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FDA to review baby formula production rules to prevent bacterial illness

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Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

The U.S. health regulator said on Tuesday it would review guidance and rules about manufacturing infant formula as part of its strategy to prevent bacterial illness similar to Abbott Laboratories’ (ABT.N) products this year.

The Food and Drug Administration will also consider whether to establish a dedicated group of investigators and realign staff across two of its divisions to better support regulatory oversight of infant formula, among other measures, it said.

The FDA’s statement follows a major shortage of baby formula earlier this year due to a shutdown at Abbott’s plant in Michigan after complaints of infection by a bacteria called cronobacter sakazakii.

The plant shutdown and the recall of Abbott infant formula products deepened a supply shortage and sent parents in the United States scrambling. Abbott’s plant was restarted in July.

While the bacterial infection is considered rare and is not reportable in most states, it can be deadly in newborns. Abbott’s products were recalled following reports of four cases and two deaths.

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