FDA notified of suspected infant formula illness four months before recall

The Minnesota baby who fell ill in September survived but was hospitalized for 22 days, the state told POLITICO. According to the FDA, Cronobacter sakazakii is a rare but serious foodborne pathogen that can cause “serious and life-threatening infections,” including sepsis and meningitis, as well as intestinal damage.

Identifying the source of foodborne outbreaks is extremely difficult because most people eat a wide variety of foods and cannot remember exactly what they ate days or weeks after the fact. But foodborne illnesses in infants are much simpler to solve. Babies usually consume only one source of nutrition: breast milk or infant formula, or in some cases both.

“It often takes time to gather enough information to put the pieces of a puzzle together – or at least enough pieces to clarify the actions needed to protect public health,” said Doug Schultz, spokesperson for the Department of Health. Minnesota Health, explaining why an illness may not trigger a recall. State agencies cannot institute nationwide recalls; only the FDA has this power.

“As part of Minnesota’s investigation of her case, exposure information was collected, including information about the formula given to the infant (lot numbers, etc.),” ​​Schultz said. “This information has been shared with the CDC and the FDA.”

Two other reports of Cronobacter sakazakii occurred between September and December, according to the FDA, although the agency did not respond to questions about when exactly it received them. The agency also received a complaint about Salmonella Newport illness. The four hospitalized infants reportedly consumed powdered formula from the Sturgis facility. One death was reported, but the FDA said it “has not been confirmed to be solely attributable to Cronobacter infection.”

FDA Issues Consumer Warning and Voluntary Recall of Abbott Nutrition the evening of February 17. The agency also launched an inspection of the Sturgis facility in response to the illnesses, but it did not say when that inspection took place.

“The FDA has initiated an on-site inspection at the facility,” the agency said in its Thursday warning. “Findings to date include several positive results for Cronobacter from environmental samples taken by the FDA and adverse inspection observations by FDA investigators. A review of internal company records also indicates environmental contamination by Cronobacter sakazakii and the destruction of the product by the company due to the presence of Cronobacter.

The FDA said Thursday that its investigation was “ongoing.”

A spokesperson for Abbott Nutrition said the company received complaints between September 2021 and the end of January 2022. standard quality,” the spokesperson said.

“We appreciate the trust parents place in us for safe, high-quality food and we will do whatever it takes to maintain that trust and resolve this situation,” the spokesperson said in an email.

The spokesperson noted that all infant formula is tested for both pathogens and must test negative before any product is sold.

Microbiological testing is an important tool for food safety, but it can miss contamination issues.

In 2017, an inspector general’s report found the FDA had serious flaws in its food recall process. “Recalls have not always been issued promptly because the FDA lacks adequate procedures to ensure companies take prompt and effective action to initiate voluntary food recalls,” the report concludes.

The agency has since attempted to bolster its response to foodborne outbreaks. In December, the agency released a plan to resolve outbreaks more quickly and said it had expanded its rapid response teams to help federal and state officials work better together, among other changes.


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