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 must still grant approval to resume production at its Sturgis, Michigan plant once the company has taken the steps. The factory has been shut down since February after several babies who had used formula produced there fell ill and two died.
Abbott described the agreement with the FDA as a “consent decision” and said it would require federal court approval. Once the agency allows the factory to reopen, the company said 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.
It was unclear how soon the FDA would approve the factory’s reopening.
Abbott’s factory has been offline since February, when the FDA discovered a deadly bacteria called cronobacter while sweeping in and near production lines. Abbott disputed that characterization, saying the bacteria were found in “high care” areas indicating 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 childhood illnesses and two deaths in Minnesota, Texas and Ohio. Abbott said, “there is no conclusive evidence linking Abbott’s formulas to these teething problems.”
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 powdered oatmeal and fruit juice, although pediatricians say formula or breast milk is a vital source of nutrition from birth to first birthday.
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 formula without proper hand hygiene, according to agency documents.
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.
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.
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:
“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 supply 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.”