Day 1 - Monday, May 23

SESSION 1: SETTING THE STAGE

Welcome and Introductions: What ODS Does

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

Objectives: (1) Provide welcome, (2) provide an overview of the NIH’s Office of Dietary Supplements, and (3) give an overview of the practicum, including what participants can expect to learn and the focus of each session.

Overview of Dietary Supplement Use

Regan Bailey, Ph.D., M.P.H., R.D., Texas A&M University

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 the US populations.

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.

Panel Discussion

Break

SESSION 2: RULES AND REGULATION

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.

Moderator: Paul Thomas, Ed.D., R.D.N.

Food vs. Drugs vs. Dietary Supplements

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

Objectives: (1) Describe how dietary supplements were overseen and regulated by the FDA prior to enactment of DSHEA in 1994, 2) 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.

What the U.S. Food and Drug Administration (FDA) Does

Gerie Voss, Center for Food Safety and Applied Nutrition, Office of Dietary Supplement Programs, Division of Policy and Regulations Implementation, U.S. Food and Drug Administration (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.

What the Federal Trade Commission (FTC) Does

Tawana Davis, J.D., Division of Advertising Practices in the Bureau of Consumer Protection at the U.S. Federal Trade Commission (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.

Panel Discussion

Break

SESSION 3: DATA BASES AND RESOURCES

Moderator: Karen S. Regan, M.S., R.D.

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.

Optional Reading & Reference List

Finding Information on Dietary Supplement Products

Leila G Saldanha, PhD, RD, FAND, , ODS, NIH

Objectives: 1) Describe the rules and requirements that govern the information printed on supplement labels and how this differs from food labels, (2) describe special issues in labeling of dietary supplements; and (3) illustrate uses of the Dietary Supplement Label Database (DSLD)

Adjourn

Day 2 - Tuesday, May 24

SESSION 4: RIGOR AND REPRODUCIBILITY IN DIETARY SUPPLEMENTS RESEARCH

Moderator: Sanem Hosbas Coskun, Ph.D.

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 nongovernment 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.

Optional References and Resources List

Break

SESSION 5: EFFICACY AND SAFETY

Moderator: LaVerne Brown, Ph.D.

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.

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.

Interactions between Supplements and Drugs

Bill Gurley, Ph.D., University of Mississippi, National Center for Natural Products Research

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.

Break

SESSION 6: SPECIAL TOPICS

Moderator: Rebecca Costello, Ph.D.

Resilience Research at NIH Office of Dietary Supplements

LaVerne Brown, Ph.D., ODS, NIH

Objectives: (1) Describe the process utilized to conceptualize, define, and harmonize resilience research across multiple NIH Institutes, Centers, Offices, and domains; and (2) Discuss best practices for the application of the resilience concept in the design of research studies.

NIH Support for Research and Training on Nutrition and Dietary Supplements

Patricia Haggerty, Ph.D. , ODS, NIH

Objectives: (1) Describe the NIH extramural funding system; (2) Describe different types of funding mechanisms and funding opportunities; and (3) Describe which federal agencies provide funding for nutrition research and training.

Adjourn

Day 3 - Wednesday, May 25

SESSION 6: SPECIAL TOPICS, CONTINUED

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.

Dietary Supplements and Immunity: Lessons Learned from COVID-19

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

Objectives: (1) Provide an overview of the types of dietary supplements that might affect immune function and inflammation; and (2) summarize the scientific evidence on the safety and effectiveness of selected ingredients in these products and the quality of that evidence, highlighting studies conducted during the COVID-19 pandemic.

Break

SESSION 7: MEETING THE STAKEHOLDERS

Moderator: Paul Coates, Ph.D.

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

Jay Sirois, Ph.D., Consumer Healthcare Products Association

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

     AHPA Presentation Links and Resources

Brian Wommack, J.D., Council for Responsible Nutrition

Panel Discussion

Panel 2: Meet the Watchdogs

Tod Cooperman, M.D., ConsumerLab.com

Jensen N. Jose, J.D., Center for Science in the Public Interest

Sally Squires, M.S., M.S.

Panel Discussion

Break

Panel Discussion: Panel 1 and Panel 2

Final Wrap-up to Practicum

Adjourn