After several infant formula product recalls due to bacterial contamination, the Food and Drug Administration (FDA) is calling on manufacturers and retailers to enhance their safety measures. In February, formula company Reckitt recalled 145,000 cans of Simply Plant-Based Infant Formula that were potentially tainted with Cronobacter sakazakii bacteria. Earlier this week, Perrigo Company recalled several batches of Gerber’s Good Start Infant Formula for the same reason.
Cronobacter sakazakii is found naturally in the environment. It doesn’t pose much risk to adults, but the bacteria can cause sepsis and meningitis in babies. Infants younger than two months old are most likely to get sick from a Cronobacter infection, and the prognosis is often grim. Once a newborn is infected, the mortality rate is between 50% and 80%. The bacteria can survive in dry conditions, so it’s often found in powdered formula. The Cronobacter bacteria has been linked to other formula recalls. Manufacturing giant Abbott temporarily closed a plant last year after formula produced at the facility was linked to two infant deaths. The site closure exacerbated an infant formula shortage partially caused by supply chain issues, and parents are still struggling to find infant formula today.
For parents who rely on formula, the threat of bacterial contamination can be a significant stressor. Premature infants and babies with weakened immune systems are most at risk for Cronobacter illness. To complicate the issue, Cronobacter also lives on home surfaces like kitchen counters, making it difficult to pinpoint where an infection originated.
The FDA letter, dated March 8, is directed to infant formula manufacturers, packers, distributors, exporters, importers, and retailers. The agency said its strategy is designed to improve the microbiological safety of powdered formula. The suggested reforms include:
- Asking companies to report Cronobacter and Salmonella infections to the federal government, even if the lots weren’t distributed to the public.
- Establishing protocols to help prevent contamination and requiring companies to meet all regulatory standards set by the FDA.
- Reducing the amount of water in manufacturing facilities because bacteria thrive in wet environments, and the FDA observed water in areas that were supposed to be dry during plant inspections.
- Implementing environmental monitoring programs to test specifically for Cronobacter pathogens. Some facilities test for other bacteria and miss Cronobacter contamination in the process.
- Following a corrective action plan once Cronobacter is discovered at a manufacturing facility and investigating the source of contamination.
- Identifying potential bacteria that can harm young children aside from Cronobacter and salmonella.
It’s unclear whether formula companies will adhere to all of the guidelines suggested by the federal government. Still, the looming threat of a recall offers ample reason to update best practices. Product recalls cost companies millions of dollars in direct costs, not including damage to a brand’s reputation or the cost of potential lawsuits. Families affected by Cronobacter infections are suing the manufacturers who sold the contaminated formula to the public.
Other Baby Formula Health Risks
Manufacturers have also faced questions about whether baby formula products cause necrotizing enterocolitis (NEC), a gastrointestinal condition that primarily affects premature infants. Newborn babies fed cow’s milk-based formulas are more likely to receive an NEC diagnosis than breastfed children. The disease has a mortality rate of up to 50 percent and can cause lifelong complications, including intestinal failure and developmental delays.
Parents of children who developed the condition after ingesting formula have filed NEC baby formula lawsuits against the makers of Similac and Enfamil. Even if a child survives an NEC diagnosis, the financial and emotional toll the disease takes on their life can be catastrophic. A lawsuit can help parents recover money lost to medical bills, future medical expenses, and any pain and suffering they experienced due to the diagnosis. Some babies need special care because of NEC complications, and a parent may have to stop working to become a caretaker. In this case, a parent’s diminished earning capacity could also be considered during litigation. If your child has been diagnosed with a health condition that could be linked to baby formula, a personal injury lawyer can help you determine your next best steps.