FDA and Abbott Reach Agreement on Baby Formula to Try to Ease Shortage

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

The FDA must still grant approval, once the company has taken steps, to resume production at the plant in Sturgis Mich. It has been shut down since February after several babies who consumed the formula that had been produced there fell and two died.

Abbott described the agreement with the FDA as a “consent decree” and said it would require federal court approval. Once the agency permits the plant to reopen, the company said production could begin within about two weeks and translate to more formulas in shelves in six to eight weeks. The company said it would continue flying formula from a plant in Ireland.

It was unclear how soon the FDA might approach reopening the plant.

Abbott’s plant has been offline since February, when the FDA discovered a deadly bacterium, called cronobacter, while swabbing in and near production lines. Abbott disputed that characterization, saying the bacteria were found in “high care” areas that open proximity to open products, but not necessarily in or on the production lines themselves.

The same type of bacteria has been linked to four recent infant illnesses and two deaths in Minnesota, Texas and Ohio. “There is no conclusive evidence linking Abbott’s formulas to these infant illnesses,” said Abbott.

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 that they have fed their infants with powdered oatmeal cereals and fruit juices, even though pediatricians say formula or breast milk is a crucial source of nutrition from birth to first birth.

In addition to the FDA’s actions, Representative Rosa DeLauro, a Democrat from Connecticut, said in an interview Monday that she planned to introduce a bill that would ease the import of infant formula from FDA-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 shortages.

“Both the company and the FDA have got to be held accountable in order to move forward,” Ms. DeLauro said. She said she had called for an investigation by the Health and Human Services inspector general, and invited Abbott to testify at a hearing set for May 25.

Problems at the Abbott Sturgis plant surfaced in September during the FDA’s first routine inspection there since the Covid-19 pandemic began. Inspectors discovered standing water inside the plant and personnel worked directly with the formula without proper hand hygiene, according to agency documents.

The following month, a whistleblower who worked at the plant filed a complaint under the Food Safety Modernization Act claiming that plant leaders celebrated concealing information from the FDA and omitting key information from official documents.

The FDA returns to the plant on Jan. 31 and discovered persistent problems, including the presence of cronobacter bacteria near production lines, according to agency records.

The FDA and Abbott shut down manufacturing and release a wide-ranging recall of Abbott’s infant formula on Feb. 17. Since then, supplies have dwindled in stores, setting parents on frantic trips to find formulas to feed their babies, some of whom reject a new or unfamiliar taste.

On Monday morning, the FDA, Commissioner, Dr. Robert. Calif., CNN reported that the agency was working on a supply chain to get the formula back on store shelves.

“We really do expect that within, you know, a few weeks we will have things back to normal,” Dr. Califf said.

Dr. Califf also pushed back on reports about the degree of shortage. He described the events since the production shutdown as “relatively unpredictable consequences.” He also said the supply numbers quoted in some reports, which showed formula supplies at 56 percent of normal, were “incorrect” and said the White House had more accurate figures. White House officials point to data from the retail research firm IRI showing the in-stock rate is near 80 percent.

None of those figures seemed relevant to Angela Coleman, 32, of Sacramento, who found a shelter at the local Target completely stripped of the infant formula Monday. She said the only item in stock was the toddler formula. She drove 16 miles to a store near her parents’ home to find the last two cans of formula favored by her nine-month-old son.

“You kind of want to buy it whenever you see it because you don’t want to be at the point where you run out,” she said. Most retail outlets have formulas on limit purchases.

Dr. Califf is expected to appear before a House Appropriations subcommittee on Thursday to answer lawmakers’ questions. He said in a CNN interview that the agency has nine staff members focused on baby formula and was given funds for four more.

“We’re going to need more than that,” Dr. Califf said. “This is a huge part of the well-being of Americans and our most vulnerable young children, so we’re very concerned about it.”

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