isapp consensus statement on prebiotics

Prebiotic definition updated by ISAPP

June 16, 2017. Prebiotic definition updated by ISAPP.

ISAPP published a consensus statement updating the prebiotic concept – Expert consensus document: The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of prebiotics. Available open access from Nature Reviews in Gastroenterology and Hepatology, this paper offers a new definition of prebiotic: a substrate that is selectively utilized by host microorganisms conferring a health benefit. The consensus panel was led by Prof. Glenn Gibson, University of Reading, co-founder and past president of ISAPP. In 1995, Prof. Gibson, along with Professor Emeritus Marcel Roberfroid, first coined the term ‘prebiotic’. This new definition embraces progress in microbiome science and prebiotic innovation.

Publication of this consensus statement is just in time for the ISAPP 2017 annual meeting, which will be held June 27-29, 2017.

ISAPP’s previous consensus statement provided clarity on the definition and scope of the term ‘probiotic’. It remains the most highly downloaded paper published by Nature Reviews in Gastroenterology and Hepatology. It has been downloaded over 35,000 times.

2017 Probiotic Product Guide

2017 Updated Clinical Guide for Probiotic Products Now Available

May 22, 2017. 2017 updates to the Clinical Guide for Probiotic Products are available. These helpful guides grade levels of evidence for commercial probiotic products in the United States and Canada.

infographic on effects of probiotics and prebiotics on microbiota

ISAPP Publishes two new infographics

May 10, 2017. ISAPP publishes two new infographics: “Effects Of Probiotics And Prebiotics On Our Microbiota” and “The Gut Microbiota: Our Microbial Partners”. Check them out for consumer-friendly information on basic facts about our gut microbiota and the interplay with probiotics, prebiotics and colonizing microbiota.  See all ISAPP infographics here.

World Gastroenterology Association

WGO updates Guidelines on Probiotics and Prebiotics

April 18, 2017. – The World Gastroenterology Organisation published a 2017 update of Practice Guideline on Probiotics and Prebiotics. Currently, the updated version is only available in English, but the 2011 version is still available in French, Mandarin, Portuguese, Russian, and Spanish. Note especially updated Tables 8 and 9, which list strains associated with graded evidence for GI benefits for adults and children. This update was chaired by Prof. Francisco Guarner (former ISAPP board member) and co-chaired by Dr. Mary Ellen Sanders (ISAPP Executive Science Officer). Prof. Hania Szajewska led the effort on pediatric indications. Dr. Dan Merenstein and Prof. Seppo Salminen served as invited experts.

women & their microbes conference

Conference: Women & their Microbes

April  19, 2017. Announcing an innovative conference, Women & their Microbes. Latest research on the female oral microbiome, the role of the skin microbiome in women’s health, the impact of pregnancy stress on the microbiome, and the vaginal microbiota will be presented. Friday, June 2, Amsterdam. Register.

How to decipher european probiotic labels

New ISAPP infographic on EU probiotic labeling

March 20, 2017. Probiotic Product Labels in the European Union

Understanding the information that is – and isn’t – on a probiotic product label can be difficult. ISAPP created an infographic to help understand the information on the label of a dietary supplement probiotic product.  Different regions around the world have different regulatory labeling requirements for probiotic products. See here for an example of a product sold in the United States. This infographic featured on this page, ‘Deciphering a Probiotic Product Label: EU Version’, shows an example of a probiotic food supplement that would be marketed in the European Union (EU). However, even within the EU, different countries differ with regard to label requirements.

Probiotic product labels lack information about what health benefits are associated with the product. This is due to a combination of regulatory restrictions and scientific limitations. For the probiotics sold as nutritional supplements in the EU, all health claims are assessed by the European Food and Safety Authority (EFSA). Furthermore each European country has its own country-specific rules. As of today, no health claims for probiotics have been approved by EFSA, and therefore, labels typically contain little or no description of what benefits you can expect from the probiotic. Some European countries cannot even put the word ‘probiotic’ on a product label.

However, this does not mean that evidence for probiotic benefits is necessarily lacking. (See here for more details about probiotics and their associated health benefits.) But it can mean that products containing probiotic strains that have been extensively studied cannot communicate the health benefits because of regulatory restrictions. For example, the types of studies conducted, the populations of people studied or the endpoints of the research may not meet regulatory guidelines. On the other hand, some commercial products may not have been evaluated in controlled human studies. Today’s EU labels do not allow distinguishing between these two extremes. EU probiotic product labeling does not give consumers enough information to determine the best products for their needs.  To help with this situation, companies sometimes provide information to the extent allowed by law through the use of third party channels such as independent scientists, healthcare professionals, or clinical organizations. Thus, European consumers must rely on their own research into products in addition to information from their healthcare professionals.

The use of probiotic products for specific consumer or patient groups requires assessment by professionals. It is therefore advised to always consult your physician or health care provider to decide if a specific probiotic product may be beneficial for you.

According to the FAO/WHO 2002 Working Group on Guidelines for the Evaluation of Probiotics in Food (page 39 of this combined document), the following information should be on a probiotic label:

  • Genus, species and strain designation for each probiotic strain in the product.
  • Minimum viable numbers of each probiotic strain at the end of the shelf-life, typically expressed in colony forming units (cfu). (Note: in practice, products often give a total count for all strains combined. In this case it is not possible to know if all strains in a product are at roughly the same level or at very different levels.)
  • The suggested serving size (or dose) must deliver the effective dose of probiotics related to any health benefit communicated on the label.
  • Health claim(s) (as allowed by law and substantiated by studies)
  • Proper storage conditions
  • Corporate contact details for consumer information

These principles were reiterated in ‘Best Practices Guidelines for Probiotics’ (2017) developed by the Council for Responsible Nutrition (CRN). Neither the FAO/WHO nor the CRN guidelines carry the force of law.

See related infographics:

Deciphering a Probiotic Product Label. US Version

Probiotics

Prebiotic

Fermented Foods

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Executive Science Officer, Mary Ellen Sanders, PhD, Appointed to Expert Panel

March 20, 2017. ISAPP’s Executive Science Officer, Mary Ellen Sanders, PhD, was appointed chair of the United States Pharmacopeia’s Probiotics Expert Panel. The goal of this panel is to assist in developing quality standards for probiotics used for dietary supplements. The efforts of this panel are intended to pave the way for probiotic manufacturers to market products that can be verified for quality against science-based public standards. The Expert Panel will make recommendations to and work at the direction of the Non-Botanical Dietary Supplements Expert Committee of USP.

image of FDA comments

ISAPP posts comments with the FDA on Dietary Supplements

December 9, 2016. ISAPP posts comments with the FDA on Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry.

Comments discussed:

  1. Exclusion of novel substances as dietary ingredients
  2. Identity of a live microbial ingredient
  3. Chemical alteration
  4. Assessment of antibiotic resistance gene transfer
  5. History of safe use
  6. Strain- vs. species-specific information
  7. Requirements for filing a NDIN for the product, rather than the ingredient
benefits of fermented foods article

Health Benefits of Fermented Foods

December 19, 2016. Health Benefits of Fermented Foods: Microbiota and Beyond was published today as an outcome from a discussion group led by Bob Hutkins PhD and Maria Marco PhD at the 2016 ISAPP meeting. This paper explores the health benefits attributed to both the microbes and the transformations they bring about in the making of fermented foods.

how to decipher a probiotic label

Deciphering a Probiotic Label

December 13, 2016. – Not sure how to read a probiotic product label? ISAPP developed a new infographic defining terms on a probiotic label and explaining the many different components of a label. This infographic describes a dietary supplement probiotic for the U.S. market, but coming soon are similar ones for other countries.

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probiotic recommendations for at-risk populations cropped image

ISAPP publishes probiotic recommendations for at-risk populations

November 10, 2016. – ISAPP, in collaboration with IPA, publishes paper on use of probiotics in at-risk populations. This paper gives healthcare providers information about using probiotic dietary supplements in at-risk populations. Probiotics should be used in cases where the research shows a benefit for patient populations. But we need to work with industry to be sure that appropriate microbiological quality standards are followed for such products. The paper is published open access in the November/December 2016 issue of the Journal of the American Pharmacists Association. Download here. By Mary Ellen Sanders, PhD, Executive Science Officer ISAPP.

Gregor Reid, ISAPP Board of Directors

Reid Named Fellow of Royal Society of Canada

Prof. Gregor Reid, PhD, a founding board member of ISAPP, a former President of ISAPP and the current advisor to the ISAPP Students and Fellows Association (SFA), was recently named a Fellow by the Royal Society of Canada.  This honor was bestowed by his peers in recognition of outstanding scientific achievement. Prof. Reid has been a leader in the probiotic field since the 1980s. When most of his peers were investigating the impact of probiotics on gut health, his innovative research focused on Lactobacillus probiotics targeting urinary tract and vaginal health. Recently, he has worked to bring affordable probiotic foods to developing countries. His out-of-the-box thinking has benefited ISAPP greatly throughout the years. He championed the creation of the SFA, he created the crowd favorite rapid-fire Late Breaking News session at the ISAPP annual meetings, and he has published more ISAPP reviews, commentaries and letters to the editor than any other individual board member. Gregor has hosted two ISAPP annual meetings: in 2002, the very first ISAPP meeting and in 2008 – again ahead of the times – when he showcased a speaker on the Do’s and Don’ts of Social Media, exposing many meeting attendees to Twitter for the first time. He has more than once hired professional comedians to entertain at the ISAPP meetings and can always be counted on for his jovial demeanor when it’s time to unwind after a hard day’s work. Congratulations, Gregor, for being recognized as an outstanding scientist and thank you for being an outstanding contributor to ISAPP.

sign at the FDA

ISAPP files comments with the FDA on their partial stay of sections of their guidance for INDs

June 28, 2016 – ISAPP disagrees with the approach FDA has taken to address their overreach of requiring investigational new drug applications for most human research on foods or supplements in the United States. In response to criticism of their 2014 final guidance, Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application, the FDA filed a partial stay of some requirements for INDs (see Partial Stay and Republication of Guidance). ISAPP considers this action to be insufficient to fully address the problems caused by their guidance, especially as it relates to probiotic research.

See ISAPP’s comments.

CVRIA logo

European Union ruling may interfere with communication about probiotics and prebiotics

July 25, 2016 – A European Union court ruling may impede direct communication on scientific substantiation of health benefits of (probiotic and prebiotic) foods to healthcare providers. From the Court ruling:  “Article 1(2) of Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods, as amended by Commission Regulation (EU) No 1047/2012 of 8 November 2012, must be interpreted as meaning that nutrition or health claims made in a commercial communication on a food which is intended to be delivered as such to the final consumer, if that communication is addressed not to the final consumer, but exclusively to health professionals, falls within the scope of that regulation.”

Prebiotics Not ‘Fiber’ Under New U.S. Food Labeling Regulations

Food labels cannot list prebiotics as fiber under new food labeling regulations. The FDA has narrowed the definition of dietary fiber, which now excludes inulin and other prebiotics. ISAPP posted comments urging the FDA to recognize the many established health benefits of prebiotics, but our opinion did not prevail. The FDA final rule allows added fiber to include [beta]-glucan soluble fiber, barley beta fiber psyllium husk, cellulose, guar gum, pectin, locust bean gum, and hydroxypropylmethylcellulose.  The FDA expressed its intention to further consider available scientific data on other isolated or synthetic, non-digestible carbohydrates, including inulin. The change of fiber labelling is one of many other changes to the nutrition facts box, including required declaration of added sugars and changes to “reference amounts customarily consumed”. Blog post including many useful links.

isapp logo

ISAPP Launches ISAPPScience.org

The International Scientific Association for Probiotics and Prebiotics (ISAPP) is a non-profit, science-based organization of scientists focused on advancing the science of probiotics and prebiotics. Since our founding in 2002, ISAPP’s web platform was www.isapp.net. Today we launched www.isappscience.org to better reflect our non-profit, service-oriented nature and to better serve our stakeholders.

Clinical Guide to Probiotics supplements Canada

2016 Clinical Guide to Probiotic Supplements Now Available

Clinical Guide to Probiotic Supplements available in Canada: 2016 edition is now available. This guide is authored by Dragana Skokovic-Sunjic BScPhm RPh NCMP and summarizes strength of evidence determined by a Committee of Medical Reviewers. The industry-supported Alliance for Education on Probiotics sponsors this activity. This guide is a handy resource that provides evidence levels for probiotics (41 products are included) for different clinical indications. It is available here and as a free PROBIOTIC GUIDE mobile app (on GooglePlay and the App Store). This year, ISAPP board member Eamonn Quigley MD FRCP FACP MACG FRCPI joined the Committee of Medical Reviewers. Contact Maëva Cruchet maeva.cruchet@nulledelman.com for further information.

Gut Microbiota for Health logo

Gut Microbiota for Health Launches New Website

The Gut Microbiota for Health website has a new look. The new site offers information for clinicians, researchers and lay persons on the impact of gut microbiota on health. The goal of the site is to become the most trusted reference worldwide for scientific information on the gut microbiota.

Prevalence of Probiotic Use

Prevalence of Probiotic Use Among Patients in The USA

Yi et al. (2016) published a survey of probiotic use among 145 hospitals in the United States. They note that 96% of hospitals surveyed used probiotics but that many specific probiotics used in hospitals lack convincing evidence of efficacy.

Gregor Reid, Francisco Spain

Reflections on ISAPP’s Legacy, A Commentary by Gregor Reid, former ISAPP President and current ISAPP Board Member.

As I travel this January 27th 2016 on the speed train from Madrid to Seville in the south of Spain, I review the program of the 7th Workshop Probioticos, Prebioticos y Salud: Evidencia Cientifica. Initiated by former ISAPP Board Member Dr Francisco (affectionately Pancho) Guarner, the organization has grown to the point of hosting over 400 delegates this year.

 

It is yet another indicator of the legacy of ISAPP and the growth of these areas stimulated by consumer demand, industry engagement and clinical evidence. With other such organizations in India, Indonesia, Poland and perhaps elsewhere, the network is captivating.

 

A recent paper conceptualized by Irene Lenior-Wijnkoop, the pioneer industry supporter of ISAPP, ‎shows the enormous economic benefit of probiotics to nations and healthcare systems. In hospitals around the world, including one in my hometown of London, Ontario, premature babies now have a lower risk of potentially deadly necrotizing enterocolitis through probiotics. At other sites, bulk transplantation of beneficial microbes is saving lives.

 

As the Spanish countryside whisks by, just as it did two weeks ago in Holland and two months ago in China, I can’t help but reflect on the passing of time and the rapidity of advances in our fields since we collectively began this journey in 2002.  The telegraph poles, trees, animals, forests, roads and buildings that form the human influenced ecosystem‎ appear like multiple nodes affected by pro and prebiotics. The wonders of nature.

 

The conference reflects this, with talks on the virome, cardiovascular disease, diet, reproduction, infectious diseases, gastric liver and lung diseases, allergies and so much more.

 

Sometimes it feels like our progress and ability to translate our work to humans and animals is like a small flower on the horizon. ‎But with water and sun, the seeds spread and the landscape ignites with colour. It might sound overly romantic, but we are the water and the sun, and our job is to nurture these through science and showing the benefits of the cultures.

 

At this meeting, I will be reminding the audience that the amazing blessings we each have did not start by chance, but as a gift. It is our duty to humankind and the duty of rich corporations to make sure all people of the planet have access to a healthy future through microbes. It’s actually not as difficult as it sounds. It just takes commitment.

 

Empower the poor and they will show you the path to life.

the journal of family practice logo

Recommendations for Probiotic and Prebiotic Use from the Journal of Family Practice

January 6, 2016. The Journal of Family Practice published a paper recommending probiotics or prebiotics. The paper grades available evidence for IBS, IBD, antibiotic associated diarrhea, acute infectious diarrhea, traveler’s diarrhea, eczema and diabetes and recommends specific uses for patients. Authors state: “There’s evidence to suggest that probiotics, prebiotics, and a high-fiber diet can help manage various illnesses.” Paper available here.

international dairy federation logo

Flow Cytometry for Probiotic Enumeration

January 4, 2016. The International Dairy Federation in conjunction with the International Organization for Standardization (ISO) has released a method for quantifying starter cultures and probiotics used in dairy products. This method – which would replace the decades-old plate count method – can be adapted to high-throughput analysis, reducing testing time and improving precision. The report, published in Bulletin IDF No. 478/2015, can be purchased from IDF. Press release.

CFSAN logo

CFSAN Nutrition Program Review Report

The FDA Law Blog reported on a documented prepared in December 2014 by the FDA Center for Food Safety and Applied Nutrition. The report was obtained through the Freedom of Information Act.  The Nutrition Program Review Report focused on prioritizing CFSAN activities in order to enhance nutrition for Americans. Of interest to ISAPP in this report is that probiotics and prebiotics are used several times as examples of bioactive food components that may be beneficial to health. The report advised that FDA monitor the science and developments in the marketplace related to probiotics and other bioactive food components. It states that such increased awareness of the science behind these substances would help in understanding the truthfulness of claims made on products.

nature reviews gastroenterology & hepatology icon

ISAPP Consensus Panel Paper on Probiotics: “Hot Paper” on Web of Science

Stakeholders in the probiotic field continue to find value in the expert consensus document, The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic, published in 2014 in Nature Reviews in Gastroenterology and Hepatology. This paper has earned accolades of “Highly Cited Paper” and “Hot Paper“ on Thomson Reuters’ Web of Science. Metrics tracked by Nature Reviews shows that this paper has been downloaded almost 20,000 times.

Hania Szajewska

Prof. Hania Szajewska Receives Award for Work on Nutrition and Health in Children

Professor Hania Szajewska of the Medical University of Warsaw received the A.I. Virtanen Prize of 10,000 Euros for her research on nutrition and health in children. Professor Szajewska delivered a lecture titled “The benefits of probiotics in childhood” after receiving the award. The award is named for Artturi Ilmari Virtanen, the only Finnish winner of a science Nobel Prize.