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The Mary Frances Picciano Dietary Supplement Research Practicum

2021 Agenda (EDT)

The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) offers this intensive practicum to provide fundamental knowledge of dietary supplements geared toward faculty, Ph.D. students, and postdocs at academic institutions; health care practitioners; and other professionals with advanced biomedical degrees. Since the practicum will be held this year virtually, we have decided to open it up to a broader audience. Its three main goals are to::

  1. Provide participants with a thorough overview and grounding about issues, concepts, controversies, and unknowns about dietary supplements and supplement ingredients. A cross-cutting theme will be the importance of scientific investigations to evaluate the safety and efficacy of these products for health promotion and disease prevention.
  2. Provide participants with information, ideas, and resources to provide instruction about dietary supplements at their academic institutions.
  3. Instill interest among students and investigators attending the practicum to consider undertaking research in the field of dietary supplements.

Agenda (Eastern Time)

Day 1 | Day 2 | Day 3

Day 1 - Tuesday, May 25



11:00 a.m.

Welcome and Introductions: What ODS Does

Jaime Gahche, Ph.D., Practicum Director, ODS, NIH

11:30 a.m.

Overview of Dietary Supplement Use

Regan Bailey, Ph.D., M.P.H., R.D., Purdue University

12:15 p.m.

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.

1:00 p.m.





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

1:10 p.m.

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

Anthony Lee, J.D., M.P.A., 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.

1:55 p.m.

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.

2:40 p.m.

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.

3:25 p.m.

Panel Discussion

3:45 p.m.





Moderator: Nancy Potischman, Ph.D., ODS, NIH

3:55 p.m.

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; (2) Describe different types of funding mechanisms and funding opportunities; and (3) Describe which federal agencies provide funding for nutrition research and training.

4:40 p.m.


Day 2 - Wednesday, May 26




Moderator: Rebecca Costello, Ph.D., ODS, NIH

11:00 a.m.

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.

11:45 a.m.

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.

12:30 p.m.

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.

1:25 p.m.





Moderator: Sanem Hosbas Coskun, Ph.D. and Stephen Wise, Ph.D., ODS, NIH

1:30 p.m.

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.

2:15 p.m.

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.

3:00 p.m.





Moderator: Laverne Brown, Ph.D., ODS, NIH

3:15 p.m.

Dietary Supplements in the Time of 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 with respect to COVID-19 for selected ingredients in these products and the quality of that evidence.

4:00 p.m.

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

4:45 p.m.


Day 3 - Thursday, May 27



11:00 a.m.

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.

11:45 a.m.

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.

12:30 p.m.




Moderator: Leila Saldanha, Ph.D., R.D., ODS, NIH

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

12:45 p.m.

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

1:00 p.m.

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

1:15 p.m.

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

1:30 p.m.

Panel Discussion


Panel 2: Meet the Watchdogs

1:45 p.m.

Tod Cooperman, M.D.,

2:00 p.m.

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

2:15 p.m.

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

2:30 p.m.

Panel Discussion

2:45 p.m.


3:00 p.m.

Panel Discussion: Panel 1 and Panel 2

3:30 p.m.

Final Wrap-up to Practicum

3:45 p.m.


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