The U.S. Food and Drug Administration (FDA) issued warning letters on Wednesday to three prominent infant formula manufacturers in a bid to bolster safety standards within the infant formula industry.
The letters were sent to ByHeart, Mead Johnson Nutrition, and Perrigo Wisconsin. Inspections of their facilities uncovered violations of FDA health regulations, which led to voluntary recalls in December 2022, February, and March.
The FDA clarified that the warning letters are not linked to ongoing recalls and that the products manufactured by these companies and presently available in the market do not present any risks to consumers.
“The FDA is issuing these letters now as part of its normal regulatory process and to reinforce to these firms the importance of instituting and maintaining appropriate corrective actions when they detect pathogens to ensure compliance with the FDA’s laws and regulations,” the agency said in a statement.
Crucially, the FDA has clarified that it does not currently recommend the disposal or avoidance of any specific infant formula brands. According to the agency, no instances of confirmed contamination have been identified in distributed products.
The previous recalls aimed to eliminate potentially contaminated products that might have contained Cronobacter sakazakii, which can be found in dry foods.
The FDA said its action underscores its commitment to stringent regulatory oversight and the assurance of optimal conditions for the production of infant formula.
The recalls undertaken by the three manufacturers have effectively removed any potentially compromised batches from circulation. As a result, the current supply of infant formula on the market remains unaffected by these actions, the agency said.
The letters are intended to prompt the companies to fix their problems and comply with the FDA’s standards. The agency requires the companies to adhere to rigorous cleaning and sanitation procedures, carry out comprehensive investigations into instances of contamination, and reassess their sanitation policies.
The FDA has given the companies 15 days to respond and outline the corrective actions they intend to take. The agency has urged the companies to evaluate their cleaning schedules, practices, and procedures before releasing products before follow-up inspections.
“The FDA is committed to identifying and acting on issues early to prevent any firms from reaching the level of concern that prompted last year’s large-scale recall and contributed to the infant formula shortage,” said Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition.
“Over the last year the FDA has continued to increase our oversight of powdered infant formula facilities. 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,” he added.
Mr. Prater said infant formula manufacturers are responsible for ensuring they make safe products. The FDA continues to discuss its concerns with the infant formula industry, he added.
Avoiding last year’s notable infant formula shortage is also top of mind for the agency, according to Mr. Prater.
Last year, the FDA implemented a strategy to reduce Cronobacter sakazakii illnesses associated with powdered infant formula. This approach included working with Congress to improve regulatory tools and increase funding for industry oversight.
After the U.S. Center for Disease Control and Prevention got involved, Cronobacter infections among infants under one year of age were added to the Nationally Notifiable Conditions List.
The FDA sought to assure consumers that infant formula supplies within the United States were safe and in good supply since the beginning of the year.
The health advisories follow a year marked by shortages in the infant formula market during 2022. The FDA indicated that the availability of baby formula has been hovering around 85 percent nationwide since January.
The previous shortage was blamed on a blend of health-related concerns, challenges within the supply chain, and perceived inadequacies in the FDA’s response, according to an internal inquiry conducted within the agency.
