September 6, 2018
"We recognize that there is a growing public interest in the role of live microbials, often in dietary supplements sold as probiotics, in the maintenance of overall health. Empowering consumers with more information can help them make better choices about products for themselves and for their families," said Steven Tave, director of the FDA’s Office of Dietary Supplement Programs. "Today’s action, when final, will allow companies that sell dietary supplements to voluntarily include in the Supplement Facts label information about the quantity of live microbial ingredients by colony forming units (CFUs), as well as the quantity by weight that is already required by current regulation."
The draft guidance issued today advises companies that manufacture, market or distribute dietary supplements of the conditions under which we intend to exercise enforcement discretion to allow firms to voluntarily declare, in the Supplement Facts label, the quantity of live microbial ingredients in colony forming units (CFUs), in addition to the quantitative amount by weight, which is required by regulation. Available information indicates that allowing firms to declare the CFUs within the Supplement Facts label will provide consumers with a useful description of the quantity of live microbial dietary ingredients. Ensuring that consumers have access to reliable, science-based information about FDA-regulated products is a pivotal element of the FDA’s public health mission.
This draft guidance, which is open for public comment, is part of larger efforts by the agency to respond to rapidly evolving innovation in microbiome-based products, including dietary supplements. The FDA 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 diseases. The FDA encourages those interested to watch the webcast.
For more information:
- Constituent Update
- Draft Guidance: Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials: Guidance for Industry
- Science and Regulation of Live Microbiome-Based Products Used to Prevent, Treat, or Cure Diseases in Humans
- Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.