FDA Issues Warning About Probiotics Sold for Preterm Infants

On October 26, 2023, the United States Food and Drug Administration (FDA) issued a press release raising concerns about probiotics sold for preterm infants. The organization has sent letters to healthcare providers warning them to avoid these products. Additionally, two warning letters have been issued to companies illegally marketing their products.

According to the news release, probiotics are traditionally sold as food products or dietary supplements containing live organisms such as bacteria or yeast. Although some providers may recommend these products for patients with certain health conditions, the FDA maintains that using them in preterm infants can be dangerous and potentially fatal.

While many healthcare professionals have turned to probiotics to prevent necrotizing enterocolitis, the products can increase the risk of invasive disease or infection.

Necrotizing enterocolitis — characterized by poor feeding, vomiting, lethargy, and abdominal tenderness — occurs when an invasive bacterial infection affects the intestinal wall, causing inflammation and cellular destruction. Left untreated, the condition can cause intestinal perforation, sepsis, and death. This condition is one of the most common complications for infants in the neonatal intensive care unit, with almost 70 percent of cases in preterm infants.

Although scientists and clinicians are still unsure about the exact pathology of the disease, some studies have theorized that probiotic use can minimize the risk of necrotizing enterocolitis in preterm infants.

A meta-analysis and systematic review published in Pediatric Gastroenterology, Hepatology, and Nutrition notes that, across 56 studies, evidence suggests that probiotics may help prevent necrotizing enterocolitis.

Despite these claims, the FDA reports that probiotics used in hospital settings to prevent necrotizing enterocolitis have been linked to invasive diseases that caused an infant death in 2023, adding to the nearly 30 reported adverse events since 2018.

“Adverse events in any infant following the use of a probiotic are a concern to the FDA. We especially want to make clear that products containing live microorganisms may present serious risks to preterm infants in hospital settings,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA press release.

“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.”

The FDA has issued warning letters to two companies that have included probiotic compounds in their products to address these concerns. One letter went to Abbott Laboratories for Similac Probiotic Tri-Blend, and another was sent to Infinant Health Inc. for Evivo with MCT Oil.

Beyond warning these companies about inappropriate or unapproved ingredients, labels, and advertisements, the organization acknowledges the conflicting data on probiotics to prevent necrotizing enterocolitis. However, the administration also emphasizes that the potential for harm outweighs the hypothesized benefits.

“Protecting public health, especially of the most vulnerable populations such as preterm infants, is one of the highest priorities for the FDA,” added Jim Jones, the FDA’s deputy commissioner for human foods.

“We are encouraging all involved in the care of preterm infants, including parents, caregivers, and healthcare providers, to be aware of the possible risks associated with the administration of probiotic products to preterm infants in hospital settings. The FDA continues to investigate these incidents and is committed to using our available resources and authorities to identify and address potentially unsafe products in the market.