FDA Commissioner Robert Califf testified in a Senate hearing that baby formula shortages should ease by July.
“It’s going to be gradual improvement up to probably somewhere around two months until the shelves are replete again,” Califf said during testimony before the Senate Health, Education, Labor, and Pensions Committee.
Several factors led to the shortage. According to CNBC, formula became scarce as the pandemic disrupted supply chains and contributed to worker shortages. When Abbott shut down its plant in Sturgis, Michigan, shortages became a crisis as parents tried to stock up on formula.
“We knew that ceasing plant operations would create supply problems, but we had no choice given the unsanitary conditions,” Califf told lawmakers.
Abbott currently has the largest share of the American infant formula market, and the Sturgis plant is one of only three the manufacturer operates.
According to Califf, FDA inspectors found bacterial contaminations, standing water, and roof leaks.
Four infants who consumed formula from the Sturgis plant fell ill with Cronobacter infections, and two died from the illness.
FDA and CDC have not confirmed a link between the illnesses and the bacteria in the plant.
Abbott released a statement saying the plant will resume operation on June 4, but it could take six to eight weeks for products to reach store shelves.
Abbott says it will prioritize EleCare, its specialty formula, and try to have supply ready by June 20.
The company said it would provide the formula free to children in need.
Califf told lawmakers that the facility needs to implement upgrades and other steps to comply with a federal consent decree and meet U.S. food safety standards before reopening.
Califf also stated that until the facility was back up to normal production levels, he recommended a high level of oversight to ensure that standards are met.
This month, the FDA eased restrictions on imports to deal with the crisis.
Previously, 98% of all baby formula in the United States was produced domestically by just three companies.
According to the Biden administration, the easing of restrictions is a temporary measure until American supply chains stabilize.
Additionally, the U.S. Department of Defense has committed to Operation Fly Formula, which airlifts about 1.5 million 8-ounce bottles from Europe.
The Dallas Express reported that the first lots arrived last Sunday from Germany and were delivered to Indianapolis, Indiana, for processing.
