FDA Commissioner Talks Probiotics, Supplements and Disease

Based on growing scientific and public interest in the role of microorganisms in the maintenance of overall health and prevention and treatment of disease, the US Food and Drug Administration says it is playing a key role in “sorting through the science and the science fiction of this evolving field,” noted comission Scott Gottleib in a statement released by the agency. In the statement released yesterday, FDA said it will host a workshop on the subject next month.

In 2016, the FDA issued a guidance document that explains how researchers studying probiotics as drugs can meet the manufacturing requirements necessary for early clinical trials. More work and continued partnership between the FDA and various stakeholders is needed to advance the clinical science necessary to appropriately understand the safety and effectiveness of these products. We are committed to these goals.

The FDA has also not approved any probiotic as a live biotherapeutic product (LBP), a biological product other than a vaccine that contains live organisms used to prevent or treat a disease or condition in humans. However, there are FDA-regulated foods, including dietary supplements, containing probiotics that are legally available, though these products cannot lawfully be marketed to cure, mitigate, treat, or prevent any diseases. The 2016 guidance also clarifies how some LBPs that are lawfully marketed as a food or dietary supplement can also be studied for investigational use.

The FDA is also considering ways to provide additional clarity on information provided on the supplement facts label for declaring colony forming units of probiotics and weight.
Given the strong interest and rapidly evolving science in this field, the agency is convening a workshop co-hosted with the National Institutes of Health on Sept. 17 that will discuss microbiome-based products and how manipulation of the microbiome may potentially be used to prevent or treat a variety of different diseases. Presentations will be given on a variety of topics including: 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. The workshop will also include panel discussions. 
 
No word on whether or not the workshop or FDA's rising level of interest will extend to topical products.