The US Food and Drug Administration (FDA) has issued warning letters to three baby formula manufacturers, ByHeart Inc., Mead Johnson Nutrition (a subsidiary of Reckitt Benckiser Group), and Perrigo’s Wisconsin unit, to improve their bacterial contamination control measures.
The FDA stated that it does not anticipate any disruption in the supply of infant formula, but the warning letters are evidence of the agency’s increased scrutiny of the sector in the wake of last year’s spate of recalls.
According to the FDA, the companies’ policies for preventing bacterial contamination during manufacture were insufficient.
ByHeart said it is “committed to working closely with the FDA to address their concerns” and that it has “a strong track record of safety and quality.”
Mead Johnson said it is “committed to providing safe and high-quality infant formula” and that it is “working with the FDA to address their concerns.”
Perrigo said it is “committed to providing safe and high-quality products” and that it is “reviewing the FDA’s letter and will take appropriate action.”
The warning letters from the FDA are unrelated to any active product recalls. However, these followed product recalls by the corporations last year over worries about the bacterium Cronobacter sakazakii. Infants who contract Cronobacter sakazakii may develop life-threatening infections like sepsis and meningitis.
The FDA’s warning letters are evidence of the organization’s growing emphasis on the safety of infant formula. Since Abbott Laboratories’ Michigan-based plant was shut down owing to worries about bacterial contamination last year, the sector has come under scrutiny. The closure caused a shortage of infant formula across the country.
The FDA is working to make baby formula more widely available while still ensuring its safety. Additionally, the agency has suggested additional rules for the sector.