The U.S Food and Drug Administration is warning health professionals of the risks associated with the regarding use of dietary supplements containing live bacteria or yeast in immunocompromised persons. A premature infant administered a dietary supplement, ABC Dophilus Powder (Solgar), as part of in-hospital course of treatment, developed gastrointestinal mucormycosis caused by the mold Rhizopus oryzae and died. Rhizopus oryzae 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.
FDA, along with the Centers for Disease Control and Prevention (CDC) and the Connecticut Department of Public Health, are investigating the death of this preterm infant who developed gastrointestinal mucormycosis. In mid-November, Solgar issued a recall for certain lots of ABC Dophilus Powder and public health warnings were issued advising customers and consumers not to use the recalled product.
FDA is informing healthcare providers that dietary supplements, 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.