Agenda

Day 1 (Monday, June 9): Setting the Stage

8:30 am to 11:15 am

Session 1: Who Takes What for Why, and How Do We Know?

Goals: (1) Explain purpose of the practicum and its organization, (2) describe the size and sales of the dietary supplement marketplace, and (3) examine the use of dietary supplements and reasons for their use in the U.S. population generally and among specific subgroups.

Each presentation is 30 minutes followed by 15 minutes of questions.

8:30 am to 9:15 am

Presentation 1: Welcome and Overview

Objectives: (1) Provide welcome, (2) characterize the world of dietary supplements (size, sales, etc.), and (3) give an overview of the practicum, including what participants can expect to learn and the focus of each session.

Paul M. Coates, PhD
NIH Office of Dietary Supplements

9:15 am to 10:00 am

Presentation 2: Who's Taking What?

Objectives: (1) Describe the studies/surveys that describe 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

10:00 am to 10:15 am

Break

10:15 am to 11:00 am

Presentation 3: Why Are They Taking Them?

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, and (3) explore whether reasons for use differ depending on number and types of supplements taken.

Johanna T. Dwyer, DSc, RD
NIH Office of Dietary Supplements

11:00 am to 11:15 am

Questions and Discussion with Session 1 Speakers

11:15 am 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 and discussion.

11:15 am to Noon

Presentation 1: The Dietary Supplement Health and Education Act (DSHEA) and Before

Objectives: (1) Describe how dietary supplements were overseen and regulated by 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

Noon to 1:30 pm

Lunch

1:30 pm to 2:15 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

2:15 pm to 3:00 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

3:00 pm to 3:15 pm

Break

3:15 pm to 4:00 pm

Presentation 4: Supplement Labels

Objectives: (1) Provide historical information on the Commission on Dietary Supplement Labels mandated by DSHEA, (2) explain the rules that govern the kinds and presentation of information on supplement labels, (3) contrast supplement labels with labels for foods and medicines, and (4) describe special issues in labeling herbal supplements.

Kenneth D. Fisher, PhD
NIH Office of Dietary Supplements

4:00 pm to 4:45 pm

Presentation 5: Claims on Supplements and Foods

Objectives: (1) Provide brief historical overview of health-related claims on dietary supplements (and foods) and contrast with drug claims, (2) explain the different types of health-related claims allowed on supplements and rules governing their use, and (3) emphasize the monitoring and enforcement activities of FDA and FTC regarding claims for supplements on labels, in third-party literature, on websites, and in advertising.

Paul R. Thomas, EdD, RD
NIH Office of Dietary Supplements

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 10): To Market, To Market

8:30 am to Noon

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 and discussion.

8:30 am to 9:15 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 with a hypothetical example.

Meghan Murphy, PhD
U.S. Food and Drug Administration

9:15 am to 10:00 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.

John W. Finley, PhD
Louisiana State University

10:00 am to 10:15 am

Break

10:15 am to 11:00 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.

Steven Dentali, PhD
American Herbal Products Association

11:00 am to 11:45 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 an example, 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

11:45 am to Noon

Questions and Discussion with Session 3 Speakers

12:30 pm to 1:15 pm

(Optional) NIH 101

Presentation and slide tour of the NIH

Noon to 1:30 pm

Lunch

1:30 pm to 5:00 pm

Session 4: What's in the Bottle?

Goals: (1) Explain how dietary supplements present unique challenges in validating the identity of their constituents and ensuring product quality as compared to most medications, (2) describe the FDA's final rule to ensure good manufacturing practices for dietary supplements and the ongoing efforts of various third-party organizations to evaluate product quality, (3) evaluate good and bad examples of how dietary supplements have been characterized in published journal articles, and (4) explain why detailed descriptions of product identity and quality are essential to advancing research on these products.

Each presentation is 30 minutes followed by 15 minutes of questions and discussion.

1:30 pm to 2:15 pm

Presentation 1: Identity and Quality

Objectives: (1) Provide an understanding of the complexity of many dietary supplements—that with their mix of bioactive substances they present formidable analytical challenges in assaying the identity, characteristics, and quality of ingredients, (2) discuss the various methods by which constituents are assayed in supplements to ensure quality, including meeting specifications for identity, purity, and strength, and (3) describe activities to develop standards and reference materials for ingredients in supplements and why they are important.

Joseph M. Betz, PhD
NIH Office of Dietary Supplements

2:15 pm to 3:00 pm

Presentation 2: Good Manufacturing Practices (GMPs) for Supplements and Evaluating Quality

Objectives: (1) Provide an overview of the growing awareness of supplement-quality concerns and government, commercial, and non-profit efforts to address this problem and provide product-selection advice, (2) briefly describe FDA's new regulations on GMPs for supplements, (3) compare and contrast the business models and approaches taken by the major third-party evaluators to evaluate supplement quality and make available their findings, (4) evaluate the strengths and weaknesses in efforts to assess and ensure product quality, and (5) describe the Product Quality Working Group at NIH's National Center for Complementary and Alternative Medicine (NCCAM).

Marguerite Klein, MS, RD
NIH Office of Dietary Supplements

3:00 pm to 3:15 pm

Break

3:15 pm to 4:00 pm

Presentation 3: 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 Swanson, PhD, RD
NIH Office of Dietary Supplements

4:00 pm to 4:15 pm

Questions and Discussion with Session 4 Speakers

4:15 pm to 6:00 pm

(Optional) Special Event:

Shuttle bus tour of the NIH campus and tour of the NIH Clinical Center

Day 3 (Wednesday, June 11): Meeting the Stakeholders

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.

Each speaker in each panel will have 15 minutes to speak. The remaining 30 minutes will be for questions and discussion, with the moderator questioning panelists as appropriate to create debate.

Location:
Wilbur J. Cohen Building (at 330 Independence Avenue, S.W.)

8:45 am to 10:00 am

Panel 1: Professional Players

• Mary Lee Watts, MPH, RD
  American Society for Nutrition
• Maria Oria, PhD
  Food and Nutrition Board, Institute of Medicine
• Mary Hastings Hager, PhD, RD
  American Dietetic Association

10:05 am to 11:20 am

Panel 2: Face to Face with the Industry

• Steven M. Mister, Esq.
  Council for Responsible Nutrition
• Michael McGuffin
  American Herbal Products Association
• Robert W. Henderson, PD
  Nutramax Laboratories, Inc.

11:30 am to 12:45 pm

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
• Sally Squires, MS
  The Washington Post

12:45 pm to 1:00 pm

Questions and Discussion with Speakers

1:00 pm

Adjourn

Day 4 (Thursday, June 12): Assessing the Health Effects of Foods and Supplements, Part 1

8:30 am to Noon

Session 5: Understanding the Principles

Goals: (1) Describe the methodologies employed to evaluate the health effects of foods and supplements and their respective strengths and weaknesses, (2) discuss how biomarkers are identified and used to evaluate exposure and status in regard to ingredients in dietary supplements, and 3) provide a solid grounding in the concepts of efficacy and safety, including how they are defined, measured, studied, and reported.

Each presentation is 30 minutes followed by 15 minutes of questions and discussion.

8:30 am to 9:15 am

Presentation 1: Measuring Food and Supplement Intakes

Objectives: (1) Describe and discuss the strengths and weaknesses of methods used to collect data on supplement use and related behaviors, (2) discuss the issue of whether users and nonusers differ in the quality of their diets, and (3) provide an overview of the federal government's National Nutrition Monitoring system.

Regan L. Bailey, PhD, RD, LDN
NIH Office of Dietary Supplements

9:15 am to 10:00 am

Presentation 2: 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

10:00 am to 10:15 am

Break

10:15 am to 11:00 am

Presentation 3: Efficacy: The Concept and Its Measurement

Objectives: (1) Explain the concept of efficacy and how it is defined, measured, studied, and reported in regard to dietary supplements, (2) provide examples to illustrate the variety of ways in which the efficacy of supplement ingredients have been evaluated, and (3) describe the value of evidence-based reviews and how they are conducted.

Barnett S. Kramer, MD, MPH
NIH Office of Disease Prevention

11:00 am to 11:45 am

Presentation 4: 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

11:45 am to Noon

Questions and Discussion with Session 5 Speakers

Noon to 1:30 pm

Lunch

1:30 pm to 4:45 pm

Session 6: Special Focus on Dietary Supplement Databases

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.

• 1:30 pm to 2:15 pm
  MEDLINE/PubMed
  • Susan M. Pilch, PhD, MLS
    NIH Library

• 2:15 pm to 3:00 pm
  IBIDS (International Bibliographic Information on Dietary Supplements)
  • Rebecca B. Costello, PhD
    Andrea T. Lindsey, MS
    Lora Wilder, ScD, RD
    NIH Office of Dietary Supplements

• 3:00 pm to 3:15 pm
  Break

• 3:15 pm to 4:00 pm
  CRISP (Computer Retrieval of Information on Scientific Projects)
  HNRIM (Human Nutrition Research and Information Management) System
  CARDS (Computer Access to Research on Dietary Supplements
  • Karen S. Regan, MS, RD
    NIH Office of Dietary Supplements

• 4:00 pm to 4:30 pm
  NOADS (NHANES [National Health and Nutrition Examination Survey] Online Analyst of Dietary Supplements)
  • Mary Frances Picciano, PhD
    NIH Office of Dietary Supplements

• 4:30 pm to 4:45 pm
  Questions and Discussion with Session 6 Speakers

Day 5 (Friday, June 13): Assessing the Health Effects of Foods and Supplements (Part 2) and The Big Picture

8:30 am to 10:00 am

Session 7: 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, and (2) describe considerations to be addressed in the conduct of a research study on supplements.

Each presentation is 30 minutes followed by 15 minutes of questions and discussion.

8:30 am to 9:15 am

Presentation 1: Conducting a Study 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
Tufts University, Human Nutrition Research Center on Aging

9:15 am to 10:00 am

Presentation 2: The Different Types and What They Tell Us

Objectives: (1) Provide an overview of the range of research studies on dietary supplements, addressing their respective strengths and weaknesses and what each contributes to the mix of knowledge, (2) describe the different levels of evidence from anecdotal reports to clinical trials and evidence-based reviews, and (3) give several examples of how combinations of these types of studies have advanced understanding of specific supplements.

William R. Harlan, MD
NIH National Library of Medicine

10:00 am to 10:15 am

Break

10:15 am to 12:30 pm

Session 8: Science, Policy, Action, and Advice

Goals: (1) Describe how public and regulatory policies pertaining to dietary supplements is generally built over time upon a strong foundation of science, (2) discuss the issues and challenges of communicating information about supplements to various audiences, and (3) provide atten dees a final opportunity to ask questions and discuss supplement-related issues with ODS staff and guests.

Each of the first two presentations is 30 minutes followed by 15 minutes of questions and discussion.

10:15 am to 11:00 am

Presentation 1: Moving From Science to Policy

Objectives: (1) Discuss how science is used to advance knowledge about dietary supplements and develop public policies about these products, (2) illustrate the science-policy continuum, using vitamin D as an example, and (3) describe the factors, forces, and people involved in translating science to public policy for supplements.

Patsy M. Brannon, PhD, RD
Cornell University

11:00 am to 11:45 am

Presentation 2: Communicating Scientific Information About Dietary Supplements

Objectives: (1) Describe today’s environment for learning about supplements in which commercial, industry, and advocacy groups provide information in various media, (2) provide examples of communication efforts about supplements and evaluate the nature of their messages, reach, and effectiveness, and (3) discuss the tools for communicating effectively about supplements and tailoring the messages according to the needs of various audiences.

Susan T. Borra, RD
International Food Information Council

11:45 am to Noon

Questions and Discussion with Sessions 7 & 8 Speakers

Noon to 12:15 pm

Presentation 3: Resources of the Office of Dietary Supplements

Objective: Describe materials by ODS that may be of value to participant.

Anne L. Thurn, PhD
NIH Office of Dietary Supplements

12:15 pm to 12:30 pm

Final Discussion and Q&A with ODS Staff and Speakers

Objectives: (1) Answer final questions from participants, and (2) discuss the work of NIH and ODS regarding dietary supplements.

12:30 pm

Adjourn