in its Sturgis plant, and their illnesses occurred at different times in different states. Abbott concluded that there was no cause for the illnesses.
FDA officials called that reasoning nonsense in the press briefing. The lack of a genetic match is not proof that the formula is not the source of the infections.
Susan Mayne, director of the FDA's Center for Food Safety and Applied Nutrition, emphasized in the press briefing that C. sakazakii is not a reportable disease in this country. When there are cases, health officials don't immediately start an outbreak investigation, they don't start genetic testing, and they don't identify clinical clusters as they do for other pathogens. Only two of the four sick infants have genetic sequences from the FDA and CDC. The CDC has a database of about 238 genetic strains of C. sakazakii, which is very small compared to other pathogens.
AdvertisementMayne said that they were limited in their ability to determine if the consumption of the product from the Abbott Sturgis plant was linked to the four cases.
The FDA isolated multiple strains of C. sakazakii from the environment inside the plant when they were doing testing, which was after the cases were identified.
Frank Yiannas, the FDA's deputy commissioner for Food Policy and Response, said that the genetic data for C. sakazakii in this outbreak is minimal. There are examples in the scientific literature of multi-strain outbreaks over time from one source.
Yiannas said that the products have been tested and most tested negative for C. sakazakii. That is not meaningful. Some of the end batches of formula are 400,000 to 500,000 pounds, but the end-product testing plans only involve a series of 30 samples that are 10 grams each, Yiannas said.
He said that an over-reliance on end-product testing is not the best way to assure food safety.
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