Agenda

Day 1 (Monday, June 4): Setting the Stage

8:30 am to 8:45 am

Welcome and Opening Remarks

Paul M. Coates, Regan Bailey, and Paul R. Thomas

8:45 am to 12:15 pm

Session 1: Monitoring Dietary Supplement Use in the United States

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.

8:45 am to 9:15 am

Presentation 1: Dietary Supplements: Overview and Setting the Stage

Objectives: (1) Define the category of dietary supplements, (2) provide an overview of the dietary supplement marketplace, and (3) briefly address the extent of research on dietary supplement ingredients.

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

9:15 am to 10:00 am

Presentation 2: Monitoring Biomarkers in the National Health and Nutrition Examination Survey

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 10:30 am

Break

10:30 am to 11:15 am

Presentation 3: Measuring Dietary Supplement Use

Objectives: (1) Describe the national monitoring efforts of dietary supplement use, with emphasis on the National Health and Nutrition Examination Survey (NHANES), (2) discuss the methodologies for collecting supplement information and their strengths and weaknesses, (3) describe supplement use over time in the United States, (4) describe strategies for combining nutrient data from foods and dietary supplements, and (5) discuss relevant research of dietary supplement use.

Regan Bailey, PhD, RD
NIH Office of Dietary Supplements

11:15 am to 12:00 pm

Presentation 4: Motivations for Dietary Supplement Use

Objectives: (1) 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.

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

12:00 pm to 12:15 pm

Questions and Discussion with Session 1 Speakers

12:15 pm to 1:30 pm

Lunch (on your own)

1:30 pm to 5:15 pm

Session 2: 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.

1:30 pm to 2:15 pm

Presentation 1: Efficacy and Effectiveness: The Concepts and Their Assessment

Objectives: (1) Explain the concept of efficacy, how it is defined, studied, and reported in regard to diet, (2) explain the concept of effectiveness and how it is different from efficacy in how it is defined, studied, and reported in regard to diet, and (3) describe the value of evidence-based reviews and how they are conducted.

Denise Simons-Morton, MD, PhD
NIH National Heart, Lung, and Blood Institute

2:15 pm to 3:00 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.

Christine L. Taylor, PhD
NIH Office of Dietary Supplements

3:00 pm to 3:30 pm

Break

3:30 pm to 4:15 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, and (4) note strengths and weaknesses of commercial efforts to assess product quality.

John H. Cardellina II, PhD
McCormick & Company, Inc. (formerly with NIH Office of Dietary Supplements)

4:15 pm to 5:00 pm

Presentation 4: Challenges in Advancing Research on Botanical Dietary Supplements

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.

Barbara C. Sorkin, PhD
NIH Office of Dietary Supplements

5:00 pm to 5:15 pm

Questions and Discussion with Session 2 Speakers

5:15 pm

Welcome Session and Evening Presentation

Paul M. Coates, PhD
NIH Office of Dietary Supplements

Day 2 (Tuesday, June 5): "A Product Intended to Supplement the Diet"

8:15 am to 12:00 pm

Session 3: It's the Law: Rules, Regulations, and Standards

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) describe the development of recommended dietary intakes for nutrients and their purposes.

8:15 am to 9:00 am

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.

Donna V. Porter, PhD, RD
Congressional Research Service (retired)

9:00 am to 9:45 am

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.

Daniel Fabricant, PhD
U.S. Food and Drug Administration

9:45 am to 10:15 am

Break

10:15 am to 11:00 am

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

11:00 am to 11:45 am

Presentation 4: Assisting the Regulators: Analytical Methods, Quality Assurance, and Reference Standards

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, NSF, National Institute of Standards and Technology and others in these efforts to help ensure the manufacture of high-quality dietary supplements.

Joseph M. Betz, PhD
NIH Office of Dietary Supplements

11:45 am to 12:00 pm

Questions and Discussion with Session 3 Speakers

12:00 pm to 1:15 pm

Lunch (on your own)

1:15 pm to 5:00 pm

Session 4: 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.

1:15 pm to 2:00 pm

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.

Adrianne Bendich, PhD, FACN
Consultants in Consumer Healthcare LLC (formerly with GlaxoSmithKline)

2:00 pm to 2:45 pm

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.

Doris Tancredi, PhD
Kraft Foods

2:45 pm to 3:15 pm

Break

3:15 pm to 4:00 pm

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.

Vasilios Frankos, MS, PhD
Herbalife International of America, Inc

4:00 pm to 4:45 pm

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 College of Pharmacy

4:45 pm to 5:00 pm

Questions and Discussion with Session 4 Speakers

Day 3 (Wednesday, June 6): Scientific, Educational, Business, and Political Environments

8:15 am to 12:00 pm

Session 5: Doing the Studies

Goals: (1) Provide overview of epidemiological and clinical studies with 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) provide overview of nutritional research in a military setting and the associated opportunities and challenges, and (4) 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.

8:15 am to 9:00 am

Presentation 1: Research-Design Issues with Epidemiological Studies on Dietary Supplements

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.

Christopher T. Sempos, PhD
NIH Office of Dietary Supplements

9:00 am to 9:45 am

Presentation 2: Conducting a Clinical Trial with Dietary Supplements

Objectives: (1) Describe the different types of clinical-research studies on supplements and their respective strengths and weaknesses, (2) describe the institutional, research, regulatory, and other considerations to be addressed in conducting a study on supplements, (3) 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 (4) address the need to fully characterize the supplement under study, using examples from published studies.

Robert M. Russell, MD
NIH Office of Dietary Supplements

9:45 am to 10:15 am

Break

10:15 am to 11:00 am

Presentation 3: Nutrition Research in the Military Setting

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 our research studies with the military compared to a non-military population, (3) present recent data on research studies in the military.

James P. McClung, PhD
U.S. Army Research Institute of Environmental Medicine (USARIEM)

11:00 am to 11:45 am

Presentation 4: Standards of Reporting Dietary Supplement Research Studies

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 advancing the research agenda on specific supplements, and (3) discuss recommendations from various professional groups to researchers for characterizing the supplements being evaluated in various studies and the details that should be provided when preparing manuscripts.

Douglas L. Weed, MD, MPH, PhD
DLW Consulting Services, LLC

11:45 am to 12:00 pm

Questions and Discussion with Session 5 Speakers

12:00 pm to 1:15 pm

Lunch (on your own)

1:15 pm to 2:00 pm

Special Presentation: Dietary Supplement Databases

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.

Joyce Merkel, MS, RD
NIH Office of Dietary Supplements

2:00 pm to 5:20 pm

Session 6: 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.

2:00 pm to 3:15 pm

Panel 1: A Conversation with the Industry

Robert W. Henderson, PD, ND
Nutramax Laboratories, Inc.

Michael McGuffin
American Herbal Products Association

Steven Mister, Esq.
Council for Responsible Nutrition

3:15 pm to 3:45 pm

Break

3:45 pm to 5:00 pm

Panel 2: Meet the Watchdogs

David Schardt, MS
Center for Science in the Public Interest

Tod Cooperman, MD
ConsumerLab.com

Natasha Singer
The New York Times

5:00 pm to 5:20 pm

Questions and Discussion with Session 6 Speakers

Day 4 (Thursday, June 7): The Big Picture

8:15 am to 12:15 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 the examples of vitamin D and folic acid, and (3) describe the science and promotion of genetic testing and the goal of "personalized nutrition" and whether it may have implications for dietary supplement use.

8:15 am to 9:00 am

Presentation 1: Case Study: Vitamin D and the Dietary Reference Intakes (DRI) Process

Objectives: (1) Describe the DRIs and the DRI process, with particular applicability to vitamin D, (2) provide 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.

Patsy M. Brannon, PhD, RD
Cornell University

9:00 am to 9:45 am

Presentation 2: Case Study: Folate and Folic Acid

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, (3) describe previous research studies relating folic acid to neural tube defects, and how current research is being conducted on this vitamin.

James L. Mills, MD, MS
Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH

9:45 am to 10:15 am

Break

10:15 am to 11:00 am

Presentation 3: Case Study: Omega-3 Fatty Acids

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.

Cindy D. Davis, PhD
NIH Office of Dietary Supplements

11:00 am to 11:45 am

Presentation 4: Nutrigenomics, Genetic Tests, and Personalized Nutrition

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 genotype 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.

Kathryn Camp, MS, RD, CSP
NIH Office of Dietary Supplements and Office of Rare Diseases Research

11:45 pm to 12:00 pm

Questions and Discussion with Session 7 Speakers

12:00 pm to 12:15 pm

Final wrap-up to practicum

1:30 pm to 4:00 pm

Thursday Afternoon Optional Event

Tour of the NIH and the NIH Clinical Center