FDA cracks down on illegal probiotic product usage for hospitalised preterm infants

Recently, the United States Food and Drug Administration (US FDA) has taken several steps to tackle the selling of non-pharmaceutical grade probiotic products to healthcare providers for the treatment and prevention of disease in preterm infants. This action includes two warning letters to probiotic providers, as well as a warning to healthcare providers against the use of probiotics in preterm infants.

On September 28th, 2023, Infinant Health were sent a warning letter regarding marketing materials related to their Evivo with MCT Oil product.  Evivo with MCT Oil is a probiotic product, containing the live bacterium “Bifidobacterium longum subsp. Infantis”. Evivo’s website describes it as a “ready-to-use, single-serve liquid, clinically shown to help stabilize and protect the infant gut microbiome.”

The warning letter alleged that based on information on the Evivo website, along with its product information sheet, Evivo with MCT Oil is an unapproved new drug, an unlicensed biological product, and an adulterated food. Statements leading to the warning included a product information sheet that allegedly described the product as “designed specifically for infants in the Neonatal intensive care unit (NICU)”, a product page expressing the intended use for the product was “[e]xclusively for Healthcare Settings”, and references to articles which discussed the use of the product in the mitigation, treatment, or prevention of disease – with one article being titled “Bifidobacterium longum subsp. infantis EVC001 Administration Is Associated with a Significant Reduction in the Incidence of Necrotizing Enterocolitis in Very Low Birth Weight Infants”.

Evivo with MCT Oil was voluntarily recalled by Infinant Health and is currently unavailable to purchase on their online stone.

The day after Infinant Health’s warning letter, the FDA published an additional warning letter to healthcare providers entitled “WARNING REGARDING USE OF PROBIOTICS IN PRETERM INFANTS”. The letter stated that “preterm infants who are given probiotics are at risk of invasive, potentially fatal disease caused by the bacteria or fungi contained in probiotics”. The FDA revealed it was investigating the role of Evivo with MCT Oil in the death of a preterm infant who developed sepsis after being given the product. The letter reminded healthcare providers that currently “the FDA has not approved any probiotic product for use as a drug or biological product in infants” and referenced adverse events caused by probiotic administration to preterm infants including case reports of bacteraemia and fungemia.

Only a month after Infinant Health’s warning letter, the FDA hit another probiotic provider with a similar letter. On October 24th 2023, the US FDA issued a warning letter to Abbott Laboratories over information on its website and marketing materials for their probiotic dietary supplement, Similac Probiotic Triblend – containing strains: B. infantis (Bb-02), S. thermophilus (TH-4) and B. lactis (BB-12).

The letter alleged that handouts provided to hospital staff by Abbott sales representatives, along with information on an Abbott-owned website, contained statements which indicated the product was “intended for use in the mitigation or prevention of disease” making it an unapproved drug and an unlicensed biological product. The FDA alleged Abbott’s materials contained references to probiotics improving outcomes for “Necrotizing enterocolitis (NEC)”, “Late-onset sepsis”, and “feeding intolerance”. One Abbott infographic allegedly read “Importantly, giving probiotics to preterm infants can reduce the incidence of NEC.”

Abbott has since discontinued sales of the probiotic supplement and is recalling over 226,000 packets due to the warning according to Food Safety News.

In a news release published on October 26, 2023, Peter Marks, M.D., Ph.D., director of the FDA’s Centre for Biologics Evaluation and Research remarked

“Adverse events in any infant following the use of a probiotic are a concern to the FDA. We especially want to make clear that products containing live microorganisms may present serious risks to preterm infants in hospital settings… With today’s message, we want to warn parents, caregivers, and healthcare providers that if these products are used for the prevention or treatment of disease, they have not undergone the agency’s rigorous premarket process to evaluate their safety, effectiveness and quality for these medical uses.”

Whilst there are no approved probiotics for preventing or treating disease in infants there are a number of live biotherapeutic products in development to target NEC. These include a phase 3 candidate being developed by Sweden-based Infant Bacterial Therapeutics, as well as a number of pre-clinical candidates by Siolta Therapeutics, Scioto biosciences, and Genome and Company.


  1. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/infinant-health-inc-formerly-evolve-biosystems-inc-667715-09282023
  2. https://www.evivo.com/
  3. https://www.independent.co.uk/news/fda-ap-illinois-washington-connecticut-b2436748.html
  4. https://www.fda.gov/media/172606/download
  5. https://fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/abbott-laboratories-669353-10242023
  6. https://www.fda.gov/news-events/press-announcements/fda-raises-concerns-about-probiotic-products-sold-use-hospitalized-preterm-infants
  7. https://www.foodsafetynews.com/2023/11/similac-probiotics-product-under-recall-after-adverse-reactions-in-preterm-babies/
  8. https://ibtherapeutics.com/
  9. https://www.sioltatherapeutics.com/
  10. https://sciotobiosciences.com/
  11. https://genomecom.co.kr/
Daniel Quinn