Mary Frances Picciano
Dietary Supplement Research Practicum
May 22-24, 2023
Zoom

SESSION 1: Setting the Stage — Moderators: Jaime Gahche and Edwina Wambogo

Welcome and Overview of the NIH’s Office of Dietary Supplements

Jaime Gahche, PhD, MPH , NIH’s Office of Dietary Supplements

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 in the U.S.

Alexandra Cowan, PhD, MS , 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, DSc, RD, NIH’s Office of Dietary Supplements

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.

Break 1:00 pm – 1:15 pm

SESSION 2: Rules and Regulation — Moderator: Patricia Haggerty

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

Gerie Voss, JD , 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

Mary Johnson, JD , 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.

Break 2:45 pm – 3:00 pm

NIH Support for Research and Training on Nutrition

Roberto Flores, PhD, MS, MPH and Nicholas Jury, PhD , NIH, Office of Nutrition Research

Objectives: (1) Describe the different types of funding opportunities for nutrition research at NIH; and (2) discuss NIH Nutrition Strategic Plan.

NIH Support for Research and Training on Dietary Supplements

Patricia Haggerty, PhD, NIH's Office of Dietary Supplements

Objectives: (1) Provide an overview and opportunities in dietary supplements research funding at NIH; (2) describe the funding mechanisms at ODS; and (3) describe training opportunities.

Dietary Supplements and the U.S. Department of Defense

Jonathan Scott, PhD and Andrea Lindsey, MS, 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.

Resilience Research at NIH Office of Dietary Supplements

LaVerne Brown, PhD, NIH's Office of Dietary Supplements

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.

SESSION 3: Assessing the Health Effects of Supplement Ingredients — Moderator: LaVerne Brown

Doing the Studies: The Different Types and What They Tell Us

Joe Betz, PhD, NIH’s Office of Dietary Supplements, Special Volunteer

Objectives: (1) Provide an overview of the range of research studies on supplement, addressing their respective strengths and weaknesses and what each contributes to the mix of knowledge; and (2) describe the different levels of evidence from anecdotal reports to clinical trials and evidence-based reviews.

Efficacy and Effectiveness: Lines of Evidence in Supplement Research

Howard Sesso, ScD, MPH, 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.

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

Mary Hardy, MD, 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.

Break 1:15 pm – 1:30 pm

SESSION 4: Rigor and Reproducibility in Dietary Supplement Research — Moderator: Sanem Hosbas Coskun

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

Adam Kuszak, PhD, NIH’s Office of Dietary Supplements

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; and (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 C. Sorkin, PhD, NIH’s Office of Dietary Supplements

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.

Reading Materials and Resources

Break 3:00 pm – 3:15 pm

Dietary Supplement Databases

Joyce Merkel, MS, RD, NIH's Office of Dietary Supplements

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.

Readings and Resources List

Dietary Supplement Ingredient Database

Karen Andrews , USDA-ARS, Methods and Application of Food Composition Laboratory

Objectives: (1) Describe the Supplement Ingredient Database (DSID); (2) provide details about the research projects and the types of supplements studied and present results from these studies; and (3) illustrate the uses of DSID.

Finding Information on Dietary Supplement Products

Leila G Saldanha, PhD, RD, FAND , NIH's Office of Dietary Supplements

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)

Dietary Supplement Assessment Methods

Edwina Wambogo, PhD, NIH's Office of Dietary Supplements

Objectives: (1) Describe the methodologies employed to collect supplements data and their respective strengths and weaknesses; (2) describe considerations in the collection of the data; and (3) provide an overview of the NHANES Dietary Supplement Data collection process.

Dietary Intake Assessment using ASA24

Kirsten Herrick, PhD, NIH, National Cancer Institute

Objectives: (1) Provide an overview of dietary assessment in ASA24 and other dietary assessment tools available through NCI; and (2) demonstrate the Respondent Nutrition Report for ASA24.

Ethnobotany and its translation to biomedical research

Ina Vandebroek, PhD, New York Botanical Garden, and Ella Vardeman, PhD Candidate, Biology PhD program at the City University of New York

Objectives: (1) Provide an introduction to ethnobotanical research; and (2) learn how data from ethnobotanical research is being used in 21st century research on phytochemistry and human health.

Studying synergy between the chemical constituents of a dietary supplement

Nadja Cech, PhD, The University of North Carolina at Greensboro

Objectives: Describe (1) the importance of; and (2) methods used to learn how chemical constituents within a botanical product may interact to exert effects in humans or other animals.

Optimizing botanical dietary supplement evidence for a clinical trial

Amala Soumyanath, BPharm, PhD, Oregon Health and Science University

Objectives: (1) Describe the challenges of optimizing a botanical product for an early phase clinical trial; and (2) describe methods used to learn how chemical constituents within a botanical product may interact to exert effects in biological systems.

SESSION 5: Special Topics — Moderator: Gretchen Vannice

Dietary Supplements and Immunity: Lessons Learned from COVID-19

Carol Haggans, MS, RD, NIH’s Office of Dietary Supplements

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.

Reference List

How to Use Virtualization and AI to Make Supplement Trials Cheaper, Faster, Better

Jeffery Chen, MD, MBA, CEO & Cofounder, Radicle Science

Objectives: Describe (1) how decentralized trials can dramatically reduce trial cost and time, while increasing diversity of study populations to make them more relevant to the target audience; (2) how widely available validated Patient Reported Outcome measures (PROs), like those from the NIH PROMIS initiative, can be used in a trial to substantiate a variety of claims without the expense of clinician assessments; (3) ways a clinical trial can increase the chance of the active arm outperforming placebo with statistical significance, and thus substantiating a claim; (4) which biomarkers can be accurately tested for via direct-to-consumer collection kits for saliva and blood in a decentralized trial, without the expense of laboratory visits; and (5) how unblinding participants at study conclusion and providing them with a summary of their data can reduce/eliminate the need to pay participant incentives.

Break 12:30 pm – 12:45 pm

SESSION 6: Dietary Supplement Quality — Moderators: Patricia Haggerty and Jaime Gahche

U.S. Food and Drug Administration (FDA) Good Manufacturing Practices (GMPs)

Rebecca Allen, PhD, Consumer Safety Officer, U.S. Food and Drug Administration (FDA)

Objectives: (1) Provide an overview of Current Good Manufacturing Practices (CGMPs) for Dietary Supplements (21 CFR part 111) and its key requirements; (2) highlight common compliance issues and challenges; and (3) explore the broad impact the CGMPs for Dietary Supplements on the dietary supplement industry.

U.S. Pharmacopoeia

Seong Jae Yoo, PhD, Senior Manager, Verification Program, USP

Objectives: (1) Describe the overarching role of USP in the dietary supplement space; (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 and how this fits into the quality discussion; and (3) detail the process for 3rd party verification.

ChromaDex

Andrew Shao, PhD , Senior Vice President of Global Regulatory & Scientific Affairs, ChromaDex

Objectives: (1) Explain how biologically active natural substances are evaluated as potential dietary-supplement ingredients; (2) describe the various models supplement companies (ChromaDex in particular) may use to market and distribute their products; and (3) detail the major steps involved in identifying, processing, and manufacturing a high-quality supplement.

ConsumerLab.com

Tod Cooperman, MD , President, ConsumerLab.com

Objectives: (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.

American Herbal Products Association

Merle Zimmermann, PhD, Chief Information Analyst, AHPA

Objectives: (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.

Council for Responsible Nutrition

Steven M. Mister, Esq., President & CEO

Objectives: (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 Discussion

Adjourn 3:30 pm