Day 1

Registration

Welcome and Setting the Stage: What ODS Does

Joseph Betz, Ph.D., Acting Director of ODS, NIH

Overview of Dietary Supplement Use

Jaime Gahche, Ph.D., M.P.H, ODS, NIH

Break

SESSION 1: RESEARCH AND REGULATION

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 information about when supplements require an Investigational New Drug (IND) application.

Food vs. Drugs vs. Dietary Supplements

Joseph Betz, Ph.D., Acting Director of ODS, NIH

Objectives: (1) Provide information on the principles on 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.

Panel Discussion

Lunch (on own)

What the Federal Trade Commission (FTC) Does

Tawana Davis, 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.

Dietary Supplements and the U.S. Department of Defense

Jonathan Scott, Ph.D. and Andrea Lindsey, M.S.,
Uniformed Services University of the Health Sciences

Objectives: (1) Describe dietary supplement use in the Department of Defense (DoD); (2) Identify issues associated with dietary supplement use within the DoD; (3) Introduce ongoing DoD dietary supplement research initiatives; and (4) Introduce Operation Supplement Safety.

Break

SESSION 2: RIGOR AND REPRODUCIBILITY IN DIETARY SUPPLEMENTS RESEARCH

Analytical Characterization of Dietary Supplements: 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.

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.

Adjourn

Day 2

SESSION 3: EFFICACY, SAFETY, AND MOTIVATIONS FOR USE

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.

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.

Break

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

Mary Hardy, M.D., George Washington University Medical School

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.

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.

Lunch (on own)

SESSION 4: SPECIAL TOPICS

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.

Emerging Science: The Microbiome and Nutrition

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

Objectives: (1) Define the human microbiome; (2) describe the evidence that diet and dietary supplements con modulate the gastrointestinal microbial community structure; (3) describe the evidence that the gastrointestinal microbiome can influence the response to dietary components; (4) describe the relationship between dietary components and the microbiome and chronic diseases such as obesity, cardiovascular disease, and cancer.

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.

Break

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.

Adjourn

Day 3

SESSION 5: 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

Laura Harkness, Ph.D., R.D., FACN, Church
& Dwight Co., Inc.

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

Jay Sirois, Ph.D, Consumer Healthcare Products Association

Panel Discussion

Panel 2: Meet the Watchdogs

Tod Cooperman, M.D., ConsumerLab.com

Laura MacCleery, J.D., Center for Science in the
Public Interest

Sally Squires, M.S., M.S., Senior Vice President at Powell Tate,
The Lean Plate Club Blog, and WTOP Contributor

Panel Discussion

Break

Panel Discussion: Panel 1 and Panel 2

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.

Final Wrap-up to Practicum

Jaime J. Gahche, Ph.D., M.P.H., Practicum Director, ODS, NIH

Joseph Betz, Ph.D., Acting Director of ODS, NIH

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

Adjourn

Tours of NIH Clinical Center (optional)