Baby Formula Industry Lobbied to Weaken Safety Standards

The Abbott Nutrition facility in Sturgis, Michigan, which produces much of the US baby food supply, was closed in February, bringing production lines to a standstill. Following a voluntary recall and investigation by the Food and Drug Administration and the Centers for Disease Control and Prevention, the shutdown stemmed from a bacterial outbreak whose effects would be felt months later. As of September last year, five babies who had eaten the plant’s formula developed bacterial infections. Two of them died.

The production hiatus is now contributing to a national formula shortage, a crisis that experts say will last for months.

Questions now arise about alleged problems at Abbott’s factory, which produces popular brands such as Similac, Alimentum and EleCare. A recently unveiled whistleblower document alleges that Sturgis factory managers falsified reports, released untested infant formula and concealed crucial safety information from federal inspectors.

But eight years earlier, the formula industry rejected an opportunity to take a more proactive approach — not just to increase delivery capacity, but also to prevent a potential outbreak. Evidence shows that the industry successfully mobilized against a 2014 FDA proposal to increase regular safety inspections of factories used to manufacture baby food.

At the time, the FDA had proposed rules to prevent adulteration of baby food at every step of the process to prevent contamination by salmonella and Cronobacter sakazakii, leading to the closure of the Sturgis plant this year.

The largest infant formula manufacturers quickly resigned to delay safety proposals. The International Formula Council, now known as the Infant Nutrition Council of America, is the lobbying group representing Abbott Nutrition (owned by Abbott Laboratories), Gerber (owned by Nestlé), Perrigo Co., and Reckitt Benckiser Group, the 89 percent controlling companies. of the US baby food market

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had used a cost-benefit analysis that “overestimates the expected annual incidence of Cronobacter infection” using “outdated data.”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

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

In June, after months of deliberation, the FDA released a new interim final proposal addressing some of the industry’s concerns. The rules reduced the frequency of stability tests for new infant formulas from every three months to every four months. The FDA has also granted a number of exemptions to manufacturers, allowing them to evade testing requirements if the “new infant formula is not likely to differ from the stability of formulas of similar composition, processing and packaging for which extensive stability data is available.”

Later that year, the lobbying group petitioned the FDA to reconsider the safety manufacturing rule with even lower standards, including fewer inspections. In a letter to regulators, Mountford wrote that compliance costs would be just over $20 million a year, including increased personnel and lab costs. “The IFC believes that the additional requirements for end-of-life testing under the Final Rule are unnecessary, burdensome and do not provide additional public health benefit,” Mountford wrote in the September 2014 request. frequency of manufacture and store inventories,” the letter noted, “nearly all infant formulas are consumed early in the shelf life (consumers typically purchase and use infant formulas between 3 and 9 months after manufacture and do not store infant formulas at home).”

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

if critics noted that the formula industry had great leeway to expand production and increase spending on safety standards. Abbott announced last year that it had spent $5 billion to buy its own shares.

Abbott Nutrition, which did not respond to a request for comment, has declined to inform other outlets if additional cases of Cronobacter have been identified.

The House Committee on Energy and Commerce will hold a hearing on May 25 to look into this.

The Abbott whistleblower’s charge was brought to the FDA and Rep. Rosa DeLauro, D-Conn. sent and made public last month. DeLauro has demanded that regulators act quickly in getting answers from the company. Despite a whistleblower’s tip, the FDA did not inspect the Sturgis plant until Jan. 31 this year, and the recall was not published until Feb. 17, according to a report by Food Safety News.

According to a recent survey, about 40 percent of baby food products sold out in the week beginning April 24. Desperate parents have reportedly turned to eBay, where buses 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 deficiency has other contributing factors. The US maintains strict import limits for European brands of infant formula, despite studies showing that products covered by European Union regulations have high safety and nutritional standards. Competing brands in the US tried to ramp up production to make up for the loss of Abbott Nutrition’s Sturgis plant, but ran into supply chain problems.

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