FDA & Abbott reach deal on baby formula

After a nationwide shortage of infant formula for several months, one of the leading domestic suppliers, Abbott, says it’s reached an agreement with the Food and Drug Administration to restart production at its largest factory in the U.S.

In an interview on NBC’s “Today” show, FDA Director Robert Califf said he was “comfortable” with Abbott Nutrition’s prediction that its Sturgis, Mich., plant could be up and running again in about two weeks.

After production resumes, Abbott said it will take six to eight weeks before new products begin arriving in stores. The company didn’t set a timeline to restart production.

Brian Deese, the White House’s National Economic Council director, added the Biden administration would also take steps Monday to allow more imported formula into the U.S. to address the shortage.

Abbott’s plant came under scrutiny earlier this year after four infants became sick with bacterial infections after consuming powdered formula from the factory, resulting in the deaths of two children.

Chicago-based Abbott has emphasized that its products have not been directly linked to the bacterial infections in children.

The company halted production in February and recalled several brands of formula. Those steps squeezed supplies already strained by supply chain disruptions and parents’ stockpiling during COVID-19.

Califf, who has six grandchildren, including one on baby formula, said the government is working hard to ease the shortage but wants to make sure any formula on the market is safe.

“I know how important this is to parents, and the entire FDA staff is entirely focused on this,” Califf said. “But we also have to be safe.”

Califf said the FDA would investigate why it took three months from a whistleblower’s first complaint to when the agency sent inspectors in January to investigate possible contamination issues at the plant.

“We always want to be as fast as we can possibly be while also being diligent,” Califf said.