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Navigating the United States FDA advisory: Probiotics in Preterm Infants

Journal of Perinatology (2026)Cite this article

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Abstract

Necrotizing enterocolitis (NEC) is a severe gastrointestinal emergency in preterm infants, leading to high mortality and long-term complications. Probiotics have been extensively studied and shown in multiple randomized trials and meta-analyses to significantly reduce the incidence of severe NEC, all-cause mortality, and late-onset sepsis. Despite strong evidence and international guidelines supporting their use, probiotic administration in US neonatal intensive care units has sharply declined following a 2023 FDA advisory. The FDA cited safety concerns, lack of product quality control, and the unapproved drug status of probiotics as reasons for this warning. This paper reviews the compelling evidence for probiotic efficacy, examines the FDA’s rationale, and contrasts US policy with global practices. It highlights the risk-benefit imbalance of withholding probiotics, analyzes the resulting clinical dilemma, and proposes a path forward through regulatory reform, ongoing research, and stakeholder collaboration to ensure access to this potentially life-saving intervention for preterm infants.

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Authors and Affiliations

  1. Division of Neonatology, Department of Pediatrics, Nemours Children’s Hospital, Orlando, FL, USA

    Sreekanth Viswanathan

  2. Institute for Clinical Research and Learning Health Care, UTHealth at Houston, Houston, TX, USA

    Kanekal Suresh Gautham

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  1. Sreekanth Viswanathan
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  2. Kanekal Suresh Gautham
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Contributions

SV conceptualized the study theme and design, drafted the initial manuscript, critically revised the content, and approved the final manuscript as submitted. KSG contributed to the study design, critically revised the manuscript for important intellectual content, and approved the final manuscript as submitted. All authors agree to be accountable for all aspects of the work.

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Correspondence to Sreekanth Viswanathan.

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A. Guarantor of the article: SV. Any potential competing conflicts of interests: None.

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Viswanathan, S., Gautham, K.S. Navigating the United States FDA advisory: Probiotics in Preterm Infants. J Perinatol (2026). https://doi.org/10.1038/s41372-026-02574-4

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