USA

FDA to take action to address baby formula shortage by speeding review of imports

The White House said Monday that the Food and Drug Administration (FDA) will be working to expedite the importation of baby formula to address nationwide shortages caused in part by the shutdown of a major supplier in Michigan.

“FDA will prioritize review of applications that are most likely to be successful and will get the most formula to U.S. shelves as quickly as possible,” White House press secretary Karine Jean-Pierre said at the White House briefing. “Companies will need to apply with the FDA, and FDA is prepared to review applications quickly and respond to them rapidly.”

She promised, “All companies will meet the FDA’s gold standard for quality control, and only safe products will come to America’s shelves.” 

But Jean-Pierre did not offer a timeline for when imports could be approved. 

“We want to make this happen quickly,” she said, adding, “We know how urgent and important this is to parents who need to make sure that they have safe formula for their babies and infants.”  

The FDA said on its website that it is offering a “streamlined import entry review process” for products from foreign facilities that have “favorable inspection records.” 

And it also said that it would expedite the necessary certificates of products that are already allowed into the U.S., to enable them to have “flexibility” in the movement of those formula products.

At retailers across the U.S., 43% of the top-selling baby formula products were out of stock as of the week ending May 8, according to the most recent analysis from Datasembly, which tracks baby formula stock at more than 11,000 stores. Formula was even scarcer in five states, where more than half of the top-selling products were missing from stores. 

Domestic production of baby formula should be ramping up again soon: the Abbott Nutrition baby formula manufacturing facility in Michigan that has been shuttered since February is “likely” to resume operations in two weeks, according to the FDA. Abbott on Monday entered a consent decree with the FDA paving the way for reopening the plant. 

Melissa Quinn and Nancy Cordes contributed to this report.

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