Today, the U.S. Food and Drug Administration (FDA) has issued warning letters to three infant formula manufacturers as part of its ongoing commitment to enhance regulatory oversight, ensuring the safest possible conditions for infant formula production.
The warning letters, citing violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA’s Infant Formula regulations, have been directed towards ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC. These actions are a response to FDA inspections conducted over the past few months. During these inspections, the FDA provided inspectional observations and closely monitored the firms as they initiated recalls in December 2022, February 2023, and March 2023 to remove potentially contaminated products containing Cronobacter sakazakii from the market.
It’s important to note that the FDA is not advising parents and caregivers to discard or avoid purchasing any specific infant formula at this time. The agency has not identified any distributed products with confirmed contamination, and the recalls were effective in removing the potentially contaminated batches from the market. These warning letters are unrelated to ongoing recalls, and the FDA expects no impact on the availability of infant formula in the market.
The FDA is issuing these letters to emphasize the importance of implementing and maintaining appropriate corrective actions when pathogens are detected. This includes conducting thorough root cause investigations, followed by proper cleaning and sanitation activities. Additionally, firms are required to evaluate their cleaning and sanitation practices, schedules, and procedures before releasing their products. Each company has 15 working days to respond to the FDA, explaining the corrective actions they are taking. The FDA will assess the adequacy of these actions during its review of the responses and future inspections of the facilities.
Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition, emphasized that infant formula manufacturers must ensure the safety of their products. The FDA has been actively engaging with the infant formula industry to address concerns and prevent issues that led to last year’s large-scale recall and contributed to the infant formula shortage.
These actions are part of the FDA’s ongoing efforts to strengthen the safety and resilience of the infant formula supply in the U.S. The agency has been working with Congress to enhance regulatory tools and funding, collaborating with the U.S. Centers for Disease Control and Prevention (CDC) to address Cronobacter infections, and hiring staff to establish a dedicated cadre of infant formula investigators and an Office of Critical Foods to bolster regulatory oversight.
It’s important to reassure consumers that the U.S. infant formula supply remains healthy, with consistent in-stock rates at 85% or higher since the start of 2023, thanks to the FDA’s actions outlined in the National Strategy to Increase the Resiliency of the Infant Formula Market.
For parents and caregivers, following manufacturer instructions for preparing powdered infant formula is crucial. The CDC recommends using ready-to-feed liquid infant formula for infants less than 2 months old, premature infants, or those with weakened immune systems when possible, as it is sterile and the safest option. However, when preparing powdered formula, caregivers should heat water to at least 158°F/70°C, add the powdered formula, mix, and then cool the formula to body temperature (98.6°F) before feeding.
Caregivers should be especially attentive to manufacturer instructions for metabolic and specialty formulas, as some caution against heating above 100°F to prevent a loss of vitamins and nutrients.
The FDA remains committed to regulatory oversight and industry engagement to enhance infant formula safety, including conducting annual inspections, maintaining dialogue with manufacturers, and advancing prevention-based research and activities.
In addition to these efforts, the FDA is dedicated to unifying and strengthening the FDA Human Foods Program, driven by findings and recommendations from an external evaluation conducted by the Reagan-Udall Foundation, following the agency’s response to the infant formula supply chain challenges.