Agenda
Day 1 | Day 2 | Day 3 | Day 4 | Day 5
The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) offers this intensive practicum to provide fundamental knowledge of dietary supplements to faculty, PhD students, and post-docs at academic institutions; healthcare practitioners; and other professionals with advanced biomedical degrees. Its three main goals are to:
- Provide participants with a thorough overview and grounding about issues, concepts, controversies, and unknowns about dietary supplements and supplement ingredients. A crosscutting theme will be the importance of scientific investigations to evaluate the efficacy, safety, and value of these products for health promotion and disease prevention and treatment;
- Provide participants with information, ideas, and resources so that they might provide some or more instruction about dietary supplements at their academic institutions; and
- Instill interest among students and investigators attending the practicum to consider undertaking research in the field of dietary supplements.
Day 1 (Monday, June 1): Setting the Stage |
8:30 am to Noon |
Session 1: Who Takes What for Why, and How Do We Know?
Goals: (1) Explain purpose of the practicum and its organization, (2) examine the use of dietary supplements and reasons for their use in the U.S. population generally and among specific subgroups, and (3) describe methodologies to collect data on food and supplement use.
Each presentation is 30 minutes followed by 15 minutes of questions. |
8:30 am to 9:00 am |
Presentation 1: Welcome and Overview
Objectives: (1) Provide welcome, (2) give overview of the practicum, including what participants can expect to learn and the focus of each session, and (3) describe some of the work and resources of ODS.
Paul M. Coates, PhD
NIH Office of Dietary Supplements |
9:00 am to 9:15 am |
Questions for Speaker |
9:15 am to 9:45 am |
Presentation 2: Who Takes Dietary Supplements?
Objectives: (1) Describe the studies/surveys that detail what dietary supplements consumers are taking, (2) discuss the methodologies for collecting this information and their strengths and weaknesses, and (3) describe supplement use in special populations (children, elderly, etc.).
Mary Frances Picciano, PhD
NIH Office of Dietary Supplements |
9:45 am to 10:00 am |
Questions for Speaker |
10:00 am to 10:15 am |
Break |
10:15 am to 10:45 am |
Presentation 3: Reasons for Using Dietary Supplements
Objectives: (1) Followup 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.
Johanna T. Dwyer, DSc, RD
NIH Office of Dietary Supplements |
10:45 am to 11:00 am |
Questions for Speaker |
| 11:00 am to 11:30 am |
Presentation 4: Measuring Food and Supplement Intakes
Objectives: (1) Provide overview of dietary assessment methods, (2) explain usual nutrient intake distributions, (3) provide background on the methods of dietary and dietary-supplement assessment in the National Health and Nutrition Examination Survey (NHANES), and (4) discuss relevant research comparing methods to assess dietary supplement use.
Regan L. Bailey, PhD, RD, LDN
NIH Office of Dietary Supplements |
11:30 am to 11:45 am |
Questions for Speaker |
11:45 am to Noon |
Questions and Discussion with Session 1 Speakers |
Noon to 1:30 pm |
Lunch |
1:30 pm to 5:00 pm |
Session 2: It's the Law: Rules and Regulations
Goals: (1) Provide a solid grounding in the oversight and regulation of dietary supplements within the federal government, (2) describe the roles of the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) pertaining to supplements, and (3) examine the rules (and their history) that govern the labeling of ingredients in dietary supplements and health-type claims on supplement labels and in product advertising.
Each presentation is 30 minutes followed by 15 minutes of questions. |
1:30 pm to 2:00 pm |
Presentation 1: The Dietary Supplement Health and Education Act (DSHEA) and Before
Objectives: (1) Describe how dietary supplements were overseen and regulated by the FDA prior to enactment of DSHEA in 1994, (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.
William B. Schultz, JD
Zuckerman Spaeder, LLP |
2:00 pm to 2:15 pm |
Questions for Speaker |
2:15 pm to 2:45 pm |
Presentation 2: What the Food and Drug Administration (FDA) Does
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.
Vasilios H. Frankos, PhD
U.S. Food and Drug Administration |
2:45 pm to 3:00 pm |
Questions for Speaker |
3:00 pm to 3:15 pm |
Break |
3:15 pm to 3:45 pm |
Presentation 3:
What the Federal Trade Commission (FTC) Does
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.
Michelle K. Rusk, JD
U.S. Federal Trade Commission |
3:45 pm to 4:00 pm |
Questions for Speaker |
4:00 pm to 4:30 pm |
Presentation 4: Supplement Labels and Claims
Objectives: (1) Provide historical overview of labels and health-related claims on dietary supplements (and foods) and contrast with drug claims, (2) explain health-related claims (i.e., health, qualified health, structure-function, and nutrient-content) on supplements and rules for their use, and (3) address monitoring and enforcement activities of FDA and FTC for labeling and claims for supplements on labels, associated literature, websites, and advertising.
Paul R. Thomas, EdD, RD
NIH Office of Dietary Supplements |
4:30 pm to 4:45 pm |
Questions for Speaker |
4:45 pm to 5:00 pm |
Questions and Discussion with Session 2 Speakers |
6:00 pm to 7:30 pm |
Reception
Hyatt Regency Bethesda |
Day 2 (Tuesday, June 2): To Market, To Market |
8:00 am to 11:30 am |
Session 3: Drugs, Foods, and Supplements: On Different Paths
Goals: (1) Compare and contrast the means, methods, scientific study, and regulatory oversight involved in bringing medicines, foods, and dietary supplements to the American marketplace, and (2) address the interactions of supplements with drugs, including how they are assessed, the state of current knowledge, and issues of physiological possibilities vs. clinical implications.
Each presentation is 30 minutes followed by 15 minutes of questions. |
8:00 am to 8:30 am |
Presentation 1: Bringing a Drug to Market
Objectives: (1) Explain how biologically active substances are evaluated as potential drug candidates, including the four phases of clinical trials, (2) describe how pharmaceutical companies and the FDA work together to turn drug candidates into federally approved medications, and (3) illustrate all the steps in the process of bringing a drug to market.
Meghan M. Murphy, PhD
U.S. Food and Drug Administration |
8:30 am to 8:45 am |
Questions for Speaker |
8:45 am to 9:15 am |
Presentation 2: Bringing a Food to Market
Objectives: (1) Explain how natural products are evaluated as potential foods by interested entities, (2) describe the major steps involved in bringing a new food to market, and (3) discuss the extent to which a company interacts with FDA in this process.
Debra L. Miller, PhD
Director of Nutrition, The Hershey Company
|
9:15 am to 9:30 am |
Questions for Speaker |
9:30 am to 9:45 am |
Break |
9:45 am to 10:15 am |
Presentation 3: Bringing a Supplement to Market
Objectives: (1) Explain how biologically active natural substances are evaluated as potential dietary-supplement ingredients by interested entities, (2) describe the various models supplement companies may use to market and distribute their products, and (3) detail the major steps involved in identifying, processing, and manufacturing a high-quality supplement.
Anthony L. Almada, MS
IMAGINutrition, Inc.
|
10:15 am to 10:30 am |
Questions for Speaker |
10:30 am to 11:00 am |
Presentation 4: Interactions Between Supplements and Drugs
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.
Bill J. Gurley, PhD
University of Arkansas for Medical Sciences |
11:00 am to 11:15 am |
Questions for Speaker |
11:15 am to 11:30 am |
Questions and Discussion with Session 3 Speakers |
11:30 am to 12:30 pm |
Lunch |
11:50 am to 12:20 pm |
(Optional) NIH 101
Presentation and slide tour of the NIH |
12:30 pm to 3:00 pm |
Session 4: Understanding the Principles
Goals: (1) Provide a solid grounding in the concepts of efficacy and safety, including how they are defined, measured, studied, and reported, (2) explain how dietary supplements present unique challenges in validating the identity of their constituents and ensuring product quality as compared to most medications, and (3) illustrate ways in which efficacy, safety, and quality of dietary supplements are evaluated.
Each presentation is 30 minutes followed by 15 minutes of questions. |
12:30 pm to 1:00 pm |
Presentation 1: Efficacy and Effectiveness: The Concepts and Their Measurement
Objectives: (1) Explain the concepts of efficacy and effectiveness, and how they are defined, distinguished, measured, studied, and reported in regard to dietary supplements, and (2) provide examples to illustrate the variety of ways in which the efficacy and effectiveness of supplement ingredients have been evaluated, and (3) introduce the concept of cost effectiveness in evaluating supplements.
Lawrence M. Friedman, MD
NIH National Heart, Lung, and Blood Institute (retired) |
1:00 pm to 1:15 pm |
Questions for Speaker |
1:15 pm to 1:45 pm |
Presentation 2: Safety: The Concept, Its Measurement, and Reporting
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.
Elizabeth A. Yetley, PhD
NIH Office of Dietary Supplements (retired) |
1:45 pm to 2:00 pm |
Questions for Speaker |
2:00 pm to 2:30 pm |
Presentation 3: Identity and Quality
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, (4) note strengths and weaknesses of commercial efforts to assess product quality, and (5) describe the Product Quality Working Group at NIH's National Center for Complementary and Alternative Medicine (NCCAM).
Joseph M. Betz, PhD
NIH Office of Dietary Supplements |
2:30 pm to 2:45 pm |
Questions for Speaker |
2:45 pm to 3:00 pm |
Questions and Discussion with Session 4 Speakers |
3:15 pm to 5:15 pm |
(Optional) Special Event
Tour of the NIH Clinical Center, National Library of Medicine, and overall NIH campus. |
Day 3 (Wednesday, June 3): Meeting the Stakeholders |
8:30 am to about
1:00 pm |
Attendees will visit with those who study, advocate, regulate, or educate on dietary supplements in Washington DC. Questions for speakers to address: (1) Describe the purposes of your organization (agency, etc.) in relation to dietary supplements. What are its perspectives and views 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.
Location:
Russell Senate Office Building, Washington DC
Panel 1: Legislative Opportunities
Senator Orrin G. Hatch (R-Utah)
United States Senate
Donna V. Porter, PhD, RD
Congressional Research Service
Location:
Wilbur J. Cohen Building, Washington DC
Panel 2: Face to Face with the Industry
Steven M. Mister, Esq.
Council for Responsible Nutrition
Daniel Fabricant, PhD
Natural Products Association
Steven Dentali, PhD
American Herbal Products Association
Panel 3: Meet the Consumer Groups & Media
David Schardt, MS
Center for Science in the Public Interest
Peter Lurie, MD, MPH
Public Citizen's Health Research Group
Rob Stein
The Washington Post
Questions and Discussion with Speakers |
Day 4 (Thursday, June 4): Assessing the Health Effects of Supplement Ingredients and Locating Information |
8:30 am to Noon |
Session 5: Doing the Studies
Goals: (1) Provide an overview of the different types of research on dietary supplements, the kinds of information each type provides, and their relative strengths and weaknesses, (2) give examples of how these studies have advanced understanding of specific supplements, (3) describe considerations to be addressed in the conduct of a research study on supplements, and (4) present good and bad examples of how dietary supplements have been characterized in published journal articles.
Each presentation is 30 minutes followed by 15 minutes of questions and discussion. |
8:30 am to 9:00 am |
Presentation 1: The Different Types and What They Tell Us
Objectives: (1) Provide an overview of the range of research studies on supplement, 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.
Paul D. Sorlie, PhD
NIH National Heart, Lung, and Blood Institute |
9:00 am to 9:15 am |
Questions for Speaker |
9:15 am to 9:45 am |
Presentation 2: Case Study: Garlic
Objectives: (1) Use this particular dietary supplement as an example to illustrate the range of studies described in the previous talk 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.
John Milner, PhD
NIH National Cancer Institute |
9:45 am to 10:00 am |
Questions for Speaker |
10:00 am to 10:15 am |
Break |
10:15 am to 11:00 am |
Presentation 3: Research-Design Issues with Epidemiological Studies on Dietary Supplements
Objectives: (1) define nutritional epidemiology as it pertains to dietary supplements, (2) 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 (3) 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.
Christopher T. Sempos, PhD
NIH Office of Dietary Supplements |
10:45 am to 11:00 am |
Questions for Speaker |
11:00 am to 11:30 am |
Presentation 4: Conducting a Clinical Trial with Dietary Supplements
Objectives: (1) Describe the institutional, research, regulatory, and other considerations to be addressed in conducting a study on supplements, (2) discuss the many variables that can affect the results of clinical trials on supplements and how they need to be recognized and/or addressed prior to conducting the study, and (3) address the need to fully characterize the supplement under study, using examples from published studies.
Robert M. Russell, MD
NIH Office of Dietary Supplements |
11:30 am to 11:45 am |
Questions for Speaker |
11:45 am to Noon |
Questions and Discussion with Session 5 Speakers |
Noon to 1:30 pm |
Lunch |
1:30 pm to 5:00 pm |
Session 6: Finding Information on Dietary Supplements
Goals: (1) Participants will learn the purpose and value of several databases that inform users about research on dietary supplement ingredients, identify the contribution of dietary supplements to total nutrient intakes from all sources, and provide data on the nutrients and bioactive components in specific foods. They will become familiar with the content and navigation of these databases and complete several exercises to learn the value and limitations of these resources.
Each presentation is 30 minutes followed by 15 minutes of questions and discussion.
|
1:30 pm to 2:00 pm |
Presentation 1: MEDLINE/PubMed Database
Susan M. Pilch, PhD, MLS
NIH Library |
2:00 pm to 2:15 pm |
Questions for Speaker |
2:15 pm to 2:45 pm |
Presentation 2: IBIDS (International Bibliographic Information on Dietary Supplements) Database
Rebecca B. Costello, PhD
NIH Office of Dietary Supplements |
2:45 pm to 3:00 pm |
Questions for Speaker |
3:00 pm to 3:15 pm |
Break |
3:15 pm to 3:45 pm |
Presentation 3: RCDC (Research, Condition, and Disease Categorization), RePORT (Research Portfolio Online Reporting Tool), HNRIM (Human Nutrition Research and Information Management System), and CARDS (Computer Access to Research on Dietary Supplements)
Karen S. Regan, MS, RD
NIH Office of Dietary Supplements |
3:45 pm to 4:00 pm |
Questions for Speaker |
4:00 pm to 4:30 pm |
Presentation 4: Characterizing Supplements in Journal Articles
Objectives: (1) Provide examples from the published literature to demonstrate both superior and inadequate descriptions of supplement identity, purity, and strength, (2) explain why adequate characterization of dietary supplements in published research is important to forwarding the research agenda on specific supplements, and (3) discuss recommendations from various professional groups to researchers for characterizing the supplements being evaluated in various trials and the details that should be provided when preparing manuscripts.
Christine A. Swanson, PhD, MPH, RD
NIH Office of Dietary Supplements |
4:30 pm to 4:45 pm |
Questions for Speaker |
4:45 pm to 5:00 pm |
Questions and Discussion with Session 6 Speakers |
Day 5 (Friday, June 5): The Big Picture |
8:30 am to 12:30 pm |
Session 7: Science, Action, Advice, and Policy
Goals: (1) Describe how public and regulatory policies pertaining to dietary supplements is generally built over time upon a strong foundation of science, (2) illustrate these points with case studies on vitamin D and the Dietary Reference Intakes (DRIs), (3) discuss the issues and challenges of communicating information about supplements to various audiences, and (4) provide a final opportunity to ask questions and discuss supplement-related issues with ODS staff and guests.
Each presentation is 30 minutes followed by 15 minutes of questions. |
8:30 am to 9:00 am |
Presentation 1: NHANES and Biomarkers of Exposure
Objectives: (1) Define biomarkers and how they are selected and used to evaluate exposure and status to various ingredients found in supplements, (2) discuss how biomarkers are identified, evaluated, measured, and used for specific nutrients, (3) describe the strengths and weaknesses of using biomarkers as surrogate measures of exposure and how some biomarkers are more strongly associated with exposure than others, and (4) provide overview of the National Health and Nutrition Examination Survey (NHANES).
Clifford L. Johnson, MSPH
National Center for Health Statistics |
9:00 am to 9:15 am |
Questions for Speaker |
9:15 am to 9:45 am |
Presentation 2: Case Study: Vitamin D
Objectives: (1) Provide overview of vitamin D, including its effects on health, metabolic trafficking, and fate, (2) describe the factors, forces, and people involved in translating science to public policy for vitamin D, (3) describe the reasons and sources of debate among vitamin D experts as to "optimal" levels of intake and their benefits, and (4) describe the "Vitamin D Initiative" at the NIH and note the re-evaluation of recommended intakes for vitamin D and calcium by the Food and Nutrition Board.
Patsy M. Brannon, PhD, RD
Cornell University |
9:45 am to 10:00 am |
Questions for Speaker |
10:00 am to 10:15 am |
Break |
10:15 am to 10:45 am |
Presentation 3: Case Study: Probiotics
Objectives: (1) Provide overview of probiotics and their availability in both foods and dietary supplements, (2) describe some unique issues in conducting research on these products and why the literature to date provides little consensus on their value and safety.
Marguerite Klein, MS
NIH Office of Dietary Supplements |
10:45 am to 11:00 am |
Questions for Speaker |
11:00 am to 11:30 am |
Presentation 4: Informing Policy Through Science
Objectives: (1) Discuss how science is used to advance knowledge about nutrition and dietary supplements and to develop public policies about these products, and (2) illustrate the science-policy continuum using the Dietary Reference Intakes as an example.
Linda D. Meyers, PhD
Food and Nutrition Board, Institute of Medicine of the National Academies |
11:30 am to 11:45 am |
Questions for Speaker |
11:45 am to Noon |
Questions and Discussion with Session 7 Speakers |
Noon to 12:30 pm |
Final Questions and Discussion with ODS Staff and Speakers
|
12:30 pm |
Adjourn |
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