The FDA has issued a warning about the risks associated with the use of dietary supplements containing live bacteria or yeast among immunocompromised patients.
The warning follows the death of a preterm infant who developed gastrointestinal mucormycosis caused by Rhizopus oryzae after receiving ABC Dophilus Powder (Solgar), according to an FDA press release.
In November, Solgar issued a voluntary recall after CDC testing indicated the presence of R. oryzae in unopened containers of its dietary supplement.
Dietary supplements typically are not regulated as drugs by the FDA and are not subject to premarket review or approval requirements for safety and effectiveness nor the agency’s manufacturing and testing standards, according to the release.
“FDA advises practitioners to approach the application of these interventions with caution,” the release said. “FDA encourages health care providers who use dietary supplements containing live bacteria or yeast as drugs (eg, to treat, mitigate, cure or prevent disease) to submit an investigational new drug application for FDA review.”