The infant developed sepsis from the bacterium in the probiotic product—Evivo with MCT Oil made by Infinant Health—and subsequently died.

In a statement to Ars, the FDA said it quickly investigated the death after receiving an initial report on July 31.

“In September 2023, genomic sequencing data analysis performed by the FDA found that the probiotic bacteria present in Evivo with MCT Oil was a genetic match to the bacterium isolated from the infant’s blood,” the agency said.

The agency noted that the case isn’t the first of its kind; there have been previous reports of infections and sepsis in infants due to the use of probiotics containing bacteria and yeast.

“Given the lack of FDA-regulated pharmaceutical-grade products in the United States, conflicting data on safety and efficacy, and potential for harm in a highly vulnerable population, current evidence does not support the routine, universal administration of probiotics to preterm infants, particularly those with a birth weight of <1000 g.” Still, a 2021 report found that approximately 10 percent of very premature infants in the US receive some sort of probiotic preparation while receiving specialized care in hospitals.

The agency criticized the California-based company for clearly marketing its unapproved product—sold as a dietary supplement—for use in the prevention of a serious disease in highly vulnerable pre-term infants.

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