The Food and Drug Administration (FDA) is relaxing import rules for baby formula amid a national shortage crisis, according to a Monday announcement.
The U.S. will allow formula produced for foreign markets to be sold in the U.S., according to the FDA announcement. The U.S. typically produces 98% of its formula, with the remainder coming from Mexico, Ireland and the Netherlands.
Companies will need to get FDA approval for product safety and nutrition to sell their formula in the U.S., and the agency will prioritize applications for products that can make it to U.S. shelves fast and in large quantities.
The FDA announcement comes amid a nationwide baby formula shortage. By April 24, 40% of the top baby formula products were out of stock, according to CBS News, while 31% of formula was out of stock April 3, compared to 11% in November.
Today, we’re announcing a guidance that outlines increased flexibilities regarding importation of certain infant formula products to further increase the availability of infant formula across the country while protecting the health of infants. https://t.co/gxI39tty5D pic.twitter.com/VFVgjysVwx
— U.S. FDA (@US_FDA) May 16, 2022
“Today’s action paves the way for companies who don’t normally distribute their infant formula products in the U.S. to do so efficiently and safely,” said FDA Commissioner Robert M. Califf in a statement. “With these flexibilities in place, we anticipate that those products that can quickly meet safety and nutrition standards could hit U.S. stores in a matter of weeks.”
The FDA also allowed a Michigan Abbott Nutrition plant to begin producing formula again Monday following a February shutdown related to a recall of one of its formula products.
The FDA announced its investigation of the plant Feb. 17 for possible connections to bacterial outbreaks, but neither the Centers for Disease Control and Prevention nor the FDA proved that any babies had gotten sick from Abbott’s formula, according to The Wall Street Journal.
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