Wednesday September 27, 2023

Three baby formula makers warned over bacteria contamination. Should you be alarmed?

Baby formula makers Mead Johnson Nutrition, ByHeart Inc, and Perrigo's Wisconsin unit have received warning letters from the Food and Drug Administration

By Web Desk
August 31, 2023
A representative image of baby formula.—Twitter/file
A representative image of baby formula.—Twitter/file 

The US Food and Drug Administration (FDA) has taken action by issuing cautionary notices to three manufacturers of baby formula, urging them to better their bacterial contamination control.

However, the FDA has clarified that it anticipates no disruption to the supply of these crucial products.

ByHeart Inc., Mead Johnson Nutrition (a subsidiary of Reckitt Benckiser Group), and Perrigo's Wisconsin unit have all received warning letters from the regulatory body.

The FDA cited concerns over the inadequacy of measures put in place by these companies to safeguard baby formula against contamination during manufacturing.

Perrigo responded by expressing its commitment to closely collaborate with the FDA and thoroughly examine the contents of the warning letter. The company assured that all its infant formula offerings available to parents and caregivers align with the stringent food safety criteria outlined by the FDA.

These FDA warnings do not correspond with any ongoing product recalls. Instead, they stem from observations made in the wake of recalls carried out by these three firms from December to March, a period during which they withdrew items potentially compromised by the bacterium cronobacter sakazakii.

The FDA commended the effectiveness of the recalls in removing possibly contaminated product batches from the market, even though the warning letters themselves are not tied to ongoing recalls. 

This move follows intensified scrutiny of infant formula production subsequent to shortages experienced last year, brought about by the shutdown of Abbott Laboratories' Michigan-based unit. 

This shutdown occurred due to concerns over bacterial infections linked to products from the facility, resulting in recalls and the temporary closure of operations.