Warning Letters Were Issued to Infant Formula Manufacturers by the FDA For Violations

The FDA has issued warning letters to infant formula manufacturers ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin LLC for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the federal agency stated in a press release.

The FDA inspected each company’s facilities, in which the agency issued inspectional observations and exercised oversight of each firm as recalls were initiated in December 2022, February 2023, and March 2023, respectively, for the removal of products potentially contaminated with Cronobacter sakazakii from the marketplace.

As part of its normal regulatory process, the warning letters were issued to reinforce the “importance of instituting and maintaining appropriate corrective actions when they detect pathogens to ensure compliance with the FDA’s laws and regulation” to the respective firms.

“Infant formula manufacturers are responsible for ensuring they make safe products, and the agency has remained in ongoing discussions with the infant formula industry to address the agency’s concerns. 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, Center for Food Safety and Applied Nutrition, FDA.

“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.”

Caregivers and parents are not advised to discard or avoid the purchase of any specific infant formula at this time, and the FDA is not aware of any distributed product where contamination was confirmed. Further, the agency believes the recalls were effective in removing the potentially affected batches of product from the market. Current recalls are not associated with the warning letters issued, and the FDA is not expecting availability of the infant formula to be impacted.

Each company will have 15 working days to respond to the federal agency, explaining the corrective actions they are taking. These actions will be assessed by the FDA and reviewed at the next inspection of the facilities, where verification for proper implementation of corrective practices will take place. The warning letters are part of an effort from the FDA to strengthen safety and resiliency of the United States infant formula supply. Since the start of 2023, the infant formula has been considered healthy, as in-stock rates have been at 85% or higher.