Gregor Reid with the Tukwamuane Yogurt mamas in Mwanza, Tanzania outside their community kitchen

Our Mission

To advance scientific excellence in probiotics and prebiotics

ISAPP observes World Digestive Health Day, May 29, 2014. ISAPP collaborated with the World Gastroenterology Organisation to prepare educational materials, including guidelines on choosing a probiotic and prebiotic, the WGO Handbook on Gut Microbes and informative videos. Go to educational materials.


 

ISAPP Activities


ISAPP Annual Meetings

ISAPP Publications

ISAPP Meets to FTC to Gain Clarity on Substantiation of Probiotic Claims

On February 11, ISAPP, represented by Mary Ellen Sanders (executive director), Daniel Merenstein, Greg Leyer (Sr. ISAPP-IAC representative) and Chris Cifelli (Jr. ISAPP-IAC representative), met with Mr. Richard Cleland, Assistant Director, Division of Advertising Practices with the Federal Trade Commission to gain a better understanding of FTCs perspective on conducting research intended to substantiate structure/function or health claims for foods in the United States. Mr. Cleland’s forthright approach in his responses was much appreciated. This report itemizes the questions posed by ISAPP and the responses provided by Mr. Cleland.

ISAPP Responds to FDA Guidance on Investigational New Drug Requirements

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). (November 26, 2013) 

ISAPP Convened Expert Panel on Definition of “Probiotic”

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 has been submitted to Nature Reviews in Gastroenterology and Hepatology. 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 current implementation of the word ‘probiotic’ by all stakeholders. The Panel. (October 25, 2013) 

ISAPP Prepares for 2014 World Digestive Health Day

ISAPP is working with the World Gastroenterology Organisation to develop educational materials on probiotics, prebiotics and the gut microbiome in conjunction with WGO’s 2014 World Digestive Health Day (May 29, 2014). The theme of the 2014 WDHD is “Gut Microbes - Importance in Health & Nutrition.” 

ISAPP collaborates with American Gastroenterological Association and ILSI-North America on Webinar Series

Successful webinar series features a distinguished faculty and covers the topics of: Human Gut Microbiota and Health, Interventions to Influence Health and Disease with Probiotics, Clinical Endpoints Using Probiotics and Prebiotics for IBD, IBS, and Infectious Diarrhea, and Practical Guidelines on Probiotics and Prebiotics Use. A written summary of this webcast was published: Wallace et al. 2011. Human gut microbiota and its relationship to health and disease. Nutr Rev. 2011 Jul;69(7):392-403. (April - June, 2010) 

LATEST NEWS

October 7, 2014

Published today in Am J Reprod Immunol, and open access:  Microbes Central to Human Reproduction. . The authors, let by Dr. Gregor Reid, summarize an ISAPP discussion group from 2014 meeting. 

September 28, 2014

Health Point Productions has just released, "MicroWarriors" Special Edition. This Documentary Film on probiotics is a re-release with new footage from interviews featuring ISAPP board members, Prof. Gregor Reid and Mary Ellen Sanders. Some of the other experts include: Glenn Gibson PhD, Todd Klaenhammer PhD, Jose Saavedra MD, Robert Martindale MD, Simin Meydani PhD and Tri Duong PhD. Health Point Productions has offered to send a free copy of this Special Edition to the first 500 ISAPP Members who respond.  Contact David Knight of Health Point Productions at microwarriorsmovie@sbcglobal.net.

 

September 26, 2014

ISAPP Board member, Michael Cabana, MD, MPH, joined 2 other experts (David Mills, Ph.D. and Mark Underwood, MD) in a continuing education program on Prebiotics, Probiotics, and the Microbiota. Official Audio CME Program of the American Academy of Pediatrics. 

September 8, 2014

The Dannon Company Graduate Scholarship. The third Yogurt and Probiotics Fellowship Program offers a scholarship of $25,000 to a current or incoming graduate student who shows a strong interest in the research of nutritional and functional benefits of yogurt and probiotics. Candidates must be currently enrolled in or applying to a full-time graduate program. Applications due November 15, 2014. Information.

 

September 8, 2014

ISAPP filed comments regarding with the European Food Safety Authority regarding its intent to revise the guidance on scientific requirements for health claims on foods related to gut and immune function.  ISAPP’s opinion is that EFSA should completely revise the guidance document, rather than limit comments to issues that have arisen in submitted dossiers. ISAPP also suggested that maintenance of homeostasis in all aspects of healthy human physiology should be considered as a beneficial health effect.  EFSA document. ISAPP comments.

 

August 1, 2014

ISAPP files comments with the FDA regarding impact of Proposed Rule on labeling prebiotics on foods. ISAPP requests that the FDA modify the Proposed Rule as follows: (1) benefits of added fibers be explicitly expanded to include a broader range of potential physiological beneficial effects, (2) implement a phase-in period to allow adequate time to develop required substantiation, and (3) use a notification process rather than a pre-market approval process for substantiation.  ISAPP Comment. FDA website link

June 10, 2014

ISAPP’s consensus statement on the scope and appropriate use of the term probiotic was published today in Nature Reviews in Gastroenterology and Hepatology. The paper is open access.  Key conclusions of the paper include that with minor edits, the 13-year old FAO/WHO definition of probiotic was endorsed; that sufficient evidence from human studies on commonly studied probiotic species allows use of the term ‘probiotic’ at a species-, not strain-, level; and undefined consortia of microbes such as those used for fecal microbial transplants do not fall under the scope of probiotics. The panel of experts comprised 12 internationally recognized scientists and the paper was endorsed by the ISAPP board of directors.

 

June 5, 2014

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.  

May 1, 2014

The Yogurt in Nutrition Initiative announced a request for research proposals focused on health benefits associated with yogurt consumption. The competition is for one $30,000 USD grant. Research teams from public organizations or researchers at universities or hospitals may apply. The deadline for submission of applications is June 30, 2014. This call is supported by Danone Institute International in collaboration with the American Society for Nutrition (ASN) and the International Osteoporosis Foundation (IOF). Information.

 

April 28, 2014

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. InformationNutraingredients article with video interview

April 8, 2014

ISAPP filed comments with the FDA on its guidance, which requires that essentially all human research to evaluate functional effects of foods be conducted under an IND. ISAPP requested that FDA revise the current guidance to remove their requirement for INDs for human research conducted on foods and that the guidance make it clear that prebiotics and probiotics have lawful, recognized food uses, which should be able to be researched in the USA without an IND.

Comments by the law firm, Hyman, Phelps & McNamara, also are of interest. 

 

March 31, 2014

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.  

March 11, 2014

ISAPP joined the American Society of Nutrition, Institute of Food Technologists, ILSI-North America and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition in a meeting March 5 with FDA's Center for Food Safety and Applied Nutrition to share concerns with a guidance that stipulates human research conducted on functional endpoints for foods requires an investigational new drug (IND) application. Dr. James Heimbach represented ISAPP and, along with ASN's Sarah Ohlhorst, filed this report. Referenced Survey Results. See related posts February 25, February 5, 2014, November 26, 2013 and September 25, 2013. 

February 25, 2014

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.

 

February 24, 2014

On February 11, ISAPP, represented by Mary Ellen Sanders (executive director), Daniel Merenstein, Greg Leyer (Sr. ISAPP-IAC representative) and Chris Cifelli (Jr. ISAPP-IAC representative), met with Mr. Richard Cleland, Assistant Director, Division of Advertising Practices with the Federal Trade Commission to gain a better understanding of FTCs perspective on conducting research intended to substantiate structure/function or health claims for foods in the United States. Mr. Cleland’s forthright approach in his responses was much appreciated. This report itemizes the questions posed by ISAPP and summarizes the responses provided by Mr. Cleland.

 

February 5, 2014

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. 

ISAPP ANNUAL MEETING

June 19-20, 2014

ISAPP 2014 Annual Meeting will be held in Aberdeen, Scotland. This meeting is in collaboration with the open-registration Rowett-INRA meeting, Gut Microbiology: From Sequence to Function. ISAPP will co-organize one day of lectures (June 19) and will convene by-invitation workshops and wrap-up session on June 20. More information.
Colin Hill (ISAPP President 2011-2014)
3230 Arena Boulevard, Suite 245-172 | Sacramento, CA 95834 | USA
Contact Mary Ellen Sanders at 1-303-793-9974 | info@isapp.net