(StraightNews.org) – The Food and Drug Administration (FDA) has warned hospitals not to give probiotics to preterm babies following the death of an infant. The agency launched an investigation when a baby died after using Evivo with MCT Oil – a probiotic manufactured in California. In a warning to hospitals and pediatricians, the agency said, “Genomic sequencing data demonstrate the bacterium that caused sepsis in this infant was a genetic match to the bacteria contained in this probiotic.”
The hospital that allegedly administered the fatal dose has not been named. Manufacturer Infinant Health said it is cooperating with the FDA investigation and has ceased further product distribution. In a statement, the company said Evivo with MCT Oil is used in hospitals for neonatal care, but the FDA has warned the company that it is “an unapproved new drug and unlicensed biological product” that Infinant Health had introduced into “interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act.”
In a letter copied to legal counsel, the FDA advised the company to review its “website, product labels, and other labeling and marketing materials to ensure that you are lawfully marketing your products.” This must be carried out immediately, the letter states, or “enforcement action without further notice” will be taken – including seizure and/or injunction.
Infinant Health makes various claims about its creation, including that it helps with “colic symptoms such as gas and fussiness, or experiencing diaper rash.” It advertises Evivo by stating that it aids in establishing a healthy gut, significantly improves breast milk digestion, promotes a healthy immune system, and assists sleep. The company also states that Evivo meets “all FDA regulations for food products and has been used by parents, hospitals, and providers for five years with over 4.7 million feedings to date in over 60,000 babies.”
A 2021 report found that 1 in 10 pre-term or “extremely low gestational age” babies are provided with probiotics in hospitals.
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