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The FDA and Abbott enter into an agreement on baby formula to try to alleviate the deficiency




The Food and Drug Administration on Monday reached an agreement with Abbott Laboratories on the steps needed to reopen the company’s closed infant formula facility, which could begin to alleviate the lack of infant formula that has frightened and annoyed parents across the country.

The FDA said it expected Abbott to resume production in about two weeks, and was ready to assess the progress of the Sturgis plant, Mich. It has been closed since February after several babies who had eaten breast milk substitutes that had been produced there became ill and two died.

The agreement stems from a Declaration of Complaints and Consent from the US Department of Justice with the company and three of its leaders. These court records say that the FDA found a deadly bacterium, called cronobacter, in the facility in February, and that the company found several 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 employees “have been reluctant or unable to implement sustainable corrective actions to ensure the safety and quality of food produced for infants,” which led to the need for legal action, the documents said.

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

The company said on Monday that production can begin within about two weeks and can be translated into more formula on the shelves in six to eight weeks. The company said it would continue to fly the formula from a plant in Ireland.

The agreement said Abbott must hire a qualified expert to monitor a number of improvements at the Sturgis plant.

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

The closure of the facility exacerbated an existing supply crisis, as parents rushed to fill up the formula. With store shelves bare in some communities, some have been so desperate that they have fed their infants oatmeal powder and fruit juices, even though pediatricians say that breast milk substitute or breast milk is a crucial source of nutrition from birth to first birthday.

Susan Mayne, a top food regulator in the FDA, said Monday night that the agency issued guidance to encourage international formula manufacturers 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 products to the shelves.

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 facilitate the process of importing infant formula from FDA-regulated foreign plants. She also said she plans to hold hearings in the house to assess what went wrong ahead of the discovery of the bacteria and the deficiency.

“Both the company and the FDA must be held accountable for moving forward,” DeLauro said. She said she had requested an investigation by the Inspector General of Health and Human Services, and invited Abbott to testify during a hearing scheduled for May 25.

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

The following month, a notifier working at the facility filed a complaint under the Food Safety Modernization Act, claiming that facility managers celebrated hiding information from the FDA and omitting key information from official documents.

The FDA returned to the plant on January 31 and discovered persistent problems, including the presence of Cronobacter bacteria near production lines, according to the agency’s documents.

The FDA and Abbott shut down production and issued a comprehensive recall of Abbott’s infant formula on February 17. Since then, supplies have declined in stores, which has put parents on hectic trips to find infant formula to feed their babies, some of whom reject a new or unknown taste.

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. Violation of the agreement could result in daily fines of $ 30,000 with a ceiling of $ 5 million over the course of a year, according to court records.

“We know that millions of parents and caregivers are dependent on us, and we are deeply saddened that our voluntary recall exacerbated the nationwide lack of formula,” said Robert Ford, Abbott’s CEO, in a statement. “We will work hard to regain the trust that mothers, fathers and caregivers have shown in our formulas for more than 50 years.”

On Monday morning, FDA Commissioner Dr. Robert M. Califf told CNN that the agency was working on the supply chain to get the necessary formula back on store shelves.

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

Dr. Califf also withdrew reports on the extent of the deficiency. He described the events since the cessation of production as “relatively unpredictable consequences.” He also said that the supply figures given in some reports, which showed formula supplies of 56 percent of the normal, were “incorrect” and said that the White House had more accurate figures. White House officials pointed to data from the detailed analysis firm IRI showing the stock price of nearly 80 percent.

None of these 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 160 km to a store near her parents’ home to pick up the last two boxes of the formula that her nine-month-old son prefers.

“You kind of want to buy it when you see it because you do not want to be at the point where you run out,” she said. Most outlets have set restrictions on formula purchases.

Dr. Califf is expected to appear before a subcommittee on housing grants on Thursday to answer lawmakers’ questions. He said in the CNN interview that the agency has nine employees with a focus on infant formula and received funding for four more.

“We’ll need more than that,” said Dr. Califf. “This is a big part of the welfare of Americans and our most vulnerable young children, so we are very concerned about that.”



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