FDA Outlines Strategy To Review Infant Formula Production Rules

The FDA would review guidance and rules about manufacturing infant formula as part of its strategy to prevent bacterial illness similar to Abbott Laboratories ABT products this year.
The FDA will also consider establishing a dedicated group of investigators and realigning staff across two of its divisions to better support regulatory oversight of infant formula, among other measures.
The agency also seeks to improve oversight of the safe production of powdered infant formula.
Related: Infant Formula Fiasco Weighs On Abbott's Q3 Earnings, Still, It Raised FY22 EPS Guidance.
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.
Between September 2021 and February 2022, the FDA received complaints about four cases of illness or death in infants who consumed powdered infant formula.
FDA's internal review concluded that numerous shortcomings hampered the agency's response to the U.S. infant formula supply problems this year.
Price Action: ABT shares are up 0.93% at $104.10 on the last check Wednesday.
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