Meeting with CBER. On May 22, ISAPP’s Executive Science Officer (Mary Ellen Sanders) and Daniel Merenstein MD (Georgetown University) met with Peter Marks MD PhD, Deputy Director of Center for Biologics Evaluation and Research/FDA, and three other CBER representatives, to discuss CBER oversight of probiotic research as investigational new drugs. Concerns were expressed regarding requiring phase 1 safety studies, the lack of a waiver option, and inhibition of investigator-initiated studies. The meeting was a productive beginning to these discussions. Report.

ISAPP board members, Gregor Reid and Mary Ellen Sanders, were interviewed by Shane Starling of Nutraingredients for a new documentary film, “MicroWarriors” The Special Edition. The special edition will be a completely re-editied and mastered version from the 2011 probiotic documentary film, “MicroWarriors” The Power of Probiotics. In addition, it will include new graphics and images, plus bonus material added and narration by Leonary Nimoy. The special edition film will be released in the Spring of 2014. MicroWarriors 2: The Origin and the Destiny is currently in production and will be released in the Fall/Winter of 2014. Information. Nutraingredients article with video interview.

Webcasts of the lectures and workshop wrap-ups from the Gut Microbiota for Health World Summit (convened in Miami, March 8-9, 2014) are now available. Click here.

ISAPP will meet March 5 with FDA’s Center for Food Safety and Applied Nutrition to discuss conducting human research on foods. The FDA made it clear in a guidance from September 2013 that human research conducted on functional endpoints for foods requires an investigational new drug (IND) application. However, the FDA re-opened the comment period on that guidance, and ISAPP – along with American Society of Nutrition, Institute of Food Technologists and ILSI-North America – will share concerns with CFSAN that the IND requirement for food research is misguided. As succinctly stated by Dr. James Heimbach, who will be representing ISAPP at the meeting, “A substance can’t be an investigational new drug unless it is a drug, and FDA is attempting to declare legitimate food ingredients that provide benefits other than taste or aroma to be drugs.” See related posts from February 5, 2014, November 26, 2013 and September 25, 2013.

The FDA is re-opening comments on portions of its Guidance on Determining if Human Research Studies Require an Investigational New Drug Application. ISAPP intends to file comments reflecting concerns that the current guidance (published in final form September 2013) unduly restricts human research on functional properties of foods and supplements, harming U.S. researchers, consumers and industry. Comments due to the FDA April 7, 2014. Submit comment. See related Latest News posts on September 25, 2013 and November 26, 2013.

U.S. Pharmacopeia (USP) is accepting comments on a proposed monograph for testing the identity, concentration and purity of Bacillus coagulans GBI-30, 6086. As the first probiotic monograph with USP, this is a noteworthy development. USP press release. USP Food Ingredients.

ISAPP is signatory, along with other professional societies, on a letter requesting that the FDA retract its final guidance (issued September 2013) on when food and dietary supplement research must be conducted under and Investigational New Drug Application. A face-to-face meeting with the FDA was also requested. Letter. (See also ISAPP Latest News post on September 25, 2013 below).

An expert panel addressing proper use of the term “probiotic” was convened by ISAPP October 24, 2013 in London UK. The panel, chaired by Prof. Glenn Gibson, comprised 10 academic experts and ISAPP’s executive director. A fast-track manuscript indicating conclusions from the discussion is being prepared by the panelists. Although the panel agreed to continue endorsement of the FAO/WHO 2001 definition of probiotics, the manuscript will discuss how research and developments over the past 12 years since the definition was proposed impact today’s implementation of the word ‘probiotic’ by all stakeholders. The Panel

The Global Probiotics Council, a committee established in 2004 by DANONE Research and Yakult Honsha Co., Ltd., announced the 6th annual Young Investigator Grant for Probiotics Research. Three $50,000 annual grants will support new research on probiotics and gastrointestinal microbiota in the United States. Young Investigators committed to basic research on gastrointestinal microbiota, probiotics and their role in health and wellness should apply (by February 12, 2013). Information.

The term “probiotic” will no longer be allowed on food labels in the EU starting December 14, 2012. EFSA has remained unconvinced that the strength of the science behind probiotic products meets their efficacy standards. Conferring a health benefit is imbedded in the term, “probiotic;” therefore, the term can only be used on products with an approved health benefit. NUTRAingredients article.

ISAPP sponsors speakers at first Probiotic Association of India conference in New Delhi. Report.

Webcast now available: “The New Microbiota & Probiotics Paradigm: from Mechanisms to Clinical Applications”, featuring the following lectures and Q&A:

• Stability and Disrupting the Microbiota, Patrick Schloss, PhD, University of Michigan
• Intestinal Dysbiosis as a Basis for Functional Gastrointestinal Disorders, Stephen M. Collins, MBBS, FRCP(UK), FRCPC, McMaster University
• Restoring a Healthy Microbiota: What Tools Do We Have? R. Balfour Sartor, MD, University of North Carolina – Chapel Hill
  Sponsored by an educational grant from the Dannon Company, Inc. and Yakult Hosha Co., Ltd