Despite a national shortage, Abbott plans to restart production of its baby formula, but it could take up to 10 weeks before it hits the shelves.
On Monday, the company reached an agreement with Food and Drug Administration (FDA) regulators on the steps needed to reopen its plant in Sturgis, Michigan, which had been temporarily closed due to product safety concerns.
“After FDA approval, Abbott could restart the site within two weeks; from the time of restart, product would be available on shelves in six to eight weeks,” according to a company statement.
According to the company, the Centers for Disease Control and Prevention “completed its investigation with no findings of a link between Abbott formulas and infant illnesses.” The FDA also announced additional steps to combat supply chain issues, stating that it was attempting to make it easier for foreign manufacturers to ship more formula into the country.
“The FDA expects that the measures and steps it is taking with infant formula manufacturers and others will mean that more and more supply is on the way, or on store shelves, moving forward,” FDA Commissioner Robert Califf said.
The baby formula shortage, which left panicked parents with empty shelves, was sparked in part by Abbott’s February recall of several of its brands. The move came amid an investigation sparked by concerns that bacteria linked to baby illnesses and deaths may have been present in the products.
Formula production was halted while the company was investigated for safety concerns. The voluntary recall included the brands Similac, Alimentum, and EleCare, all of which were manufactured at the company’s Sturgis facility.
As demand for fewer products increased, retailers such as CVS and Walgreens rationed their stock supply. Supply chain issues caused by COVID-19 disruptions exacerbated the situation, and many stores reported that they were completely sold out. Abbott is one of only four companies that manufactures roughly 90% of the country’s baby formula, with its brands accounting for nearly half of the market.
The FDA conducted a six-week inspection of Abbott’s Sturgis plant and published a list of issues it demanded be resolved before the plant could reopen in March, such as sanitary standards on the premises.
The company emphasized that its products were not directly linked to bacterial infections in children, and samples taken from the plant did not match bacteria strains collected from the affected babies.
“Our number one priority is getting high-quality formulas to infants and families, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage,” said Abbott Chairman and CEO Robert B. Ford. We are excited to collaborate with the FDA to quickly and safely re-open the facility. We understand that millions of parents and caregivers rely on us, and we sincerely regret that our voluntary recall exacerbated the nationwide formula shortage. We will work hard to regain the trust that mothers, fathers, and caregivers have placed in our formulas for over 50 years.”
Desperate mothers who were unable to breastfeed and relied on formula to feed their babies told Newsweek about their “panic” in trying to find scarce supplies, as well as their concern about what would happen to their baby if they did not get some before their current supply ran out.
Mothers moved by the plight of desperate parents unable to obtain baby formula began donating their own surplus breast milk to feed the babies, prompting parents to turn to human milk banks. According to Lindsay Groff, executive director of the Human Milk Banking Association of North America, demand for breast milk from its banks has “more than doubled.” “I would say it’s through the roof with people inquiring about formula alternatives—the phones are ringing off the hook,” she added.
