FDA Sends Warning To Hospitals

The Food and Drug Administration (FDA) sent a serious warning to hospitals and healthcare providers late last month.

Officials and medical professionals within the FDA told hospitals that under no circumstances should they give probiotics to premature babies.

This warning comes after the tragic death of a premature infant who was given a probiotic substance known as Evivo with MCT Oil.

Following the regimen of the probiotic substance, the infant reportedly developed sepsis and later died due to a chronic buildup of bacteria from the probiotics.

The FDA sent out this warning letter to hospitals and healthcare facilities across the nation, the letter reads:

The Epoch Times explained the issue with probiotics in premature infants:

Preterm infants who are given probiotics can risk developing a fatal infection because of the bacteria or fungi contained in the products, said the FDA.

Probiotics are not approved for use as a drug or biological product in babies, the FDA said, adding that they are a supplement that is not subjected to the agency’s “rigorous manufacturing and testing standards.”

Neonatal doctor Kanekal Suresh Gautham shared his perspective: “The use of probiotics in neonates in the US is now IMO a lost cause. The first nail in the coffin was the 2021 AAP COFN statement. The recent FDA alert sealed the fate of probiotics. IMO we should focus now on reducing intestinal dysbiosis in neonates in other ways.”

The use of probiotics in neonates in the US is now IMO a lost cause. The first nail in the coffin was the 2021 AAP COFN statement. The recent FDA alert sealed the fate of probiotics. IMO we should focus now on reducing intestinal dysbiosis in neonates in other ways:#neotwitter

— Dr. K. S. Gautham (@Dr_KSGautham) October 3, 2023

Sharing our article on probiotics for prevention of NEC. Will inform some of the current discussions on #neotwitter
after FDA alert@Chetta_Milk_Lab @BrianKingNeo @docfortots
Use of Probiotics to Prevent NEC—Evidence to Clinical Practice https://t.co/MMpMmKSmf5

— Dr. K. S. Gautham (@Dr_KSGautham) October 1, 2023

CNN featured this response from Infinant Health—the company that produces Evivo with MCT Oil:

The company’s marketing of the probiotic as a drug treatment violated several components of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, the warning says.

In a statement, Infinant Health said it has agreed to recall Evivo with MCT Oil and notified health care providers and hospitals.

“We are cooperating with FDA’s ongoing investigation” into the infant’s death, the company says.