The Food and Drug Administration reached an agreement with Abbott Laboratories Monday on steps needed to reopen the company’s shuttered baby food plant.
The FDA said it expected Abbott to resume production in about two weeks, and was standing by to review progress at the Sturgis, Michigan plant. The factory has been closed since February after several babies who had used the formula produced there fell ill and two died.
The agreement stems from a complaint and clearance decision by the United States Department of Justice with the company and three of its executives. According to those court records, the FDA found a deadly bacteria called cronobacter at the plant in February and later that month found more tranches of the bacteria.
According to the complaint, the same Sturgis plant 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’s staff “has been unwilling or unable to take sustainable corrective action to ensure the safety and quality of food for infants,” leading to the need for legal action, the documents say.
In a release, Abbott said, “There is no conclusive evidence linking Abbott’s formulas to these teething problems.”
The company said Monday that production could begin in about two weeks and translate to more formula on shelves in six to eight weeks. The company said it will continue to fly formula from a factory in Ireland.
Under the agreement, Abbott must hire a qualified expert to oversee a number of improvements to the Sturgis facility.
As frustration mounted on the crib side and in supermarket aisles, the agency was in a race to replenish depleted supplies that have become political fodder for Republicans against the Biden administration.
The factory shutdown exacerbated an existing supply crisis as parents rushed to stock up on the formula. With shelves empty in some communities, some are so desperate to feed their babies oatmeal and powdered fruit juice, though pediatricians say formula or breast milk is a vital source of nutrition from birth to first birthday.
Susan Mayne, a leading FDA food regulator, said Monday evening that the agency has issued guidelines urging international formula makers to ship their products to the United States. She said the eased import restrictions would be in effect for 180 days and it could take weeks to get more product on the shelves.
In addition to the FDA’s actions, Representative Rosa DeLauro, a Connecticut Democrat, said in an interview Monday that she plans 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 of Representatives to look at what went wrong in the run-up to the discovery of the bacteria and shortages.
“Both the company and the FDA must be held accountable to move forward,” said Ms. DeLauro. She said she had called for an investigation by the Inspector General of Health and Human Services and invited Abbott to testify at a hearing on May 25.
Problems at the Abbott Sturgis plant came to light in September during the FDA’s first routine inspection there since the start of the Covid-19 pandemic. Inspectors discovered standing water at the factory and personnel working directly with the formula without proper hand hygiene, according to documents from the agency.
The following month, a whistleblower who worked at the factory filed a complaint under the Food Safety Modernization Act alleging that factory leaders celebrated hiding information from the FDA and omitting important information from official documents.
The FDA returned to the factory on Jan. 31 and found lingering problems, including the presence of cronobacter bacteria near production lines, according to the agency’s data.
The FDA and Abbott have halted production and issued a comprehensive recall of Abbott’s infant formula on Feb. 17. new or unfamiliar taste.
Navigating the US Baby Food Shortage
A growing problem. A nationwide baby food shortage – caused in part by supply chain problems and exacerbated by a recall from baby food manufacturer Abbott Nutrition – has left parents confused and concerned. Here are some ways to deal with this uncertainty:
The agency’s agreement with Abbott requires the company to notify the FDA if it finds contamination and store any sample of cronobacter it finds for three years. Violations of the agreement can result in daily fines of $30,000, capped at $5 million per year, according to court data.
“We know that millions of parents and caregivers depend on us and we are deeply sorry that our voluntary recall has exacerbated the nationwide shortage of formulas,” Abbott CEO Robert Ford said in a statement. “We will work hard to regain the trust that moms, dads and carers have placed in our formulas for over 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 expect everything to be back to normal in a few weeks,” said Dr. Califf.
dr. Califf also pushed back on reports about the extent of the deficit. He described the events since the production shutdown as “relatively unpredictable consequences”. He also said the delivery figures quoted in some reports, showing formula stock was 56 percent of normal value, were “inaccurate” and said the White House had more accurate numbers. White House officials pointed to data from the retail research firm IRI showing the stock is closer to 80 percent.
None of those numbers seemed relevant to Angela Coleman, 32, of Sacramento, who Monday found the shelves at a local Target completely emptied of infant formula. She said the only item in stock was toddler food. She drove 15 miles to a store near her parents’ house to get the last two cans of formula her nine-month-old son preferred.
“You kind of always want to buy it when you see it because you don’t want to be at the point where you run out,” she said. Most stores have limits on formula purchases.
dr. Califf is expected to appear before a home loan subcommittee on Thursday to answer questions from lawmakers. He said in the CNN interview that the agency has nine employees who focus on baby food and has received funding for another four.
“We need more than that,” said Dr. Califf. “This is a big part of the well-being of Americans and our most vulnerable young children, so we’re very concerned about it.”
