The infant formula industry successfully lobbied to weaken bacteria safety testing standards

The infant formula industry successfully lobbied to weaken bacteria safety testing standards

The infant formula industry successfully lobbied to weaken bacteria safety testing standards

Abbott Nutrition The Sturgis, Michigan plant, which produces much of the US infant formula supply, closed in February, bringing production lines to a screeching halt. Following a voluntary recall and investigation by the Food and Drug Administration and the Centers for Disease Control and Prevention, the shutdown stems from a bacterial outbreak whose effects will be felt months later. Since last September, five babies who had consumed the formula of the plant have contracted bacterial infections. Two of them died.

The pause in production is now contributing to a nationwide shortage of infant formula, a crisis that experts say will continue for months.

Questions are now swirling about alleged problems at the Abbott-owned factory, which produces popular brands such as Similac, Alimentum and EleCare. A recently leaked whistleblower document claims that officials at the Sturgis plant falsified reports, released untested infant formula and withheld crucial safety information from federal inspectors.

But eight years ago, the formulas industry rejected the opportunity to take a more proactive approach – not only to increase supply capacity, but also to prevent a possible epidemic. Records show the industry successfully mobilized against a 2014 FDA proposal to increase regular safety inspections of factories used to make infant formula.

At the time, the FDA proposed rules to prevent adulteration of infant formula at any stage of the process to prevent contamination with salmonella and Cronobacter sakazakii, which led to the closure of the Sturgis plant this year.

The biggest infant formula manufacturers have moved quickly to delay safety proposals. The International Formula Council, now known as the Infant Nutrition Council of America, is the advocacy group representing Abbott Nutrition (part of Abbott Laboratories), Gerber (part of Nestlé), Perrigo Co. and Reckitt Benckiser Group, the companies that control 89% of the infant formula market in the United States

In March 2014, the group wrote to FDA officials asking for more time to respond to the proposed rules. The agency, according to the industry, had used a cost-benefit analysis that “overestimates the expected annual incidence of Cronobacter infection” using “outdated data”. Formula reps asked for another 30-45 days.

“We believe the agency and the industry would benefit from the additional time,” wrote Mardi Mountford, an official with the International Formula Council.

This June, after months of deliberation, the FDA published a new draft final proposal that incorporated some of the industry’s concerns. The rules reduced the frequency of stability testing for new infant formula from every three months to every four months. The FDA has also provided a number of exemptions to manufacturers, allowing them to opt out of testing requirements if the “new infant formula is unlikely to differ in stability from formulas with similar composition, processing, and packaging for which there are many stability data”.

Later that year, the lobby group asked the FDA to revise the safety manufacturing rule with even lower standards, including fewer inspections. In a letter to regulators, Mountford wrote that compliance costs would reach just over $20 million a year, including increased personnel and lab costs. “The IFC believes that the additional requirements for end-of-shelf-life testing under the final rule are unnecessary and burdensome and provide no additional public health benefit,” Mountford wrote in the September 2014 request.” Based on the frequency of manufacturing and storage inventories,” the letter notes, “virtually all infant formula is consumed at the beginning of its shelf life (consumers typically purchase and use infant formula between 3 and 9 months after manufacture and do not store infant formula at home).”

The Infant Nutrition Council of America did not respond to a request for comment from The Intercept.

Like reviews As noted, the infant formula industry had wide latitude to increase production and increase spending on safety standards. Abbott announced last year that it had spent $5 billion to buy its own stock.

Abbott Nutrition, which did not respond to a request for comment, declined to tell other outlets if any other cases of Cronobacter had been identified.

The House Energy and Commerce Committee is scheduled to hold a May 25 hearing to investigate.

Abbott’s whistleblower allegation was sent to the FDA and Representative Rosa DeLauro, D-Conn., in October 2021 and made public last month. DeLauro demanded that regulators move quickly to get answers from the company. Despite the whistleblowing, the FDA did not inspect the Sturgis plant until January 31 of this year, and the recall was not issued until February 17, according to a Food Safety News report.

According to a recent survey, around 40% of baby formulas ran out in the week that started April 24. Desperate parents have reportedly turned to eBay, where canisters cost more than six times the retail price. Viral images of empty shelves have alarmed parents and the Biden administration has said it will take urgent action to address the shortage.

The shortage has other contributing factors. The United States maintains strict limits on imports of European brands of infant formula, despite studies showing that products subject to European Union regulations have high safety and nutrition standards. Competing brands in the United States tried to increase production to compensate for the loss of Abbott Nutrition’s factory in Sturgis, but encountered supply chain problems.

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