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.
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:
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.
December 9, 2016. ISAPP posts comments with the FDA on Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry.
- Exclusion of novel substances as dietary ingredients
- Identity of a live microbial ingredient
- Chemical alteration
- Assessment of antibiotic resistance gene transfer
- History of safe use
- Strain- vs. species-specific information
- Requirements for filing a NDIN for the product, rather than the ingredient
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.
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.
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.
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.
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.”
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.
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 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 email@example.com for further information.
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.
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.
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.
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.
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.
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.
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.
November 24, 2015. Last week, U.S. Pharmacopeial Convention (USP) convened a workshop to discuss the value of probiotic monographs, including technical challenges that exist in developing them. USP can provide third-party verification of probiotic product content, which would improve end-user confidence in probiotic products. USP was established in 1820 and functions today as a scientific nonprofit organization that sets standards for medicines, food ingredients, and dietary supplements worldwide. Information,
November 9, 2015. ISAPP Board Members Prof. Gregor Reid and Prof. Glenn Gibson traveled to China delivering the message of the importance of the science of probiotics and prebiotics. Report.
October 30, 2015. FDA issued a stay on some provisions of their guidance pertaining to the need for an IND for human research on foods. ISAPP, along with other stakeholders involved in food research, filed comments objecting to guidance position that most human research needed to be conducted under an IND. The section of the guidance dealing with “Live Organisms” remains in effect and the impact of this on probiotic research remains to be seen. See legal perspectives on this action.
July 31, 2015. Three ISAPP board members (Drs. Salminen, Quigley and Sanders) and a gastroenterologist from University of Singapore (Dr. Reuben Wong) traveled to Bangkok to speak in an ISAPP-organized symposium at the Asian Federation of Societies of Lactic Acid Bacteria. The symposium focused on “The Future of Probiotics and Prebiotics.” The local hosts provided gracious hospitality and the audience of 341 from 23 countries was engaged in the latest science about clinical recommendations, gut barrier effect, use of probiotics in pediatrics and the ISAPP consensus panel. Meeting information. Photos from the meeting’s opening and closing ceremonies.
July 22, 2015. IPA Europe announces a launch event, “Towards a Clear Status for Probiotics in Europe”. September 30, 3016. Brussels. Register for event.
June 14, 2015. ISAPP responded to a request by the White House Office of Science and Technology Policy for input on microbiome research priorities. ISAPP response.