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.
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 See blog post by Hyman, Phelps & McNamara, P.C., Medical Food Draft Guidance – Has the FDA Bitten off More than it Can Chew?
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).
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 …
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
See the newly released report from the ISAPP meeting held in Cork, Ireland October 1-3, 2012. Download meeting report
The Global Probiotics Council, a committee established in 2004 by DANONE Research and Yakult Honsha Co., Ltd., announced the 6th annual Young Investigator Grant for Probiotics Research. Three $50,000 annual grants will support new research on probiotics and gastrointestinal microbiota in the United States. Young Investigators committed to basic research on gastrointestinal microbiota, probiotics and their role in health and wellness should apply (by February 12, 2013). Information.
Continuing Medical Education: “Probiotics for GI Health in 2012: Issues and Updates” posted today and is available free of charge.
The term “probiotic” will no longer be allowed on food labels in the EU starting December 14, 2012. EFSA has remained unconvinced that the strength of the science behind probiotic products meets their efficacy standards. Conferring a health benefit is imbedded in the term, “probiotic;” therefore, the term can only be used on products with an approved health benefit. NUTRAingredients article.
The ISAPP Board of Directors responds to the accusation of publication bias in the field of probiotic research: no evidence that publication bias for probiotic field is any different than other fields. ISAPP calls for publication of all studies (positive, negative or null) and full disclosure of conflicts of interest. Open letter.
ISAPP sponsors speakers at first Probiotic Association of India conference in New Delhi. Report.
Science Friday radio interview with Susan Lynch, UCSF, on microbial colonization of healthy sinuses, “Microbes benefit more than just the gut.”
Webcast now available: “The New Microbiota & Probiotics Paradigm: from Mechanisms to Clinical Applications”, featuring the following lectures and Q&A:
Students (undergraduates and graduates), post-doctoral fellows and residents can submit probiotic studies to Digestive Disease Week and compete for cash prizes as part of the Probiotic Challenge, sponsored by Lallemand Human Nutrition and the American Gastroenterological Association (AGA) Institute. The Challenge aims to stimulate research in probiotics. Abstracts are due to DDW December 1, 2012.
Confusion at the Yogurt Aisle. Time for Probiotics 101. Story on National Public Radio, Morning Edition News.
Lallemand Human Nutrition, in partnership with the American Gastroenterological Association, announced a new edition of the “Probiotic Challenge,” a competition for students working on probiotic research. If selected by the AGA and a team of judges, winners can present their study at DDW2013 and win cash prizes.
National Public Radio interview with John Cryan, professor at University College Cork in Ireland, on study published in PNAS showing that Lactobacillus rhamnosus JB-1 reduced anxiety and depression-like behaviors in stressed mice.
Probiotic industry members, Valio, Danone, Yakult, Chr Hansen, DuPont-Danisco, Probi and Lallemand formed the Global Alliance for Probiotics (GAP) to collaborate on defining a path forward for health claims for probiotics in the European Union. Read Nutraingredients article.
The Institute of Medicine held a workshop February 22-23, 2012 on The Human Microbiome, Diet, and Health. Slides from this forum will be posted March 2 and a written summary of conclusions will be published.
FDA’s Center for Biologic Evaluation and Research (CBER) issued a finalized guidance for industry on when an Investigational New Drug (IND) application is required for human research on live biotherapuetic agents. The draft guidance on a similar topic issued by CBER and the Center for Drug Evaluation and Research (CDER) October 2010 has not been finalized. This final guidance acknowledges that live microbes (probiotics) intended for use as foods or dietary supplements can be investigated with human studies without an IND. The new guidance falls short of acknowledging an IND-free research path for human studies on medical foods, foods for special dietary uses or to research a food Health Claim. Foods or dietary supplements being studied for drug purposes (cure, mitigate, treat, diagnose, or prevent disease) will require an IND.
The Dannon Company announces the Dannon Probiotics Fellow Program to support the education of a student who excels in science and shows a strong interest in probiotics studies. The winner receives a scholarship equivalent to one year’s tuition (up to $25,000, payable to the educational institution) and an all-expense paid trip to the Danone Research Center in France. Application deadline is March 31, 2012. Information.
U.S. Pharmacopeia (USP, a standards-setting organization since 1820) recently announced publication of a monograph, “Microbial Food Cultures Including Probiotics,” in Food Chemical Codex. General considerations for identification and enumeration, intended use in food, safety, regulatory status, and purity are discussed.
The Global Probiotics Council has announced the fifth year of the Young Investigator Grant for Probiotics Research. The purpose of the two annual grants of $50,000 each is to contribute to the advancement of probiotics and gastrointestinal microbiota research in the United States, and to impact academic and career development of young investigators, attracting them into the field of probiotics and microbiota. Application deadline: February 15, 2012. Application procedures and additional details on the program can be found at www.probioticsresearch.com.
ISAPP submits comments to the FDA on the draft guidance on new dietary ingredient notifications. ISAPP comments are grounded in the overall principle that NDIN requirements should have a reasonable potential to add to the overall understanding of safety (or to the existing data base with respect to a risk) and, if that potential is very low, we recommend that FDA endorse the use of discretion to conclude that additional testing is unnecessary.
The World Gastroenterology Organisation has updated its 2008 practice guideline for probiotics and prebiotics. Of special interest are the updated Tables 8 and 9, which summarize the probiotic or prebiotic, dose and grading of evidence for a number of GI clinical conditions for which there is evidence. The table is global in focus, and the document – available now in English – will be available in other languages soon. WGO Practice Guideline – Probiotics and Prebiotics – 2011.
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