January 24, 2011
“Microwarriors. The Power of Probiotics.” The trailer for this recently launched documentary on probiotics is available on YouTube. www.microwarriorsmovie.com
“Microwarriors. The Power of Probiotics.” The trailer for this recently launched documentary on probiotics is available on YouTube. www.microwarriorsmovie.com
Regulatory issues that impact the probiotic and prebiotic fields seem to be an overriding concern of late. In Europe, EFSA’s NDA panel continues to reject all probiotic/prebiotic health claims, including claims submitted by Danone that Actimel can help with antibiotic-associated diarrhea and Yakult that its product can help defend against pathogens of the upper respiratory tract. Evidence provided by Danone included a human trial published in the British Medical Journal. Evidence provided by Yakult included a recent human study being submitted for publication conducted at Loughborough University, UK (NUTRA ingredients-usa.com report). European prebiotic and probiotic researchers expressed disagreement with the EU health claim approval process, registering their dissatisfaction on a website http://www.gut-health.eu/ designed to tally likeminded scientists on this issue (NUTRA ingredients-usa.com report). In the USA, the FTC settled with Dannon over what claims it considers substantiated. Dannon agreed to some wording changes and qualifications on servings needed for gut regularity claim, but the settlement leaves Dannon able to continue making claims on immune support for DanActive and on digestive comfort and regularity for its Activia product (NUTRA ingredients-usa.com report). The FDA Centers for Biologic Evaluation and Research and Drug Evaluation and Research (CBER and CDER, respectively) published a draft guidance document on when researchers must file an Investigational New Drug application when doing human research. In ISAPP’s opinion, this guidance did not adequately address the lawful conduct of human research on foods in the US without the need for an IND. ISAPP filed comments January 11 outlining its concerns with the draft guidance as written.
Young Investigator Grant for Probiotics Research announced. Young investigators committed to basic research on gastrointestinal microbiota, probiotics and their role in health and wellness should apply. Application deadline: February 15, 2011. Two grants made available by Danone and Yakult in the amount of $50,000 are available. www.probioticsresearch.com
FDA Law Blog produced by Hyman, Phelps & McNamara law firm, recently noted an article (originally published in Food Chemical News) titled “The Cost of Inadequate Substantiation”, which provides perspective by two US food law attorneys on FDA inaction and FTC action on allegedly false or misleading health benefit advertising claims on foods in the USA.
2010 ISAPP meeting report was published in Functional Food Reviews, and is available open access.
ISAPP Past President Gregor Reid recently published an article titled “Putting Science First: The International Scientific Association for Probiotics and Prebiotics (ISAPP)” in Functional Food Reviews.
Recent action by European Union may serve to suppress publication of research to substantiate health claims used in food labeling. Read article in Food and Drug Law Institute’s Update.
European Food Safety Authority published a scientific report titled “Bibliographic review on the potential of microorganisms, microbial products and enzymes to induce respiratory sensitization.” Report.
Danone Research launches probiotic research bulletin titled “Probiotic Watch,” which features summaries of newly published research and commentaries by acclaimed scientists, including 2 former ISAPP board members, Drs. Bruno Pot and James Versalovic.
The conclusions from the ILSI Europe Prebiotic Task Force has been published, “Prebiotic Effects: Metabolic and Health Benefits”. Dr. Marcel Roberfroid served
as lead author on this paper, which was published in the British Journal of Nutrition. Link to article.
Report from 2009 ISAPP meeting discussion group on mucosal immunity published
in Gut Microbes, authored by O’Flaherty, Saulnier, Pot and Versalovic.
ISAPP board member, Michael Cabana, MD, MPH, offered commentary in the Journal of Pediatrics [157(5):864-5; 2010] regarding interpretation of recent metaanalysis
(Pediatrics 2010;125:921-30) on use of probiotics in NEC. He questioned the value of aggregating different probiotic preparations into one metaanalysis and emphasized that – contrary to the opinions expressed in the metaanalysis – that further research is needed to assess the effectiveness of specific probiotic strains for NEC.
The 4th year of the Young Investigator Grant for Probiotics Research sponsored by Danone Research and Yakult has been announced. 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, 2011. Application procedures and additional details on the program can be found at www.probioticsresearch.com.
FASEB Summer Research Conference titled “Probiotics, Intestinal Microbiota and the Host: Physiological and Clinical Implications” will be held July 24-29, 2011, at Carefree Resort, Carefree, Arizona. Organizers: W. Allan Walker, MD, Harvard Medical School and Mary Ellen Sanders, PhD, ISAPP Executive Director. Additional program details will be available December 2010 at www.faseb.org/src.
EFSA announces Stakeholder meeting to be held December 2, 2010 in Amsterdam. The topic will be scientific substantiation of health claims related to gut health and immune function. Registration on EFSA website in September 2010. Additional information from EFSA’s Dr. Juliane Kleiner juliane.kleiner@nullefsa.europa.eu.
Conference Considers Options for US Federal Regulation of Probiotics. On June 14, 2010, The University of Maryland School of Law hosted the first of a series of multidisciplinary meetings being held as part of a Human Microbiome Project ELSI (Ethical, Legal, Social Implications) grant to study federal regulation of probiotics. The project is headed by Diane E. Hoffmann, MS, JD, Associate Dean for Academic Programs and Director, Law and Health Care Program, University of Maryland School of Law. Participants in the conference included members of academia and the scientific research, business, legal and federal regulatory communities, and included two ISAPP board members, Gregor Reid and Mary Ellen Sanders . This initial meeting focused on identifying key regulatory issues and achieving a broad-based understanding of the science relating to probiotics and the current federal regulatory framework for probiotics. Subsequent sessions will focus on attempting to find answers to these questions. The next meeting is being planned for January 2011. June 14 meeting agenda.
International Dairy Federation Elie Metchnikoff Prize 2010 winners announced in Tromsö, Norway. The IDF Elie Metchnikoff Prize 2010 was awarded in three categories Nutrition and Health, Biotechnology and Microbiology. Awardees included 2 ISAPP Board of Directors members, Prof. Todd R. Klaenhammer and Prof. Colin Hill. In addition, Dr. Irene Lenoir-Wijnkoop from Danone Research, who leant her support in the conceptualization and early implementation stages of ISAPP’s creation, received the Elie Metchnikoff Prize 2010 Award of Recognition. Details
ILSI Europe Functional Foods Task Force has issued a report “Beyond PASSCLAIM – Guidance to Substantiate Health Claims on Foods” from a meeting held 14-16 December 2009 in Nice, France.
The 4-part lecture Webinar Series on Probiotics and Prebiotics, developed in collaboration with the International Life Sciences Institute (ILSI) North America, the American Gastroenterological Association and ISAPP, concluded on June 3, 2010. The 1-hour lectures will be archived at the GI Learn section of the AGA website.
NIH/FDA-supported evidence-based review due out summer of 2010 titled
“Safety of Probiotics Used to Reduce Risk and Prevent or Treat Disease”
Probiotic safety report of 2008 ISAPP discussion group “Assessment of probiotic safety for human use” has been published by Gut Microbes. Open access
NIH National Center for Complementary and Alternative Medicine announces funding opportunities in the area of probiotics and prebiotics. Information
The American Society for Nutrition in partnership with the American Academy of Family Physicians will present a free webinar on nutrition and digestive health (July 14).
Information
At the 7th annual meeting of ISAPP this past November, a student/fellow association (SFA) of ISAPP was founded. Under the insightful leadership of Delphine Saulnier, the organization has approved a constitution and started a website and Facebook page and proposed many additional activities. See http://www.isapp-sfa.com/ for information.
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