Abbott announced Monday that it has reached a deal with the U.S. Food and Drug Administration to reopen its baby formula manufacturing facility in Michigan.
The company said that after the FDA approves, the site could be reopened in two weeks, and once the restart begins, product could hit the shelves within six-to-eight weeks.
President Joe Biden's administration has worked to bring the plant, the country's largest, back online after it was shut down early this year due to safety issues.
"Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage," Robert B. Ford, chairman and CEO, Abbott, said in a statement. "We look forward to working with the FDA to quickly and safely re-open the facility."
"We know millions of parents and caregivers depend on us and we're deeply sorry that our voluntary recall worsened the nationwide formula shortage," Ford added. "We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years."
Following Abbott's announcement, the Justice Department formally filed the proposed consent decree, beginning the process of reopening the plant.
“The actions we are announcing today will help to safely increase the supply of baby formula for families,” Attorney General Merrick Garland said. “The Justice Department will vigorously enforce the laws ensuring the safety of our food and other essential consumer products, and we will work alongside our partners across government to help make sure those products are available to the American people.”
In the meanwhile, the White House also offered formula manufacturers and retailers transportation and logistics support to ease the nationwide shortage of baby formula.
The White House said it is working with all major formula producers to boost production, including reaching out to their suppliers to encourage them to prioritize production and delivery of formula ingredients. It comes as the Biden administration has come under intense pressure over the last week to do more to ease the shortage of formula that has forced parents of infants to go to significant lengths to feed their children.
The shortage stems from a February recall by Abbott, the nation’s largest formula maker, that shuttered the company’s Michigan plant and exacerbated ongoing supply chain disruptions among formula makers, leaving fewer options on stores shelves across much of the country. The shortage has led retailers like CVS and Target to limit how many containers customers can purchase per visit and forced some parents to swap and sell formula online.
The CDC concluded its probe without finding a link between Abbott formulas and infant illnesses, the company said Monday.
Prior to the announcement from Abbott, White House press secretary Karine Jean-Pierre said Monday that getting safe baby formula on the shelves is President Biden's top priority.
"It's important to remember the shortage exists because Abbott closed the facility because of safety concerns from the FDA, the FDA is working closely with Abbott to bring the facility back online safely," she emphasized. "That's the key here: safely. We want to make sure that this is done in a safe way."
"We're also moving as quickly as possible to safely bring in additional product from other countries as soon as today as well," she added. "We will be able to make an announcement on the expedited process to bring additional safe conduct product to the American storage to American store shelves and throughout the weekend."
The new White House spokesperson said that the administration is "leaving no stone unturned" when it comes to addressing the shortage, including weighing using the Defense Production Act to bolster manufacturing.
"We're leaving no stone unturned, and every option is on the table," Jean-Pierre said, adding that the administration's priority "is to make more supplies available as soon as possible."
Jean-Pierre said that the Biden administration is working with the four top formula manufacturers to "identify transportation, logistical and supplier hurdles to increasing production of formula" at FDA- and U.S.-authorized facilities "to expand the amount and speed of FDA-approved formula being shipped into the country and ensure that formula is quickly moving to retailers from factories."
The White House is also working with retailers such as Target, Amazon and Walmart "to identify parts of the country that may be at risk of critically low supply of infant formula and have offered to work with manufacturers and retailers to bring more formula to those parts of the country," including providing transportation and logistical support.
"We are also contacting suppliers ... to inform them that their materials are critical for boosting U.S. infant formula production and they should prioritize their production and delivery," she added. "We want them to know we're standing ready to provide the resources or support needed to move safely to get to get this to the selves as soon as possible."
Earlier Monday, FDA Commissioner Robert Califf told ABC News’ “Good Morning America” that an announcement is forthcoming about importing baby formula from abroad, noting that the key is making sure the instructions for the formula are in languages that mothers and caregivers can understand.
The FDA warned families against making their own baby formula because it has 30 distinct constituents that have to be in the right amount, otherwise the formula can possibly be dangerous to consume.
Abbott’s voluntary recall was triggered by four illnesses reported in babies who had consumed powdered formula from the Michigan plant. All four infants were hospitalized with a rare type of bacterial infection and two died.
Abbott is one of just four companies that produce roughly 90% of U.S. formula, so its shutdown squeezed already tight supplies.
After a six-week inspection, FDA investigators published a list of problems in March, including lax safety and sanitary standards and a history of bacterial contamination in several parts of the plant.
But Chicago-based Abbott has emphasized that its products have not been directly linked to the bacterial infections in children. Samples of the bacteria found at its plant did not match the strains collected from the babies by federal investigators. The company has repeatedly stated it is ready to resume manufacturing, pending an FDA decision.
Former FDA officials say fixing the type of problems uncovered at Abbott’s plant takes time, and infant formula facilities receive more scrutiny than other food facilities. Companies need to exhaustively clean the facility and equipment, retrain staff, repeatedly test and document there is no contamination.
Even if the facility reopens soon, the FDA will still face scrutiny for its handling of the issues at the plant.
FDA inspectors visited the factory in September for a routine inspection, around the time that the first bacterial infection was reported in an infant. Although inspectors uncovered several violations— including standing water and unsanitary conditions— the FDA did not shut down the plant or issue any formal warning.
Only after several more illnesses were reported did the FDA return to the plant in January, this time finding a history of bacterial contamination in several parts of the plant. Abbott then shut down the facility and recalled several powdered formulas in mid-February.
Rep. Rosa DeLauro, D-Conn., reported last month that a whistleblower had contacted the FDA in October about unsafe conditions and practices at the plant, including falsifying plant records and failing to properly test formula for contamination.
She and other lawmakers are set to question FDA Commissioner Califf about that issue and others at a hearing scheduled for Thursday.