FDA issues warning letters for illegally selling probiotics to treat disease in preterm infants

30 Oct 2023 — The FDA raises concern about the risks probiotics pose to preterm infants in hospital settings as they contain live bacteria or yeast. The agency has issued warning letters to Abbott Laboratories and Infinant Health regarding their probiotic products sold to treat or prevent diseases in preterm infants. 

According to the agency, preterm infants who are administered a probiotic are “at risk of invasive, potentially fatal disease or infection” caused by the bacteria or yeast in the products, based on medical literature. Probiotics have been associated with over two dozen adverse events in the US since 2018 and contributed to one infant death in 2023.