Probiotic products contain live organisms, such as bacteria or yeast, and are commonly marketed as foods or dietary supplements. The FDA said preterm infants receiving probiotics are at risk of invasive, potentially fatal disease or infections caused by the bacteria or yeast present in these products. The agency has issued warning letters to companies for the illegal distribution of these types of products and recently alerted health care providers about the risks.

The FDA emphasizes that these products have not undergone the agency’s rigorous premarket process to evaluate their safety, effectiveness, and quality for these medical uses.

Since 2018, over two dozen additional adverse events associated to these products have been reported in the United States. The most recent death was associated with the now recalled probiotic Evivo with MCT Oil, manufactured by Infinant Health. Abbott Laboratories also received a warning letter regarding its product Similac Probiotic Tri-Blend and agreed to discontinue sales and collaborate with the FDA to take additional corrective actions. Importantly, this issue pertains to a single probiotic additive for formula used by fewer than 200 hospitals and does not affect Abbott’s commercially available infant formula products.

The FDA previuosly noted that no probiotics have been approved for use as a drug or biological product in babies, as they fall under the category of dietary supplements and are not subject to the agency’s rigorous manufacturing and testing standards for other medications regulated by the FDA.