WASHINGTON: The US Food and Drug Administration (FDA) has issued warnings to three baby formula manufacturers, urging them to enhance their measures for controlling bacterial contamination in their products.
While the FDA reassured that it anticipates no disruptions in the supply of baby formula, these warning letters signal the agency’s heightened vigilance over the industry, stemming from a series of recalls in the previous year.
The three companies that received the FDA’s warning letters are ByHeart Inc., Mead Johnson Nutrition (a subsidiary of Reckitt Benckiser Group), and Perrigo’s Wisconsin unit. According to the FDA, these firms have not implemented adequate procedures to prevent bacterial contamination during the manufacturing process.
Concerns Over Safety of Baby Formula
ByHeart, responding to the FDA’s warning, expressed its commitment to collaborating closely with the agency to address their concerns, underlining its strong record of safety and quality. Mead Johnson emphasized its dedication to providing safe and high-quality infant formula and stated its willingness to work with the FDA to address the issues raised. Perrigo conveyed its commitment to delivering safe and high-quality products and revealed that it is in the process of reviewing the FDA’s letter, vowing to take appropriate action.
Notably, the FDA’s warning letters do not coincide with any ongoing product recalls. However, they come in the wake of last year’s product recalls by these companies due to concerns about the bacterium known as Cronobacter Sakazakii. This bacterium can lead to severe infections, including sepsis and meningitis, in infants.
These warning letters reflect the FDA’s increased focus on enhancing the safety of baby formula. The industry has faced heightened scrutiny since the closure of Abbott Laboratories’ Michigan-based plant last year due to concerns regarding bacterial contamination. This shutdown resulted in a nationwide shortage of baby formula.
