U.S. regulators have inspected baby food factories at least once a year in the past, but they haven’t inspected any of the top three manufacturers in 2020, according to federal data reviewed by The Associated Press.
When they finally entered an Abbott Nutrition facility in Michigan after a two-year hiatus, they found standing water and lax sanitation. But inspectors offered only voluntary suggestions for solving the problems and issued no formal warning.
The inspectors would return five months later after four babies who consumed powdered food from the plant contracted bacterial infections. They found bacterial contamination at the factory, leading to a four-month shutdown and a lingering inventory shortage turned into a full-blown crisis that left parents scrambling to find formula and forcing the US to ship products from abroad.
The, caused by the COVID-19 pandemic, is receiving new attention from Congress and government watchdogs investigating the string of missteps that led to the crisis. Under a recent bill, the Food and Drug Administration is required to inspect infant feeding facilities every six months. And the government’s health inspector general has launched an investigation into the FDA’s handling of Abbott’s facility, the largest in the US.
FDA skipped thousands of inspections
factory at the beginning of this month under a legally binding deal with the FDA, but the shutdown and the nationwide shortage showed how concentrated the industry has become in the US, with a handful of companies accounting for about 90% of the market. to take.
As COVID-19 swept through the US in early 2020, the FDA pulled most of its safety inspectors from the field and skipped thousands of routine factory inspections.
The FDA conducted more than 800 “mission-critical” inspections during the first year of the pandemic, the agency said in a statement. Regulators selected facilities for inspections based on whether they posed a specific safety risk or were needed to produce a major medical therapy.
Only three of the country’s 23 facilities that make, package or distribute formulas made it. The FDA resumed routine inspections in July 2021.
The inspection reports reviewed by the AP show a gap of as much as 2 1/2 years between the FDA inspections in 2019 and when regulators returned to factories owned by the three leading formula manufacturers: Abbott, Reckitt and Gerber. .
In fact, the FDA has yet to return to one major factory owned by Reckitt and two by Gerber, according to the agency’s data. All of these facilities operate around the clock to boost US formula production.
“The FDA would have had more opportunities to address these issues if they had inspected during the pandemic,” said Sarah Sorscher, a food safety specialist at the Center for Science in the Public Interest. She acknowledged the difficult trade-off faced by the FDA when it withdrew its inspectors to reduce their exposure to COVID-19. “There was certainly a price to be paid for protecting their workers at that time.”
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 questions about the gaps. The agency said it has skipped about 15,000 U.S. inspections because of COVID, but it has already made up for about 5,000, exceeding its own targets.
Under current law, the FDA is only required to inspect the formula facilities every three to five years, but the agency has consistently inspected the facilities annually — until the pandemic.
“Our top priority now is to address the urgent need for infant formula in the US market, and our teams are working day and night to make that possible,” the FDA said.
But outside experts say the gap in inspections is a blind spot in the government’s response, which managed to avoid shortages of drugs and other medical supplies.
FDA Commissioner Robert Califf says regulators knew closing Abbott’s plant would lead to supply problems, but there was little evidence of urgency between when inspectors closed the plant in February and recent emergency measures to increase imports from abroad. to make possible.
Drugs over food safety
Long-time food safety specialists see a deeper problem at the highest levels of the FDA, where doctors and medical scientists have for decades prioritized the oversight of drugs and medical products over food.
“It’s quite challenging for them to get involved in this area because they don’t have the background, knowledge and experience in it,” said Steven Mandernach, executive director of the Association of Food and Drug Officials, which represents the state. represents. – level inspectors.
The FDA shares oversight of food production and safety with the United States Department of Agriculture. FDA inspections of food facilities peaked in 2011 and have declined for most years since, despite increased funding and powers by Congress. The FDA said that while US inspections have declined, inspections of foreign facilities have increased.
There is no assurance that additional inspections during COVID-19 would have prevented the contamination problems at the shutdown Sturgis, Michigan plant. And Abbott says his products have not been directly linked to the infections, two of which were fatal.
But the plant has had problems before, including a 2010 recall of the formula due to possible contamination with insect parts.
“I think facilities that had issues that could pose a food safety risk should have been part of the FDA’s mission-critical work,” Mandernach said. “And this facility would have been one of them.”
Not having regular inspections — or even the threat of them — can lead to culture shifts at factories like Abbott’s, Mandernach noted.
“If you’re driving down the highway and you know the state troopers have been fired, could you go a little faster than if you knew a trooper was on duty?” asked Mandernach.