skip to navigation | skip to content
The Mary Frances Picciano Dietary Supplement Research Practicum

2016 Agenda

The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) offers this intensive practicum to provide fundamental knowledge of dietary supplements to faculty, Ph.D. students, and postdocs at academic institutions; health care practitioners; and other professionals with advanced biomedical degrees. 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 efficacy, safety, and value of these products for health promotion and disease prevention and treatment.

  2. Provide participants with information, ideas, and resources so that they might provide some or more 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

Day 1 | Day 2 | Day 3

Day 1 — Tuesday, June 7

7:30 a.m.

Registration

8:45 a.m.

Welcome, Overview, and Setting the Stage

Paul Coates, Ph.D., Director of ODS, NIH

Objectives: (1) Define the category of dietary supplements; (2) provide an overview of the dietary supplement marketplace; and (3) describe the national monitoring efforts of dietary supplement use, with emphasis on the National Health and Nutrition Examination Survey.

 

SESSION 1: THE RULES AND THE REGULATION

9:15 a.m.

The Dietary Supplement Health and Education Act (DSHEA) and Before

Loren Israelsen, J.D., President of the United
Natural Products Alliance

Objectives: (1) Describe how dietary supplements were overseen and regulated by the U.S. Food and Drug Administration (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.

10:00 a.m.

Break

10:15 a.m.

What the U.S. Food and Drug Administration Does

Cara Welch, 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 examples of the types of regulatory actions FDA has taken against potentially harmful and/or mislabeled supplements.

11:00 a.m.

What the Federal Trade Commission (FTC) Does

Michelle Rusk, 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.

11:45 a.m.

Panel Discussion

12:00 p.m.

Lunch (on own)

 

SESSION 2: UNDERSTANDING THE PRINCIPLES

1:15 p.m.

Analytical Characterization of Dietary Supplements: Overview of Methods, Standards, and Quality Assurance

Adam Kuszak Ph.D., ODS, NIH

Objectives: (1) Describe the principles of botanical supplement characterization by introducing the concepts of identity, purity, quality, and composition; (2) provide an overview of the need for researchers to fully define the reagents and interventions used in research, and describe how certified reference materials, calibration standards, and analytical methods can help meet this need; (3) describe Federal efforts that support characterization of the identity, purity, and quality of ingredients in dietary supplements; and (4) introduce relevant work of the U.S. Pharmacopeia, AOAC International, NSF International, and others to help ensure the manufacture of high-quality dietary supplements.

2:00 p.m.

Identity, Quality, and Certification/Testing

Andrew Erickson, M.S., NSF International

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.

2:45 p.m.

Break

3:15 p.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.

4:00 p.m.

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

Christine Taylor Ph.D., ODS, NIH

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.

4:45 p.m.

Adjourn

Day 2 — Wednesday, June 8

 

SESSION 3: SUPPLEMENT USE IN THE UNITED STATES

8:45 a.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.

9:30 a.m.

Nutrition Research in the Military

Patricia Deuster, Ph.D., M.P.H., CNS, FACSM,
Uniformed Services University of the Health Sciences

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 out research studies with the military compared with a nonmilitary population; and (3) present recent data on research studies in the military.

10:15 a.m.

Break

10:30 a.m.

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.

11:15 a.m.

Emerging Science: The Microbiome and Nutrition

Cindy Davis, Ph.D., ODS, NIH

Objectives: (1) Define the human microbiome; (2) describe the evidence that diet and dietary supplements can 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.

12:00 p.m.

Lunch (on own)

1:15 p.m.

Special Presentation: 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.

 

SESSION 4: MEETING THE STAKEHOLDERS

Attendees will visit with 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.

2:00 p.m.

Panel 1: A Conversation With the Industry

Brian Cornblatt, Ph.D. & Grace Cornblatt, Ph.D.,
Nutramax Laboratories, Inc.

Steven Dentali, Ph.D., Herbalife International of
America, Inc.

Steven Mister, Esq., Council for Responsible
Nutrition

2:45 p.m.

Panel Discussion

3:00 p.m.

Break

3:15 p.m.

Panel 2: Meet the Watchdogs

David Schardt, M.S., Center for Science in the
Public Interest

Tod Cooperman, M.D., ConsumerLab.com

Anahad O’Connor, The New York Times

4:00 p.m.

Panel Discussion

4:15 p.m.

Panel Discussion: Panel 1 and Panel 2

4:45 p.m.

Adjourn

Day 3 — Thursday, June 9

 

SESSION 5: UNDERSTANDING RESEARCH ISSUES

8:45 a.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.

9:30 a.m.

Nutrigenomics, Genetic Tests, and Personalized Nutrition

Elaine Trujillo, M.S., R.D., National Cancer
Institute, NIH

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 led to the use of genotypes to predict disease and assess health; (3) 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.

10:15 a.m.

Break

10:30 a.m.

The Epidemiology of Global Micronutrient Deficiency

Kerry Schulze, Ph.D., M.S., Johns Hopkins
University

Objectives: (1) Understand the framework for undernutrition; (2) characterize the most common micronutrient deficiencies around the world; and (3) describe the strategies for intervention to reduce micronutrient deficiencies.

11:15 a.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.

11:45 a.m.

Lunch (on own)

1:00 p.m.

Supplemental Soy and Disease Prevention: How Strong Is the Evidence?

Mindy Kurzer, Ph.D., University of Minnesota

Objectives: (1) Use this particular dietary supplement as an example to illustrate the range of studies and how each type of study has contributed to overall knowledge of this ingredient; and (2) describe some issues in conducting research on soy products and assessments of their value and safety.

1:45 p.m.

Special Case Nutrient: Folate and Vitamin B6

Luisa Rios-Avila, Ph.D., ODS, NIH

Objectives: (1) Use these particular dietary supplements as an example to illustrate the range of studies and how each type of study has contributed to overall knowledge of these ingredients; (2) describe the effects of inadequate folate and vitamin B6 status on one-carbon metabolism, and the association of low folate and low vitamin B6 levels with increased risk for chronic diseases; and (3) describe the importance of the identification of functional biomarkers for assessment of vitamin B6 status.

2:30 p.m.

Break

2:45 p.m.

Analysis of the Evidence

Paul Thomas, Ed.D., R.D., 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.

3:30 p.m.

Final Wrap-Up to Practicum

Regan Bailey, Ph.D., R.D., Practicum Director,
ODS, NIH

Paul Coates, Ph.D., Director of ODS, NIH

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

4:00 p.m.

Adjourn