“This is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage,” said Robert Ford, chairman and chief executive of Abbott, who noted that the shortage was also exacerbated by a voluntary recall by the company of formula that had been possibly tainted by a bacteria that sickened and killed infants.
“We know millions of parents and caregivers depend on us and we’re deeply sorry that our voluntary recall worsened the nationwide formula shortage. We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years,” he added. Once the FDA confirms the initial requirements have been met, Abbott could restart operations at the site within two weeks, the company said.
“The FDA is working closely with Abbott to bring the facility back online safely,” White House spokeswoman Karine Jean-Pierre told reporters Monday afternoon. “That is the key here, safely. We want to make sure that it is done in a safe way. We are very close to having a path forward to safely reopening the facility.” She said the administration is also “moving as quickly as possible” to bring in more formula from overseas.
In February, the FDA ordered Abbott to shut down its production facility in Sturgis, which produces Similac, EleCare and several other leading powdered formulas. Cronobacter bacteria had been found in infants who consumed formulas produced at the Sturgis plant. Two infants became sick, and two died. This prompted a voluntary recall by Abbott as well as an FDA inspection that found the plant did not maintain acceptable sanitary conditions.
On Friday, the White House announced that invoking the Defense Production Act to produce baby formula amid the shortage was on the table.
Four major companies — Abbott, Gerber, Mead Johnson and Perrigo Nutritionals — control 90 percent of the infant formula supply in the United States. To make up for the Sturgis facility shortfall, Abbott has prioritized infant formula production at its other plant in Columbus, Ohio, converting other liquid manufacturing lines into making liquid Similac, and has brought in millions of cans of product from its Ireland production facility.
Perrigo has stepped up production to ship 37 percent more formula in the past three months than the same period last year and Gerber is running formula factories at capacity to accelerate product availability to retailers and online.
Still, grocery store shelves have dipped more than 40 percent below full stock in recent weeks, retailers are rationing popular brands and parents have traveled miles to locate formula for their infants.
“As soon as today, we will be able to make an announcement on the expedited process to bring additional safe product to American store shelves,” Jean-Pierre said.