FDA instructs baby formula companies to inform it of bacteria discoveries

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FDA baby formula companies call to action overview: 

• Who: The U.S. Food and Drug Administration has issued a call to action to baby formula companies following a rash of Cronobacter illnesses among infants in late 2021 and early 2022. 
• Why: The Cronobacter illnesses were linked to an Abbott Laboratory production plant in Sturgis, Michigan and led to recalls and a subsequent nationwide baby formula shortage.
• Where: The FDA issued its call to action to baby formula companies nationwide.

The U.S. Food and Drug Administration has issued a call to action to powdered baby formula manufacturers, distributors, exporters, importers, and retailers regarding its strategy to prevent future outbreaks of Cronobacter. 

The FDA is revealing its new strategies after a number of Cronobacter illnesses were suffered by infants in late 2021 and early 2022 that the agency connected to a Sturgis, Michigan facility run by Abbott Laboratories. 

Abbott was eventually forced to recall a number of its popular infant formulas and temporarily shut down the facility, after the FDA determined the company had failed to maintain sanitary conditions at the plant. 

“This recall and the temporary shutdown of the plant was a major contributing factor to the infant formula shortage experienced across the U.S. in 2022,” the FDA said, in its call to action. 

The FDA has provided baby formula companies with a number of steps they can take to help prevent future Cronobacter illnesses, such as making sure to control water in dry production areas, verifying the effectiveness of controls through environmental monitoring. 

“Environmental monitoring is an important verification measure to ensure that sanitation and hygiene controls are effectively preventing pathogens from entering or persisting in dry production areas,” the FDA said. 

FDA advises baby formula companies to implement ‘effective supply-chain controls for biological hazards’

The FDA is also advising baby formula companies to implement “appropriate corrective actions” following the isolation of a pathogen taken from a product or environmental sample, and to implement “effective supply-chain controls for biological hazards.” 

Baby formula companies are also urged to identify “all relevant biological hazards” beyond Cronobacter, such as Salmonella and Clostridium botulinum. 

“Although much of the recent focus has been on Cronobacter spp., FDA reminds the industry that there are other known or reasonably foreseeable biological hazards associated with powdered infant formula,” the FDA said. 

Last month, Abbott filed a document with the U.S. Securities and Exchange Commission that revealed the company is facing a criminal investigation into its infant formula manufacturing by the U.S. Attorney’s Office for the Western District of Michigan. 

If your child developed a bacterial infection after consuming recalled Abbott baby formula products, you may qualify to participate in an Abbott baby formula injuries lawsuit investigation.

Read About More Class Action Lawsuits & Class Action Settlements:

• Abbott Didn’t Maintain Sanitary Conditions at Plant Where Recalled Baby Formula Is Made, FDA Says
• Similac, Alimentum and EleCare Infant Formulas Recalled Due To Possible Contamination
• Formula shortage update: FDA, companies take steps to alleviate the problem
• Feds launch Abbott infant formula investigation