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# FDA Planning Microbiome Product Conference
- URL: https://www.fdaweb.com/fda-planning-microbiome-product-conference/
- Published: 2018-08-16T12:00:00.000Z
- Updated: 2026-09-15T00:26:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142132

FDA commissioner **Scott Gottlieb** says the agency and the National Institutes of Health will co-host a 9/17 workshop to 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,” Gottlieb says in an agency [statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm617168.htM?ref=fdaweb.com) on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans.

The workshop is part of a broader effort to advance regulatory science in the field, Gottlieb says, and make sure that FDA establishes modern, efficient policies for how to evaluate products that fall under the agency’s different regulatory authorities. “We recognize the potential benefit offered by these products,” he says, “but we also have identified certain risks. We need to make sure that these are properly evaluated when these products are marketed and used as drugs, and that consumers have good information on which to base decisions when probiotics are used in conventional foods and dietary supplements. By doing our part in facilitating the conduct of well-designed clinical trials, 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.”

The statement also references a 2016 FDA guidance explaining how researchers studying probiotics as drugs can meet the manufacturing requirements necessary for early clinical trials. “More work and continued partnership between FDA and various stakeholders is needed to advance the clinical science necessary to appropriately understand the safety and effectiveness of these products,” Gottlieb says. “We are committed to these goals.” The guidance also clarified how some live biotherapeutic products that are lawfully marketed as a food or dietary supplement can also be studied for investigational use.

According to Gottlieb, the agency additionally is considering ways to provide additional clarity on information provided on the supplement facts label for declaring colony forming units of probiotics and weight.