The baby formula maker Abbott has reached an agreement with US health regulators to restart production at its largest domestic factory amid a nationwide formula shortage that has left shelves bare and parents scrambling.
Monday’s agreement with the Food and Drug Administration (FDA) amounts to a legally binding agreement between regulators and the company on steps needed to reopen the plant in Sturgis, Michigan, which had been under investigation for safety concerns.
However, it will be well over a month before any new products ship from the site to help alleviate the situation. After production resumes, Abbott said it will take between six and eight weeks before the formula will begin arriving in stores.
Abbott is one of just four companies that produce roughly 90% of US formula, and its brands account for nearly half that market.
The company didn’t set a timeline to restart production or offer further details about the terms of the deal.
The FDA announced additional steps to ease the supply chain crunch, saying it was was streamlining its review process to make it easier for foreign manufacturers to begin shipping more formula into the US.
“The FDA expects that the measures and steps it’s taking with infant formula manufacturers and others will mean more and more supply is on the way or on store shelves moving forward,” FDA commissioner Robert Califf told reporters.
Califf said the US will prioritize companies that can provide the largest shipments and quickly show documentation that their formulas are safe and compatible with US nutrition standards. The policy is structured as a temporary measure lasting six months.
It comes as Joe Biden’s administration faces intense pressure to do more to ease the shortage that has left
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