ISAPP Activities

ISAPP Activities

Interested in what ISAPP does? Here is a list of ISAPP-conducted activities over the years.

ISAPP responds to use of outdated nomenclature

In response to a published paper that used outdated nomenclature, ISAPP board members responded with a published commentary: Commentary: Probiotic nomenclature matters.

ISAPP files comments with the FDA on requirements for INDs

The FDA published an approach to requirements for Investigational New Drugs for human research on foods that ISAPP considered inadequate. ISAPP responded with a comment published here.

ISAPP submits proposal to the US Preventive Services Task Force on probiotics and AAD

On behalf of ISAPP, Dan Merenstein submitted a proposal to the United States Preventive Services Task Force asking them to consider making a recommendation on probiotics for antibiotic associated diarrhea. Unfortunately, they responded saying that this health issue was outside their scope and they would not investigate.

ISAPP attends an ILSI-North America Microbiome Committee meeting

March 2016. ISAPP participated in an ILSI-North America Microbiome Committee meeting to discuss paths forward for linking microbiota changes to health in humans.

ISAPP convenes prebiotic consensus panel

On December 9, 2016, ISAPP convened a consensus panel of academic experts in London to discuss the current concept of prebiotics. The panel discussed definition, selectivity, specificity, functionality, health effects, and more. The panel is preparing a paper to summarize conclusions.

ISAPP launches review paper on “Live Microbes in Fermented Foods”

What is the best dietary source of live microbes? To help answer this question, ISAPP has coordinated a review paper to be authored by board member Robert Hutkins (University of Nebraska) on ‘Live Microbes in Fermented Foods’. The objective is to compile what is known about levels of live microbes in fermented foods. Submission goal is June of 2017.

ISAPP sponsors systematic review on the impact of probiotics on antibiotic use

ISAPP is sponsoring a systematic review on probiotics and antibiotic use. The protocol, “Does probiotic consumption reduce antibiotic utilization for common acute infections? A systematic review”, was registered with PROSPERO, registration number CRD42016052694. This review is important to determine if probiotics might have a role to play in public health efforts on antibiotic stewardship.

ISAPP sponsors systematic review and meta-analysis on the impact of L. reuteri on colic in infants

The individual patient data meta-analysis on the impact of Lactobacillus reuteri on colic in infants will be submitted for publication by the end of 2016. This ISAPP-sponsored collaboration of nine academic experts will provide the best assessment of current evidence on this topic. The protocol was previously published, paper available here.

ISAPP files comments with FDA on NDI draft guidance

On December 9, ISAPP responded to the FDA draft guidance, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry.” ISAPP expressed concerns about several aspects of the FDA’s stated approach to new dietary ingredients for dietary supplements, including the lack of direct pathway for newly isolated microbes to become supplements. Comments were submitted electronically Comment Tracking Number: 1k0-8thx-lv15.

ISAPP sponsors update of WGO probiotic and prebiotic clinical guidelines

ISAPP provided a stipend to facilitate the 2016 update of the World Gastroenterology Organisation Global Guidelines on Probiotics and Prebiotics. This guideline, which has the most downloads of all practice guidelines produced by WGO, is available in six languages. The previous update was in 2011. The goal is to have the updated guidelines posted by the end of 2016.

ISAPP’s 2014 probiotic consensus panel paper continues to have impact

The 2014 ISAPP consensus paper published in Nature Reviews in Gastroenterology and Hepatology paper continues as a highly sought perspective paper on proper use of the term ‘Probiotic’. This paper has been downloaded over 27,000 times and achieved Highly Cited Paper on Web of Science Core Collection It also had an Altmetric score of 143 which showed it was Picked up by 5 news outlets; Blogged by 4; Referenced in 2 Wikipedia pages; and Mentioned in 1 Google+ posts.

ISAPP engages FDA over reducing requirement of INDs for probiotic research conducted in human subjects

For several years, ISAPP has fought to improve the situation regarding FDA’s position of requiring Investigational New Drug Applications for human research on probiotics, and more recently on most food and dietary supplement research. Requiring INDs has discouraged human research on probiotics in the US. Our ongoing efforts included a private meeting with CBER (report), a meeting with Center for Food Safety and Applied Nutrition (report), filing comments on several FDA guidances or proposals on the topic (here and here), and most recently by focusing on this issue in a discussion group at our 2015 ISAPP meeting in Washington DC (report). We are happy to report that on October 30, 2015, the FDA has stayed sections of this guidance. We believe ISAPP’s actions played an important role in the FDA decision.

ISAPP comments on EU guidance on health claims for foods

European regulatory situation was also addressed by ISAPP, with comments filed September 8, 2014 regarding EFSA’s intent to revise the guidance on scientific requirements for health claims on foods related to gut and immune function. ISAPP comments.

ISAPP files comments with the White House Office of Science and Technology Policy

Provided input on microbiome research priorities to the White House Office of Science and Technology Policy (June 2015). ISAPP comments.

ISAPP files comments with FDA regarding labeling of fibers on foods

ISAPP filed comments with the FDA regarding impact of Proposed Rule on labeling prebiotics on foods. ISAPP Comment.

ISAPP Sponsors Speaker at Probiotic Association of India Conference in Delhi

ISAPP sponsored Prof. Bruno Pot, Institut Pasteur de Lille, to speak at the 2nd Annual Conference of the Probiotic Association of India (PAi) and International Symposium on “Probiotics and Microbiome: Gut and Beyond”, held November 3-4, 2014 in Delhi, India. Report.

ISAPP Goes to Bangkok

ISAPP is organizing a Special Session at the 8th Asian Conference on Lactic Acid Bacteria, Prebiotics, Probiotics, Health Benefits and Applications, to be held July 8-10, 2015 in Bangkok. This represents ISAPP’s first collaboration with the Asian Federation of Societies For Lactic Acid Bacteria.

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 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 Collaborates with WGO for 2014 World Digestive Health Day

World Gastroenterology Organisation World Digestive Health Day, theme Gut Microbes. Importance in Health and Disease.

ISAPP’s Consumer Guidelines – updated in 2014

Probiotics, Prebiotics and Gut Microbes – informational video clips

WGO Handbook on Gut Microbes. Francisco Guarner, MD, PhD, editor. This concise, readable handbook comprises 18 chapters on gut microbiota, probiotics and prebiotics written by different experts with the goal of translating science into practice.

WGO Practice Guideline – Probiotics and Prebiotics, 2011. These guidelines are currently being updated, with expected publication if the Fall of 2014.

ISAPP Collaborates on University of Maryland NIH Project on Federal Regulation of Probiotics

ISAPP served on an advisory board to the University of Maryland NIH project “Federal Regulation of Probiotics: An Analysis of the Existing Regulatory Framework and Recommendations for Alternative Frameworks.” Both Gregor Reid and Mary Ellen Sanders participated in this project. Meeting Report 1. Meeting Report 2. Meeting Report 3. Final report. Science Magazine Policy Forum article (October 2013), “Probiotics: Finding the Right Regulatory Balance.”  (June 2010-October 2013)

ISAPP Assists in Development of USP Monograph for Live Microbial Cultures

Collaborated with Food Chemical Codex (part of the United States Pharmacopeia) and a team of specialists in lactic acid bacteria to develop a monograph for live microbial cultures. The hope is that this will be a first step toward establishing standards for the use of live microbes in foods. (January – March 2012)

ISAPP Files Comments on FDA New Dietary Ingredient Draft Guidance

ISAPP filed comments on FDA draft guidance, “Draft Guidance for Industry. Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” requesting that the FDA reconsider imposing burdensome requirements that would have little impact on safety of dietary supplements. (December 12, 2011)

ISAPP posts ISAPP Wikipedia page

ISAPP Wikipedia page (May 20, 2011)

ISAPP Files Comments on FDA Investigational New Drug Draft Guidance
ISAPP submitted comments to the FDA regarding the draft guidance document “Investigational New Drug Applications (INDs)—Determining Whether Human Research Studies Can Be Conducted Without an IND.” US regulatory consultant and longtime ISAPP associate, James Heimbach, took the lead in preparing a response, which was embellished after circulating among the board and US and European legal counsel. ISAPP’s primary concern with the guidance document is that it proposes to address all human research, but the document does not adequately or appropriately address the lawful conduct of human research on foods in the US without the need for an IND. If this guidance is issued, it may have a chilling effect on the willingness of institutional review boards in the US to approve conduct human research without an IND out of fear of FDA reprisal. ISAPP’s comments. (January 12, 2011)
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)
ISAPP Clarifies the Definition of a Probiotic

In an Open Letter, ISAPP considers nuances in the FAO/WHO definition of probiotic. Probiotics are live microorganisms, which when administered in adequate amounts confer a health benefit on the host. The field of probiotics is developing rapidly as evidenced by expansion of research and increased familiarity of probiotics to the general public. Over the years the FAO/WHO definition of probiotics remains applicable to scientific, industrial and regulatory communities, as long as it is interpreted correctly. Examples of misuse of the term exist both in the commercial arena, when the term is used on products with no substantiation of human health benefits, and in the scientific arena, where the term has been used to describe bacterial components, dead bacteria or bacteria with uncharacterized health effects in humans. (June 9, 2009)

ISAPP Co-Sponsors Conference on "Developing Probiotics as Foods and Drugs - Scientific and Regulatory Challenges"

ISAPP collaborated with the Drug Information Association to sponsor a meeting convened in Adelphi, Maryland, titled “Developing Probiotics as Foods and Drugs – Scientific and Regulatory Challenges.” The Conference Proceedings were published as a Supplement in Clinical Infectious Diseases. The aim of this conference was to provide an overview of the historical and current human use of probiotics, what is known regarding the properties of the organisms, mechanisms of action, and the translation of basic science advances into clinical studies and potentially new probiotic applications. The current level of scientific evidence supporting the use of probiotics in the management of disease conditions or in maintaining well-being was discussed. The conference addressed the US regulatory status of probiotics, both as “foods” — including dietary supplements, and as “drugs.” The discussion included a review of the global marketplace for probiotics, as well as the current US regulatory milieu and its impact on scientific research and evaluation of safety and biologic activity. Research and policy recommendations which would advance the field of probiotics were made by experts present at the meeting. (October 16-17, 2006)

Establishing Standards for Probiotic Products: ISAPP's Role
ISAPP meets with US Pharmacopeia to discuss probiotic standards: meeting report

Meeting Summary (May 18, 2005)

ISAPP Sends Delegate to EFSA Meeting on Food Safety

On behalf of ISAPP, James Heimbach attended the European Food Safety Authority meeting in Brussels on“Scientific Colloquium on Microorganisms in Food and Feed: Qualified Presumption of Safety.” Report. (December 13-14, 2004)

ISAPP Convenes First Meeting in Conjunction with the FAO/WHO Probiotic Guidelines Committee

The first ISAPP meeting was held immediately following the FAO/WHO committee, which established the oft-cited guidelines for use of probiotics. (May 1, 2002)

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