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Mary Frances Picciano Dietary Supplement Research Practicum Presentation Videos

Practicum attendees

The 2017 Office of Dietary Supplements (ODS) Mary Frances Picciano Dietary Supplement Research Practicum presentations and panels were videotaped and are available for viewing on the NIH Office of the Director YouTube channel. 

This 2.5-day annual event for faculty, students, and health practitioners provides a thorough overview of issues, concepts, unknowns, and controversies about dietary supplements and supplement ingredients. It also emphasizes the importance of scientific investigations to evaluate the efficacy, safety, and value of these products for health promotion and disease prevention as well as how to carry out this type of research.  

For information about the next Practicum. external link disclaimer


OPENING

Welcome and Setting the Stage: What ODS Does - Paul Coates, Ph.D., ODS, NIHexternal link disclaimer
Overview of Dietary Supplement Use - Regan Bailey, Ph.D., M.P.H., R.D., ODS, NIH and Purdue Universityexternal link disclaimer
Paul Coates, Ph.D., director of the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) sets the stage for the 2017 ODS Mary Frances Picciano Dietary Supplement Research Practicum. Dr. Coates welcomes the participants and describes the history, mission, and work of ODS, which was established by the Dietary Supplement Health and Education Act of 1994 (DSHEA). Regan Bailey, Ph.D., M.P.H., R.D, practicum director and scientific consultant at ODS and associate professor in the Department of Nutrition Science at Purdue University, follows with a detailed overview of U.S. dietary supplement use by adults and children based on data from the National Health and Nutrition Examination Survey (NHANES), including the most commonly used dietary supplement products in the U.S.
  
SESSION 1: RESEARCH AND REGULATION 

What the U.S. Food and Drug Administration (FDA) Does - Sibyl Swift, Ph.D., FDAexternal link disclaimer
Sibyl Swift, Ph.D., special assistant in the U.S. Food and Drug Administration’s (FDA) Office of Dietary Supplement Programs, talks about the FDA’s dietary supplement-related responsibilities and how the FDA’s regulation of dietary supplement products differs from those covering conventional foods and medicine. Dr. Swift explains the FDA’s role in regulating supplements versus the manufacturer’s responsibility for marketing them, as well as FDA’s post-marketing responsibilities for supplements, including safety monitoring and the provision of product information. She provides examples of the types of regulatory actions FDA has taken against potentially harmful and/or mislabeled supplements.

What the Federal Trade Commission (FTC) Does - Michelle Rusk, J.D., FTCexternal link disclaimer
Michelle Rusk, J.D., senior staff attorney in the Division of Advertising Practices, Bureau of Consumer Protection at the Federal Trade Commission (FTC), explains the FTC’s dietary supplement-related responsibilities and how its regulation of these products differs from conventional foods. Ms. Rusk describes several FTC activities related to ensuring that supplement advertising is truthful and not misleading, and regulatory actions it has taken against offenders.

Dietary Supplement Research and Regulation Panel Discussion - Michelle Rusk, J.D., FTC  and Sibyl Swift, Ph.D., FDAexternal link disclaimer
Michelle Rusk, J.D., senior staff attorney in the Division of Advertising Practices, Bureau of Consumer Protection at the Federal Trade Commission (FTC) and Sibyl Swift, Ph.D., special assistant in the U.S. Food and Drug Administration’s (FDA) Office of Dietary Supplement Programs, respond to questions from the audience, following their presentations.

Food vs. Drugs vs. Dietary Supplements - Joe Betz, Ph.D., ODS, NIHexternal link disclaimer
Joseph Betz, Ph.D., director of the Analytical Methods and Reference Materials Program in the National Institutes of Health (NIH) Office of Dietary Supplements (ODS), presents information on the principles upon which food, drugs, and dietary supplements are regulated. Dr. Betz explains the differences in labeling requirements for foods and dietary supplements and provides examples of companies that inadvertently crossed the lines between conventional foods, dietary supplements, and drugs when they introduced new products to the market. 

NIH Support for Research and Training on Nutrition and Dietary Supplements - Abby Ershow, Sc.D., R.D., ODS, NIHexternal link disclaimer
Abby Ershow, Sc.D., R.D., senior nutrition scientist in the National Institutes of Health (NIH) Office of Dietary Supplements (ODS), explains how to navigate the NIH extramural funding system and talks about funding opportunities for research on nutrition and dietary supplements. Dr. Ershow describes the funding mechanisms and which federal agencies provide funding for nutrition research and training.

SESSION 2: RIGOR AND REPRODUCIBILITY IN DIETARY SUPPLEMENTS RESEARCH

Analytical Characterization of Dietary Supplements: Overview of Methods, Standards, and Quality Assurance - Adam Kuszak, Ph.D., ODS, NIHexternal link disclaimer
Adam Kuszak, Ph.D., health policy analyst in the National Institutes of Health (NIH) Office of Dietary Supplements (ODS), talks about the principles of dietary supplement characterization by introducing the concepts of identity, purity, quality, and composition. Dr. Kuszak provides an overview of the analytical challenges and needs in dietary supplement research, and the importance of standards and reference materials. He also describes the work of the federal agencies and non-government organizations which develop analytical methods and reference materials to enhance dietary supplement research and assess product quality.
 
Challenges in Research on Botanical Dietary Supplements - Barbara Sorkin, Ph.D., ODS, NIHexternal link disclaimer
Barbara Sorkin, Ph.D., director of the National Institutes of Health (NIH) Centers for Advancing Research on Botanicals and Other Natural Products (CARBON) Program, at the NIH Office of Dietary Supplements (ODS) talks about how the concepts of efficacy, safety, and identity/quality are addressed in studying botanicals and plant-derived ingredients. Dr. Sorkin provides an overview of the CARBON Program, its research emphases, and examples of ongoing research.

SESSION 3: EFFICACY AND SAFETY
 
Efficacy and Effectiveness: Lines of Evidence in Supplement Research - Howard Sesso, Sc.D., M.P.H., Harvard Medical Schoolexternal link disclaimer
Howard Sesso, Sc.D., M.P.H., associate professor of medicine at Harvard Medical School, explains the concepts of efficacy and effectiveness, and how they are defined, measured, studied, and reported in regard to dietary supplements. Dr. Sesso describes the different types of research studies used to determine efficacy and effectiveness and provides examples of research with dietary supplements. Dr. Sesso is also an associate epidemiologist at the Divisions of Preventive Medicine and Aging at Brigham and Women’s Hospital, and an associate professor of epidemiology at the Harvard T.H. Chan School of Public Health. .
 
Safety: The Concept of Safety, Its Measurement, and Reporting - Christine Taylor, Ph.D., ODS, NIHexternal link disclaimer
Christine Taylor, Ph.D., senior nutrition scientist at the National Institutes of Health (NIH) Office of Dietary Supplements (ODS), explains the concept of safety and how it is defined, measured, studied, and reported in regard to dietary supplements. Dr. Taylor provides examples to illustrate the ways in which the safety of various supplement ingredients have been evaluated. She discusses the patchwork of systems in place to monitor for adverse effects of supplements and how safety concerns vary by population subgroups.
 
Supplemental Soy and Disease Prevention: How Strong Is the Evidence? - Mindy Kurzer, Ph.D., University of Minnesotaexternal link disclaimer
Mindy Kurzer, Ph.D., professor of nutrition and director of the Healthy Foods, Healthy Lives Institute at the University of Minnesota, talks about soy supplement research, illustrates the range of soy studies, and describes how each type of study has contributed to overall knowledge of this ingredient. She discusses many of the issues in conducting research on soy products and making assessments of their value and safety. Dr. Kurzer presents some of the relevant research on soy/soy components in relation to heart health, hot flashes, and breast cancer risk. 
 
Interactions between Supplements and Drugs - Bill Gurley, Ph.D., University of Arkansas for Medical Sciences College of Pharmacyexternal link disclaimer
Bill J. Gurley, Ph.D., professor of pharmaceutical sciences at the University of Arkansas for Medical Sciences (UAMS) College of Pharmacy and director of the UAMS Clinical Pharmacokinetics Research Laboratory, describes some of the major means and mechanisms by which ingredients in supplements and medicines may interact and the potential clinical implications of these interactions. Dr. Gurley illustrates these concepts with examples including St. John’s wort, ephedra, and licorice root.  He discusses the extent to which interactions between supplements and drugs are studied; are reported by health professionals; pose clinically relevant risks to consumers; and are catalogued in places accessible to health professionals and consumers.
 
Dietary Supplements and the U.S. Department of Defense - Patricia Deuster, Ph.D., M.P.H., CNS, FACSM, Uniformed Services University of the Health Sciencesexternal link disclaimer
Patricia Deuster, Ph.D., M.P.H., C.N.S., F.A.C.S.M., professor in the Department of Military and Emergency Medicine and director of the Consortium for Health and Military Performance, a Defense Center of Excellence at the Uniformed Services University of the Health Sciences (USU) School of Medicine, describes the different types of research studies on dietary supplements in the military and their respective strengths and weaknesses. She discusses differences in carrying out research studies with the military compared with a nonmilitary population and presents recent data on research studies in the military. Dr. Deuster introduces the Operation Supplement Safety (https://www.opss.org/external link disclaimer) program and other DoD dietary supplement research initiatives.

SESSION 4: MEETING THE STAKEHOLDERS

Attendees will hear from those who study, advocate, regulate, or educate on dietary supplements. Topics for speakers to address include: (1) Describe the purposes of your organization in relation to dietary supplements and what its perspectives and views are regarding these products; and (2) describe your activities in matters related to supplements (including manufacture, marketing, and regulation) and in providing information/education about these products.

Meeting the Stakeholders: Conversation with the Industry (Panel 1 of 2)external link disclaimer  - Michael McBurney, Ph.D.,  DSM Nutritional Products Inc.; Merle Zimmerman, Ph.D., American Herbal, and  Steven Mister, Esq., Council for Responsible Nutritiexternal link disclaimeronexternal link disclaimer
Michael McBurney, Ph.D., vice president of science, communications, and advocacy at DSM Nutritional Products Inc., Merle Zimmerman, Ph.D., chief information analyst for the American Herbal Products Association, and Steven Mister, Esq., president and CEO of the Council for Responsible Nutrition, describe the missions and activities of their organizations in relation to dietary supplement products and their perspectives and views regarding these products.
  
Meeting the Stakeholders: Meet the Watchdogs (Panel 2 of 2)external link disclaimer - David Schardt, M.S., Center for Science in the Public Interest, Mark Anderson, Ph.D., ConsumerLab.com, and Sarah Klein, Prevention Magaziexternal link disclaimerneexternal link disclaimer
David Schardt, M.S., senior nutritionist at the Center for Science in the Public Interest, Mark Anderson, Ph.D., vice president of research at ConsumerLab.com, and Sarah Klein, staff writer at Prevention Magazine, talk about the missions of their organizations in relation to dietary supplements and their perspectives and views regarding these products. Each describes their activities related to providing information/education about dietary supplements.
 
Discussion with Industry and Watchdog Panels - Industry: Michael McBurney, Ph.D.,  DSM Nutritional Products Inc.; Merle Zimmerman, Ph.D., American Herbal, and  Steven Mister, Esq., Council for Responsible Nutrition. Watchdogs: David Schardt, M.S., Center for Science in the Public Interest, Mark Anderson, Ph.D., ConsumerLab.com, and Sarah Klein, Prevention Magazineexternal link disclaimer
Presenters from the “Meet the Industry” and “Meet the Watchdogs” panels take questions from the audience. The representatives from the dietary supplement industry are Michael McBurney, Ph.D., vice president of science, communications, and advocacy at DSM Nutritional Products Inc., Merle Zimmerman, Ph.D., chief information analyst for the American Herbal Products Association, and Steven Mister, Esq., president and CEO of the Council for Responsible Nutrition.  The representatives from the “watchdog” panel are David Schardt, M.S., senior nutritionist at the Center for Science in the Public Interest, Mark Anderson, Ph.D., vice president of research at ConsumerLab.com, and Sarah Klein, staff writer at Prevention Magazine.
  
SESSION 5: SUPPLEMENT USE IN THE UNITED STATES

Motivations for Dietary Supplement Use - Johanna Dwyer, D.Sc., R.D., ODS, NIH and Tufts Universityexternal link disclaimer
Johanna Dwyer, D.Sc., R.D., a senior scientist in the National Institutes of Health (NIH) Office of Dietary Supplements ODS, talks about why people take supplements. She discusses the strengths and weaknesses of methodologies to collect this information and explores whether reasons for use differ depending on number and types of supplements taken. Dr. Dwyer describes results from the National Health and Nutrition Examination Survey (NHANES) on motivations for supplement use. In addition to her role at NIH, Dr. Dwyer is the Jean Mayer U.S. Department of Agriculture (USDA) Human Nutrition Research Center on Aging at Tufts, a professor of medicine and community health at Tufts University School of Medicine and the Friedman School of Nutrition Science and Policy at Tufts, and director of the Frances Stern Nutrition Center at the Medical Center.

Dietary Supplement Databases and Other Useful Places - Joyce Merkel, M.S., R.D., ODS, NIHexternal link disclaimer
Joyce Merkel, M.S., R.D., scientific and health communications consultant in the National Institutes of Health (NIH) Office of Dietary Supplements (ODS), describes the purpose and value of several databases (including PubMed/Medline, ClinicalTrials.gov, NIH Dietary Supplement Label Database, and more) that provide information on dietary supplement ingredients. She illustrates the content and navigation of these databases and other resources, and comments on the value and limitations of these resources. She introduces other credible resources for information on dietary supplements including fact sheets, monographs, evidence reports, and she demonstrates how to establish alerts to receive updates on supplement research and news. 

Dietary Supplements for Weight Loss - Carol Haggans, M.S., R.D., ODS, NIHexternal link disclaimer
Carol Haggans, M.S., R.D., scientific and health communications consultant in the National Institutes of Health (NIH) Office of Dietary Supplements (ODS), gives an overview of the weight-loss supplement market and the types of products available. She summarizes the scientific evidence for selected ingredients in these products (including hoodia, chitosan, garcinia cambogia, raspberry ketone, chromium, and green tea) and the quality of that evidence. Ms. Haggans uses ephedra as a case study and discusses potential safety issues for weight-loss supplement ingredients, including possible interactions with drugs and other supplements.
 
Analysis of the Evidence - Paul Thomas, Ed.D., R.D.N., ODS, NIHexternal link disclaimer
Paul Thomas, Ed.D., R.D.N., scientific consultant in the National Institutes of Health (NIH) Office of Dietary Supplements (ODS), illustrates the state of the science on the value or lack of value of selected dietary supplement ingredients (including multivitamins, antioxidants, biotin, and sodium bicarbonate) to promote health and manage problems. He provides examples from the published literature of good versus poor research on supplement ingredients. Using evidence-based approaches, Dr. Thomas offers advice on selecting, recommending, and using dietary supplements.
 
Final Wrap-up to Practicum - Regan Bailey, Ph.D., R.D., Practicum Director, ODS, NIH, Paul Coates, Ph.D., Director of ODS, NIH, and Paul Thomas, Ed.D., R.D., ODS, NIHexternal link disclaimer
During this final session of the 2017 Mary Frances Picciano Dietary Supplement Research Practicum, participants have the opportunity to ask any questions of three panelists: Regan Bailey, Ph.D., M.P.H., R.D., director of the practicum and scientific consultant at the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) and associate professor in the Department of Nutrition Science at Purdue University, Paul Coates, Ph.D., Director of ODS, and Paul Thomas, Ed.D., R.D., scientific consultant at ODS. Topics discussed include the challenges related to dietary supplements that participants face in caring for their patients in their disciplines (medicine, nursing, dentistry, nutrition, etc.), and more details about the inner-workings of ODS.