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FDA Calls On Infant Formula Industry to Improve Food Safety

The FDA penned a letter asking the infant formula industry to improve the safety of powdered baby formula. Powdered infant formula has made headlines over bacterial contamination that has put the health and lives of babies at risk. Most notably, Abbott Laboratories faces dozens of infant formula recall lawsuits after reports of bacterial illnesses among infants. The agency has addressed members of the baby formula industry to follow its new strategy to protect infants from tainted products. 

Abbott Formula Illnesses

The FDA developed this new strategy to avoid future bacterial illnesses related to powdered formula and in response to the Abbott recall in 2021. In late 2021 and early 2022, the FDA received reports of infant illnesses and deaths caused by a bacteria called Cronobacter sakazakii. This germ thrives in dry environments and proves especially harmful for infants. 

Testing at an Abbott Laboratories plant in Michigan revealed several instances of Cronobacter at the facility. In addition to the hazardous bacteria, the FDA inspection uncovered unsanitary conditions, prompting a recall and the plant’s shutdown. 

FDA Expects Better Conditions and Regulations From Infant Formula Industry 

The letter sent on March 8 calls upon infant formula manufacturers, packers, distributors, exporters, importers, and retailers to monitor food safety risks in powdered baby formula. The FDA has outlined several ways to prevent bacterial contamination, including: 

• Evaluating every step of the production process, from purchasing ingredients to storing and distributing finished products
• Full compliance with all regulations 
• Considering the concerns shared in the letter 
• Notifying the FDA if an adulterated or misbranded infant formula product has left the facility

The agency asks that firms voluntarily notify them when a product sample tests positive for Cronobacter or Salmonella, even if the affected lot(s) have not been distributed. 

Furthermore, the FDA noted several areas for improvement in the infant formula industry: 

• Controlling water in dry production areas
• Direct testing for Cronobacter 
• Corrective actions to prevent contaminated products from entering the market and to find the root cause 
• Ensuring sanitary conditions of suppliers and informing suppliers of the intended use of raw materials 
• Identifying all relevant biological hazards, not just Cronobacter 

With this letter, the FDA hopes the infant formula industry will ensure the safety of our most vulnerable population. 

The Lake Law Firm Can Help You File an Infant Formula Lawsuit

This letter highlights the disgraceful conditions of baby formula production. Manufacturers should take greater care in providing infants with safe formula. These companies should not have to be reminded by the FDA to maintain clean environments and enforce proper procedures. Infant formula claims allege companies neglected the health of infants by distributing contaminated formula. If tainted formula harmed your child, an infant formula attorney from The Lake Law Firm is here to support you. 

The Lake Law Firm was founded by Edward J. Lake, Esq., a personal injury lawyer for over 25 years. Our dedicated team of attorneys is committed to seeking justice on behalf of those who have suffered injury or death due to the negligence of others. Our experienced attorneys handle many different types of pharmaceutical drugs, medical devices, and other defective products. The lawyers in our firm have helped collect millions of dollars for their clients. An infant formula attorney will advocate for you and your rights. Please contact us today for a free confidential case evaluation at (888) 525-3529.