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

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

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. 

January 10, 2014

World Gastroenterology Organisation released a new webcast Irritable Bowel Syndrome (IBS): What is it, what causes it and can I do anything about it?”; an educational program for the general public. The webcast was developed from the WGO World Digestive Health Day 2012 Campaign and covers the following topics: What is IBS?, How to communicate symptoms to help the doctor make the right diagnoses, Progress in IBS, Could it be something else?, What can I do to deal with my symptoms?, How about diet or dietary supplements?, Managing IBS, and Living with IBS. 

January 9, 2014

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

January 7, 2014

Law firm expresses concern that the FDA seeks to greatly constrict medical food category in the United States. See blog post by Hyman, Phelps & McNamara, P.C., Medical Food Draft Guidance – Has the FDA Bitten off More than it Can Chew? 

November 26, 2013

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 18, 2013

This week in Nairobi, Kenya, ISAPP Board member, Dr. Gregor Reid, will lead an International Conference and Workshop on the Microbiome and Probiotics. Hosted at the International Livestock Research Institute (ILRI), the event is supported by ISAPP and sponsored by the Maternal-Infant Microbiome and Immunity (MIMI) Canadian Institutes for Health Network and the Ministry of Agriculture, Kenya. read more ...

October 25, 2013

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 

October 16, 2013

The final report for the NIH-funded project titled Federal Regulation of Probiotics (conducted by The University of Maryland School of Law) is available for download. See also a Policy Forum article in Science that summarizes the key findings, especially is support of an abbreviated process for investigational new drugs for probiotics, Probiotics: Finding the Right Regulatory Balance. Press release

October 16, 2013

The final report for the NIH-funded project titled Federal Regulation of Probiotics (conducted by The University of Maryland School of Law) is available for download. See also a Policy Forum article in Science that summarizes the key findings, Probiotics: Finding the Right Regulatory Balance. 

September 25, 2013

FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research and Center for Food Safety and Applied Nutrition published a final guidance on when an IND is required for human research. This guidance, although not binding, indicates that the FDA does not consider it acceptable to conduct human research on functional foods (including probiotic and prebiotic foods). Any human research conducted on a probiotic or prebiotic food, whether for a structure/function or reduction of risk of disease endpoint, must be conducted under an investigational new drug application. Human research on foods can only be conducted without an IND if you are investigating taste, aroma, or nutritive value, or to support an already authorized Health Claim (i.e., reduction of risk of disease claim). In a blog post about this new guidance, Wes Siegner & Paul M. Hyman made a chilling recommendation: “Carefully design study protocols to avoid IND implications, or if that is not possible, conduct studies that IRBs and FDA will not permit in the U.S. without an IND in Canada or Europe.” (Italics added for emphasis.) 

September 17, 2013

ISAPP posts comments to the 2015 US Dietary Guidelines Advisory Committee, requesting that the committee consider the value of a diet containing probiotics and prebiotics for reducing disease risk in Americans. Due to a quirk during posting, the comments display as submitted by “Mary Ellen Sanders,” but both comments, limited to 5,000 characters each, were approved by the full ISAPP Board of Directors. The comment on prebiotics was written by Glenn Gibson, Mary Ellen Sanders, Juliet Ansell, George Fahey and Stephan Theis, and the comment on probiotics was written by Mary Ellen Sanders, Irene Lenoir-Wijnkoop, Seppo Salminen and Chris Cifelli. Probiotic comment. Prebiotic comment

September 17, 2013

FDA’s Center for Food Safety and Applied Nutrition announced its 2013-2014 program priorities. Item 4.3.2: Develop studies that harness the human microbiome to advance nutrition based endpoints. 

September 17, 2013

Dietary Supplement Label Database contains the full label contents from a sample of dietary supplement products marketed in the U.S. This database is a joint project of the National Institutes of Health, the Office of Dietary Supplements and the National Library of Medicine. 

September 17, 2013

Two radio reports from National Public Radio feature the gut microbiome as a target for improving health and preventing disease:  

August 15, 2013

FDA gives Lactobacillus reuteri orphan drug designation for preventing necrotizing enterocolitis in preterm infants with birth weight less than or equal to 1,500 grams, but FDA approval for orphan indication not yet granted. Press release. Orphan drug in the USA: regulations and history

August 14, 2013

ILSI Europe publishes review: Monitoring immune modulation by nutrition in the general population: identifying and substantiating effects on human health. Open access paper

August 13, 2013

American Gastroenterological Association, under the auspices of their Center for Gut Microbiome Research and Education, conducted a Congressional Briefing in Washington DC titled “The Gut Microbiome — The Future of Research & Patient Care.” Video of the one-hour lecture session featuring Drs. Loren Laine, Gary Wu, Rob Knight and Martin Blaser is now posted

August 7, 2013

Last month, NIH hosted a by-invitation meeting on “Human Microbiome Science: Vision for the Future.” The 3-day meeting provided an overview of cutting-edge work in NIH-supported microbiome research. Slides from talks are found at http://www.genome.gov/27554404

August 6, 2013

Commentary published from discussion group from 2012 meeting in Cork: The Evidence is in; Probiotics Improve Neonatal Outcomes. Authored by Drs. Andi Shane, Girish Deshpande and Daniel J. Merenstein, this paper highlights evidence for prevention of morbidity and mortality associated with necrotizing enterocolitis and calls for comparative effectiveness design for any future studies. Also from the 2012 meeting, the discussion group led by Karen Scott and Nathalie Delzenne was just summarized in a paper (lead author, Paul Sheridan) submitted to Gut Microbes, Can prebiotics and probiotics improve therapeutic outcomes for undernourished individuals? 

June 14, 2013

ISAPP concludes 11th annual meeting. One hundred ten academic and industry scientists met June 13-14 at the site of the New York Academy of Sciences for the by-invitation component of the ISAPP annual meeting. Five parallel discussion groups addressed topics of importance to probiotics, prebiotics and the human microbiome, including impact on the first 1000 days of life, defining a healthy microbiome, brain/gut interactions, personalized probiotics and inclusion in dietary guidelines. This meeting followed a sold-out, open-registration conference Probiotics, Prebiotics, and the Host Microbiome: The Science of Translation, funded in part by the National Institutes of Health, which was attended by over 300 scientists. 

June 7, 2013

ISAPP prepares for annual meeting. Over 300 scientists will gather at the New York Academy of Sciences facility in New York City June 12 for a sold-out Conference focused on probiotics, prebiotics and the human microbiome. This meeting is followed June 13-14 with the by invitation ISAPP meeting. Meeting information for participants now posted

June 6, 2013

Ireland is the first country to adopt the EFSA position banning the use of the words ‘probiotic’ and ‘prebiotic.’ See “Probiotic Health Claims” on Food Safety Authority of Ireland website. Use of the term ‘live’ or ‘active’ bacteria is also banned: “Any terms that imply probiotic activity (i.e. imply that the bacteria in the product may be beneficial for health) are health claims and are not permitted. For example if terms like ‘live’ or ‘active’ are used to describe bacteria, these imply a probiotic function and therefore are considered to be health claims. No health claims have been approved for ‘probiotic’ and therefore terms that imply a probiotic function are not permitted”. 

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