FDA Reaches Agreement With Top Baby Formula Maker to Reopen Plant

The shelves at a Marc's grocery store, which has started rationing cans of powdered baby formula, in the west Cleveland suburb of Lakewood, Ohio, on May 13, 2022. Customers are limited to three 12.5-ounce cans of Enfamil during the shortage that has been caused by a recall of other brands produced by Abbott Labs in Michigan. (Michael Sakal/The Epoch Times)

Abbott Laboratories, the baby formula producer at the center of a nationwide shortage, stated on May 16 that it reached an agreement with the U.S. Food and Drug Administration (FDA) to reopen its plant in Sturgis, Michigan, after it was subject to a federal investigation over alleged bacterial contamination.

The company cautioned, however, that it could take six to eight weeks from the start of production to when formula products actually start to show up on supermarket shelves across the United States, as parents grapple with shortages.

The agreement between the FDA and Abbott, meanwhile, is called a consent decree, meaning it is subject to court approval, according to Abbott.

“This is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage,” Abbott CEO Robert Ford said in a statement. “We look forward to working with the FDA to quickly and safely re-open the facility.”

He added that “we know millions of parents and caregivers depend on us and we’re deeply sorry that our voluntary recall worsened the nationwide formula shortage” and will “work hard to re-earn the trust that moms, dads, and caregivers have placed in our formulas for more than 50 years.”

More than 40 percent of baby formula products are out of stock across the United States during the week ending May 8, analytics firm Datassembly stated. The supply shortage was caused, in part, by the shutdown of the Sturgis plant after four infants who allegedly consumed formula made in the facility got sick with a type of bacterial infection, including two deaths.

FDA officials said they found the presence of the bacteria Cronobacter sakazakii in the Abbott plant, although the firm last week suggested in a statement that the bacteria wasn’t linked to sick children and deaths. In February, Abbott, the largest maker of baby formula in the United States, halted production and recalled several types of formula, including the top-selling Similac brand.

Earlier on May 16, FDA Commissioner Robert Califf told the “Today” show that he doesn’t expect the baby formula shortage to last until the end of 2022, while White House press secretary Karine Jean-Pierre said the United States is working to import more baby formula products from other countries in the meantime.

In the May 16 statement, Abbott didn’t immediately detail the terms of its agreement with the FDA.

“We now have a path forward,” Califf told “Today.” “Abbott is responsible for the timeline, but I’m very comfortable with what they said about two weeks. ... That’s entirely within the realm of possibility and I think quite likely.”

Starting last week, Republicans have increasingly put pressure on the Biden administration to take action to alleviate the shortage, while one Florida lawmaker said she received information and photos showing federal officials sent baby formula products to an illegal immigrant holding facility near the Texas–Mexico border.