On Monday, the Food and Drug Administration reached an agreement with Abbott Laboratories on steps needed to rebuild the company’s closed infant formula plant, which could alleviate a shortage of infant formula that frightens and annoys parents across the country.
The FDA must still give approval once the company takes action to resume production at the plant in Sturgis, Michigan. It has been discontinued since February after several babies who used the mixtures that were made there fell ill and two died.
Ebat described the deal with the FDA as a “consent decree” and said it would require federal court approval. Once the agency allows the plant to rebuild, the company said production could begin in about two weeks, and more formulas will appear on the shelves in six to eight weeks. The company said it would continue flying formulas from a plant in Ireland.
It was unclear how quickly the FDA could approve the opening of the plant.
The Abbott plant has been offline since February, when the FDA discovered a deadly bacterium called cronobacter, swapping swabs in and near production lines. Ebat challenged this characteristic, 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 infant diseases and two deaths in Minnesota, Texas and Ohio. Ebat said that “there is no convincing evidence of a link between Ebat’s mixtures and these childhood diseases.”
The opening of the plant exacerbated the current supply crisis as parents rushed to stock up on mixes. When store shelves in some communities were bare, some were so desperate that they fed their babies oatmeal and fruit juice, even when pediatricians say formula or breast milk is a critical source of nutrition from birth to first birthday.
In addition to the FDA’s actions, a spokeswoman for Rosa DeLavra, a Democrat from Connecticut, said in an interview Monday that she plans to introduce a bill that will facilitate the process of importing infant formula from foreign FDA-regulated factories. She also said she plans to hold hearings in the House of Representatives to consider what went wrong ahead of the detection of bacteria and deficiency.
“Both the company and the FDA must be held accountable to move forward,” Ms. DeLavra said. She said she had called for an investigation by the inspector general of health and social services and invited Ebat to testify at a hearing scheduled for May 25.
Problems at the Abbott Sturgis plant emerged in September during the first regular FDA inspection since the start of the Covid-19 pandemic. According to the agency, inspectors found stagnant water at the plant and staff who worked directly with the mixture, without proper hand hygiene.
The following month, an informant who worked at the plant filed a complaint under the Food Safety Modernization Act, alleging that plant managers celebrated the concealment of information from the FDA and omitted key information from official documents.
The FDA returned to the plant on Jan. 31 and found persistent problems, including the presence of cronobacter bacteria near production lines, according to agency records.
The FDA and Abbott stopped production and on February 17 announced a broad recall of Abbott infant formula. Since then, stocks in stores have dwindled, forcing parents to go on insane trips in search of formula to feed their children, some of whom are giving up new or unfamiliar tastes.
FDA Commissioner Dr. Robert on Monday morning. M. Calif told CNN that the agency is working on a supply chain to return the necessary formula to store shelves.
Navigating the baby formula shortage in the US
A growing problem. The shortage of infant formula across the country – partly caused by supply chain problems and exacerbated by the withdrawal of baby food maker Abbott Nutrition – has caused parents to be confused and worried. Here are some ways to manage this uncertainty:
“We really expect that in a few weeks we will be back to normal,” said Dr. Caliph.
Dr. Caliph also declined to report on the extent of the deficit. He described the events after the cessation of production as “relatively unpredictable consequences”. He also said that the supply figures given in some reports, which showed formula supplies at 56 per cent of the norm, were “incorrect” and said the White House had more accurate figures. Representatives of the White House pointed to data from research firm IRI, which shows that the rate in the warehouse is approaching 80 percent.
None of these figures seemed relevant to 32-year-old Angela Coleman of Sacramento, who on Monday found shelves at the local Target completely devoid of baby formula. She said that the only product available was a baby formula. She drove 16 miles to a store near her parents ’house to get the last two cans of the formula her nine-month-old son loved.
“You kind of want to buy it every time you see it because you don’t want to be the moment you run out,” she said. Most outlets have imposed restrictions on the purchase of blends.
Dr. Caliph is expected to appear before the House Appropriations Subcommittee on Thursday to answer questions from lawmakers. In an interview with CNN, he said the agency has nine employees who focus on baby formulas, and funds have been allocated to four more.
“We need more than that,” Dr. Caliph said. “It’s a big part of the well-being of Americans and our most vulnerable young children, so we’re very concerned about that.”