WASHINGTON — At the center of the nationwide baby formula shortage is a single factory: Abbott Nutrition’s plant that has been closed for more than three months because of contamination problems. On Monday, U.S. officials announced that they had reached a deal to work with Abbott in order to restart production at Sturgis’ Michigan facility. This is the biggest U.S. plant and the source of top brands such as Similac.
But, it is not clear when the site will go live. There are still many questions, such as what caused contamination and if U.S. regulators should have stepped in earlier to alleviate the shortage of formulas. U.S. formula manufacturers have been experiencing ongoing problems with their supply chains since the plant shut down.
WHAT CAUSED THE SHUTDOWN?
In mid-February Abbott said it would recall three batches of powdered infant formulas made at the plant. This was after four children who had been given formula were diagnosed with rare bacteria. Two infants were killed. But it’s not certain the bacteria came from the plant; strains found at the plant didn’t match the two available samples from the babies. The company stopped production and Food and Drug Administration inspectors did a six week investigation.
A preliminary report that was released in March showed signs of bacteria — Cronobacter– found on several surfaces in the plant. However, it wasn’t in the areas where the powder was made. According to plant records, Abbott detected the bacteria eight more times since 2019..
Inspectors also flagged other problems, including standing water on the floor and employees who didn’t properly sanitize their hands.
WHAT IS CRONOBACTER?
The bacteria occurs naturally in soil, water and other parts of the environment. Although rare, cronobacter infections can prove fatal to babies. Almost all previous outbreaks in the U.S. have been linked to powdered baby formulas, which don’t undergo the same high temperatures used to kill germs in many other foods.
Sometimes the bacteria can get into powdered formula after its opened at home if a dirty scoop is used or it is mixed with water that’s contaminated with the germ, according to the Centers for Disease Control and Prevention.
Cronobacter typically causes fever in infants and can sometimes lead to dangerous blood infections or swelling of the brain.
The four illnesses reported were found in Minnesota, Ohio, and Texas during September through January.
WHAT PART DID ABBOTT’S FORMULA PLAY in THE ILLNESSES
It’s not clear yet. It’s not clear if the FDA will issue a definitive ruling regarding the issues at the plant or whether the outbreak is related.
“There are many factors involved in this ongoing investigation and we’re just not in a position to make any definitive statement,” FDA Commissioner Robert Califf said Monday..
Food safety experts say the case underscores the challenges of tracing foodborne illnesses.
Because only two of the four cases had been collected, the FDA’s food director Susan Mayne said that it was difficult, “Right away we were limited in the ability” to connect the infant formula and the illness. “We simply don’t have the evidence to demonstrate that causality.”
Abbot says the lack of a strain match indicates “there is no evidence to link our formulas to these infant illnesses.”
SHOULD THE FDA HAVE STEPPED IN SOONER?
The FDA faces intense scrutiny over the steps that it took and did not take in the three months prior to the recall.
FDA inspectors visited a factory late September to conduct a routine inspection. This was around the same time as the initial bacterial outbreak in Minnesota. Although inspectors uncovered several violations– including standing water and unsanitary conditions — they didn’t find any bacteria and let the plant stay open. It’s unclear if inspectors were even aware of the first reported illness.
After three additional cases had been reported, FDA went back to the facility in January and discovered the bacteria.
The FDA is primarily concerned with ensuring food safety. They have additional regulations and standards for foods that are suitable for children and babies. But former FDA officials say the agency is supposed to consider potential shortages that result from shutting down plants.
In previous cases, the FDA has worked with companies to shift production to other facilities or find alternative supplies.
The FDA is doing that now under a new policy that eases imports of baby formula from foreign manufacturers. But both the agency and the White House are facing questions on why that step wasn’t taken sooner.
“We always believe we can do better in terms of the time frame,” Califf said.
Rep. Rosa DeLauro (D-Conn.) reported last month about a whistleblower who had made allegations regarding unsafe conditions at the plant. She claimed that the FDA was contacted in October by a whistleblower with concerns over falsifying records of the facility and not properly testing for contamination. The FDA didn’t interview the whistleblower till late December, she said. DeLauro, as well as other legislators will be asking Califf questions on Thursday.
WHEN WILL THE PLANT RESTART PRODUCTION?
Both Abbott and the FDA say that they’re working quickly to get the manufacturing process back on track. Officials from the FDA say that it is up to Abbott to prove its Michigan facility meets strict safety standards.
Former FDA officials say fixing the type of problems uncovered at Abbott’s plant takes time, and infant formula facilities receive more scrutiny than other food types. The company must thoroughly clean and retrain employees, test for contamination, and then document the results.
Even after opening the facility, Abbott estimates that it may take 8-10 weeks for new products to start shipping out of stores. It continues to make baby formula in its U.S. plants and abroad.
Follow Matthew Perrone on Twitter: @AP_FDAwriter
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