2013 Draft Agenda

Day 1 (Tuesday, June 4)

8:30 a.m.

Welcome, Overview, and Setting the Stage

Regan Bailey, Ph.D., R.D., Practicum Director, Office of Dietary Supplements (ODS)

Objectives: (1) Define the category of dietary supplements; (2) provide an overview of the dietary supplement marketplace; and (3) describe the national monitoring efforts of dietary supplement use, with emphasis on the National Health and Nutrition Examination Survey.

SESSION 1: THE RULES AND THE REGULATION

9:15 a.m.

The Dietary Supplement Health and Education Act (DSHEA) and Before

Donna V. Porter, Ph.D., R.D., Specialist in Nutrition and Food Policy, Congressional Research Service (retired) (invited)

Objectives: (1) Describe how dietary supplements were overseen and regulated by the Food and Drug Administration (FDA) prior to enactment of DSHEA in1994; (2) trace the development of DSHEA, its passage into law, and the political and other forces involved; and (3) explain the intent and implementation of the major provisions of DSHEA.

10:00 a.m.

Break

10:15 a.m.

What FDA Does

Daniel Fabricant, 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 postmarketing 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 K. Rusk, J.D., FTC (invited)

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

Noon

Lunch

SESSION 2: UNDERSTANDING THE PRINCIPLES

1:15 p.m.

Analytical Methods, Quality Assurance, and Reference Standards

Joseph M. Betz, Ph.D., ODS, NIH

Objectives: (1) Identify efforts beyond those by FDA and FTC to help characterize the identity, purity, and quantity of ingredients in dietary supplements; (2) describe work in such areas as development of reference materials, calibration standards, and analytical methods and why it is important; and (3) discuss the relevant work of the U.S. Pharmacopeia, AOAC, National Science Foundation, National Institute of Standards and Technology, and others in these efforts to help ensure the manufacture of high-quality dietary supplements.

2:00 p.m.

Identity, Quality, and Certification/Testing

Ed Wyszumiala, USP

Objectives: (1) Illustrate that the mix of bioactives in many supplements presents formidable analytical challenges in assaying the identity, characteristics, and quality of ingredients; (2) discuss methods by which constituents are (or could or should be) assayed in supplements to ensure quality, including specifications for identity, purity, and strength; (3) note activities to develop standards and reference materials for ingredients and why they are important; and (4) note strengths and weaknesses of commercial efforts to assess product quality.

2:45 p.m.

Break

3:15 p.m.

Clinical Trials: Why and How They Are Done

Denise G. Simons-Morton, M.D., Ph.D., National Heart, Lung, and Blood Institute, NIH

Objectives: (1) Describe clinical trials on dietary supplements and their respective strengths and weaknesses; (2) discuss when a clinical trial is necessary; and (3) explain the concepts of efficacy and effectiveness, and how they are defined, studied, and reported in regard to dietary supplements.

4:00 p.m.

Safety: The Concept, Its Measurement, and Reporting

Christine L. 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.

4:45 p.m.

Panel Discussion

5:00 p.m.

Adjourn

Day 2 (Wednesday, June 5)

SESSION 3: SUPPLEMENT USE IN THE UNITED STATES

8:45 a.m.

Motivations for Dietary Supplement Use

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

Objectives: (1) Provide follow-up to 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.

Nutrition Research in the Military

Patricia A. Duester, Ph.D., M.P.H., 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.

10:15 a.m.

Break

10:30 a.m.

Case Study: Challenges in Research on Botanical Dietary Supplements

Barbara C. Sorkin, Ph.D., ODS, NIH

Objectives: (1) Provide overview of the NIH Botanical Research Centers Program, research emphases, and examples of research activity; (2) illustrate how concepts of efficacy, safety, and identity/quality are addressed in studying botanicals and plant-derived ingredients; and (3) identify research issues that are unique or especially relevant to studying herbal products and ingredients.

11:15 a.m.

Dietary Supplements for Weight Loss

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

Noon

Panel Discussion

12:15 p.m.

Lunch

SESSION 4: UNDERSTANDING RESEARCH ISSUES

1:30 p.m.

The Different Types of Studies and What They Tell Us

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

Objectives: (1) Provide an overview of the range of research studies on supplements, addressing their respective strengths and weaknesses and what each contributes to the mix of knowledge, and (2) describe the different levels of evidence from anecdotal reports to clinical trials and evidence-based reviews.

2:15 p.m.

Research Design Issues With Dietary Supplements

Christopher T. Sempos, Ph.D., ODS, NIH

Objectives: (1) Describe the different types of epidemiological research studies on supplements and their respective strengths and weaknesses; (2) define nutritional epidemiology as it pertains to dietary supplements; (3) describe the types and sources of measurement error, methods used to adjust for it, and how it may influence research findings and study interpretations; and (4) identify other variables that can affect the results of epidemiological studies on supplements and how they need to be recognized and/or addressed prior to conducting the study.

3:00 p.m.

Break

3:15 p.m.

Nutrigenomics, Genetic Tests, and Personalized Nutrition

Kathryn Camp, M.S., R.D., CSP, ODS, NIH

Objectives: (1) Describe how these three topics are linked, and the extent of scientific and public interest; (2) note the growth in scientific knowledge that has lead to the use of genotypes to predict disease and assess health; (2) identify commercial applications of direct-to-consumer genetic testing that make nutritional and dietary-supplement recommendations; and (4) cite public policies and research on the value and potential benefits and risks of genetic testing among healthy individuals.

4:00 p.m.

Panel Discussion

5:00 p.m.

Adjourn

Day 3 (Thursday, June 6)

SESSION 5: WHEN THE LINES BLUR

8:30 a.m.

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

John Milner, Ph.D., Beltsville Human Nutrition Research Center, U.S. Department of Agriculture

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 garlic products and assessments of their value and safety.

9:15 a.m.

Case Study: Foods as Dietary Supplements, Global Perspective

Speaker TBD

10:00 a.m.

Break

10:30 a.m.

Case Study: Iodine

Christine Swanson, Ph.D., ODS, NIH

11:15 a.m.

Interactions Between Supplements and Drugs

Bill J. 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.

Noon

Lunch

1:15 p.m.

Special Presentation: Dietary Supplement Databases

Joyce M. 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.

SESSION 6: MEETING THE STAKEHOLDERS

Attendees will visit with those who study, advocate, regulate, or educate on dietary supplements. Topics for speakers to address: (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.

2:00 p.m.

Panel 1: A Conversation With the Industry

Robert W. Henderson, P.D., N.D., Nutramax Laboratories, Inc.

Michael McGuffin, American Herbal Products Association (invited)

Steven M. Mister, Esq., Council for Responsible Nutrition

3:15 p.m.

Break

3:45 p.m.

Panel 2: Meet the Watchdogs

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

Tod Cooperman, M.D., ConsumerLab.com

Natasha Singer, The New York Times

4:45 p.m.

Panel Discussion

5:00 p.m.

Adjourn

Day 4 (Friday, June 7)

SESSION 7: SCIENCE, ACTION, ADVICE, AND POLICY

8:30 a.m.

Case Study: Vitamin D and the Dietary Reference Intakes (DRI) Process

Patsy M. Brannon, Ph.D., R.D., Cornell University

Objectives: (1) Describe the DRIs and the DRI process, with particular applicability to vitamin D; (2) provide an overview of vitamin D including its effects on health; (3) describe the reasons and sources of debate among vitamin D experts as to "optimal" levels of intake and their benefits; and (4) describe uses of the DRIs especially as they may be relevant to dietary supplements.

9:15 a.m.

Case Study: Folate and Folic Acid

James L. Mills, M.D., M.S., Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH

Objectives: (1) Use this particular dietary supplement to illustrate the breadth of research studies on it and how each type of study has contributed to overall knowledge of this vitamin; (2) describe some issues in conducting research on folic acid trials in the United States; and (3) describe previous research studies relating folic acid to neural tube defects, and how current research is being conducted on this vitamin.

10:00 a.m.

Break

10:30 a.m.

Case Study: Omega-3 Fatty Acids

Cindy D. Davis, Ph.D., ODS, NIH

Objectives: (1) Use this particular dietary supplement to illustrate the breadth of research studies on it and how each type of study has contributed to overall knowledge of this ingredient, and (2) describe some issues in conducting research on omega-3 fatty acid products and assessments of their value and safety.

11:15 a.m.

Analysis of the Evidence

Paul Thomas, Ed.D., R.D., 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 vs. poor research on supplement ingredients; and (3) emphasize the use of evidence-based approaches in recommending and using dietary supplements.

Noon

Final Wrap-up to Practicum