Day 1 — Wednesday, May 31

7:30 a.m.

Registration

9:00 a.m.

Welcome and Setting the Stage: What ODS Does

Paul Coates, Ph.D., ODS, NIH

9:30 a.m.

Overview of Dietary Supplement Use

Regan Bailey, Ph.D., M.P.H., R.D., ODS, NIH

10:00 a.m.

Break

SESSION 1: RESEARCH AND REGULATION

10:15 a.m.

What the U.S. Food and Drug Administration (FDA) Does

Sibyl Swift, Ph.D., FDA

Objectives: (1) Describe FDA’s supplement-related responsibilities and how its regulation of these products differs from those covering conventional foods and medicines; (2) explain FDA’s role in regulating supplements versus the manufacturer’s responsibility for marketing them; (3) discuss FDA’s post-marketing responsibilities for supplements, including safety monitoring and the provision of product information; and (4) provide examples of the types of regulatory actions FDA has taken against potentially harmful and/or mislabeled supplements.

11:00 a.m.

What the Federal Trade Commission (FTC) Does

Michelle Rusk, J.D., FTC

Objectives: (1) Explain FTC’s supplement-related responsibilities and how its regulation of these products differs from conventional foods; and (2) describe several FTC activities related to ensuring that supplement advertising is truthful and not misleading, and regulatory actions it has taken against offenders.

11:45 a.m.

Panel Discussion

12:00 p.m.

Lunch (on own)

1:15 p.m.

Food vs. Drugs vs. Dietary Supplements

Joe Betz, Ph.D., ODS, NIH

Objectives: (1) Provide information on the principles of how food, drugs, and dietary supplements are regulated; (2) explain the differences in labeling requirements for foods and dietary supplements; and (3) provide real life examples encountered by companies that inadvertently crossed the lines between conventional foods, dietary supplements, and drugs when they introduced new products to the market.

2:00 p.m.

NIH Support for Research and Training on Nutrition and Dietary Supplements

Abby Ershow, Sc.D., R.D., ODS, NIH

Objectives: (1) Describe the NIH extramural funding system and what are the funding opportunities for research on nutrition and dietary supplements; (2) summarize what the funding mechanisms include; (3) describe which federal agencies provide funding for nutrition research and training.

2:45 p.m.

Break

SESSION 2: RIGOR AND REPRODUCIBILITY IN DIETARY SUPPLEMENTS RESEARCH

3:00 p.m.

Analytical Characterization of Dietary Supplements: Overview of Methods, Standards, and Quality Assurance

Adam Kuszak, Ph.D., ODS, NIH

Objectives: (1) Introduce the principles of dietary supplement characterization by introducing the concepts of identity, purity, quality, and composition; (2) provide an overview of the analytical challenges and needs in dietary supplement research, and the importance of standards and reference materials; (3) describe the work of federal agencies and non-government organizations to develop analytical methods and reference materials to enhance dietary supplement research and assess product quality.

3:45 p.m.

Challenges in Research on Botanical Dietary Supplements

Barbara Sorkin, Ph.D., ODS, NIH

Objectives: (1) Illustrate how concepts of efficacy, safety, and identity/quality are addressed in studying botanicals and plant-derived ingredients; and (2) provide an overview of the NIH Centers for Advancing Research on Botanicals and Other Natural Products (CARBON) Program, research emphases, and examples of research activity.

4:30 p.m.

Adjourn

Day 2 — Thursday, June 1

SESSION 3: EFFICACY AND SAFETY

8:45 a.m.

Efficacy and Effectiveness: Lines of Evidence in Supplement Research

Howard Sesso, Sc.D., M.P.H.,
Harvard Medical School

Objectives: (1) Explain the concepts of efficacy and effectiveness, and how they are defined, measured, studied, and reported in regard to dietary supplements; (2) provide examples of research with dietary supplements to try to evaluate these concepts; and (3) describe the different types of research studies used to determine efficacy and effectiveness.

9:30 a.m.

Safety: The Concept of Safety, Its Measurement, and Reporting

Christine Taylor, Ph.D., ODS, NIH

Objectives: (1) Explain the concept of safety and how it is defined, measured, studied, and reported in regard to dietary supplements; (2) provide examples to illustrate the ways in which the safety of various supplement ingredients have been evaluated; and (3) discuss the patchwork of systems in place to monitor for adverse effects of supplements and how safety concerns vary by population subgroups.

10:15 a.m.

Break

10:30 a.m.

Supplemental Soy and Disease Prevention: How Strong Is the Evidence?

Mindy Kurzer, Ph.D., University of Minnesota

Objectives: (1) Use this particular dietary supplement as an example to illustrate the range of studies and how each type of study has contributed to overall knowledge of this ingredient; and (2) describe some issues in conducting research on soy products and assessments of their value and safety.

11:15 a.m.

Interactions between Supplements and Drugs

Bill Gurley, Ph.D., University of Arkansas
for Medical Sciences College of Pharmacy

Objectives: (1) Describe some major means and mechanisms by which ingredients in supplements and medicines may interact and the potential clinical implications of these interactions; (2) illustrate these concepts with examples; and (3) discuss the extent to which interactions between supplements and drugs are studied, reported by health professionals, pose clinically relevant risks to consumers, and are catalogued in places accessible to health professionals and consumers.

12:00 p.m.

Lunch (on own)

1:15 p.m.

Dietary Supplements and the U.S. Department of Defense

Patricia Deuster, Ph.D., M.P.H., CNS, FACSM,
Uniformed Services University of the Health Sciences

Objectives: (1) Describe the different types of research studies on supplements in the military and their respective strengths and weaknesses; (2) discuss differences in carrying out research studies with the military compared with a nonmilitary population; and (3) present recent data on research studies in the military.

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.

Panel 1: A Conversation With the Industry

2:00 p.m.

Michael McBurney, Ph.D.,
DSM Nutritional Products Inc.

2:15 p.m.

Merle Zimmerman, Ph.D., American Herbal
Products Association

2:30 p.m.

Steven Mister, Esq., Council for Responsible
Nutrition

2:45 p.m.

Panel Discussion

3:00 p.m.

Break

Panel 2: Meet the Watchdogs

3:15 p.m.

David Schardt, M.S., Center for Science in the
Public Interest

3:30 p.m.

Mark Anderson, Ph.D., ConsumerLab.com

3:45 p.m.

Sarah Klein, Prevention Magazine

4:00 p.m.

Panel Discussion

4:15 p.m.

Panel Discussion: Panel 1 and Panel 2

4:45 p.m.

Adjourn

Day 3 — Friday, June 2

SESSION 5: SUPPLEMENT USE IN THE UNITED STATES

8:45 a.m.

Motivations for Dietary Supplement Use

Johanna Dwyer, D.Sc., R.D., ODS, NIH

Objectives: (1) Provide follow-up to a previous presentation with a focus on why people report they take supplements; (2) discuss the strengths and weaknesses of methodologies to collect this information; (3) explore whether reasons for use differ depending on number and types of supplements taken; and (4) describe results from the National Health Interview Survey on motivations for supplement use.

9:30 a.m.

Special Presentation: Dietary Supplement Databases

Joyce Merkel, M.S., R.D., ODS, NIH

Objectives: (1) Describe the purpose and value of several databases that provide information on dietary supplement ingredients; (2) illustrate the content and navigation of these databases; and (3) comment on the value and limitations of these resources.

10:15 a.m.

Break

10:30 a.m.

Dietary Supplements for Weight Loss

Carol Haggans, M.S., R.D., ODS, NIH

Objectives: (1) Provide an overview of the weight-loss supplement market and the types of products available; (2) summarize the scientific evidence for selected ingredients in these products and the quality of that evidence; and (3) using ephedra as a case study, discuss potential safety issues for weight-loss supplement ingredients, including possible interactions with drugs and other supplements.

11:15 a.m.

Analysis of the Evidence

Paul Thomas, Ed.D., R.D.N., ODS, NIH

Objectives: (1) Illustrate the state of the science on the value or lack of value of selected dietary supplement ingredients to promote health and manage problems; (2) provide examples from the published literature of good versus poor research on supplement ingredients; and (3) emphasize the use of evidence-based approaches in recommending and using dietary supplements.

12:00 p.m.

Final Wrap-up to Practicum

Regan Bailey, Ph.D., R.D., Practicum Director,
ODS, NIH

Paul Coates, Ph.D., Director of ODS, NIH

Paul Thomas, Ed.D., R.D., ODS, NIH

12:30 p.m.

Adjourn