FDA commissioner says baby formula crisis likely over ‘within two months’
Food and Drug Administration Commissioner Robert Califf told lawmakers Thursday that the baby formula crisis is likely to be over in about two months as desperate parents still face empty shelves.
Califf said at a Senate hearing that while “I can’t be exact … my expectation is that within two months we should be beyond normal and with a plethora [of supply].”
He added, “Due to all the measures being taken, the shortage is going to be getting better and better.”
The US government this month allowed foreign imports by waiving onerous labeling requirements that contributed to about 98% of the pre-crisis supply being domestically produced by just three companies.
The shortage has hit some states especially hard and began with the February closure of an Abbott Nutrition factory in Michigan over safety concerns. Two infant deaths were believed to be linked to bacterial contamination at the plant, but an investigation ultimately failed to confirm a link, authorities said.
Still, the factory in Sturgis near the Indiana border has yet to reopen. Califf said Thursday that it has numerous problems, including puddles on the ground and leaks in the roof. He likened it at one point to dining at an unsanitary restaurant.
The issue became a political hot potato after Republicans took aim at the Biden administration’s management of the crisis, which gradually grew after the February plant closure.
This month, the White House launched a military initiative called Operation Fly Formula to expedite deliveries of formula from other nations with similar standards.
Lawmakers from both parties took turns prodding Califf on his agency’s performance, with Sen. Maggie Hassan (D-NH) demanding to know the FDA’s plans to fix the crisis — after the agency blamed mailroom issues for the slow processing of an October whistleblower complaint about the Abbott factory.
Across the ideological spectrum, senators slammed the fact that nearly all pre-crisis US formula was made by three companies.
Socialist Sen. Bernie Sanders (I-Vt.) told Califf, “I hope you will focus on increasing the number of companies that are producing so we don’t run into this problem again.” And Sen. Mike Braun (R-Ind.) slammed what he called an “oligopoly” and raised the possible streamlining of regulations to increase competition.
“It’s not good for the country to have such an undiversified supply chain and manufacturing chain for a critical product like that that’s used by so many people,” Califf said, insisting, “I don’t think FDA regulation is at the basis of that. Anyone who meets the criteria within the US or outside the US that wants to import can bring formula in.”
Libertarian Sen. Rand Paul (R-Ky.), meanwhile, took aim Thursday at 17% tariffs on foreign formula imports that were imposed by the Trump administration’s USMCA trade deal with Canada and Mexico.
“The agreement between Mexico and Canada and the United States that was signed in the previous administration put an extra tariff on Canadian formula and Mexican formula,” Paul said. “So those are economic barriers to it. And we have to look at the whole picture.”
