Congressional leaders will press baby formula manufacturers and government regulators at a hearing Wednesday in their efforts to find out what happened to the US baby formula supply and why it’s taking so long to restock store shelves.
In a background memo released in advance of the hearing, Rep. Frank Pallone, D-New Jersey, chairman of the House Committee on Energy and Commerce, laid out a timeline of the crisis, which started with supply chain problems and worsened considerably after a nationwide recall and the shutdown of a manufacturing plant that produced nearly half the infant formula consumed in the United States.
The memo says that as many as 75% of American caregivers partially depend on formula to provide nutrients to their infants up to 6 months of age. The shortage has been most acute for low-income families, those in rural areas and children with medical needs that limit the kinds of formulas they can drink.
Three companies manufacture 95% of the baby formula sold in the United States: Abbott, Reckitt and Gerber. Abbott controls about 42% of the nation’s formula supply and holds the contracts to supply about half of low-income families who participate in the Special Supplemental Nutrition Program for Women, Infants and Children, or WIC.
On September 20, 2021, the US Food and Drug Administration was notified that a child had been diagnosed with an infection caused by Cronobacter bacteria. Cronobacter infections can be serious and even fatal in infants. If the bacteria crosses into the brain, it can cause abscesses and brain damage or even death. Cronobacter thrives in dry environments and is known to be a contaminant of baby formula.
Between September 20 and February 17, 2022, the FDA would learn about four Cronobacter infections in infants, including two deaths.
The agency received the report the same day its inspectors arrived at Abbott’s Sturgis, Michigan, plant for a routine inspection that lasted until September 24. The inspectors documented findings that included failure to maintain the building in a “clean and sanitary condition.”
On October 20, the FDA got a detailed report from a former employee at Abbott that accused the company of falsifying records, hiding information from FDA inspectors, releasing untested infant formula and maintaining lax cleaning practices, as well as an atmosphere of retaliation against workers who raised concerns.
According to a news release from Rep. Rosa DeLauro, D-Connecticut, the FDA did not interview the whistleblower until late December, and it did not hold an in-person “for cause” inspection of the plant until January 31, 2022.
Abbott Nutrition recalled certain lots of its Similac, Alimentum and EleCare baby formulas on February 17.
A team of FDA inspectors made a total of 24 visits to Abbott’s manufacturing plant between January 31 and March 18. The agency found that the company failed to establish processes and maintain surfaces in the facility to prevent formula contamination. The FDA found Cronobacter bacteria in five environmental samples at the plant, but none was found in the product itself.
Genetic testing of the Cronobacter strains found at the plant did not match bacteria sampled from infected patients.
While the agency’s inspection was ongoing, Abbott shut down its facility to correct problems identified by the FDA, according to the agency’s timeline of events.
The investigation into the Cronobacter illnesses and contamination at the Sturgis plant created a perfect storm in an industry hobbled by supply chain challenges.
Several of the raw materials used in formula production (such as milk and vegetable oil) and packaging (such as plastic and tin) have had supply chain disruptions in recent months, the memo says. Rising prices for other commodities because of global conflicts, labor shortages and transportation and logistics challenges were contributing factors, the memo says.
Panic-buying has contributed to the shortage in recent weeks, which in turn led some stores to limit sales. Others have raised prices, and scams have proliferated on social media.
Other factors contributed to the shortage, like the way WIC grants exclusive contracts to manufacturers, import taxes and restrictions designed to protect US milk producers, and a limited domestic manufacturing base, which has made it difficult to quickly ramp up production.
The memo also cites inconsistent consumer demand. During the pandemic, families that needed formula stocked up early, which caused demand to surge. Later, demand fell as families used what they had at home. And fewer babies were born during the first year of the pandemic, which has been followed by a slight uptick in the birthrate. This volatility has made it difficult for manufacturers to plan production schedules, the memo notes.
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The memo outlines government action to alleviate the shortage. On May 16, Abbott entered into a proposed consent decree with the FDA, creating a pathway to resume production at its Sturgis facility.
Last week, the House passed two bills: one that included $28 million in emergency spending to increase US formula supply and one that intends to protect the WIC program from future shortages. President Biden has invoked the Defense Production Act so manufacturers can get the raw materials they need, and Operation Fly Formula has sped up imports.
Reckitt and Gerber have ramped up production enough to compensate for Abbott’s lost production, the memo says.
FDA Commissioner Dr. Robert Califf has said the agency plans to investigate the timeliness of its response to safety lapses at the Sturgis plant.