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Infant formula contamination: FDA issues warning letter to three US firms

The US Food and Drug Administration (FDA) has issued warning letters to three infant formula manufacturers – ByHeart, Mead Johnson Nutrition, and Perrigo – urging them to address manufacturing practices to prevent bacterial contamination.

In notifications sent out last month, ByHeart, Mead Johnson Nutrition (Reckitt), and Perrigo, received warnings arising from Agency inspections of these facilities in previous months.

These warnings come off the back of these firms issuing recalls in December 2022, February 2023 and March 2023 that removed products potentially contaminated with Cronobacter sakazakii from retail.

“Infant formula manufacturers are responsible for ensuring they make safe products, and the agency has remained in ongoing discussions with the infant formula industry to address the agency’s concerns,” said Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition.

“These letters are intended to help the industry continuously improve the safety of their manufacturing practices, so that parents and caregivers can be confident that the formula they feed their children is safe and nutritious.”

FDA's communication does not relate to any new concerns or issues

In response, Perigo told Reuters, "We are in the process of carefully reviewing the FDA's letter and plan to work closely with the agency."

The Michigan-based company, which is now dealing with the FDA’s findings from its Wisconsin facility, added that all its infant formula products available to parents and caregivers complied with the FDA's food safety requirements.

In a statement, Mead Johnson Nutrition pointed out that the FDA's communication was part of its enhanced regulatory oversight and did not relate to any new concerns or issues, rather it reflected findings from previous inspections.

ByHeart said that prior to receipt of the warning letter, it had already submitted comprehensive responses to FDA’s observations from that inspection and there was no disruption to its manufacturing facilities or supply.

“Rest assured that no distributed ByHeart product has ever tested positive for contaminants and our recently relaunched product is manufactured end to end by us, including final packaging,” they added.

Further details of the FDA’s warning letters

Crucially, the FDA does not advise parents and caregivers to discard or avoid purchasing any particular infant formula at this time.

The agency is not aware of any distributed product where contamination was confirmed and believes that the recalls were effective in removing the potentially contaminated batches of product from the market.

Additionally, these warning letters are not associated with any current recalls and therefore the FDA does not anticipate any impact to the availability of infant formula on the market.

The FDA’s latest action promptly follows last year’s large-scale recall that contributed to the infant formula shortage.

Cronobacter sakazakii at the centre of recent recalls

In December 2022, ByHeart announced it had voluntarily recalled five batches of the firm’s Whole Nutrition Infant Formula due to potential cross-contamination with Cronobacter sakazakii.

This was swiftly followed by a February 2023 recall by Mead Johnson Nutrition that voluntarily recalled two select batches of ProSobee 12.9 oz. Simply Plant-Based Infant Formula for the same reason.

The latest recall for potential Cronobacter sakazakii contamination occurred in March 2023, where Perigo, voluntary recalled certain lots of Gerber Good Start SoothePro Powdered Infant Formula in the U.S., that were manufactured at the Company’s Gateway Eau Claire, Wisconsin manufacturing facility.

In an attempt to allay concerns about supplies of infant formula available in the US market, the FDA quoted in-stock rates at 85% or higher since the beginning of 2023.

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“The current strength of this market can be largely attributed to the many actions taken by the FDA and other U.S. government partners through 2022 and 2023, which are outlined in the FDA's National Strategy to Increase the Resiliency of the Infant Formula Market.”

Possible consequences arising from Cronobacter infection

Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine).

Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths and abnormal movements.

Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.

The three companies now have 15 working days to respond to the FDA to explain what corrective actions they are taking.