The news comes weeks after the agency announced it was investigating the death of a preterm baby that was given a probiotic in the hospital, which ultimately caused the child's death.'Probiotic products contain live organisms such as bacteria or yeast and are commonly marketed as foods, including as dietary supplements,' the agency said in a news release Thursday.
'With today's message, we want to warn parents, caregivers and healthcare providers that if these products are used for the prevention or treatment of disease, they have not undergone the agency's rigorous premarket process to evaluate their safety, effectiveness and quality for these medical uses,' Marks said.The FDA says these products have been associated with 'more than two dozen other reported adverse events in the United States since 2018.