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FDA could allow foreign-made infant formula to be shipped to US

Baby Formula Shortage
Posted at 10:52 AM, May 16, 2022
and last updated 2022-05-16 14:24:03-04

As the Biden administration tries to put an end to an infant formula shortage around the U.S., the Food and Drug Administration said it could soon allow foreign-made products to enter the market.

Health and Human Services Secretary Xavier Becerra told CNN that certain products are not allowed to be sold in the U.S. He said that the FDA could allow in products as long as they meet safety requirements.

“What we are looking to do is make available that supply from abroad that we can assure people will be safe and make it more readily available,” he told CNN. “There are certain requirements that some manufacturers don't meet that don't have so much to do with nutrition or safety that prohibit us being able to allow to import it. We're going to do what we can to increase supply, work with importers so that supply, so long as it is safe, will make it to the U.S."

Another issue slowing supply was a February recall that subsequently caused a Michigan plant operated by Abbott to shut down. Abbott officials and the FDA have said they have been working together to reopen the plant.

The recall was prompted after two infants died and two others were hospitalized after consuming Abbott-made infant formula. Abbott said in a statement last week that it could not find any evidence that the infants were sickened by Abbott-made products.

“We conduct microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter or Salmonella,” Abbott said. “All retained product tested by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter and/or Salmonella. No Salmonella was found at the Sturgis facility. The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the facility and has not been linked to any known infant illness.”

Becerra said getting the Abbott plant fully operational is important for getting shelves restocked with formula.

"We have to count on Abbott putting its production lines back in place. If they don't move quickly to address safety concerns that even they acknowledge because they shut down the plant and recalled some of their product, then it becomes difficult because they are a big manufacture - 40 percent - that comes from Abbott. So they have to get back online,” Becerra told CNN.