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FDA Commissioner Gottlieb Issues Statement On Advancing the Science and Regulation of Live Microbiome-Based Products

  • FDA Commissioner Scott Gottlieb, MD, issued a statement on August 16 regarding the role of microorganisms on health.  Dr. Gottlieb provided background on the use and regulatory status of microorganisms.
  • Also in his statement, Commissioner Gottlieb provided the underlying rationale for his statement via the example of probiotics administered to premature infants as a preventive measure against a serious disease called  necrotizing enterocolitis.  He pointed out that there have been both benefits and serious side effects reported from the use of probiotics for this disease, noting that data collected on the impact of probiotics are hard to interpret because there is a lack of systemization in the studies.  He also noted that different probiotic preparations have been studied or other interventions have been administered in conjunction with the probiotics.  He concluded by stating that the key is determining when the benefit of probiotics outweighs the potential risks, warning that FDA will consider taking action when it sees unsafe or violative products.
  • FDA has not approved any probiotic as a live biotherapeutic product – a biological product other than a vaccine that uses live organisms – as a drug.  However, there currently are probiotic-containing foods, including dietary supplements, on the market.  Foods with probiotics may not be legally marketed to cure, mitigate, treat, or prevent any disease.
  • FDA is convening a workshop on September 17 to discuss the “clinical, manufacturing, and regulatory considerations associated with microbiome-based products.”  FDA has also issued a guidance document regarding the manufacturing requirements for microorganisms to be used in drug clinical trials.
© 2018 Keller and Heckman LLP


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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...