Major baby formula plant could open next week, but the crisis is far from over
The baby formula plant that triggered a nationwide crisis when it shut down earlier this year might reopen as early as next week. But it could still take months for product to land on store shelves.
Food and Drug Administration commissioner Dr. Robert Califf testified on Thursday in front of Congress about the shortage, and the shuttered Abbott manufacturing facility in Sturgis, Michigan.
“I think we are on track to get it open within the next week to two weeks,” he said during the remote, live streamed hearing.
Abbott did not immediately respond to Fortune’s request for comment.
The ongoing crisis has revealed that the baby formula industry in the U.S. is dominated by just a few major manufacturers. That means that a shutdown of a single facility can have major consequences for the ability for people to buy baby formula around the country.
Abbott Nutrition voluntarily shut down its Sturgis facility on Feb. 17 in response to several reports between Sept. 2021 and Feb. 2022 of children falling ill or dying after consuming formula products produced at the site.
Those reports, along with a whistleblower testimony submitted late last year, prompted the FDA to investigate the plant between Jan. 31 and March 18. Their investigation identified several health and safety violations separate from the potential bacterial contamination leading to reported infant deaths.
Though Abbott has said that its own investigation into the contamination found no connection between the formula produced at its plant and the infant illnesses and deaths, the FDA’s additional findings have kept the plant shut down. A settlement between Abbott and the FDA, announced this week, is currently awaiting court approval in Michigan. Once approved, the plant can reopen.
The closure of that single plant has had a profound domino effect, making it hard for caregivers to find competitor products as people snap up any formula they can find. For weeks, parents as well as their friends and family have been spending countless hours scouring stores in person and online for what they need to feed their children.
But even if the plant does open, it could take months before baby formula is back in stock. In resuming production, Abbott will need to restart equipment and conduct multiple test runs and checks on its ingredients and products.
“From the time Abbott restarts the site, it will take six to eight weeks before product is available on shelves,” the company said in its most recent press release.
The federal government has taken drastic measures to ease the shortage. On Wednesday, President Joe Biden invoked the Defense Production Act to prioritize formula production while also approving “Operation Fly Formula” to import formula more quickly from overseas. Meanwhile, the FDA has said it has had conversations with other formula manufacturers to increase production.
Earlier this week, Biden announced that the FDA would loosen requirements for foreign formula products entering the U.S.
Abbott has also announced its own steps for addressing the crisis, including ramping up production at its other domestic sites, flying in product from an Irish facility, increasing the volume and worth of its formula coupons, and providing rebates for competitor products for the USDA’s WIC participants wherever the company has an exclusive contract.
At the hearing, Califf used the crisis as evidence that the FDA needs better funding. The agency is asking for $76 million in funding for its food arm as part of its budget request for next year.
“We have a critical opportunity here to invest in FDA’s ability to work with partners to ensure a safe, adequate supply of infant formula,” he said, adding that the agency currently does not have the authority or resources to monitor supply chain disruptions.
“We could be one natural disaster, quality mishap, or cyber attack from being here again,” he said.
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