FDA issues health care provider letter for probiotics in preterm infants


The FDA has issued a Dear Healthcare Provider Letter highlighting information about the use of probiotics in preterm infants and the risk for potentially fatal disease caused by bacteria or fungi contained in these products. 

FDA issues health care provider letter for probiotics in preterm infants | Image Credit: © Rubbina - © Rubbina - stock.adobe.com.

FDA issues health care provider letter for probiotics in preterm infants | Image Credit: © Rubbina - © Rubbina - stock.adobe.com.

Article highlights

  • FDA warning about probiotic risks in preterm infants
  • Fatal incident involving Bifidobacterium longum probiotics
  • Lack of FDA-approved infant probiotics; safety evaluation lacking in unapproved products
  • Caution from the American Academy of Pediatrics due to conflicting safety data
  • Providers required to submit Investigational New Drug Application for infant probiotic treatments

In efforts to provide safety information to health care providers about the use of products that contain live bacteria or yeast (probiotics), the FDA has issued a Dear Healthcare Provider (DHCP) Letter.

According to a press release, the federal agency warns providers that preterm infants who are given probiotics are at risk for potentially fatal disease that is caused by fungi or bacteria contained in probiotics.

In the letter, the FDA explained that a preterm infant with a birthweight of less than 1000 g was probiotic Evivo with MCT Oil (Infinant Health) during in-hospital care. The infant developed sepsis caused by the bacteriumBifidobacterium longum and died. According to the letter, “Evivo with MCT Oil is a probiotic formulated to contain the live bacterium, Bifidobacterium longum subsp. infantis.” The agency is investigating the death of the infant and noted that genomic sequencing data “demonstrate the bacterium that caused sepsis in this infant was a genetic match to the bacteria contained in this product.”

Microorganisms in probiotics have been reported to cause bacteremia or fungemia in medical literature in very preterm or low birthweight infants, with a severe clinical course in some cases. According to the American Academy of Pediatrics, because of a lack of FDA-regulated pharmaceutical-grade products, safety and efficacy data conflict, and the potential of harm in an extremely vulnerable population, “current evidence does not support the routine, universal administration of probiotics to preterm infants, particularly those with a birthweight of <1000 g.”

Currently, there are no FDA-approved probiotic products for use as a drug or biological product in infants. The agency states it is aware there are some unapproved and unlicensed probiotics that are sold for use to treat a condition or disease in infants, including to reduce the risk of necrotizing enterocolitis in preterm infants. The agency reminds providers these products have not been evaluated for compliance with manufacturing testing standards and have not undergone premarket review for safety and efficacy.

Providers who administer probiotics that contain live bacteria or yeast to treat, mitigate, cure, or prevent a condition or disease are required to submit an Investigational New Drug Application to the FDA.


FDA MedWatch – Risk of invasive disease in preterm infants given probiotics formulated to contain live bacteria or yeast. FDA. Press release. September 30, 2023. Accessed October 5, 2023. https://www.fda.gov/media/172606/download?attachment=&utm_medium=email&utm_source=govdelivery

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