The much anticipated review of probiotic safety, conducted by the US Agency for Healthcare Research and Quality Advancing Excellence in Health Care, and jointly sponsored by the National Institutes of Health (NIH) Office of Dietary Supplements (ODS), the NIH National Center for Complementary and Alternative Medicine (NCCAM), and the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN), has been published. Safety of Probiotics to Reduce Risk and Prevent or Treat Disease.

The European Food Safety Authority (EFSA) released a final technical report from a stakeholders’ meeting December 2, 2010 meeting in Amsterdam. Titled “Outcome of a public consultation on the Draft Opinion of the EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA) on a guidance on the scientific requirements for health claims related to gut and immune function,” this report includes a summary of comments received from the public on the draft guidance on gut and immune claims and the NDA panel’s response to those comments. Report. Updated guidance on gut and immune claim substantiation.

Open letter to ISAPP membership from President, Glenn Gibson. ISAPP’s 10th anniversary approaches and Glenn discusses vision for ISAPP’s next 10 years.

The NIH Office of Dietary Supplements (ODS) will be hosting a presentation by Dr. Justin Sonnenburg of Stanford University on March 9, 2011 at 11:00 am EST titled “Probiotics, Prebiotics, and Small Molecules: Manipulating Host Biology Via the Intestinal Microbiota.” To connect to the seminar via webinar, contact Cindy Lentino at ODS: lentinoc@nullod.nih.gov.

Probiotics European Scientific League (PESL) proposes independent logo to differentiate probiotic supplements that meet quality standards. The PESL will conduct testing and certification of products. Interview with Dr Jean-Pol Warzée, the general secretary and executive director of PESL, and Professor Bruno Pot, Pasteur Institute in Lille, France.

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.

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.

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.

ISAPP 2010 meeting report now available

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.

Report from 2009 ISAPP meeting discussion group on mucosal immunity published
in Gut Microbes, authored by O’Flaherty, Saulnier, Pot and Versalovic.

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.