The FDA reached a deal with Abbott Nutrition to reopen its plant in Michigan after a nationwide shortage of infant formula.
The FDA is investigating reports of infections related to powdered formula at the plant. Reports of two deaths and a Cronobacteria infection were received by the FDA.
In February, Abbott voluntarily recalled several of its infant formulas, leading to a shortage in supply and prompting retailers to limit how much formula people could buy in stores. The shortage was worsened by supply-chain issues and the FDA's slow approval process.
Abbott is the largest infant formula manufacturer in the US. Some 43% of retailers across the US reported running out of baby formula as of May 8, but it is not clear how much of the US supply the Sturgis plant produces.
The New York Times reported that the shortage has prompted some desperate parents to ration or water down formula for their kids. Some parents have started feeding their infants powdered oatmeal and fruit juice, neither of which have as much nutrition value as formula or breast milk.
A consent decree was filed by the Justice Department on behalf of the FDA, which involves an FDA inspection at the Sturgis plant and Abbott bringing in outside help to reopen it.
The consent decree needs to be approved by a federal court in Western Michigan. After FDA approval, Abbott said it could reopen the site in two weeks, and then it would take a further six to eight weeks for product to hit the shelves.
It could take months for any formula to return to stores.
Abbott said that the Centers for Disease Control and Prevention found no conclusive evidence to link its formulas to infant illnesses.
We know millions of parents and caregivers depend on us, and we are deeply sorry that our voluntary recall worsened the nationwide formula shortage, said Robert B. Ford, Abbott's chairman and CEO.
We will work hard to re-earn the trust that moms, dads, and caregivers have placed in our formulas for more than 50 years.
All Rights Reserved © 2024
