A major baby formula manufacturer unwittingly set off a national shortage when it closed a single plant in Michigan earlier this year. It’s now working with the FDA to reopen the factory, but pending court approval, that could be weeks away.
And once the plant finally does get up and running, it’ll take even longer for the new formula to reach store shelves.
On Monday, the FDA announced a proposed settlement with Abbott Nutrition that would allow the company to reopen its Sturgis, Mich. plant. In the settlement, Abbott agreed to fix multiple health and safety compliance problems identified by the FDA in its inspection of the plant carried out from Jan. 31 to March 18.
“From the time Abbott restarts the site, it will take six to eight weeks before product is available on shelves,” Abbott said in a statement to Fortune.
A number of steps must be taken before reopening the plant, including restarting equipment and conducting test runs and checks on both ingredients and final products.
“Operating at full pre-recall capacity, the plant would more than double our current production of powdered infant formula for the U.S., and our goal is to ramp up to levels at or near our previous production volumes,” an Abbott spokesperson told Fortune.
The settlement would impose several requirements on Abbott moving forward. The company must retain an independent expert to ensure its Sturgis facility complies with the law. It also mandates new product testing requirements and new protocols for ceasing production and notifying the FDA if and when contamination is identified.
“The proposed consent decree also requires the implementation of a sanitation plan, environmental monitoring plan and employee training programs,” the FDA said in a release accompanying the announcement.
In late 2021 and early 2022, four children fell ill and two died after consuming products from Abbott’s Sturgis plant. The company voluntarily recalled its products from the plant on February 17 and ceased production at the facility. Abbott has since claimed that the bacteria linked to the illnesses and deaths cannot be traced back to its plant.
While this week’s proposed settlement represents progress toward ending the formula shortage in the coming months, it’s continuing to cause parents to panic nationwide.
“We’re desperate, we’re really desperate,” says Jennifer, a mother from Alabama who declined to provide her last name to Fortune. Her daughter, now over a year old, still takes formula because of a bad reaction when she tried to transition her off of it around the one-year mark. Jennifer also helps take care of a close friend’s four children, one of whom is only five months old.
Earlier this week, she says she spent a day and a half calling retailers in her area until she found one 45 minutes away with the right product in stock: enfamil gentlease, produced by Abbott competitor Nestlé.
“There was a little bit of relief when we found it,” says Jennifer. “And then it was, ‘Oh my gosh how do we get over there tonight to get it?’” Jennifer’s husband drove out, returning later in the night with twelve cans to split between the two families.
In its release, the FDA alluded to conversations with other baby formula manufacturers that have agreed to increase production as the shortage has worsened. The agency also cited forthcoming foreign imports—the White House has made it easier to get them into the country— and the possibility of Abbott’s facility reopening as cause for hope that the shortage will end.
“The FDA recognizes that there is variation in availability throughout the country and is working with federal partners to better understand where shortages of certain formulas exist at a more local level, as well as explore further ways to alleviate more immediate and geographical supply challenges through better distribution of products,” said the FDA in its release.
Maria Diaz, a neonatal nurse in Southern California, has so far not seen effects of the shortage like what Jennifer has faced. Her hospital currently still has ample stock of formula, and has not yet needed to purchase more
“Right now, we have adequate supply,” she says. “But I think it’s going to get worse because we use Abbott’s [products].”
Abbott says it has taken its own steps to alleviate the shortage, including air-shipping formula from a plant in Cootehill, Ireland, prioritizing infant formula production in other U.S. plants, and increasing the number and value of formula coupons for all its products “to enable customers to purchase formula, either free or deeply discounted.”
The company also said it’s working with the USDA and its WIC agencies to provide rebates on competitive products in states where Abbott holds an exclusive WIC contract. WIC is the nickname for the USDA’s supplemental nutrition program for low-income families.
Until products are back on store shelves, though, parents will continue to seek out formula wherever they can. Jennifer says she has her sister-in-law in Florida on the lookout for her, but she, too, has been striking out. Currently, she has enough formula to last another few weeks before she has to start seriously hunting again.
“We have a ways to go to try and get her through this,” she says about her friend’s five-month-old daughter. “We kind of feel like it’s us against the world.”
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