Editors:Elham Reshid and Hailemariam Shimelis : Click for the PDF version
FDA is warning health professionals of the risks associated with the use of probiotics supplements (dietary supplements containing live bacteria or yeast) in immunocompromised persons. A case involving a premature infant that was administered a dietary supplement, ABC Dophilus Powder (Solgar), as part of in hospital course of treatment, developed gastrointestinal mucormycosis (caused by the mold Rhizopusoryzae) and died. Rhizopusoryzae mold was found to be present as a contaminant in an unopened container of the ABC Dophilus Powder, which is formulated to contain three species of live bacteria.
Hence, FDA is informing healthcare providers that dietary supplement, including those that are formulated to contain live bacteria or yeast, are generally not regulated as drugs by the FDA. As such, these products are not subject to FDA’s premarket review or approval requirements for safety and effectiveness, nor to the agency’s rigorous manufacturing and testing standards for drugs, including testing for extraneous organisms.
However, Natural Products Association (NPA) issued a statement concerning FDA’s alert, concerning probiotics. It stated that the incident involved a specific brand product of probiotic dietary supplement administered to a premature infant in a critical care hospital situation and a product that appears to have been contaminated with a fungal mold, which really indicates a GMP (good manufacturing practice) issue than a market wide problem with probiotic and yeast containing dietary supplements.
“The safety alert seems to castigate the entire probiotic industry that labels their products as dietary supplements,” NPA argued. “The finding of Rhizopusoryzae mold is a GMP concern that should be brought up with the manufacturer of the lot and line of product. It does not and should not affect the rest of the industry and other products sold as live bacteria or yeast.“
Further, NPA noted the product was used off label by doctors in a critical clinical setting, which is not reflective of the typical use of dietary supplements, including probiotics, by healthy consumers who purchase the products from retail. “Dietary supplements are not designed to be taken by immunocompromised persons or any other patient population,” NPA reminded, noting federal regulations require dietary supplement manufacturers to expressly state in the products’ disclaimer that they are not to diagnose, treat, cure or prevent any disease.
“Dietary supplements are to be taken by healthy individuals to supplement their diet and enhance their health. While certain hospitals have dietary supplements on their formularies, they are administered at the discretion and direction of a patient’s health care provider.”