I. Introduction

A. Overview of the Office of Dietary Supplements

The dietary supplement market now includes more than 100,000 products, and about one-half of adults and one-third of children and adolescents in the United States use dietary supplements. Yet questions remain about their cellular mechanisms, metabolism, efficacy, safety, and effects on health. To address these questions, the Office of Dietary Supplements (ODS) leads the scientific exploration of dietary supplements across the National Institutes of Health (NIH). In this new strategic planning period (2025–2029), ODS will continue to identify dietary supplement research priorities based on public health importance and will use research coordination to address critical gaps in knowledge. ODS also will continue to translate scientific advances for researchers, health professionals, public health policy decision-makers, industry leaders, and the public. This strategic plan provides a blueprint for how ODS will help to inform and shape the dietary supplement research agenda at NIH.

To provide a foundation for and stimulate new dietary supplement research opportunities, ODS has refined its vision, mission, and values (Figure 1). Its vision is to be the scientific authority and convening body for advancing the study of dietary supplements. Its mission is to coordinate cutting-edge dietary supplement research across NIH and the federal government to foster knowledge and to optimize health across the lifespan. Historically, ODS has organized its work around specific objectives called out by legislation—the Dietary Supplement Health and Education Act (DSHEA) of 1994 (see Appendix A)—or congressional appropriations reports that address dietary supplements. Going into its fourth decade, ODS will continue to meet the objectives of DSHEA while implementing an organizational structure that enables an agile response to emerging public health concerns and creation of effective collaborations across NIH Institutes, Centers, and Offices (ICOs) and federal partners. ODS will work to:

1. Create a priority-based organizational culture that empowers collaboration
2. Identify knowledge gaps of shared and timely interest across NIH ICOs and other federal agencies
3. Engage with NIH ICOs and other federal agencies to develop new research to address identified knowledge gaps
4. Use its platform to inform its audiences about relevant dietary supplement scientific advances and stimulate new ideas and partnerships to enhance the field
5. Provide support for innovative use of publicly available dietary supplement resources

Appendixes B and C include organizational charts that highlight ODS' organizational structure and its placement in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) in the Office of the Director at NIH.

B. Strategic Plan Framework

To achieve its mission, ODS will focus on three goals that emphasize research, research capacity, and stewardship:

1. To advance dietary supplement science and catalyze innovative, collaborative research to close critical knowledge gaps of public health interest
2. To expand the capacity to strengthen the field of dietary supplement science and address emerging public health concerns
3. To foster stewardship, collaboration, and accountability

ODS staff have a depth of knowledge and expertise that supports the achievement of these goals and their interconnected objectives (Figure 2).

This strategic plan began with a reexamination of feedback from subject matter experts to an interim plan (2022–2026), followed by an iterative ODS staff process to delineate areas of scientific emphasis and opportunity. This process established goals and objectives for research, research capacity, and stewardship. It also produced key strategic priorities to advance the science of dietary supplements. Appendix D presents a full description of the strategic planning process followed for the development of the ODS 2025–2029 plan. The planning process included:

• Review of past achievements and subject matter expert feedback
• Development of new ODS vision and mission statements, goals, objectives, and strategic priorities
• Review by the NIH Dietary Supplement Research Coordinating Committee (DSRCC) and other subject matter experts
• Feedback and approval from NIH leadership

During the strategic planning process, ODS identified three cross-cutting strategic priorities of high interest across NIH that intersect with dietary supplement research. They include Healthy Americans, Healthy Lifespan, and Resilience. These priorities will guide the focus of new collaborative research coordinated by ODS. Subsequent sections of the strategic plan detail ODS goals, their objectives, and the strategic priorities of the office.

The goals and their objectives depicted in Figure 2 include:

Goal 1: To advance dietary supplement science and catalyze innovative, collaborative research to close critical knowledge gaps of public health interest

1. Research Objective 1
   Advance the study of the biological effects of dietary supplements on resilience and health across the lifespan
2. Research Objective 2
   Advance the study of population-based dietary supplement use, related nutrient intake, and their effects on resilience and health across the lifespan
3. Research Objective 3
   Advance the study of the composition, quality, stability, safety, and efficacy of dietary supplements

Goal 2: To expand the capacity to strengthen the field of dietary supplement science and address emerging public health concerns

1. Research Capacity Objective 1
   Strengthen and harmonize methodological approaches and promote scientific best practices in the design, conduct, and reporting of dietary supplement research
2. Research Capacity Objective 2
   Identify and support innovative use of publicly available dietary supplement databases to inform and strengthen new research

Goal 3: To foster stewardship, collaboration, and accountability

1. Stewardship Objective 1
   Increase knowledge of and generate interest in dietary supplement research, ODS' accomplishments and activities, and its capabilities as a DPCPSI coordinating office
2. Stewardship Objective 2
   Develop information resources that translate dietary supplement research findings for ODS audiences
3. Stewardship Objective 3
   Prioritize stewardship by conducting evaluations and other processes to ensure strategic alignment and measurable return on investment for all ODS activities
4. Stewardship Objective 4
   Coordinate and support workforce and professional development opportunities

C. Implementation and Priority Setting

The overarching goal for this strategic plan period is to increase the interoperability and cross-functional nature of ODS by focusing on shared priorities. Thus, staff will work interactively when developing and implementing new activities, concepts, and research across strategic priorities. These interactions will promote communication and collaboration, ensuring a critical mass of cross-disciplinary expertise and opinions to strengthen the development of new ODS-led efforts.

Priority setting at ODS is a dynamic process that considers public health needs, knowledge gaps, and the needs and interests of its partners across NIH ICOs, federal agencies, trade organizations, and relevant professional societies. Knowledge gaps in dietary supplement research that relate to the strategic priorities and NIH ICO interests will be identified through internal ODS deliberations as well as through collaborations with NIH ICOs, other federal partners, and experts in the field. In-depth exploration of identified gaps will be used to develop concepts that will serve as the basis for new ODS research across all strategic priorities. ODS will consider key questions to identify knowledge gaps of interest and set research priorities. Depending on the issue, population, or intervention, these questions may include:

• What are the nature and prevalence of the public health issue and its relevance to the mission/interests of NIH ICOs and federal partners?
• To what extent is the population exposed to a dietary supplement or nutrient?
• How are biomarkers of nutritional exposure status and bioavailability of dietary supplements and their constituent ingredients and metabolites measured? Are these measurements reliable? Are new methods of measurement available or on the horizon that might provide more useful information than current methods?
• What is the evidence for the health effects of dietary supplements? What amounts of dietary supplement intake or dietary consumption are safe? What amounts produce an observed biological effect or health outcome?

D. Leveraging Partnerships

ODS' strategic plan will leverage its core competencies in biological, population, and analytical sciences to create new research opportunities focused on Healthy Americans, Healthy Lifespan, and Resilience. The intersection of these research objectives and cross-cutting strategic priorities allows for a more complete identification of whether, how, and why dietary supplements may or may not have an impact on resilience and health of all Americans across the lifespan. A more robust understanding of dietary supplements use and their impact on health will be gained by including other social, behavioral, environmental, dietary, economic, and market-driven factors that influence not only the lives of the populations being studied but also the integrity of the dietary supplements being consumed. Strong partnerships with NIH ICOs, other federal agencies, academic experts, and industry researchers will support ODS in its efforts to expand fundamental knowledge of dietary supplements and will help identify best practices for applying that knowledge for the betterment of the health of the U.S. populations. These partnerships expand the range of subject matter expertise beyond the ODS' core competencies. They also enhance collaboration, allow for pooled resources, and provide opportunities for constructive dialogue. ODS will continue to foster these partnerships by developing strategic liaisons inside NIH, across the federal government, and with nongovernmental partner groups. We aim to share key dietary supplement research findings, develop educational opportunities, and gather feedback on new research activities.

The NIH Dietary Supplement Research Coordinating Committee (DSRCC) was established in 2022 to increase collaboration among NIH ICOs with programs that focus on dietary supplements and/or the intersection of dietary supplements, natural products, and nutrition research. Members include program staff from NIH ICOs that have an interest in or fund extramural research related to dietary supplements as well as representatives from key federal agency partners with shared interests in dietary supplements. The DSRCC provides research coordination through the exchange of programmatic and scientific information, collaborative planning, and the implementation of relevant activities that focus on scientific gaps in dietary supplement research. The DSRCC also addresses emerging and intersecting dietary supplement research areas related to each NIH ICO's programmatic interests. The group works to promote collaborative research across NIH and within the federal government and to identify programmatic and policy issues and activities that impact ODS or to which ODS can contribute. Throughout this strategic plan period, ODS will lean on the DSRCC to initiate and expand collaborations with NIH ICOs and external colleagues and to identify opportunities to close critical knowledge gaps within its cross-cutting strategic priorities.