FDA Warns on Dangers of Live Bacteria, Yeast Supplements

The Food and Drug Administration (FDA) has issued a warning regarding the risks associated with the use of dietary supplements containing live bacteria or yeast in immunocompromised persons following the death of a premature infant administered the dietary supplement ABC Dophilus Powder (Solgar), which is formulated to contain three species of live bacteria. ABC Dophilus Powder is marketed as a dairy-, lactose-, and milk-free dietary supplement for infants and children.

As part of the in-hospital course of treatment, the premature infant was administered the ABC Dophilus Powder and developed gastrointestinal mucormycosis caused by the mold Rhizopus oryzae and died. This mold was found to be present as a contaminant in an unopened container of the ABC Dophilus Powder. A recall for certain lots of ABC Dophilus Powder was issued by Solgar in mid-November and public health warnings were issued advising customers and consumers to not use the recalled supplement. Mucormycosis is a fungal infection that may impact premature infants, infants, children, and those with weakened immune systems. Mucormycosis may occur in rare instances in consumers who are otherwise healthy.

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The FDA is warning 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. 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.

For more information visit FDA.gov.