FDA issues warning letters for illegally selling probiotics to treat disease in preterm infants

30 Oct 2023 --- The FDA raises concern about the risks probiotics pose to preterm infants in hospital settings as they contain live bacteria or yeast. The agency has issued warning letters to Abbott Laboratories and Infinant Health regarding their probiotic products sold to treat or prevent diseases in preterm infants.

According to the agency, preterm infants who are administered a probiotic are “at risk of invasive, potentially fatal disease or infection” caused by the bacteria or yeast in the products, based on medical literature. Probiotics have been associated with over two dozen adverse events in the US since 2018 and contributed to one infant death in 2023. 

The products are used to treat or prevent illnesses in hospital settings, for example, to reduce the risk of necrotizing enterocolitis — a life-threatening disease caused by intestine inflammation. 

“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,” says Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. 

“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.”

Unapproved for preterm infants 
The FDA underscores it has not approved any probiotic product for use as a drug or biological product in infants of any age. It is investigating additional reports and medical records where probiotics may have contributed to adverse events, including death.

“Protecting public health, especially of the most vulnerable populations such as preterm infants, is one of the highest priorities for the FDA,” highlights 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 administering 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.”

The organization underscores, probiotics have not been evaluated under the FDA’s manufacturing and testing standards for drugs and biological products, including testing for other organisms. 

Abbott Laboratories and Infinant Health have discontinued the sales of its probiotic blends for preterm infants.Warning letters  
Abbott Laboratories has agreed to discontinue sales of its Similac Probiotic Tri-Blend, containing the probiotic strains B. infantis (Bb-02), S. thermophilus (TH-4) and B. lactis (BB-12). The company is also working with the FDA to take additional corrective actions. 

The FDA had issued a warning letter to Abbott Laboratories for the blend last week for violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act. According to the agency, the product was an unapproved new drug and an unlicensed biological product sold for use in hospital settings for preterm infants. 

Moreover, the Similac Probiotic Tri-Blend is regarded as an adulterated dietary supplement under the FD&C Act because two of its ingredients — Bb-02 and TH-4 — do not meet applicable safety requirements for consumption by preterm infants. 

Infinant Health voluntarily recalled Evivo with MCT Oil, which is no longer available in the US. Last month, the company received an FDA warning letter regarding this probiotic for violating the same laws for selling unapproved and unlicensed products for preterm infants. Since Evivo was intended to be added to food for preterm infants, it was also an adulterated food. 

Call for clinical trials 
Literature provides conflicting data on the safety and effectiveness of probiotics for the prevention of necrotizing enterocolitis, says the FDA. Moreover, research on probiotics is complicated by using different strains in trials. 

Due to the potential for harm from these products in vulnerable populations, the FDA urges industry, clinical and research funding communities to develop high-quality clinical trials with probiotics to determine if, how and when they have applications for drugs and biological products for use in infants of any age. 

Moreover, the agency will continue to review adverse event reports for probiotics, encouraging healthcare providers to report probiotics’ use issues to the products’ manufacturer, the FDA’s MedWatch program and to the Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System. 

The FDA recently issued a letter to healthcare providers to warn them about the issue and remind them that no probiotic products have been approved for use as a drug or biological product in infants. 

By Jolanda van Hal