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 FDA 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 FDA 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 FDA 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 FDA’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 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 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 working directly with 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 omitted key information from official documents.
The FDA returned 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 issued 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 formula to feed their babies, some of whom reject a new or unfamiliar taste.
Navigating the Baby Formula Shortage in the US
A growing problem. A nationwide shortage of baby formula-triggered in part by supply-chain issues and worsened by a recall by the baby food manufacturer Abbott Nutrition-has left parents confused and concerned. Here are some ways to manage this uncertainty:
The agency’s agreement with Abbott requires the company to notify the FDA if it finds contamination and to store any sample of cronobacter it finds for three years. Violations of the agreement could result in daily $ 30,000 fines capped at $ 5 million in a year, according to court records.
“We know millions of parents and caregivers depend on us and we’re deeply sorry that our voluntary recall worsened the nationwide formula shortage,” Robert Ford, Abbott’s chief executive, said in a statement. “We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years.”
On Monday morning, the FDA commissioner, Dr. Robert. M Califf, said on CNN that the agency was working on the supply chain to get the needed formula back on store shelves.
“We really do anticipate 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 the 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 pointed to data from retail research firm IRI showing the in-stock rate at closer to 80 percent.
None of those figures seemed relevant to Angela Coleman, 32, of Sacramento, who found the shelves at a local Target completely stripped of infant formula Monday. She said the only item in stock was toddler formula. She drove 16 miles to a store near her parents’ home to get the last two cans of the 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 that point where you run out,” she said. Most retail outlets have put limits on formula purchases.
Dr. Califf is expected to appear before a House Appropriations subcommittee on Thursday to answer lawmakers’ questions. He said in the 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.”