Manufacturer Abbott plans to resume production of its infant formula amid a national shortage, but says it could take up to 10 weeks before it hits shelves.
The company reached an agreement Monday with Food and Drug Administration (FDA) regulators on steps to reopen its Sturgis, Michigan plant after it was temporarily closed due to product safety concerns.
“Following FDA approval, Abbott could restart the site within two weeks; from the time of the restart, it would take six to eight weeks before the product hits the shelves,” a company statement read. .
The company added that the Centers for Disease Control and Prevention “concluded their investigation without finding a link between Abbott formulas and childhood illnesses.”
The FDA also announced that additional steps were being taken to address supply chain issues, saying it was trying to make it easier for foreign manufacturers to ship more formulas into the country.
FDA Commissioner Robert Califf said: “The FDA expects the steps and actions it is taking with infant formula manufacturers and others will mean that more and more supplies is on the way, or on store shelves, in the future.”
The infant formula shortage – which has left parents panicking with empty shelves – was triggered in part by Abbott’s February recall of several of its brands. The move came amid an investigation sparked by fears that bacteria, which had been linked to illnesses and deaths in babies, may have been present in the products.
Formula production ceased as the company was investigated over safety concerns. The company’s voluntary recall included the brands Similac, Alimentum and EleCare, all of which were manufactured at the company’s Sturgis site.
Stores such as CVS and Walgreens then rationed their stock supply as demand grew for fewer products. Supply chain issues caused by COVID-19 disruptions exacerbated the problem, and many stores reported being completely sold out. Abbott is one of four companies that produce about 90% of infant formula in the country, with its brands accounting for nearly half of the market.
FDA inspectors carried out a six-week inspection of Abbott’s factory in Sturgis and in March released a list of issues it demanded be fixed before the factory reopened, such as sanitary standards on site.
The company pointed out that its products had not been directly linked to bacterial infections in children and that samples taken from the plant did not match bacterial strains taken from affected babies.
Abbott President and CEO Robert B. Ford said, “Our number one priority is to provide infants and families with the high-quality formulas they need, and that’s a major milestone. toward the reopening of our Sturgis facility so that we can facilitate the national shortage formula. We look forward to working with the FDA to quickly and safely reopen the facility. We know that millions of parents and caregivers depend on us and we are deeply sorry that our voluntary recall has exacerbated the nationwide formula shortage. We will work hard to regain the trust that moms, dads and caregivers have had in our formulas for over 50 years.”
Newsweek contacted Abbott and the FDA.
Desperate mothers who couldn’t breastfeed and relied on formula to feed their babies spoke to Newsweek about their “panic” trying to find scarce supplies, and their fear of what it would mean for their baby if they couldn’t get hold of any before their current supply ran out.
Parents had even turned to human milk banks as mothers moved by the plight of desperate parents struggling to obtain formula milk began donating their own surplus breast milk to feed babies. Lindsay Groff, executive director of the Human Milk Banking Association of North America, told USA Today that the demand for breast milk from her banks “has more than increased.” She added: ‘I would say it’s through the roof with people inquiring about alternatives to the formula – the phones are ringing non-stop.