Microbiome-Based Products: FDA Delves Into the Unregulated
As part of a broader push to advance the regulatory science around microbiome-based products, the US Food and Drug Administration and National Institutes of Health will host a workshop on 17 September.Currently, FDA has not approved any microbiome-based probiotics as a live biotherapeutic product (LBP), which is a biologic other than a vaccine that contains living organisms used to prevent or treat a disease or condition in humans. However, there are dietary supplements containing probiotics that are legally available, though these products cannot lawfully be marketed to cure, mitigate, treat, or prevent any diseases.
FDA Commissioner Scott Gottlieb said in a statement the agency is considering ways to provide additional clarity on supplements’ facts labels for declaring colony forming units of probiotics and weight.
“We understand that there continues to be growing interest in the potential benefits of probiotics in foods, including dietary supplements, and we are committed to working with industry on efforts to provide information that can help consumers make more informed choices about these products,” he said.
He also offered the example of researchers studying whether the administration of certain microorganisms in the form of probiotics can help prevent a serious disease in premature infants called necrotizing enterocolitis, which has been associated with systemic infection and death.
“With the health and safety of this most vulnerable population in mind, more research is needed as to whether this is a viable treatment,” he said. “The data collected so far in premature infants are difficult to interpret because different probiotic preparations have been studied, often in conjunction with other interventions.
Understanding whether the use of probiotics for premature infants can have a clinically significant beneficial effect, and which types of probiotics may be most effective, is important, as serious side effects have been reported with their use in this population. We are very concerned by these potential risks and are actively monitoring these uses.”
Other recent research found that intestinal microbes can be programmed to make up for a deficiency that causes an inherited disorder.
Presentations at the workshop will include a variety of topics, such as the regulatory framework for live microbiome-based products; safety and effectiveness of live microbiome-based products used to prevent, treat, or cure diseases in humans; and strain selection for live microbiome-based products to prevent, treat, or cure diseases in humans.
In 2016, FDA also issued guidance that explains how researchers conducting early clinical trials with LBPs can meet certain manufacturing requirements.
Workshop