November 26, 2013
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).
November 18, 2013
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 ...
October 25, 2013
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
October 16, 2013
The final report for the NIH-funded project titled Federal Regulation of Probiotics (conducted by The University of Maryland School of Law) is available for download
. See also a Policy Forum article in Science that summarizes the key findings, especially is support of an abbreviated process for investigational new drugs for probiotics, Probiotics: Finding the Right Regulatory Balance
. Press release
October 16, 2013
The final report for the NIH-funded project titled Federal Regulation of Probiotics
(conducted by The University of Maryland School of Law) is available for download
. See also a Policy Forum article in Science that summarizes the key findings, Probiotics: Finding the Right Regulatory Balance.
September 25, 2013
’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research and Center for Food Safety and Applied Nutrition published a final guidance on when an IND is required for human research
. This guidance, although not binding, indicates that the FDA does not consider it acceptable to conduct human research on functional foods (including probiotic and prebiotic foods). Any human research conducted on a probiotic or prebiotic food, whether for a structure/function or reduction of risk of disease endpoint, must be conducted under an investigational new drug application. Human research on foods can only be conducted without an IND if you are investigating taste, aroma, or nutritive value, or to support an already authorized Health Claim (i.e., reduction of risk of disease claim). In a blog post
about this new guidance, Wes Siegner & Paul M. Hyman made a chilling recommendation: “Carefully design study protocols to avoid IND implications, or if that is not possible, conduct studies that IRBs and FDA will not permit in the U.S. without an IND in Canada or Europe.
” (Italics added for emphasis.)
September 17, 2013
ISAPP posts comments to the 2015 US Dietary Guidelines Advisory Committee
, requesting that the committee consider the value of a diet containing probiotics and prebiotics for reducing disease risk in Americans. Due to a quirk during posting, the comments display as submitted by “Mary Ellen Sanders,” but both comments, limited to 5,000 characters each, were approved by the full ISAPP Board of Directors. The comment on prebiotics was written by Glenn Gibson, Mary Ellen Sanders, Juliet Ansell, George Fahey and Stephan Theis, and the comment on probiotics was written by Mary Ellen Sanders, Irene Lenoir-Wijnkoop, Seppo Salminen and Chris Cifelli. Probiotic comment
. Prebiotic comment
September 17, 2013
FDA’s Center for Food Safety and Applied Nutrition announced its 2013-2014 program priorities
. Item 4.3.2: Develop studies that harness the human microbiome to advance nutrition based endpoints.
September 17, 2013
Dietary Supplement Label Database
contains the full label contents from a sample of dietary supplement products marketed in the U.S. This database is a joint project of the National Institutes of Health, the Office of Dietary Supplements and the National Library of Medicine.
September 17, 2013
Two radio reports from National Public Radio feature the gut microbiome as a target for improving health and preventing disease:
August 15, 2013
August 14, 2013
ILSI Europe publishes review: Monitoring immune modulation by nutrition in the general population: identifying and substantiating effects on human health. Open access paper
August 13, 2013
American Gastroenterological Association, under the auspices of their Center for Gut Microbiome Research and Education, conducted a Congressional Briefing in Washington DC titled “The Gut Microbiome — The Future of Research & Patient Care.” Video of the one-hour lecture session featuring Drs. Loren Laine, Gary Wu, Rob Knight and Martin Blaser is now posted
August 7, 2013
Last month, NIH hosted a by-invitation meeting on “Human Microbiome Science: Vision for the Future.” The 3-day meeting provided an overview of cutting-edge work in NIH-supported microbiome research. Slides from talks are found at http://www.genome.gov/27554404
August 6, 2013
Commentary published from discussion group from 2012 meeting in Cork: The Evidence is in; Probiotics Improve Neonatal Outcomes
. Authored by Drs. Andi Shane, Girish Deshpande and Daniel J. Merenstein, this paper highlights evidence for prevention of morbidity and mortality associated with necrotizing enterocolitis and calls for comparative effectiveness design for any future studies. Also from the 2012 meeting, the discussion group led by Karen Scott and Nathalie Delzenne was just summarized in a paper (lead author, Paul Sheridan) submitted to Gut Microbes, Can prebiotics and probiotics improve therapeutic outcomes for undernourished individuals?
June 14, 2013
ISAPP concludes 11th annual meeting.
One hundred ten academic and industry scientists met June 13-14 at the site of the New York Academy of Sciences for the by-invitation component of the ISAPP annual meeting. Five parallel discussion groups addressed topics of importance to probiotics, prebiotics and the human microbiome, including impact on the first 1000 days of life, defining a healthy microbiome, brain/gut interactions, personalized probiotics and inclusion in dietary guidelines. This meeting followed a sold-out, open-registration conference Probiotics, Prebiotics, and the Host Microbiome: The Science of Translation
, funded in part by the National Institutes of Health, which was attended by over 300 scientists.
June 7, 2013
ISAPP prepares for annual meeting
. Over 300 scientists will gather at the New York Academy of Sciences facility in New York City June 12 for a sold-out Conference
focused on probiotics, prebiotics and the human microbiome. This meeting is followed June 13-14 with the by invitation ISAPP meeting. Meeting information for participants now posted
June 6, 2013
Ireland is the first country to adopt the EFSA position banning the use of the words ‘probiotic’ and ‘prebiotic.’
See “Probiotic Health Claims
” on Food Safety Authority of Ireland website. Use of the term ‘live’ or ‘active’ bacteria is also banned: “Any terms that imply probiotic activity (i.e. imply that the bacteria in the product may be beneficial for health) are health claims and are not permitted. For example if terms like ‘live’ or ‘active’ are used to describe bacteria, these imply a probiotic function and therefore are considered to be health claims. No health claims have been approved for ‘probiotic’ and therefore terms that imply a probiotic function are not permitted”.