On Aug. 30, the FDA issued its warnings to ByHeart Inc., Mead Johnson Nutrition under the Reckitt Benckiser Group and Perrigo Wisconsin LLC. The letters reflected findings from inspections over the last several months, which found that the three failed to ensure their infant formulas were not contaminated throughout the manufacturing process.
The letters read that these manufacturers "did not establish a system of process controls covering all stages of processing that were designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment."
The products are potentially contaminated with Cronobacter sakazakii.
The companies have 15 working days upon receipt of the letters to notify the FDA of "the specific steps the companies have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur."
Despite the warning letters, the regulator has not issued any recall notices in connection with the correspondences. It also does not expect any impact on baby formula supply.
The country experienced a severe baby formula shortage in 2022 due to supply chain issues, mainly driven by an outbreak of C. sakazakii linked to contaminated formula made at the Abbott Nutrition facility in Sturgis, Michigan. The outbreak left two infants dead. (Related: Biden sends baby formula to illegals at border while grocery stores run dry.)
This prompted Abbott to close the Sturgis facility and retailers to limit the number of formula customers can buy at one time. The FDA's February 2022 investigation concluded that Abbott "did not ensure that all surfaces that contacted infant formula were maintained to protect infant formula from being contaminated by any source." Abbott later reopened the Sturgis facility in August 2022.
The three manufacturers have responded to the regulator's warning.
A Perrigo spokesperson said in a statement that the Michigan-based company has been committed to meeting the needs of consumers, parents and caregivers. The quality and safety of their products is Perrigo's highest priority, the spokesperson added.
According to the spokesperson, the FDA letter "pertained only to its infant formula manufacturing facility located in Wisconsin, which the company acquired from Nestle on Nov. 1, 2022." The spokesperson continued: "We want to assure the public that all of Perrigo's infant formula products available to parents and caregivers are safe for infant feeding and FDA does not advise discarding or avoiding purchase of any particular infant formula.
Meanwhile, a representative for Reckitt – Mead Johnson's parent firm – said "the safety of babies is of the utmost importance to us and we can confirm that all of our infant formula products continue to meet the highest FDA standards for safety and quality."
"The FDA's communication is part of its enhanced regulatory oversight and does not relate to any new concerns or issues, as they reflect findings from previous inspections," the Reckitt representative wrote in a statement. "[There] are no safety or quality concerns with any Reckitt/Mead Johnson formula, [so] parents and caregivers can rest assured our products can be used with confidence. They don't need to do anything differently when shopping or feeding their infants."
In a statement shared with TODAY, ByHeart commended the FDA and expressed support for the agency's "enhanced oversight." It also stressed that "providing safe and high-quality infant formula" continues to be their top priority and also assured its customers that "no distributed ByHeart product has tested positive for contaminants."
"There is no disruption to ByHeart's manufacturing and we currently have three production plants across the U.S. that are operating to meet the demand for our formula," the company stated.
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Watch this short clip about the FDA warning against popular baby formulas following reports of infections.
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