Entries by Mary Ellen Sanders

ISAPP Sponsored Prof. Bruno Pot to Speak at PAi | ISAPP

ISAPP sponsored Prof. Bruno Pot, Institut Pasteur Lille, to speak at the 2nd Annual Conference of the Probiotic Association of India. The conference titled “Probiotics and Microbiome: Gut and Beyond” was held November 3-4, 2014 in Delhi, India. For further details see the report.

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 […]

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

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 a guidance that stipulates human research conducted on functional endpoints for foods requires an […]

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 […]

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 […]

February 5, 2014

The FDA is re-opening comments on portions of its Guidance on Determining if Human Research Studies Require an Investigational New Drug Application. ISAPP intends to file comments reflecting concerns that the current guidance (published in final form September 2013) unduly restricts human research on functional properties of foods and supplements, harming U.S. researchers, consumers and […]

January 10, 2014

World Gastroenterology Organisation released a new webcast “Irritable Bowel Syndrome (IBS): What is it, what causes it and can I do anything about it?”; an educational program for the general public. The webcast was developed from the WGO World Digestive Health Day 2012 Campaign and covers the following topics: What is IBS?, How to communicate […]

January 9, 2014

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.

January 7, 2014

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?

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 […]

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 […]

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 […]