October 7, 2014
Published today in Am J Reprod Immunol, and open access: Microbes Central to Human Reproduction
. . The authors, let by Dr. Gregor Reid, summarize an ISAPP discussion group from 2014 meeting.
September 28, 2014
Health Point Productions has just released, "MicroWarriors" Special Edition. This Documentary Film on probiotics is a re-release with new footage from interviews featuring ISAPP board members, Prof. Gregor Reid and Mary Ellen Sanders. Some of the other experts include: Glenn Gibson PhD, Todd Klaenhammer PhD, Jose Saavedra MD, Robert Martindale MD, Simin Meydani PhD and Tri Duong PhD. Health Point Productions has offered to send a free copy of this Special Edition to the first 500 ISAPP Members who respond. Contact David Knight of Health Point Productions at email@example.com.
September 26, 2014
ISAPP Board member, Michael Cabana, MD, MPH,
joined 2 other experts (David Mills, Ph.D. and Mark Underwood, MD) in a continuing education program on Prebiotics, Probiotics, and the Microbiota.
Official Audio CME Program of the American Academy of Pediatrics.
September 8, 2014
The Dannon Company Graduate Scholarship. The third Yogurt and Probiotics Fellowship Program offers a scholarship of $25,000 to a current or incoming graduate student who shows a strong interest in the research of nutritional and functional benefits of yogurt and probiotics. Candidates must be currently enrolled in or applying to a full-time graduate program. Applications due November 15, 2014. Information.
September 8, 2014
ISAPP filed comments regarding with the European Food Safety Authority regarding its intent to revise the guidance on scientific requirements for health claims on foods related to gut and immune function. ISAPP’s opinion is that EFSA should completely revise the guidance document, rather than limit comments to issues that have arisen in submitted dossiers. ISAPP also suggested that maintenance of homeostasis in all aspects of healthy human physiology should be considered as a beneficial health effect. EFSA document. ISAPP comments.
August 1, 2014
ISAPP files comments with the FDA regarding impact of Proposed Rule on labeling prebiotics on foods
. ISAPP requests that the FDA modify the Proposed Rule as follows: (1) benefits of added fibers be explicitly expanded to include a broader range of potential physiological beneficial effects
, (2) implement a phase-in period to allow adequate time to develop required substantiation, and (3) use a notification process rather than a pre-market approval process for substantiation. ISAPP Comment
. FDA website link
June 10, 2014
ISAPP’s consensus statement on the scope and appropriate use of the term probiotic was published today in Nature Reviews in Gastroenterology and Hepatology. The paper is open access. Key conclusions of the paper include that with minor edits, the 13-year old FAO/WHO definition of probiotic was endorsed; that sufficient evidence from human studies on commonly studied probiotic species allows use of the term ‘probiotic’ at a species-, not strain-, level; and undefined consortia of microbes such as those used for fecal microbial transplants do not fall under the scope of probiotics. The panel of experts comprised 12 internationally recognized scientists and the paper was endorsed by the ISAPP board of directors.
June 5, 2014
Meeting with CBER
. On May 22, ISAPP’s Executive Science Officer (Mary Ellen Sanders) and Daniel Merenstein MD (Georgetown University) met with Peter Marks MD PhD, Deputy Director of Center for Biologics Evaluation and Research/FDA, and three other CBER representatives, to discuss CBER oversight of probiotic research as investigational new drugs. Concerns were expressed regarding requiring phase 1 safety studies, the lack of a waiver option, and inhibition of investigator-initiated studies. The meeting was a productive beginning to these discussions. Report.
May 1, 2014
The Yogurt in Nutrition Initiative announced a request for research proposals focused on health benefits associated with yogurt consumption. The competition is for one $30,000 USD grant. Research teams from public organizations or researchers at universities or hospitals may apply. The deadline for submission of applications is June 30, 2014. This call is supported by Danone Institute International in collaboration with the American Society for Nutrition (ASN) and the International Osteoporosis Foundation (IOF). Information.
April 28, 2014
ISAPP board members, Gregor Reid and Mary Ellen Sanders, were interviewed by Shane Starling of Nutraingredients for a new documentary film, "MicroWarriors" The Special Edition.
The special edition will be a completely re-editied and mastered version from the 2011 probiotic documentary film, "MicroWarriors" The Power of Probiotics.
In addition, it will include new graphics and images, plus bonus material added and narration by Leonary Nimoy. The special edition film will be released in the Spring of 2014. MicroWarriors 2: The Origin and the Destiny
is currently in production and will be released in the Fall/Winter of 2014. Information
. Nutraingredients article with video interview
April 8, 2014
ISAPP filed comments with the FDA on its guidance, which requires that essentially all human research to evaluate functional effects of foods be conducted under an IND. ISAPP requested that FDA revise the current guidance to remove their requirement for INDs for human research conducted on foods and that the guidance make it clear that prebiotics and probiotics have lawful, recognized food uses, which should be able to be researched in the USA without an IND.
Comments by the law firm, Hyman, Phelps & McNamara, also are of interest.
March 31, 2014
Webcasts of the lectures and workshop wrap-ups from the Gut Microbiota for Health World Summit
(convened in Miami, March 8-9, 2014) are now available. Click here.
March 11, 2014
ISAPP joined the American Society of Nutrition, Institute of Food Technologists, ILSI-North America and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition in a meeting March 5 with FDA's Center for Food Safety and Applied Nutrition to share concerns with
that stipulates human research conducted on functional endpoints for foods requires an investigational new drug (IND) application. Dr. James Heimbach represented ISAPP and, along with ASN's Sarah Ohlhorst, filed this report. Referenced Survey Results. See related posts February 25, February 5, 2014, November 26, 2013 and September 25, 2013.
February 25, 2014
ISAPP will meet March 5 with FDA's Center for Food Safety and Applied Nutrition to discuss conducting human research on foods. The FDA made it clear in a guidance from September 2013 that human research conducted on functional endpoints for foods requires an investigational new drug (IND) application. However, the FDA re-opened the comment period on that guidance, and ISAPP – along with American Society of Nutrition, Institute of Food Technologists and ILSI-North America – will share concerns with CFSAN that the IND requirement for food research is misguided. As succinctly stated by Dr. James Heimbach, who will be representing ISAPP at the meeting, “A substance can’t be an investigational new drug unless it is a drug, and FDA is attempting to declare legitimate food ingredients that provide benefits other than taste or aroma to be drugs.” See related posts from February 5, 2014, November 26, 2013 and September 25, 2013.
February 24, 2014
On February 11, ISAPP, represented by Mary Ellen Sanders (executive director), Daniel Merenstein, Greg Leyer (Sr. ISAPP-IAC representative) and Chris Cifelli (Jr. ISAPP-IAC representative), met with Mr. Richard Cleland, Assistant Director, Division of Advertising Practices with the Federal Trade Commission to gain a better understanding of FTCs perspective on conducting research intended to substantiate structure/function or health claims for foods in the United States. Mr. Cleland’s forthright approach in his responses was much appreciated. This report itemizes the questions posed by ISAPP and summarizes the responses provided by Mr. Cleland.
February 5, 2014