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September 5th, 2023In a pivotal move aimed at safeguarding infant nutrition, the FDA sent a series of warning letters to major infant formula manufacturers. ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC, have found themselves in regulatory crosshairs due to recent violations that endanger infant safety. While these warning letters are not related to any ongoing recalls, they shed light on companies’ failure to take careful precautions to avoid Cronobacter sakazakii bacteria. Given the recalls and infant tragedies allegedly tied to contaminated formula, the FDA hopes to send a message to these manufacturers to get a handle on infant formula safety at their facilities.
The FDA is ramping up its dedication to improving safety in infant formula production. In the wake of a series of recalls that unfolded in December 2022, February 2023, and March 2023, it became clear that manufacturers were putting infants at risk. These months witnessed the emergence of a concerning issue: Cronobacter contamination. This dangerous, potentially fatal bacterium infiltrated certain batches of infant formula, sparking recalls and infant formula lawsuits.
The FDA received two heartbreaking reports of infant deaths linked to powdered infant formula produced by Abbott Nutrition in Michigan. It was a distressing period, marked by a total of 128 complaints, including fever, vomiting, diarrhea, and blood in stool. Amid these alarming numbers, the reports revealed a terrifying reality.
The investigations that ensued were meticulous and exhaustive. The spotlight fell on Abbott’s manufacturing environment, and while the strains infecting the infants didn’t exactly match, Cronobacter sakazakii was detected. Furthermore, all the affected infants had one thing in common: they had consumed Abbott powdered formula.
On August 30, 2023, the FDA issued warning letters to three prominent infant formula manufacturers: ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC. The FDA determined these companies violated the Federal Food, Drug, and Cosmetic Act and the FDA’s Infant Formula regulations.
First in line, ByHeart Inc., based in New York, faced the FDA’s scrutiny for violating the “Infant Formula Rule.” The FDA’s close watch began with an inspection of ByHeart Inc.’s powdered infant formula facility. What the agency uncovered was concerning.
Among the noteworthy findings was the firm’s failure to establish a comprehensive system of process controls, a vital measure against harmful microorganisms in the formula or the processing environment. Moreover, ByHeart Inc. failed to identify other sources of the contamination through proper “root cause analysis.”
Next on the list was Mead Johnson Nutrition, part of Reckitt, headquartered in Parsippany, New Jersey. The FDA set its sights on two of its facilities, one in Zeeland, MI, and the other in Wanamingo, MN. The agency discovered several red flags during the inspection.
The absence of a system of process controls to prevent infant formula from becoming tainted by bacteria was a problem in both facilities. In Zeeland, a batch of Enfamil Prosobee Simply Plant-Based Infant Formula tested positive for Cronobacter sakazakii. Similarly, in Wanamingo, the failure to conduct an independent root cause analysis in response to a positive Cronobacter test emerged as a concerning issue.
Lastly, Perrigo Wisconsin, LLC, an infant formula producer based in Eau Claire, WI, found itself in the FDA’s spotlight. The FDA’s inspection of the company’s Gateway facility revealed significant violations. Once again, the absence of a robust system of process controls came to the forefront as Cronobacter was identified in finished products. These tainted products included:
The expectations laid out by the FDA in response to these warning letters are crystal clear. Infant formula manufacturers must comply with the FDA’s laws and regulations.
Foremost among the FDA’s expectations is a thorough and unwavering commitment to root cause investigations. This means manufacturers must dig deep, trace back the steps of their production processes, and identify precisely how and why issues like Cronobacter contamination occurred.
Proper cleaning and sanitation practices are another non-negotiable aspect of the FDA’s expectations. Manufacturers must engage in meticulous attention to detail, adherence to robust cleaning schedules, and rigorous evaluation of cleaning procedures.
The clock starts ticking once a warning letter is received. Manufacturers have a vital 15-working-day window to respond to the FDA. During this time, they must outline their corrective measures in detail. It’s a period that demands swift yet well-planned action to address infant formula safety. Then, the FDA will follow up with future inspections to verify that manufacturers have implemented these actions.
In a written statement on the FDA website, Donald Prater, the acting director of the FDA’s Center for Food Safety and Applied Nutrition, stated, “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.”
The FDA aims to be proactive in identifying and addressing safety concerns early. By doing so, the agency hopes to stop issues from escalating to a point where large-scale recalls become necessary.
The agency’s prevention strategy, unveiled in November 2022, is a blueprint for facilitating infant formula safety. Part of this strategy involves close collaboration with Congress. This partnership aimed at bolstering regulatory tools and securing increased funding to oversee the infant formula industry.
Also, the FDA is working with the U.S. Centers for Disease Control and Prevention (CDC). Together, they’re striving to add invasive Cronobacter infections among infants under one year of age to the Nationally Notifiable Conditions List. This addition is a vital step toward improving surveillance and addressing outbreaks promptly. Furthermore, the FDA has begun recruiting staff to establish an Office of Critical Foods and a group of infant formula investigators.
The Lake Law Firm
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