Washington — Following attacks from parents and politicians, President Joe Biden’s administration on Monday reopens the country’s largest manufacturing plant for infant formula and relaxes import rules to allow foreign supply. We will announce the agreement. Due to safety concerns, the Michigan plant was closed earlier this year.
Brian Deese, head of the White House’s National Economic Council, said a consent decree between producer Abbott and the Food and Drug Administration would “soon be announced” paving the way for the reopening of the plant. .. He added that authorities will take steps on Monday to allow more foreign imports into the United States to address urgent supply constraints.
Infant parents were forced to spend a considerable amount of time feeding their children as the Biden administration was under strong pressure last week to do more to alleviate the milk powder shortage.
Over the weekend, the White House provided transportation and logistics support to formula makers and retailers, working with all major formula producers to drive production.
“Federal resources, including transportation and logistics resources, are available, awaiting, and ready to move assets as needed,” Dies said. I made it clear to the people. “
The shortage was due to a February recall by Abbott, the country’s largest milk powder maker, closing the company’s Michigan plant, exacerbating the ongoing supply chain disruption between milk powder makers, and shelving many stores nationwide. There are fewer options. This shortage has forced retailers such as CVS and Target to limit the number of containers customers can buy in a single visit, forcing some parents to exchange and sell formulas online.
On Monday, FDA Commissioner Robert Caliph told ABC News “Good Morning America” that federal agencies “have been working very closely with Abbott” to reopen the closed Michigan plant. This is to announce the future direction. “
Mr. Caliph said there were plans to announce the import of infant formula from abroad, and said it was important to ensure that the infant formula description was in a language that mothers and caregivers could understand.
The FDA has warned families about making their own formula because it contains 30 different ingredients that must be in the right amount. Otherwise, consuming infant formula can be dangerous.
Abbott’s voluntary recall was caused by four diseases reported in infants who ingested infant formula from plants in Michigan. All four babies were hospitalized for a rare type of bacterial infection and two died.
Abbott is one of only four companies that produce about 90% of US infant formula, so its closure has already put pressure on tight supplies.
After six weeks of inspection, FDA investigators published a list of issues in March, including loose safety and hygiene standards, and a history of bacterial contamination in some parts of the plant.
However, Chicago-based Abbott emphasizes that the product is not directly related to bacterial infections in children. Bacterial samples found at the factory did not match the strains collected from the baby by federal investigators. The company has repeatedly stated that it is ready to resume production until the FDA’s decision is made.
The terms of the Consent Decree were not immediately clear, such as what steps Abbott took to correct the problems raised by the FDA or how quickly production at the plant would resume. ..
Former FDA officials say it takes time to fix the types of problems found at Abbott’s factories, and infant formulas are being scrutinized more than other food facilities. Companies need to thoroughly clean facilities and equipment, retrain staff, and repeatedly test and document pollution-free.
Even if the facility is reopened soon, the FDA will continue to face scrutiny on the handling of issues at the factory.
FDA inspectors visited the factory for routine inspections in September, when the first bacterial infection was reported in an infant. Inspectors found several violations, including pooled water and unsanitary conditions, but the FDA did not shut down the plant or issue a formal warning.
After several more illnesses were reported, the FDA returned to the factory in January, this time discovering a history of bacterial contamination in some parts of the factory. Abbott then closed the facility and recovered some milk powder in mid-February.
Last month, lawmaker Rosa De Lauro reported that whistleblowers had contacted the FDA about factory hazards and practices, including falsification of factory records and failure to properly test prescriptions for contamination.
She and other lawmakers will ask the FDA Commissioner Caliph about the issue and other issues at a hearing scheduled for Thursday.
The White House says a deal to reopen the Abbott Formula plant in Michigan is imminent – the Chicago Tribune
Source link The White House says a deal to reopen the Abbott Formula plant in Michigan is imminent – the Chicago Tribune