FDA deal will reopen Abbott formula factory
On Monday evening, baby formula producer Abbott announced it had reached a deal with the Food and Drug Administration, laying out a path to reopen a factory in Sturgis, Michigan, that shut down amid recalls earlier this year, contributing to the current shortage.
In a statement, the company confirmed that it has entered into a consent decree with the FDA, in which the agency and company agree on the benchmarks required to resume production and ensure the facility meets safety guidelines.
“Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage,” the company said.
“We look forward to working with the FDA to quickly and safely re-open the facility,” said chairman and CEO Robert B. Ford. “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.”
In a statement issued by the Department of Justice, Attorney General Merrick B. Garland said, “The actions we are announcing today will help to safely increase the supply of baby formula for families.
“The Justice Department will vigorously enforce the laws ensuring the safety of our food and other essential consumer products, and we will work alongside our partners across government to help make sure those products are available to the American people.”
In a CNN interview earlier in the day, FDA commissioner Dr. Robert Califf had presented a somewhat rosy timeline for reopening the facility. He had predicted that once a deal was struck, the factory could reopen and resume producing formula within two weeks and be back to normal a few weeks later.
However, Abbott said things will not move quite that fast.
“From the time Abbott restarts the site, it will take six to eight weeks before product is available on shelves,” the company noted in its statement.
Once it does, Abbott says it will start producing EleCare, Alimentum and metabolic formulas, followed by Similac and related products.
In his interview Monday morning, Califf told CNN’s Kaitlan Collins that the agency plans to allow the sale of foreign-made formula in an attempt to ease the ongoing shortage.
Offering this formula in U.S. stores “would have a big effect,” Califf said.