A product based on a strain of B. infantis has been recalled after a preterm infant died from sepsis after having been administered the product in an intensive care unit.

Hank Schultz, Senior Editor

October 6, 2023

4 Min Read
Probiotic organisms

A preterm infant has died from sepsis, prompting a voluntary recall of a probiotic product and a warning from the Food and Drug Administration to healthcare practitioners and to the company itself.

Death of infant announced in warning

FDA recently issued a warning to healthcare providers about the use of probiotics in preterm infants. The death of the infant was detailed in the warning to practitioners.

According to the communication, the infant, who weighed less than 1,000 grams (2.2 pounds), had been given a probiotic product manufactured by Infinant Health.

The product, Envivo with MCT Oil, is one of two manufactured by the company based on a particular probiotic strain: Bifidobacterium infantis EVC001.

Infinant Health has issued a voluntary recall of the product, according to a company spokesperson.

In the warning, FDA identifies this as Bifidobacterium longum subspec. infantis. The document said FDA is continuing its investigation of the death.

“Genomic sequencing data demonstrate the bacterium that caused sepsis in this infant was a genetic match to the bacteria contained in this probiotic,” FDA officials wrote in the letter to healthcare providers.

Company based on wealth of research around B. infantis

Infinant, which was founded by five scientists associated with the University of California Davis, is based on the extensive science on B. infantis and its effects on the gut health and development of a healthy immune system in infants.

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B. infantis is a dominant species in the guts of breastfed babies and has been shown to feed on human milk oligosaccharides (HMOs), which are carbohydrate fractions of breast milk that are otherwise mostly undigestible by infants.

Most of the research has been done on healthy full-term infants, including this recent study by Japanese firm Morinaga on its proprietary B. infantis strain.

A 2020 review of the existing literature by Mead Johnson experts reached this conclusion: “Studies reviewed in this manuscript suggest that colonization with B. infantis might have potential beneficial effects in infants and children. B. infantis is well adapted to the infant gut, in part due to its ability to consume complex carbohydrates found in human milk (HMO).”

Use of probiotic for NEC has been studied

In addition to stimulating the development of a well-rounded gut microbiome and forming the basis of a thriving immune system, B. infantis has also shown promise in warding off necrotizing enterocolitis (NEC), an often-fatal complication for preemie babies.

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A long-term, retrospective study has been done on B. infantis EVC001 at Oregon State University on that endpoint. The probiotic was used with 438 very low birth weight babies at the university’s hospital in the years 2014 to 2020.

“Binfantis EVC001 administration was associated with significant reductions in the risk of NEC and NEC-related mortality. Binfantis EVC001 supplementation may be considered safe and effective for reducing morbidity and mortality in the NICU (neonatal intensive care unit),” the researchers concluded.

However, in the healthcare practitioners warning, FDA points to research detailing case reports of bacteremia in preterm infants associated with the use of B. infantis. The Cleveland Clinic defines bacteremia as the presence of bacteria in the blood which left untreated can lead to sepsis.

FDA didn’t concur on company’s safety assertion

In addition to the warning to healthcare practitioners, FDA sent a warning letter to the company itself.

In an email to Natural Products Insider, a company spokesperson said Infinant Health had gone through a GRAS (generally recognized as safe) self-affirmation process and then met with FDA about making a formal GRAS dossier submission to the agency.

“Infinant reached a conclusion of GRAS status for use of its ingredient in preterm infants based on an evaluation conducted in consultation with independent scientific experts,” the company spokesperson said. “Infinant then met with FDA in anticipation of submitting a GRAS notice. As FDA’s warning letter makes clear, FDA did not agree with Infinant’s conclusion, and considers the use of its ingredient in preterm infants to be an unapproved food additive use.”

FDA also warned the company about the messaging around its products, which are sold as foods, not supplements. The Envivo with MCT Oil product was specifically marketed to healthcare providers for use in NICUs and was not available to the general public.

For these reasons, FDA concluded the product was at the same time an adulterated food, a mislabeled drug and a biologic product that was lacking both an investigational new drug (IND) application and a biologics license application (BLA).

IPA:  More information still to come

George Paraskevakos, executive director of the International Probiotics Association, called the death “an unfortunate tragedy,” but cautioned against jumping to conclusions. Given that B. infantis has a record of safety, more information about this particular case is likely to come out as FDA’s investigation proceeds.

International Probiotics Association is preparing a thorough response, but we are still gathering all the information of this incident, as there are many moving parts in this story which are unclear. We have communicated with the FDA on this but since it is an ongoing investigation, they cannot share more than what has been made public. Stay tuned,” Paraskevakos said in a statement posted on LinkedIn. 

About the Author(s)

Hank Schultz

Senior Editor, Informa

Hank Schultz has been the senior editor of Natural Products Insider since early 2023. He can be reached at [email protected]

Prior to joining the Informa team, he was an editor at NutraIngredients-USA, a William Reed Business Media publication.

His approach to industry journalism was formed via a long career in the daily newspaper field. After graduating from the University of Wisconsin with degrees in journalism and German, Hank was an editor at the Tempe Daily News in Arizona. He followed that with a long stint working at the Rocky Mountain News, a now defunct daily newspaper in Denver, where he rose to be one of the city editors. The newspaper won two Pulitzer Prizes during his time there.

The changing landscape of the newspaper industry led him to explore other career paths. He began his career in the natural products industry more than a decade ago at New Hope Natural Media, which was then part of Penton and now is an Informa brand. Hank formed friendships and partnerships within the industry that still inform his work to this day, which helps him to bring an insider’s perspective, tempered with an objective journalist’s sensibility, to his in-depth reporting.

Harkening back to his newspaper days, Hank considers the readers to be the primary stakeholders whose needs must be met. Report the news quickly, comprehensively and above all, fairly, and readership and sponsorships will follow.

In 2015, Hank was recognized by the American Herbal Products Association with a Special Award for Journalistic Excellence.

When he’s not reporting on the supplement industry, Hank enjoys many outside pursuits. Those include long distance bicycle touring, mountain climbing, sailing, kayaking and fishing. Less strenuous pastimes include travel, reading (novels and nonfiction), studying German, noodling on a harmonica, sketching and a daily dose of word puzzles in The New York Times.

Last but far from least, Hank is a lifelong fan and part owner of the Green Bay Packers.

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