As the field advances, the U.S. Food and Drug Administration is playing a key role in sorting through the science and the science fiction of this evolving field.
Over the last several years, there’s been growing scientific and public interest in the role of microorganisms in the maintenance of overall health and prevention and treatment of disease. Consumers are familiar with the phrase “good” or “helpful” bacteria and the expectation that it will aid in treating or preventing various illnesses.
Microbiota, the collection of organisms in and on our body, may also affect how patients respond to certain drugs, as some research has shown the possibility of manipulating the microbiota to improve cancer treatment. There is also some preliminary evidence suggesting that certain microorganisms or “good bacteria” given proactively may help prevent some diseases.
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. This is especially important as these products are being used in vulnerable patients. We will consider taking action when we see unsafe or violative products.
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. 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.
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
FDA is convening a workshop co-hosted with the National Institutes of Health on September 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.
This workshop is part of our broader effort to advance regulatory science in this field, and make sure we establish modern, efficient policies for how we evaluate products that fall under our different regulatory authorities. By doing our part in facilitating the conduct of well-designed clinical trials, the FDA and NIH hope that the full potential of the new science of the microbiome can be realized to benefit both individual and public health.
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