The preliminary program had listed Joshua Sharfstein, MD - FDA’s principal deputy commissioner - to present, however the commissioner herself will now take to the podium to address the industry on FDA’s priorities for dietary supplements.
Speaking to NutraIngredients-USA.com, Andrew Shao, PhD, VP of scientific and regulatory affairs for CRN said: “For Dr Hamburg to take the time to speak at our conference reflects on the credibility of CRN’s annual meeting.”
While the details of Dr Hamburg’s talk are not known, Dr Shao speculated that her comments would reflect what she said recently at the Food and Drug Law Institute (FDLI) meeting, but with more detail on GMPs, adverse event reporting, and claims.
“Industry will be able to hear directly from her,” said Dr Shao. “Many folks in the industry look forward to increased enforcement of DSHEA. And this is an approach we’ve long advocated.”
While Dr Hamburg takes top billing at the conference, another big name is David Vladeck, director, Bureau of Consumer Protection at FTC.
“The industry’s environment is changing and we will know from leaders how it’s going to change, and how they are going to level the playing field,” said Dr Shao.
“There will be some very different viewpoints represented,” he added.
The annual meeting will be preceded by the CRN’s Day of Science, which will engage integrated practitioners on the issue of dietary supplements in healthcare.
“There is a large, organized community of integrated practitioners trying to revise health care practices,” said Dr Shao. “But they have not been connected with industry. We will be bringing them together to look at research issues. Researchers and integrated practitioners have common ways which we will address together.”
Three presentations will address the issue of nutrition research, looking at options beyond the traditional evidence-based medicine approach. Noted speakers include Jeffrey Blumberg, PhD from Tufts University, Alan Kristal, DrPH, from the Fred Hutchinson Cancer Research Center, and Joseph Betz, PhD, from the Office of Dietary Supplements, NIH.
“Nutritional supplements in health maintenance and the management of disease: How does one use the evidence, or lack of it?” will be discussed by Dennis Bier, MD, from Baylor College of Medicine. Dr Shao described Dr Bier as “extremely influential”, noting that he is also editor-in-chief of the American Journal of Clinical Nutrition, and chair of the Institute of Medicine's Food and Nutrition Board.
“Dr Bier is quite skeptical when it comes to dietary supplements, so I am very much looking forward to hearing his presentation,” said Dr Shao.
Registration is still open, and four options are available, said CRN. People may register for only the workshop, only the conference, both the conference and the workshop, or the workshop plus the first day of the conference. Dr Hamburg will present on the first day of the conference.
The Workshop and Conference run from October 21st to 24th at the Terranea Resort on the Palos Verdes Peninsula in California. For more information on both the workshop and conference, please visit: http://www.crnusa.org/TheConference/