The United States Food and Drug Administration Center Directors have announced a public warning against using dietary supplements that has live bacteria or yeast especially in those who are immunocompromised. This was issued following the death of an infant.
Two FDA directors have formally issued a public warning and to healthcare providers about using dietary supplements containing live bacteria or yeast especially in patients who have weak or compromised immune systems.
From the warning, it says that dietary supplements are not regulated in the United States. "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, FDA is aware that some products marketed as dietary supplements are used by providers in the practice of medicine as drugs (e.g., to treat, mitigate, cure, or prevent a disease or condition)."
The warning was issued following the death of a preterm Connecticut infant due to an invasive type of fungal disease in the gastrointestinal tract. The condition is termed as mucomycosis that was triggered after a probiotic was used in the prenatal unit.
According to the Centers for Disease Control and Prevention, the fungus was identified by investigators as Rhizopus oryzae from the dietary supplement ABC Dophilus by Solgar, Inc. in New Jersey. However, this supplement is indicated for infants and children.
The company claims that their bottles support good health and it aids in maintaining a healthy balance within the intestine's microbial ecology. They now voluntarily recalled the three lots of the product for an investigation.
The FDA and CDC has issued an investigation about the death of the infant who was born prematurely at 29 weeks age of gestation and was being treated for necrotizing enterocolitis (NEC).