21 August 2018 - Deborah Wilkes
The US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) are running a public workshop on microbiome-based products in September 2018.
The FDA's commissioner Scott Gottlieb said the workshop was part of the regulatory agency's broader effort to advance regulatory science in this field and make sure there were modern, efficient policies for evaluating products.
"We recognise the potential benefit offered by these products, but we have also identified certain risks," commented Gottlieb. "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," added Gottlieb, "the FDA and the NIH hope that the full potential of the new science of the microbiome can be realised and benefit both individual and public health."
Regulation of dietary supplements
Gottlieb pointed out the FDA had not approved any probiotic as a live biotherapeutic (LBP) but noted FDA-regulated foods containing probiotics, including dietary supplements, were legally available.
He said the FDA was considering ways to provide additional clarity on information provided on the supplement facts label 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 food, 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 added.
The workshop will discuss how the manipulation of the microbiome may potentially be used to prevent or treat a variety of diseases. Presentations will cover a range of topics including the regulatory framework for live microbiome-based products, safety and effectiveness of such products, and strain selection.
The aim is to bring together government agencies, academia, industry and other stakeholders involved in research, development and regulation of live microbiome-based products for human use.
The one-day workshop – titled 'Science and regulation of live microbiome-based products used to prevent, treat or cure diseases in humans' – will be held on 17 September 2018 in Rockville, Maryland, US.
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