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 plant, which could begin to ease the shortage 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 review progress at the Sturgis, Mitch plant. It has been discontinued since February after several children taking the formula produced there fell ill. Two died.
The agreement stemmed from a U.S. Department of Justice complaint and a decree agreeing with the company and its three executives. Those court records say the FDA found a deadly bacterium called chronobacter in the plant in February, and the agency found more strains of the bacteria later that month.
According to the complaint, the same Sturgis factory produced two batches of formulas in different production equipment in the summer of 2019 and 2020 which tested positive for bacteria.
Abbott staff “have been reluctant or unable to implement sustainable corrective measures to ensure the safety and quality of food prepared for children,” the document said, adding that legal action was needed.
In a release, Abbott said “there is no conclusive evidence to link Abbott’s formula to this child’s illness.”
The company said Monday that production could begin in about two weeks and could translate into more formulas on shelves in six to eight weeks. The agency said it would continue to fly the formula from a plant in Ireland.
Read more about baby formula deficiencies
The agreement states that Abbott must hire a qualified specialist to oversee the development of various types of Stargis facilities.
As frustration grows on the side of the cage and on the grocery aisle, the company is in a race to replenish the depleted supply that has become political food for Republicans against the Biden administration.
The plant shutdown has exacerbated an existing supply crisis, as parents rush to stock up on formulas. With some community store shelves empty, some are so desperate to feed their babies powdered oatmeal cereals and fruit juices, although pediatricians say formula or breast milk is an important source of nutrition from birth to the first birthday.
Susan Maine, a top FDA food regulator, said on Monday evening that the agency had issued instructions to international formula makers to ship their products to the United States. He said relaxed import restrictions would remain in place for 180 days and efforts to bring more products to shelves could take weeks.
In addition to the FDA’s actions, Connecticut Democrat Rosa Delauro said in an interview Monday that she plans to introduce a bill that would simplify the process of importing baby formula from FDA-controlled foreign plants. He added that he plans to hold a House hearing to review what went wrong in the race to discover bacteria and deficiencies.
“Both the company and the FDA must be held accountable for moving forward,” said Mrs. Delaware. He said he had called for an investigation by the Inspector General of Health and Human Services and invited Abbott to testify at a hearing scheduled for May 25.
During the FDA’s first routine inspection there since the start of the Covid-19 epidemic, problems arose at the Abbott Stargis plant in September. According to company documents, inspectors discovered standing water inside the plant and workers working directly with the formula without proper hand hygiene.
The following month, a whistleblower working at the plant filed a complaint under the Food Safety Modernization Act, claiming that plant leaders celebrated by concealing information from the FDA and omitting key information from official documents.
The FDA returned to the plant Jan. 31 and discovered persistent problems, including the presence of chronobacter bacteria near production lines, according to agency records.
The FDA and Abbott stopped production and on 17 February issued a comprehensive withdrawal of Abbott’s child formula. Since then, store supplies have dwindled, forcing parents to go on frantic trips to find formulas to feed their babies, some of which have rejected new or unfamiliar tastes.
Navigating the Child Source Deficit in the United States
A growing problem. The nationwide shortage of baby formula – partly due to supply-chain problems and worsened by the withdrawal of baby food by Abbott Nutrition – has left parents confused and anxious. Here are some ways to deal with this uncertainty:
The company’s agreement with Abbott requires the company to notify the FDA if contamination is found and to store any samples of the chronobacter for three years. Violation of the contract could result in a daily fine of $ 30,000 and $ 5 million a year, according to court records.
“We know that millions of parents and carers depend on us and we are deeply saddened that our voluntary withdrawal has exacerbated the nationwide formula deficit,” said Robert Ford, Abbott’s chief executive, in a statement. “We will work hard to restore the trust that mothers, fathers and carers have placed in our formula for over 50 years.”
Monday morning, FDA Commissioner, Dr. Robert M. Calliffe told CNN that the company is working on a supply chain to get the required formula back on store shelves.
“We really hope that, you know, things will get back to normal in a few weeks,” said Dr. Calif.
Dr. Caliph also backtracked on the report on the level of the deficit. He described the aftermath of the shutdown as a “relatively unexpected consequence”. He added that the number of supplies cited in some reports, which show formulas at 56 percent of normal, was “incorrect” and that the White House had more accurate figures. White House officials point to data from retail research firm IRI that the in-stock rate is close to 80 percent.
None of the figures appear to be relevant to Sacramento’s 32-year-old Angela Coleman, who snatched the shelves from a child at a local target on Monday. He said the only item in stock was baby formula. She drove 16 miles to a store near her parents’ house to get the last two cans of her nine-month-old son’s favorite formula.
“You want to buy it whenever you see it because you don’t want to be where you end up,” he said. Most retail outlets have restricted formula purchases.
Dr. Caliph is expected to appear before a House Appropriations Subcommittee on Thursday to answer questions from lawmakers. He said in an interview with CNN that nine staff members of the organization focused on child sources and four more were funded.
“We need more than that,” said Dr. Calif. “It’s a huge part of the well-being of Americans and our most vulnerable children, so we’re very concerned about that.”