FDA sketches out plan to bolster fragile US infant formula supply management
The US Food and Drug Administration announced Tuesday its initial strategy to boost and strengthen the management of the country's supply of infant formula.
The announcement came just ahead of a hearing of the House Oversight and Accountability Committee about what went wrong during last year's infant formula shortage.
Committee members and experts who testified were critical of formula makers and the FDA's food safety program, which the agency has pledged to revamp in order to protect the nation's food supply and promote better nutrition. Many experts are concerned that the formula shortage of 2022 could easily happen again, even with those changes.
"While we stand here today, more than a year since the recall, it is my view that the state of the infant formula industry today is not much different than it was then," testified Frank Yiannas, who stepped down from his role as the agency's deputy commissioner of food policy and response in late February.
"The nation remains one outbreak, one tornado, flood or cyberattack away from finding itself in a similar place to that of February 17, 2022."
A formula shortage that started in 2021 was exacerbated when the United States' largest infant formula maker, Abbott Nutrition, recalled multiple products in mid-February and had to pause production after FDA inspectors found potentially dangerous bacteria at its Sturgis, Michigan, plant.
A former Abbott employee filed a whistleblower complaint about the plant with the US Department of Labor's Occupational Safety and Health Administration in February 2021. The complaint suggested that the plant lacked proper cleaning practices and that workers falsified records and hid information from inspectors.
The complaint was filed February 16, 2021, and was passed on to Abbott and the FDA three days later.
Yiannas testified that because of the siloed nature of the agency, he wasn't made aware of the complaint until February 2022. It was only then that he learned that children had gotten sick with Cronobacter after consuming powdered formula made at the plant.
The US Centers for Disease Control and Prevention investigated at least four illnesses and two deaths in three states in connection. The agency sequenced bacteria from two of the children to compare against the samples the FDA took at the facility, but it did not find that the samples were closely related.
Abbott said in a statement Tuesday that "the quality and safety of our products is always a priority -- and it's important to remember that no sealed, distributed product from our Sturgis, Mich., facility tested positive for the presence of Cronobacter."
"As part of Abbott's quality processes, samples from every batch of powdered infant formula products are tested for Cronobacter, and they must test negative before any product is released," the company said. Yiannas said at the hearing that manufacturing runs are tested in such a way that it would not necessarily catch all contamination.
Cronobacter infections are rare but can be serious and even fatal, especially in newborns. The bacteria lives in the environment, but when these infections are diagnosed in infants, they are often linked to powdered formula.
"Clearly, I really wish, and I should have been notified sooner, so I could have initiated containment steps earlier. Had that happened, I believe we might not be here today," Yiannas said Tuesday. "Had the agency responded quicker to some of the earlier signals, I believe this crisis could have been averted or at least the magnitude lessened."
With more demand for other brands after the Abbott recalls, families across the country had to hunt through multiple stores for formula last year. Stock rates of baby formula stayed lower than they were the year before for much of 2022. Even in October, when rates had improved, nearly a third of households with a baby younger than 1 said they had trouble finding formula over the course of one week, according to a survey by the US Census Bureau.
The FDA said Tuesday that its new national strategy helps ensure that the country's supply of formula will remain constant and safe.
The agency said it will work with the industry on redundancy risk management plans that will help companies identify possible supply chain problems. It will also continue to enhance inspections of infant formula plants by expanding and improving training for agency investigators.
According to the strategy, the FDA will expedite review of premarket submissions for new products to prevent shortages. It will continue to closely monitor the formula supply and has developed a model to forecast any potential disruptions.
It also plans to work closely with the US Department of Agriculture to build in more resiliency with its Special Supplemental Nutrition Program for Women, Infants, and Children program, or WIC, the nation's largest purchaser of infant formula.
The new strategy is just a first step; the long-term strategy is expected to be released in early 2024.
Dr. Susan Mayne, director of the FDA's Center for Food Safety and Applied Nutrition, said in a statement that the new strategy aims to incentivize "additional infant formula manufacturers to enter the market."
Many parts of the strategy are underway, the FDA said.
"Safety and supply go hand-in-hand. We witnessed last year how a safety concern at one facility could be the catalyst for a nationwide shortage. That's why we are looking to both strengthen and diversify the market, while also ensuring that manufacturers are producing infant formula under the safest conditions possible," FDA Commissioner Dr. Robert Califf said in a news release. "Now, with this strategy, we are looking at how to advance long-term stability in this market and mitigate future shortages, while ensuring formula is safe."
Formula stock rates are still not where they once were before last year's crisis, Yiannas said, but the problem can't be solved overnight. He said it was a good step for Congress to ask for a resiliency report from the industry.
One positive development that came out of the crisis is that manufacturers are reporting formula volume to the FDA on a weekly basis even though there is no legal requirement to do so, he said.
Historically, the FDA has focused on food safety and nutrition, not supply chain availability, but the Covid-19 pandemic opened eyes and served as the "biggest test on the US food system in 100 years," Yiannas said. Food supply shortages made experts realize that the agency needed more intelligence on how companies' supply chains worked.
"Progress is being made, but it's not being made fast enough," Yiannas said.
The FDA is now tracking sales and stock rates of baby formula. He said he's talked to formula companies that say they have ramped up production, even though they might have cut back on the number of varieties of product they offer.
Abbott said in its statement Tuesday that it is running its US facilities at increased capacity and is importing additional formula from Europe to meet US needs. It is also building a new $500 million plant in the US.
The FDA said Tuesday that it has also done a study to better understand what led to the recall of infant formula at the Abbott plant. The agency had conducted a routine surveillance inspection at the plant in September 2021 and even then found problems like standing water and inadequate handwashing among employees.
Abbott is facing additional investigations from the US Securities and Exchange Commission, the US Federal Trade Commission and the US Department of Justice as well as lawsuits from customers.
Yiannas told the House committee Tuesday that one strategy to head off similar shutdowns would be to require manufacturers to report Cronobacter bacteria found in its products. Currently, only the Abbott plant in Michigan is required to report the bacteria as part of the consent decree that allowed it to reopen.
The FDA said in November that it would like Cronobacter infections added to the CDC's list of national notifiable diseases, which would require doctors to report cases to public health officials so the CDC and the FDA could keep better track of infections. Only two states have such a reporting requirement now.
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