WASHINGTON — U.S. regulators have historically inspected baby formula plants at least once a year, but they did not inspect any of the three biggest manufacturers in 2020, according to federal records reviewed by The Associated Press.
Two years after the last inspection, they were finally able to enter an Abbott Nutritional formula plant in Michigan. There they discovered standing water as well as lax sanitation. However, inspectors only offered suggestions and did not issue a formal warning.
After four babies who had consumed powdered formula at the plant developed bacterial infections, inspectors returned five months later. There was bacterial contamination at the factory. It led to a shutdown of four months. The crisis turned into a complete one.
Congress and watchdogs from government are examining the series of mistakes that have led to this crisis, as well as the gaps in infant formula plant inspections. The Food and Drug Administration would be required to inspect infant formula factories every six-months under a new bill. And the government’s inspector general for health has launched an inquiry into the FDA’s handling of Abbott’s facility, the largest in the U.S.
Abbott, under an agreement legally binding with FDA, resumed production at its plant this month. But the shut down and national shortage highlighted how concentrated the U.S. industry, where only a handful companies account for nearly 90%.
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The FDA withdrew most safety inspectors from field as COVID-19 spread across America in 2020. This allowed the FDA to skip thousands of routine plant inspections.
The FDA did conduct more than 800 “mission critical” inspections during the first year of the pandemic, the agency said in a statement. Facilities were selected by regulators for inspection based upon whether or not they could produce important medicine therapy.
Only three of the nation’s 23 facilities that make, package or distribute formula made the cut. In July 2021, the FDA began routine inspections.
The inspection records reviewed by the AP show gaps as large as 2 1/2 years between FDA’s 2019 inspections and when regulators returned to plants owned by the three leading formula manufacturers: Abbott, Reckitt and Gerber.
According to records, FDA has not yet returned to one of the key plants owned by Reckitt, and two that are owned by Gerber. These facilities work around the clock in order to increase U.S. formulation production.
“The FDA would have had more chances to catch these issues if they’d been inspecting during the pandemic,” said Sarah Sorscher, a food safety specialist with the Center for Science in the Public Interest. She admitted the hard decision the FDA had to make when it pulled its inspectors from COVID-19. “Certainly there was a price to pay for protecting their workers during that time.”
Baby formula manufacturers were “consistently identified as a high priority during the pandemic,” and there is currently no backlog of inspections, the agency told the AP in response to inquiries about the gaps. It claimed that it had skipped approximately 15,000 U.S. inspections because of COVID but has now made up around 5,000, surpassing its goals.
Under current law, the FDA is only required to inspect formula facilities every three to five years, but the agency has consistently inspected facilities annually — until the pandemic.
“Our top priority now is addressing the urgent need for infant formula in the U.S. market, and our teams are working night and day to help make that happen,” FDA stated.
But outside experts say the gap in inspections speaks to a blind spot in the government’s response effort, which was successful at preventing shortages of drugs and other medical supplies.
FDA Commissioner Robert Califf says regulators knew shutting down Abbott’s plant would create supply problems, but there was little evidence of urgency between when inspectors shuttered the plant in February and recent emergency measures to allow more imports from abroad.
Food safety experts who have been working in the FDA for many years see an even deeper problem. For decades, doctors and other medical professionals have emphasized the need to oversee drugs rather than food.
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“It’s very challenging for them to get engaged at all in this area because they don’t have the background, the knowledge and the experience in it,” said Steven Mandernach, executive director of the Association of Food and Drug Officials, which represents state-level inspectors.
FDA and the U.S. Department of Agriculture share oversight of food safety and production. FDA inspections of food plants peaked in 2011, and have been declining since then, despite the increased funding and power by Congress. According to the FDA, while U.S. inspections are declining, inspections of foreign facilities have increased.
There’s no certainty that extra inspections during COVID-19 would have prevented the contamination problems at the Sturgis, Michigan, plant that was shut down. Abbott claims that the products it makes are not directly related to two of these infections which resulted in death.
The plant was also affected by other problems in the past, such as a recall of a formula for 2010 because it could have been contaminated with insects.
“I think facilities that had known problems that could cause a food safety risk should have been part of FDA’s mission critical work,” Mandernach said. “And this facility would have been among those.”
Not having regular inspections — or even the threat of them — can lead to changes in culture at plants like Abbott’s, Mandernach noted.
“If you’re driving down the highway and you know the state troopers have been furloughed, might you go a little faster than if you knew there was a trooper on duty?” Mandernach asked.
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