Baby formula needs more scrutiny, FDA finds after Michigan factory crisis

• The national baby food crisis from last spring exposed flaws in investigative practices at the Food and Drug Administration
• A report, citing the FDA’s sluggish response to deadly bacteria at the Abbott baby formula factory in Sturgis, recommended broad reforms  
• The report cited the heightened importance of protecting infant formula, which it likened more to a pharmaceutical than a food

A federal report found that transit delays of lab tests, gaps in understanding a potentially fatal bacteria and the lack of a “strong food safety culture” at a Michigan factory contributed to a national shortage of baby formula that was made worse by the federal government's slow response.

The Tuesday report, issued by the U.S. Food and Drug Administration, also concluded that factories that make infant formula — like the one in Sturgis where Abbott Nutrition makes Similac — need to be regulated with more scrutiny than typical food production facilities. 

“While infant formulas … are regulated by the FDA as food, they are in many ways comparable to life-saving medications,” according to the report by Dr. Steven Solomon, director of the FDA’s Center for Veterinary Medicine and a veteran of the FDA’s regulatory office.

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Solomon noted that infant formula serves “as the sole source of nutrition for many infants and for people with certain metabolic conditions that require specialty formulas,” making product contamination and disruptions in the nation’s supply chain particularly dangerous. 

The situation at Abbott Nutrition, a division of Abbott Laboratories [NYSE: ABT], started publicly in February with a voluntary recall of various brands and shipments of powdered formula — including Similac, the most sold brand in the U.S. The recall followed reports that two infants had died and two others were sickened after consuming powdered formula made at the Sturgis plant that contained Cronobacter  — an infection that can be deadly for babies. 

It was later learned a company whistleblower filed a report regarding sanitary conditions at the plant six months before the initial recall. And, that same month, an FDA inspection found contamination risks over Cronobacter sakazakii in the plant, though it was not found in the infant food produced there.

By May, the halt in production led to a nationwide shortage of powdered baby formula and widespread concern over how the contamination risks were evaluated by the FDA, from the unaddressed whistleblower concerns to time lags in connecting the risks to children. 

In Michigan, as store shelves emptied, many local officials were able to help low-income parents access formula, said Susan Ringler-Cerniglia of the Washtenaw County Health Department. 

However, Ringler-Cerniglia said, the national crisis signaled a lack of investment in the systems meant to promote and protect health. 

“Contamination can occur in all sorts of products or in medication,” she said. “The question is really if we have adequate, routine regulation in place and the capacity to respond when something goes wrong.”

Solomon, the FDA veteran who wrote the report, concluded that there were many flaws in the FDA’s handling of the crisis, leading to 15 findings and recommendations.

“One key finding from our interviews is that there is no single action to explain the events that occurred,”  Solomon said. Instead, he continued, “the report identifies a confluence of systemic vulnerabilities.”

According to the report, solutions for the FDA include improving: 

• Information technology so that it can access and exchange data in real time.
• Staffing and improved training and equipment.
• Emergency response systems so that the agency can handle multiple simultaneous public health emergencies.
• Scientific understanding about Cronobacter, and how it should be addressed in oversight.
• Assessments of the infant formula industry.

Beyond the FDA’s regulatory authority, this “unique incident” pointed to its role in supply chain and policy considerations, the report said.

The report is based on  more than 40 interviews with at least 60 FDA staff and leadership directly involved with the investigation of the Abbott factory. 

While the FDA said its report focuses on the agency’s response, it added that “other external stakeholders” would have to address issues like the limited number of infant formula manufacturers in the U.S., improvements in the ingredient supply chain, and better product distribution controls. 

Solomon also wrote that the FDA needs more resources to make the recommended fixes.

“Simply put, if the FDA is expected to do more, it needs more,” he wrote.

Abbott, which employs an estimated 420 people in its factory and R&D facility in Sturgis, announced in late August that it was re-starting Similac production at the factory, and at that time expected it to reach store shelves in early October. An update on production was not available on Tuesday evening.

But Abbott spokesperson Karen Twigg May told Bridge Michigan in a statement Tuesday evening that the Sturgis factory is regularly tested for Cronobacter and other contaminants.

“We meet and exceed regulatory requirements for infant formula testing and we will continue raising the bar by working with FDA and industry partners to further advance infant formula safety and processes,” she said.