The Biden administration signaled it is taking additional steps to alleviate the baby formula shortage.
The Food and Drug Administration is prioritizing and reviewing applications to expand production activities from baby formula suppliers and releasing guidance to import formula that is currently not on the U.S. market, senior White House officials said.
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"We took another important step with the FDA releasing guidance under which major formula manufacturers can ask to safely import formula that is not currently being produced for the U.S. market," a senior administration official said. "Companies will need to apply with the FDA, and the FDA is prepared to review applications quickly and respond to them rapidly."
The FDA will be prioritizing applications from suppliers that will get the "most formula to your shelves as quickly as possible," the official added.
"The work that the FDA has done today with their new importation guidance is a really critical and crucial step to quickly increasing supply in the country," a senior administration official said.
Formula imports could come from countries such as Ireland, Chile, and the Netherlands, among others, though officials stressed that all imports will be rigorously tested to ensure they meet safety standards.
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Administration officials did not provide a specific timeline for when imported products are expected to hit the shelves but said more infant formula is coming off U.S. production lines than prior to Abbott's recall in February, following reports of four infants becoming severely ill with bacterial infections, two of whom died.
Earlier Monday, Abbott announced it had reached a deal with the federal regulators to reopen a production facility in Michigan. The agreement will include requirements for testing products and for Abbott to retain an independent expert to review the facility's operations to assess compliance, an administration official detailed.
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As the supply chain bounces back, families are encouraged to talk with their pediatrician about switching baby formula products as needed.
"We recognize that that's scary and and can be, can be challenging, but families should have confidence buying whatever is available and providing that to their family," a senior official said. "At the same time it is not safe ... to water down formula or to make your own infant formula at home."