FDA sends warning letters to three baby formula manufacturers

The Food and Drug Administration issued warning letters to three infant formula manufacturers Wednesday evening as the agency continues to emphasize on pediatric product safety.

The FDA sent letters to ByHeart Inc., Mead Johnson Nutrition (Reckitt) and Perrigo Wisconsin, LLC.

The letters were sent based on FDA inspections of each company’s respective facilities throughout the year, where the agency sought to remove products that were potentially contaminated with Cronobacter sakazakii, a bacteria that can cause illnesses in infants. 

Between December 2022 and March 2023, the three companies initiated recalls on potentially contaminated products.

Of note, the FDA said consumers should not discard or avoid purchasing infant formula, adding that it is not aware of any distributed products where contamination was confirmed. The agency stated that it does not anticipate the letters to impact the availability of the infant formula supply on the market.

This is an important distinction from the FDA as parents remember the severe nationwide infant formula shortage that lasted from February to July 2022 following an abrupt production stoppage at an Abbott Laboratories facility in Michigan. 

This came after several complaints of serious bacterial infections related to products manufactured there and the report of a baby’s death after consuming contaminated infant formula.

Ultimately, both the FDA and Department of Justice launched investigations into the Abbott facility and how 

Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition, said in a statement that the agency has remained in “ongoing discussions with the infant formula industry” to address concerns around product safety and ensure that another large-scale recall and subsequent shortage are avoided in the future.

“Over the last year the FDA has continued to increase our oversight of powdered infant formula facilities,” Prater said in a statement. “These letters are a reflection of this enhanced oversight and 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.”

Outside of investigations into product safety, infant formula manufacturers have faced interest from another regulatory body as well this year. 

In late May, the Federal Trade Commission launched a probe into Abbott, Nestlé and Reckitt Benckiser for allegedly colluding on bids for lucrative state contracts.