NEC Society Statement on FDA Warning

Click to read our full two-page statement

Context: The FDA recently issued communications regarding the use of probiotics in neonates:

https://www.fda.gov/news-events/press-announcements/fda-raises-concerns-about-probiotic-products-sold-use-hospitalized-preterm-infants

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/abbott-laboratories-669353-10242023

https://www.fda.gov/media/172606/download

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/infinant-health-inc-formerly-evolve-biosystems-inc-667715-09282023

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