The US Food and Drug Administration (FDA) has warned three baby formula manufacturers to improve their bacterial contamination control measures.
The FDA said it does not expect any disruption to the supply of baby formula, but the warning letters are a sign of the agency’s heightened scrutiny of the industry following a series of recalls last year.
The three companies that received warning letters are ByHeart Inc., Mead Johnson Nutrition (a subsidiary of Reckitt Benckiser Group), and Perrigo’s Wisconsin unit. The FDA said the companies had inadequate procedures in place to prevent bacterial contamination during manufacturing.
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 FDA’s warning letters do not correspond with any ongoing product recalls. However, they came after the companies recalled products last year due to concerns about the bacteria cronobacter sakazakii. Cronobacter sakazakii can cause serious infections, including sepsis and meningitis, in infants.
The FDA’s warning letters are a sign of the agency’s increased focus on baby formula safety. The industry has been under scrutiny since last year when Abbott Laboratories’ Michigan-based plant was shut down due to concerns about bacterial contamination. The shutdown led to a nationwide shortage of baby formula.
The FDA is working to increase the supply of baby formula and to ensure that it is safe. The agency has also proposed new regulations for the industry.