Following reports of infant illness last year, the FDA investigated and subsequently issued a warning not to use products manufactured at the Abbott baby food plant. Abbott responded by voluntarily shutting the facility resulting in an acute shortage of baby formula in the US – and rampant hysteria. Given Abbott’s strenuous denial that its products caused harm, one cannot help wondering if this closure was an overreaction or a calculated ploy.
During the week starting April 24, 2022, 40% of baby formula was out of stock in more than 11,000 stores nationwide. In at least six states, more than half of all available baby formula sold out in stores during the same period. Abbott Laboratories has said
"… it could take six to eight weeks for its products to reach shelves …, exacerbating a shortage of baby formula.”
In fact, it took another three months for the plant to reopen, only to be shut down again for another few months, reportedly due to weather damage.
Product shutdowns or discontinuances are not an unusual reaction after recalls or lawsuits- consider IUDs and silicone breast implants. But none of these products are as crucial as baby formula. Until recently, it wasn’t clear what problem with the plant resulted in its closure. Lawsuits had been brought for consuming products it manufactured, signaling allegations of negligence in the manufacture of baby formula were involved, but these were mostly settled, so the details of what happened are being kept out of the public eye.
What was done?
Problems with baby formula first made headlines over eight months earlier - and seemed to involve bacterial contamination. It took time before the shortage improved as the Biden Administration, in conjunction with the US Military’s “Operation “Fly Formula,” brought 39 tons of formula to the US while the FDA worked to streamline the review and approval process to get international baby formula on the shelves.
Did the streamlined approval process solve or exacerbate the shortages and alleged contamination? One can’t know.
Problems with Abbott’s powdered baby formula first surfaced about two decades ago- when bacterial contamination was alleged to have caused several cases of severe meningitis and other horrific injuries in babies. While liquid formulas are sterilized, the powdered form isn’t – and while cheaper, it was found to be the source of a specific bacteria, Chronobacter sakazakii, which can cause severe neurological illness and be fatal in babies.
Several lawsuits ensued, all settled or lost by plaintiffs (in at least one case, a $900,000 settlement was offered). Settlements were offered conditioned on a confidentiality basis, so the word didn’t get out. A scorched earth policy involving highly aggressive legal strategy and tactics followed. The presiding judge claimed these tactics were unfair to poorly funded plaintiffs’ lawyers resulting in the injuries largely going unnoticed – until 2022. (Actually, the plaintiffs’ lawyers just seemed to be outclassed and out laout-lawyerede defense bar, from what I can tell.)
In early 2022, after several infants became ill, federal regulators inspected the Abbott factory in Sturgis, Michigan. In February, the FDA issued a warning against consuming specific Abbott formulas, such as Similac. That’s when, while contesting contamination in its products, the company voluntarily shut down the facility. That closure caused the shortage. (Of course, “voluntariness” is subject to interpretation, as it followed the FDA warning on products manufactured at the facility).
An FDA investigation didn’t begin until May, when the agency asked Dr. Steven Solomon, the Center for Veterinary Medicine Director, to conduct a top-down review of agency activities and decision-making related to the Sturgis facility. Four months later, Dr. Solomon released his report. The investigation did not focus on the shortcomings of the Sturgis plant, the causes of the children who became ill, or the source of bacterial contamination, but rather the consequences of actions resulting in the shortage of baby formula. The suggested solutions revolved only around the shortage:
“The information that came out of these interviews allowed us to identify five major areas of need, with fifteen specific findings:
- Modern information technology that allows for the access and exchange of data in real-time to all the people involved in response.
- Sufficient staffing, training, equipment, and regulatory authorities to fulfill the FDA’s mission.
- Updated emergency response systems that are capable of handling multiple public health emergencies occurring simultaneously.
- Increased scientific understanding about Cronobacter, it's prevalence and natural habitat, and how this translates into appropriate control measures and oversight.
- Assessment of the infant formula industry, its preventive controls, food safety culture, and preparedness to respond to events.”
So what’s to be done now?
The baby formula industry is a behemoth. The $4 billion annual US baby formula market has been dominated by domestic producers, with imports limited and subject to high tariffs, complicating an international rescue. The Biden plan seemed to seek to circumvent these obstacles but didn’t address the alleged contamination issue.
“The sale of commercial milk formula is a multi-billion dollar industry that uses political lobbying alongside a sophisticated a highly effective marketing playbook to turn the care and concern of parents… into a business opportunity.”
- Prof. Nigel Rollins, WHO
Another factor impedes greater profitability of the industry – and addressing it would surely result in less illness in children: the consensus in the medical community that breast-feeding is superior to formula and that formula milk companies “exploit parent’s emotions and manipulate scientific information to generate sales at the expense of the health and rights of families, women, and children.”
Fewer than half of infants in the world are breast-fed. In the US, over 80% of children receiving breast milk at some point, and about a quarter receive some breast milk at six months. But the steady decline in exclusive breast-feeding from month-to-month indicates that breast-feeding families may need stronger support systems to reach their breast-feeding goals.
For example, some people believe that problems of infancy are caused by breast-feeding - including not producing enough milk. The baby formula industry takes advantage of these misperceptions.
“The formula milk industry uses poor science to suggest, with little supporting evidence, that their products are solutions to common infant health and developmental challenges….”
- Professor Linda Wichter, Wits University, South Africa
In February of 2023, the Lancet featured a series highlighting the power and political clout of the industry and called for an international treaty to end irresponsible formula milk marketing. According to their report, “regulations need to be urgently strengthened.” Experts claim nothing short of tighter marketing and advertising restrictions or even an international treaty would stem current violations of a 1981 Code that prohibits idealizing the use of manufactured formula “and exploits poor science to create an untrue story to sell more product.”
Abbott claims it is working with the FDA to address their concerns while stressing that no Chronobacter was found in its products. In April, Abbott submitted a corrective action plan to the FDA. In May, a federal judge approved an agreement between the FDA and Abbott that laid out the steps the company needed to take to restart production. It opened its plant in July after an earlier restart in June was truncated – apparently due to heavy rains.
But the story does not end here
In January 2023, the DOJ announced it was investigating the Sturgis plant. Why? Perhaps, as CNN reported, the FDA investigation of the Sturgis plant found the potentially deadly Cronobacter sakazakii bacteria in several areas – although Abbott strenuously maintains it was not found in its products.
And the federal government is still worried about contamination:
Two months ago, the FDA issued a new call to action to the infant formula industry to protect babies from illnesses caused by Salmonella and Cronobacter sakazakii, calling for companies to notify the FDA if these organisms were found in its products.
Last week, the FDA circulated a memo updating its contamination prevention program, providing advance to parents and manufacturers and detailing the history of the debacle, including a link to an update on its restructuring of the food safety and regulatory program.
“This letter is intended to assist industry in improving the microbiological safety of powdered infant formula.”
- FDA Commissioner Dr. Robert Califf and Susan Mayne, director of the Center for Food Safety and Applied Nutrition
Now, one year later, we still don’t know why the Abbott plant was closed for the better part of five months.