Archive for category: News

June 14, 2015. ISAPP responded to a request by the White House Office of Science and Technology Policy for input on microbiome research priorities. ISAPP response.

May 12, 2015. ISAPP responds to the request by NIH-National Center for Complementary and Integrative Health for input into the Center’s future research efforts and priority setting. ISAPP response.

The 8th annual Young Investigatory Grant for Probiotic Research has been announced by Global Probiotics Council of Danone Nutricia Research and Yaklult Honsha Co., Ltd. Three annual grants of $50,000 USD supports innovative research on probiotics and gastrointestinal microbiota in the United States. Information.

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 microwarriorsmovie@nullsbcglobal.net.

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.

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.

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.

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.

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.

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.

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 industry. Comments due to the FDA April 7, 2014. Submit comment. See related Latest News posts on September 25, 2013 and November 26, 2013.

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.