F.D.A. and Abbott Reach Agreement on Baby Formula to Try to Ease

The Food and Drug Administration on Monday reached an agreement with Abbott Laboratories on the steps needed to reopen the company’s shuttered baby formula plant, which could begin to ease the shortage of infant formula that has frightened and exasperated parents nationwide.

The F.D.A. said it expected Abbott to restart production in about two weeks, and was poised to review progress at the plant in Sturgis, Mich. It has been shut down since February after several babies who had consumed formula that had been produced there fell ill and two died.

The agreement stems from a U.S. Department of Justice complaint and consent decree with the company and three of its executives. Those court records say the F.D.A. found a deadly bacteria, called cronobacter, in the plant in February and the company found more tranches of the bacteria later that month.

According to the complaint, the same Sturgis factory had also produced two batches of formula in the summer of 2019 and 2020 on different production equipment that tested positive for the bacteria.

Abbott staff “have been unwilling or unable to implement sustainable corrective actions to ensure the safety and quality of food manufactured for infants,” leading to the need for legal action, the documents state.

In a release, Abbott said “there is no conclusive evidence to link Abbott’s formulas to these infant illnesses.”

The company said on Monday that production could begin within about two weeks and could translate to more formula on shelves in six to eight weeks. The company said it will continue flying formula in from a plant in Ireland.

The agreement said Abbott must hire a qualified expert to oversee a variety of improvements at the Sturgis facility.

As frustration at the crib side and in grocery aisles grew, the agency has been in a race to replenish depleted supplies that have become political fodder for Republicans against the Biden administration.

The plant shutdown exacerbated an existing supply crisis, as parents rushed to stock up on formula. With store shelves bare in some communities, some have been so desperate they have fed their infants powdered oatmeal cereal and fruit juice, even though pediatricians say formula or breast milk is a crucial source of nutrition from birth to the first birthday.

Susan Mayne, a top F.D.A. food regulator, said on Monday evening the agency issued guidance to spur international formula makers to ship their products to the United States. She said the relaxed import restrictions would be in place for 180 days and the effort could take weeks to bring more product to shelves.

In addition to the F.D.A.’s actions, Representative Rosa DeLauro, a Democrat from Connecticut, said in an interview on Monday that she planned to introduce a bill that would ease the process of importing infant formula from F.D.A.-regulated foreign plants. She also said she plans to hold hearings in the House to review what went wrong in the run-up to the discovery of the bacteria and…