ODS Strategic Plan 2017-2021 & Annual Report

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ODS Annual Report 2022

I. Introduction to the NIH ODS

ODS was created at a time of rapidly growing public and congressional interest in health maintenance and wellness, in particular the concept that nutrients and other natural substances provided as supplements to the diet might offer benefits to health beyond basic nutrition. Since 1962, the U.S. Food and Drug Administration (FDA) has taken an active role in overseeing and regulating the production and marketing of dietary supplements. Nutrition labeling of packaged foods was required by the Nutrition Labeling and Education Act of 1990. This Act also permitted certain health claims to be made for these products. Related questions about the labeling and regulation of dietary supplements led Congress to pass the Dietary Supplement Health and Education Act (DSHEA) in 1994. This law classified dietary supplements as a special category of food, and the Secretary of the Department of Health and Human Services was directed to establish an Office of Dietary Supplements within the National Institutes of Health. ODS resides in the DPCPSI within the Office of the Director of NIH.

Since its inception in 1995, a year after DSHEA was passed, the mission of ODS has been to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating, and supporting dietary supplement research by funding and coordinating dietary supplement research across NIH, disseminating research results, and educating the public to foster an enhanced quality of life and health for the U.S. population. In addition to the original purpose and duties prescribed in DSHEA, Congress has mandated over the years that ODS undertake additional specific programs including:

• Develop a botanical research center initiative (initially called the Botanical Research Centers Program, now under the umbrella of the Consortium for Advancing Research on Botanical and Other Natural Products [CARBON]) (1999).
• Conduct evidence-based reviews of the efficacy and safety of dietary supplements (2001).
• Accelerate the validation of analytical methods and development of reference materials (RMs) for dietary supplements (Analytical Methods and Reference Materials [AMRM] (2001).
• Support the development of a dietary supplement label database (DSLD) (2003).

The responsibilities delineated by DSHEA and additional mandates are directly addressed by at least one of the four main ODS goals from the ODS strategic plan. The ODS 5-year strategic plan is based on its mandates and mission as provided by Congress and in tandem with the overarching mission of NIH to “seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.” The strategic planning process begins with a review and assessment of ODS program objectives and accomplishments in the context of the Office’s charge from Congress, stated mission, goals, and key emerging public health issues. The goals from the most recent strategic plan (2017–2021) are presented in Exhibit 1.

Exhibit 1: ODS Goals
 

Goal 1:	Expand the scientific knowledge base on dietary supplements by stimulating and supporting a full range of biomedical research across NIH institutes, centers, and offices (ICOs) and by developing, coordinating, and contributing to relevant initiatives, workshops, meetings, and conferences.
Goal 2:	Enhance the dietary supplement research workforce through support and coordination of training and career development.
Goal 3:	Foster development, coordination, and dissemination of research resources and tools to enhance the quality of dietary supplement research.
Goal 4:	Translate dietary supplement research findings into useful information for consumers, health professionals, researchers, and policymakers.

ODS programs and activities are structured to address these goals through a review of current and continuous public health concerns. ODS staff routinely review dietary supplement research portfolios, surveys, reports, market trends, public inquiries, and media sources to identify priority areas and knowledge gaps.

A major focus of ODS staff is to coordinate and initiate collaborations across NIH and other government and constituent communities that are key to fulfilling the ODS mission. Exhibit 2 describes ODS’s extramural funding vehicles used to achieve its mission. The value of ODS’s efforts is evident in its ability to engage and manage the wide range of expertise required to accomplish its goals. The extramural grants program especially involves hands-on, proactive engagement with NIH program officers and ICO directors. This outreach informs NIH staff of the availability of ODS programs such as co-fund opportunities and administrative supplements and communicates knowledge gaps and research interests identified by ODS through the Population Studies Program and NIH interest groups. The proactive nature of ODS outreach permits resource pooling and coordination of NIH research efforts on dietary supplements and health.

Exhibit 2:

The following are 2022 highlights of ODS activities and accomplishments as they reflect ODS’s strategic plan goals and each program’s specific objectives. A full list of activities and accomplishments can be reviewed in Appendix 1.

II.  Highlights of 2022

A. Co-funding to Enhance Dietary Supplement Research at NIH (Goal 1)

Because ODS lacks the authority and administrative infrastructure to make its own grant awards and directly issue requests for applications, it builds upon coordination and collaboration with NIH ICOs that have their own research and funding priorities. ODS staff build extensive relationships with ICO partners to set research priorities and monitor dietary supplement research expenditures by other ICOs through NIH portfolio databases to identify promising areas of collaboration. In addition, ODS staff work with NIH ICO program staff and colleagues at other federal agencies to develop and contribute to relevant initiatives and workshops and to publish key findings from workshops and other meetings. Lastly, through close communication and interactions across NIH and with the ODS-sponsored Federal Working Group on Dietary Supplements (FWGoDS) and Dietary Supplements Research Coordinating Committee (DSRCC), ODS staff develop insights into emerging public health issues related to dietary supplements and use the insights gained in communication and coordination of research support across NIH.

Once established, ODS programs and initiatives undergo periodic external evaluations and lifecycle assessments. Programs are sunset when workshops or portfolio analyses indicate that needs have been met or priorities have shifted. Exhibit 3 provides a representation of the research topics funded by ODS in FY2022.

Exhibit 3: 

B. Assessing Program Goals to Enhance Dietary Supplement Scientific Outcomes (Goals 2 and 3)

ODS and the National Center for Complementary and Integrative Health have supported the CARBON Program since 1999, with additional support at times provided by the National Institute of Environmental Health Sciences, National Cancer Institute, and National Institute on Aging. The CARBON Program currently includes Botanical Dietary Supplements Research Centers, which are focused on enhancing methods and resources for research on the health effects of complex natural products and related pilot projects. The importance of this program is clear from the prevalence of use of botanical products by the U.S. public and their prominent representation in pharmacopeias throughout the world. In 2021, an eight-member expert panel called the 2022 NIH Botanical Research Expert Panel (BREP) was formed to provide expert input on both the CARBON Program’s progress in the last decade and on future directions. The BREP held a virtual meeting in 2022 to discuss the strengths and weaknesses of the current program and areas of high potential for advancing the research over the next decade. An Executive Summary of their discussion was posted following the July 14, 2022, meeting.

The consensus of the panel was that more botanical and other natural products research is needed. In addition to recommending that CARBON work to increase recruitment of diverse investigators and efforts to publicize its achievements, they outlined several opportunity areas for the program. More specifically, the panel emphasized opportunities to

• More effectively showcase the CARBON Program by annually requiring centers to provide information on their major new contributions to knowledge about the health effects of botanicals and to methods and resources for obtaining such knowledge, both on a central CARBON website and on their own centers’ websites.
• Emphasize synergy (between natural products, their chemical constituents, and within and between CARBON components). Panelists noted emerging research interest and opportunities in several arenas. There was a unifying theme to move away from a focus on single ingredients and to move toward a broader focus on the chemical complexity of foods and herbs, their interactions with diet as a whole and with individual genetic and metabolic differences, and perhaps with differences in the microbiome. It was agreed that new tools or methods are needed to address synergies and other interactions.
• Continue to support both hypothesis-generating and hypothesis-testing research.
• Require that data produced by the centers be made available in databases that are useful for the research community (Findable, Accessible, Interoperable, and Reusable), consistent with the NIH Data Management and Sharing policy.

C. Harmonizing Science and Expanding Collaborations across the Federal Government (Goal 3)

The Resilience and Health Studies Program established in 2019 led to the development of new frameworks and the harmonization of existing tools to facilitate studies that explore the capacity of a system (molecular, physiologic, behavioral, etc.) to respond to stressors. Resilience research frameworks promote study designs that can address gaps for exploring variations in health outcomes across diverse populations (including aging and ethnic/minority populations). Contributions from the Resilience Studies Program and the Trans-NIH Resilience Working Group led to the creation of a consensus definition of resilience that is intended to be applicable across multiple domains, illustration of a resilience research conceptual model that elaborates upon the definition, and development of the Resilience Research Design Tool. Applications of these tools and resources resulted in a partnership with organizers of the Federal Plan for Equitable Long-Term Recovery and Resilience; prompted new collaborations through the ODS Resilience Studies Program’s lead role in planning, coordinating, and editing manuscripts for a Resilience Research Special Supplement; and strengthened a continued partnership with the Department of Defense Consortium for Health and Military Performance (CHAMP).

The ODS Resilience Studies Program, in partnership with CHAMP, has led research initiatives that improve understanding of biological mechanisms, or educate on the evidence, of dietary supplement ingredients that are associated with resilience outcomes. Examples include interagency agreements to investigate dietary ingredients to minimize environmental heat injury and an evidence-based review of dietary supplements for immune and resilience health outcomes. Knowledge gained from these initiatives has been disseminated via manuscripts in various scientific journals and via an online podcast series.

D. Stimulating Dietary Supplement Research and Expanding Dissemination Efforts (Goal 4)

Through its existing program workshops and meetings, ODS seminars, and ODS-led working groups, (e.g., the Trans-NIH Resilience Working Group and the FWGoDS) as well as through staff participation in 68 working groups across the NIH, other federal agencies and non-governmental organizations, ODS leverages opportunities to encourage dietary supplement research collaborations across NIH and with other federal agencies. To expand upon these efforts ODS established a new DSRCC to identify emerging and cross-cutting research areas and to develop platforms for encouraging collaborative initiatives across NIH and the federal government.

These efforts, along with other ODS activities, can enhance research coordination through the identification of co-funding and administrative supplement grant opportunities to further encourage the integration of dietary supplement research into existing research programs. For example, ODS established new scientific collaborations with NIH ICO partners on major Institute and trans-NIH funding initiatives. These include the trans-NIH Maternal Mortality Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE) solicitation for Centers of Excellence and the National Institute of Child Health and Human Development Solicitation for Transporter Elucidation Centers. These collaborations will help expand ODS’s contribution to major initiatives and may expand ODS’s portfolio of support of high-priority research at NIH.

While stimulating new research initiatives, ODS continuously works to translate the latest dietary supplements research for the scientific community, dietary supplement industry, healthcare providers, policymakers, and the public. In 2022

• ODS continuously updated existing labels in the DSLD and increased the DSLD content by 15 percent, adding 26,000 new labels to now contain more than 156,000 labels.
• The Dietary Supplement Research Practicum was presented virtually and did not limit attendance to 100 people as in years before. It was attended by 693 professionals, half from academia (faculty, research staff, students, and postdoctoral fellows) and half from a mix of health professionals, government employees, and industry representatives.
• The Population Studies Program and its partners at U.S. Department of Agriculture (USDA) and FDA released version 2.0 of the Database for the Iodine Content of Common Foods.Release 2.0 includes about 425 foods. Values are provided as “per serving” and “per 100 gram” amounts.
• The AMRM Program’s contract awards and collaborations resulted in 3 new calibration solution certified RMs for dietary supplement ingredients; 5 newly issued or updated RMs for dietary supplement matrices; the maintenance of more than 30 dietary supplement–specific RMs; 4 newly issued or updated RMs for the clinical measurement of nutrients and their metabolites; the maintenance of more than 10 clinical laboratory RMs; and the administration of 2 National Institute of Standards and Technology Dietary Supplement Laboratory Quality Assurance Programs exercises, with more than 10 total studies, to enable laboratories to improve the accuracy of their analytical measurements of nutrients, phytochemicals, and contaminants in foods and dietary supplements.
• The ODS website averaged approximately 1.3 million visits per month (a 20 percent increase from 2021). The ODS dietary supplement fact sheets page on the website, which averaged 1.2 million visits per month, included 4 new fact sheets and 20 existing fact sheets that were updated in 2022.
• ODS’s electronic subscriber audience increased from about 6,000 in March 2021 to more than 90,000 individual subscribers at the end of 2022. During this same time, the ODS Update newsletter subscriptions increased from 5,100 to more than 34,500 subscribers and Scoop consumer newsletter subscriptions from 5,000 to more than 66,700 subscribers.
• ODS staff collaborated with NIH colleagues, partners from other federal agencies, and extramural researchers to co-author 22 peer-reviewed research and review publications. These publications included dietary supplement research areas such as clinical nutrition, epidemiology, biochemistry, resilience, analytical chemistry, pharmacognosy, and pharmacology.