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ODS Strategic Plan 2017-2021

Office of Dietary Supplements Strategic Plan 2017-2021

The 5-year strategic plan for the National Institutes of Health's (NIH's) Office of Dietary Supplements (ODS) 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 most recent strategic plan covered the 2017–2021 time period.

In furtherance of the ODS and NIH mission, ODS produces an annual strategic plan report to track accomplishments and responsiveness to current and longstanding needs. The annual report also provides transparency to the ODS stakeholder community. This report highlights program accomplishments from 2020 and illustrates how ODS staff work together across their programs to meet ODS's mission and goals. The accomplishments described in this report were achieved while all staff were teleworking.

Joseph Betz, Ph.D.,
Acting Director, Office of Dietary Supplements
National Institutes of Health


 
 

ODS Annual Report 2020

I. Introduction to the National Institutes of Health (NIH) Office of Dietary Supplements (ODS)

The ODS was created at a time of high 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 Food and Drug Administration (FDA) has taken an active role in overseeing and regulating the production and marketing of dietary supplements. Its activities led Congress in 1976 to prohibit FDA from limiting the potency of vitamins and minerals in dietary supplements or regulating them as drugs based on their potency. Nutrition labels on packaged foods became required in 1990, and certain health claims that could be made for these products were permitted. Related questions about the labeling and regulation of dietary supplements led Congress to pass the Dietary Supplement Health and Education Act (DSHEA) in 1994. Dietary supplements were classified as a special category of food, and the Secretary of the Department of Health and Human Services (HHS) was directed to establish an Office of Dietary Supplements within the National Institutes of Health.

The legislation directed that “The purposes of the Office are

  1. to explore more fully the potential role of dietary supplements as a significant part of the efforts of the United States to improve health care.
  2. to promote scientific study of the benefits of dietary supplements in maintaining health and preventing chronic disease and other health-related conditions.”

The duties of the Director of ODS are to 

  1. conduct and coordinate scientific research within the NIH relating to dietary supplements and the extent to which the use of dietary supplements can limit or reduce the risk of diseases such as heart disease, cancer, birth defects, osteoporosis, cataracts, or prostatism;
  2. collect and compile the results of scientific research relating to dietary supplements, including scientific data from foreign sources or the Office of Alternative Medicine;
  3. serve as the principal advisor to the Secretary and to the Assistant Secretary for Health and provide advice to the Director of the NIH, the Director of the Centers for Disease Control and Prevention (CDC), and the Commissioner of Food and Drugs on issues relating to dietary supplements including (A) dietary intake regulations; (B) the safety of dietary supplements; (C) claims characterizing the relationship between (i) dietary supplements and (ii)(I) prevention of disease or other health-related conditions and (II) maintenance of health; and (D) scientific issues arising in connection with the labeling and composition of dietary supplements;
  4. compile a database of scientific research on dietary supplements and individual nutrients; and
  5. coordinate funding relating to dietary supplements for the 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, over the years Congress has mandated that ODS undertake additional specific programs including: 

  • Develop a botanical research center initiative (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 for dietary supplements (Analytical Methods and Reference Materials [AMRM] Program) (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 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.


Priority setting is a dynamic process within ODS that considers public health needs and knowledge gaps as well as changing trends in the dietary supplement marketplace (with its more than 100,000 products and thousands of ingredients) and consumer use of these products. Key questions are used to determine what new initiatives are needed and how the work should be approached. These questions include:

  • What is the nature of the public health issue? Is the intake of a nutrient or other supplement ingredient too low or too high? What is the evidence?
  • How are biomarkers of nutritional exposure, status, and bioavailability of dietary supplement ingredients and metabolites measured? Are there concerns about the reliability of the measurements? Are new methods available or on the horizon that might provide more useful information?
  • What is the evidence for the health effects of dietary supplements? What levels of dietary supplements influence the observed effects?
  • How should ODS and the research community identify and fill gaps in knowledge?
  • How should ODS and its partners translate the results of research for policymakers, clinicians, and the public?
  • How can ODS reach out to the greater NIH community to acquire and communicate information as well as knowledge gaps and to coordinate and support trans-NIH efforts to fill those gaps?

ODS staff routinely review dietary supplement research portfolios, surveys, reports, market trends, public inquiries, and media sources to identify priority areas and knowledge gaps.

Because ODS lacks the authority and administrative infrastructure to make its own grant awards and directly issue requests for applications (RFAs) it must depend on coordination and collaboration with NIH institutes, centers, and offices (ICOs) that have their own research and funding priorities. ODS staff rely on extensive interactions with ICOs to assist in setting 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 ICO program staff to develop initiatives, to develop and contribute to relevant 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, 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 2 presents the array of research topics funded by ODS in FY2020.

Exhibit 2:

The Category Breakout of ODS Co-Funded Grants in FY2020

II.  Innovation, Coordination, and Collaboration

As the lead federal entity addressing the scientific exploration of dietary supplements, ODS continues to advance the research agenda and knowledge base. The key to ODS’s success is the balance it achieves between its roles as a communicator of existing and new knowledge; facilitator of research; developer of resources; trainer of researchers; and coordinator and collaborator with NIH ICOs, academic researchers, federal and state agencies, and non-governmental organizations (NGOs).

The following are three examples of how ODS staff worked together across programs and activities to achieve the overall mission and goals as stated above. 
 

Coordinating Research Resources and Tools: AMRM Program

female scientist

The ODS AMRM Program has a goal to enhance the foundation for biomedical research on the health effects of nutrients, botanical constituents, and their metabolites by advancing their analytical characterization in dietary supplements and clinical/biological samples. In addition to providing resources for assuring that scientifically valid analytical methods and corresponding reference materials are available to stakeholders, the AMRM Program evaluates community resource needs, serves as a repository of tools and information, and provides guidance to investigators and across NIH on questions of natural product integrity to support the NIH-wide rigor and reproducibility initiative (https://www.nih.gov/research-training/rigor-reproducibility).

To accomplish these goals the AMRM Program coordinates multiple complementary activities with NIH ICs, government agencies, and private sector organizations. 

  • Analytical method innovation and validation are supported through an interagency agreement with the U.S. Department of Agriculture (USDA) Agricultural Research Service and administrative supplements to NIH-funded grants through partner NIH ICs.
  • Improved accuracy, precision, and reliability of analytical measurements are promoted through the development of methods, standards, and reference materials under an interagency agreement with the National Institute of Standards and Technology (NIST) and contracts with other national metrology institutes and commercial organizations. 
  • The joint coordination and conduct of laboratory quality assurance programs with NIST collects information on stakeholder priorities and provides research scientists, clinical labs, industry analysts, and regulators a means to evaluate their measurement systems and capabilities, identify and resolve problem areas, and improve performance and harmonization across analytical communities.

In addition to these ODS-organized efforts, AMRM staff participate in numerous educational, standard setting, and consensus building activities in the dietary supplement and natural product research and analytical communities to promote analytical rigor and reproducibility and, thus, support the translation of dietary supplement research to protect and improve public health.

These multifaceted AMRM activities have fostered creation and dissemination of a substantial body of resources for dietary supplement research, with new validated methods, certified reference materials, analytical laboratory guidance documents, and novel research publications produced on a yearly basis.

Innovation through Collaboration: CARBON Program

N

The purpose of the NIH CARBON Program, a collaborative partnership between ODS, the National Center for Complementary and Integrative Health (NCCIH), and the National Institute on Aging (NIA), is to coordinate and promote collaborative, transdisciplinary research on the safety, effectiveness, and mechanisms of action of botanical dietary supplements that have a high potential to benefit human health. An explicit goal of the program is to foster development of transdisciplinary research teams focused on investigation of the health effects of complex botanicals.

The program utilizes different types of awards, with synergistic but separate individual goals.

  • The Botanical Dietary Supplement Research Center (BDSRC) components of the Consortium aim to fill gaps in the foundational data needed for the design of highly rigorous and informative clinical trials of the most promising botanical dietary supplements.
  • The Natural Product Technology, Methodology, and Productivity Optimization (NP-TEMPO) Center is developing approaches expected to accelerate mechanistic research on these complex natural products, leveraging collaborations with other research groups to beta-test various applications of the NP-TEMPO approaches. The Natural Product Magnetic Resonance Databaseexternal link disclaimer (NP-MRD) is developing a unique resource, a repository dedicated to serving as a repository for only natural product nuclear magnetic resonance (NMR) spectra, while providing a growing suite of powerful tools for assigning, refining, and comparing molecular structure asignments and metadata. This repository with its associated tools provides an important new resource to support the rigor and progress of natural products research.
  • The Pilot Projects Increasing the Impact of CARBON is a competitive initiative to increase the impact of research in the BDSRC by leveraging their well-characterized products and advanced methods to enable less experienced botanical dietary supplements researchers to strengthen their own research portfolios and toolkits while also providing new information that contributes to the BDSRC specific aims.

Launched in 1999 as the NIH Botanical Research Centers Program, each renewal cycle has had an overarching theme developed by coordinating with partner NIH ICOs to create one or more funding opportunity announcement(s) (FOA[s]) with the goal of addressing broad research questions of high interest to all the partner organizations. The focus of the current centers is investigation of the mechanisms through which botanicals may modulate human resilience. Each center is required to provide an atmosphere, personnel, and resources that promote collaboration between experts in the identification and characterization of botanicals and their chemistry; experts in in vitro and in vivo model systems used to study mechanisms of resilience to stress, aging, or infection; and experts in the design and conduct of clinical trials. These collaborations strengthen the rigor of the research and enhance both innovation and the eventual utility of the research for clinical trial design.

In addition to the expected intracenter synergy, the scheduled annual CARBON investigators’ meeting provides an opportunity for interaction between center scientists with a goal of sharing of information between centers, coordination of resources, and development of serendipitous collaborations—benefits not included in the program’s specific aims. An example is work done jointly by the CARBON’s Center for Natural Products Technologies at the University of Illinois at Chicago (UIC) and the BDSRC led by the Pennington Biomedical Research Center in Baton Rouge, Louisiana. The UIC had developed a technique called Deplete and Enrich Select Ingredients to Generate Normalized Extract Resources (DESIGNER) that was applied to two Artemisia extracts studied by the Pennington researchers with their collaborators at Rutgers University for their ability to promote resilience to the development of type 2 diabetes. By using the DESIGNER technique to separate chalcones in Artemisia dracunculus, a component previously identified as contributing to this resilience, the collaborators found that there are additional constituents that also contribute to resilience by their actions on overlapping and distinct biological substrates. This information will be critical for reproducibility of future research on the Artemisia dracunculus extracts.
 

Translating the Science: Dietary Supplement Fact Sheets for Specific Purposes and Conditions

man using a laptop

Most ODS fact sheets provide an overview of the current state of knowledge for individual vitamins, minerals, and other dietary supplement ingredients, such as probiotics and omega-3 fatty acids. These fact sheets, developed with different levels of detail for health professionals and consumers, are geared to people interested in specific ingredients and they are updated periodically to include new research. In 2020, ODS completed its work on fact sheets for all essential vitamins and minerals..

ODS recognizes that people use dietary supplements for many reasons, including to achieve a better state of health, to prevent or limit the risk of disease, to improve athletic performance, and to prevent or manage a variety of health-related conditions. In response, ODS prepares fact sheets on dietary supplements for specific conditions. Currently, for example, ODS has published health professional and consumer fact sheets on supplements for weight loss, supplements for exercise and athletic performance, and supplements to treat primary mitochondrial disorders. 

ODS will prioritize the development of more fact sheets on dietary supplements for specific conditions and purposes, such as for immune health and dietary supplements in the time of COVID-19. Other areas of focus may include relaxation and sleep; bone, muscle, and joint health; hair, skin, and nails; brain health (including cognitive function, memory, and focus); cardiovascular health; diabetes and blood sugar control; and more. 

In addition, ODS plans to develop fact sheets on dietary supplements during various stages of life, including childhood and adolescence, adulthood, and older age, as well as pregnancy and lactation. These fact sheets will summarize the state of the science for the many supplement ingredients that are promoted during these various stages of life.


III.  ODS Accomplishments

The ODS Strategic Plan 2017–2021 provides a detailed description of each of the ODS programs and activities. While satisfying different goals, programs tend to have overlapping areas of focus, both within ODS and between NIH ICOs. The collaborative nature of ODS staff within ODS and across NIH helps to build strong connections within ODS, NIH, federal agencies, academic institutions, and other stakeholders within the dietary supplement community. 

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 3 describes ODS’s extramural 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 3
 

The Category Breakout of ODS Co-Funded Grants in FY2019 with a portfolio total value of $10.4M was divided as follows: CARBON Program, 40%, Other Botanicals, 8%; Calcium, 2%; Fatty Acids, 7%; General Nutrition, 4%, Iron, 2%; Minerals, 3%; Other Supplements, 13%; Other Vitamins, 13%; Probiotics, 2%; Protein, 1%; Vitamin D, 5%.

The following are key 2020 ODS accomplishments as they reflect ODS’s strategic plan goals and each program’s specific objectives.


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.

Grants Program
Objectives
To identify supplement-related public health areas and coordinate trans-NIH efforts. 

  • To support innovative research that evaluates the health effects of dietary supplements.
  • To increase the exposure to and awareness of research on dietary supplements among researchers in related fields.
Key Accomplishments
  • ODS co-funded 58 grants valued at $9.2 million across 12 NIH ICs.
  • Five administrative supplements and 1 co-funded grants were related to the microbiome.
  • ODS funded, through intraagency agreements, 7 ODS Scholar’s Projects valued at $600K across 6 NIH Institutes. 
  • ODS staff published and presented research on the microbiome and participated in NIH, federal, and other professional groups working on the microbiome.

CARBON
Objectives
To promote collaborative, transdisciplinary research on the safety, effectiveness, and mechanisms of action of botanical dietary supplements that have a high potential to benefit human health and to support the development of methods and resources that will enhance the progress of this research. 

  • To identify overarching program themes and research focus and to develop an FOA jointly with the CARBON ICO partners.
  • To develop methods and data required to understand and test the biological effects of inherently complex natural products, especially botanicals, both food and nonfood, on resilience in humans or other animal models.
  Key Accomplishments
  • The CARBON program funded 5 new CARBON centers. Each of the new centers has developed its own website, and the individual center sites are linked from the updated ODS CARBON page, which now includes additional pages for past centers.
  • The first annual meeting of the 2020–25 Consortium (and the first ever virtual CARBON meeting) was held on October 8 and 9 to provide support for early initiation of intercenter collaborations.
  • There were 21 publications that resulted from CARBON program support.

Population Studies Program
Objectives
To guide and coordinate data-collection activities across the federal government for the purpose of tracking dietary exposure to dietary supplements.  

  • To collaborate with NIH Institutes and federal agencies for the purpose of jointly characterizing patterns of dietary supplement use in the U.S. population.
  • To collaborate with NIH Institutes and federal agencies to determine the contribution of dietary supplements to the nutritional status of the population and subgroups.
  • To identify nutrients requiring additional research on dietary exposure, content in foods and supplements, biomarkers of intake, relationship of intake to risk of health conditions and risk factors, and the role of the nutrients in physiological systems. 
Key Accomplishments
  • ODS supports the National Health and Nutrition Examination Survey (NHANES) collection of dietary supplement data, prepares the data files for each 2-year cycle, and makes the data available to the research community.
  • An approach for estimation of dietary iodine intake (from foods, dietary supplements, and iodized salt) was proposed to the CDC’s National Center for Health Statistics (NCHS) and was applied during the first 3 quarters of the 2019–2020 NHANES survey cycle.
  • ODS staff participate in an interagency Iodine Working Group coordinated by CDC.
  • ODS collaborated with the CDC’s Division of Laboratory Sciences on the development of new biomarkers of red blood cell folate and an omega-3 fatty acid index, partially funding assays for the 2019–2020 NHANES blood collections for all participants 1 year of age and older.
  • ODS collaborated with NHANES on folate, vitamin D, iron, and iodine (populations: infants to elderly; data collection methods, analyses).
  • ODS collaborated with USDA, NCHS, HHS, National Academy of Sciences, Engineering, and Medicine (NASEM), CDC, Centers for Medicare & Medicaid Services (CMS), FDA, National Cancer Institute (NCI), Administration on Aging (AoA) and others on dietary supplement use across the lifespan.

N Resilience and Health Studies Program
Objectives
To coordinate NIH ICOs with strategic priorities related to, or funds dedicated to, resilience programs.

  • To coordinate a Trans-NIH Resilience Working Group for the purpose of fostering collaboration between ICOs around resilience research.
  • To coordinate the collection and harmonization of data on commonalities related to resilience outcomes, phenotype patterns, and measurements of resilience.
  • To facilitate the development of research tools to enhance the advancement of resilience research.
Key Accomplishments
  • ODS coordinated the Trans-NIH Resilience Working Group and its conceptual development retreat and developed a resilience conceptual model, research tools, and a website.
  • ODS is working with NCCIH to develop a joint resilience and health program.
  • ODS collaborated with the Uniformed Services University of the Health Sciences Center for Health and Military Performance on dietary ingredients to minimize environmental heat injury.
  • ODS is working with the Veterans Administration (VA) through an interagency agreement examining electronic health records to identify possible association between the incidence of heart failure and magnesium supplementation/status among the veteran population  


GOAL 2: Enhance the dietary supplement research workforce through support and coordination of training and career development. 

Grants Program
Objectives
To support early career scientists with an opportunity to gain experience in the study of the role of dietary supplements and/or their ingredients in health promotion and disease prevention.

  • To enhance the dietary supplement research workforce through training and career development opportunities within and outside of NIH.
Key Accomplishments
  • ODS funded 7 applications for the 2020 ODS Scholars Program (an intramural program that requires extensive coordination and spelled-out mentorship).
  • Among the 58 FY2020 co-funded grants, ODS funded 22 administrative supplements (5 first round, 7 second round, and 10 third round).
  • ODS co-funded a training grant with the Fogarty International Center (FIC) to provide training to 10 scientists in Tajikistan and 24 scientists in Indonesia on local botanicals for prevention and treatment of common inflammation-associated chronic diseases and disorders..

CARBON Program
Objectives
To focus on foundational research for the purpose of increasing the value of future clinical trials, while providing a rich environment for training and career development.

  • To facilitate the coordination of training opportunities to postgraduate and graduate students through CARBON Centers.
Key Accomplishments
  • ODS contributed directly to the training of postdoctoral fellows and graduate students as all the centers continued to train graduate students, postdoctoral fellows, and visiting and junior faculty, all of whom are continuing to publish data from the final years of the 2015–2020 CARBON awards.

AMRM Program
Objectives
To improve analytical proficiency skills through education and training initiatives, quality assurance programs to help improve laboratory performance, and dissemination of information via meeting presentations and journal publications.

  • To promote advances in analytical laboratory proficiency and capability by coordinating and supporting outreach and education in chemical and biological characterization of dietary supplements and their bioactive ingredients.
Key Accomplishments
  • Through the AMRM Program ODS supports, mentors, or provides technical guidance to postdoctoral researchers and earlier career scientists at NIST and USDA.
  • The NIST established the Health Assessment Measurements Quality Assurance Program (HAMQAP) to educate analysts in support of the measurement needs of the food, dietary supplement, and clinical communities.

Dietary Supplement Research Practicum
Objectives
To provide a thorough overview and grounding about issues, concepts, unknowns, and controversies about dietary supplements and supplement ingredients.

  • To offer a brief course in fundamental knowledge of dietary supplements to academics, Ph.D. students, and postdoctoral fellows; healthcare practitioners; and other professionals with advanced biomedical degrees.
Key Accomplishments
  • The annual practicum was cancelled due to the pandemic.

GOAL 3: Foster development and dissemination of research resources and tools to enhance the quality of dietary supplement research.

CARBON Program
Objectives
To create a NP-TEMPO Center with a focus on developing methods to accelerate research on complex natural products such as botanicals for human health and on collaborations to develop applications of these methods,

  • To support the development of methods that will be directly applicable to the biological effects of animal- and plant-derived foods and fermented foods.
  • To establish a resource that will house the majority of the world’s natural products NMR data in a format that allows facile crosslinking with other data repositories and provides tools for rapid deposit to and interrogation of the database to facilitate search and comparison of spectral data and associated structures while also allowing for other groups to develop additional tools using the deposited data.

Key Accomplishments

  • The CARBON Program supported the development of 4 new methods
    • a validation method for red clover isoflavones in human serum and dietary supplements;
    • methods for cytochrome P450 probe of the substrates caffeine, tolbutamide, dextromethorphan, and alprazolam in human serum;
    • a method to quantify cycloartane triterpenes in black cohosh extract; and
    • a method to identify metabolomic differences between invasive alien plants from native and invaded habitats.
    • The NP-MRDexternal link disclaimer was awarded in July 2020. The data repository, including standards for metadata and data integrity, is currently running in a second beta version.

AMRM Program
Objectives
To support development and dissemination of resources that scientists and analysts need to ensure that the characterization of dietary supplements, natural products, and nutrient biomarkers are precise, accurate, and reliable.

  • To catalyze analytical method development and validation for quantitative and qualitative characterization of dietary supplements and their ingredients.
  • To advance development of reference materials for dietary ingredients and natural products.

Key Accomplishments

  • Formal validation of innovative analytical methods
    • Ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) assays for red clover isoflavones in human serum and dietary supplement products (single-lab validation study).
    • High-performance liquid chromatography-diode array detection (HPLC-DAD) assay for the determination of curcuminoids in turmeric dietary supplements (a multi-laboratory validation study conducted through the NIH-ODS/NIST Quality Assurance Program).
    • 4-(dimethylamino)cinnamaldehyde (DMAC) assay for quantification of soluble proanthocyanidins in cranberry foods and dietary supplements (inter-laboratory validation study).
  • ODS renewed the FOA for an Administrative Supplement for Validation Studies of Analytical Methods for Dietary Supplement Constituents, securing a partnership with 4 NIH ICs and approval from the NCCIH Advisory Council.
  • ODS awarded 2 contracts for new dietary supplement ingredient certified reference materials (CRMs) including a calibrate solution CRM for ashwagandha constituents and a matrix-based CRM for cyanobacteria toxins and nutrients.
  • ODS’s collaboration with NIST resulted in the development of 7 newly issued or updated standard reference materials (SRMs) and the maintenance of approximately 30 dietary supplement-specific matrix-based SRMs.
  • ODS collaborated with NIST to administer the HAMQAP to enable laboratories to improve the accuracy of their analytical measurements of foods, dietary supplements, and biological samples.
  • A final report from the Vitamin D Metabolites Quality Assurance Program was completed and will be disseminated through ODS’s website and other communication vehicles.

Population Studies Program
Objectives
To lead efforts to address methodological issues in assessing dietary and dietary supplement intakes in epidemiological and other large studies.

  • To collaborate with federal partners and help coordinate the improvement of data collection and analysis tools for total nutrient consumption (food and dietary supplements).

Key Accomplishments

  • ODS collaborated with USDA and FDA to develop a database of iodine content of food, beverages, and dietary supplements.
  • ODS collaborated with NHANES on data collection methods for infant formula and iron and iodine status in pregnant/lactating women and infants.

Dietary Supplement Database Program
Objectives
To coordinate the integration of federal databases that include dietary supplement data.

  • To support the development, improvement, and expansion of dietary supplement databases.

Key Accomplishments

  • ODS maintains the DSLD, the DSID, and the Computer Access to Research on Dietary Supplements (CARDS) database in collaboration with other federal partners.

 DSLD  
 Objectives
 To maintain and expand a database with labels of products sold in the United States.
  • To perform program and policy research and inform stakeholders of findings.
  • To provide training to researchers via presentations, posters, and articles in peer reviewed journals.

Key Accomplishments

  • DSLD includes more than 125,000 labels and is accessible through a website and a mobile version.
  • DSLD data are being used to compare nutrient needs/dietary intake gaps with multivitamin/mineral and prenatal supplements.
  • Staff presented in several conferences or symposiums on dietary supplements featuring the DSLD.
DSID
Objectives
To maintain a dietary supplement ingredient database complementary to the DSLD.
  • To conduct analyses of dietary supplement ingredient concentrations and composition.
  • To support use of the DSID database for public health research.

Key Accomplishments

  • DSID data are being used to develop precise estimates of nutrient intake through dietary supplements.
  • ODS staff coauthored a submission with USDA staff for an AOAC International meeting on the use of DSID.
CARDS Database
Objectives
To maintain a database of all federally funded dietary supplement research.
  • To ensure that data collected for the database are easily accessible by stakeholders.
  • To increase the use of the CARDS database.

Key Accomplishments

  • FY2020 CARDS dietary supplement-related projects were reviewed, coded, and published.
  • FY2020 dietary supplement-related projects were added to CARDS and review and coding is in process.


Resilience and Health Studies Program
Objectives
To coordinate NIH ICOs with strategic priorities related to, or funds dedicated to, resilience programs.

  • To coordinate a Trans-NIH Resilience Working Group for the purpose of fostering collaboration between ICOs around resilience research.
  • To coordinate the collection and harmonization of data on commonalities related to resilience outcomes, phenotype patterns, and measurements of resilience.
  • To facilitate the development of research tools to enhance the advancement of resilience research.

Key Accomplishments

  • Development of the Trans-NIH Resilience webpage.
  • Development of the Trans-NIH Resilience conceptual infographic.
  • Development of the Trans-NIH Resilience decision tool.


GOAL 4: Foster development and dissemination of research resources and tools to enhance the quality of dietary supplement research.

Communications Program
Objectives
To disseminate research results and educate the public to foster an enhanced quality of life and health for the U.S. population.

  • To provide and promote the use of the most current, accurate, and useful information about dietary supplements to our audiences.
  • To support ODS scientific staff and programs.
  • To monitor the communications-related technology environment for most recent advances and evaluate their usefulness for ODS.

Key Accomplishments

  • ODS website averages 1.4 million visits and 2.5 million page views per month.
  • ODS responded to 539 public inquiries in 2020.
  • ODS hosted 9 seminar speakers and 2 meetings of the Federal Working Group on Dietary Supplements.
  • Social media: 10,000 Facebook followers; 16,000 Twitter followers.
  • Products: ODS Update has 5,100 subscribers; The Scoop has 5,000 subscribers.
  • Videos: an additional 17,000 views in 2020 for a total of 94,700 views since 2014.
  • ODS plays a key role in keeping the NIH Office of the Director; the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI); and ODS staff up to date on its activities and relevant issues. The communications team produces News o’ the Day, a daily ODS internal e-mail, to help staff stay current on news on dietary supplements, nutrition, and related topics collected from such sources as peer-reviewed journals, government documents, newspaper articles, and blog posts. ODS also contributes to the DPCPSI Spotlight, a quarterly newsletter produced by and sent to DPCPSI staff. ODS submitted information for the February, May, and October issues.
  • The ODS communications team participated in broader NIH-wide communications and nutrition groups including NIH Communications Directors, NIH Press Officers, the NIH Social Media Collaboration Team, the NIH Consumer Health Content Committee, the DPCPSI Communications Community, and the Nutrition Education Subcommittee of the Nutrition Research Coordinating Committee.
  • New fact sheets in progress: Dietary Supplements for Immunity (health professional), Multivitamins/Minerals version 2 (health professional), and Vitamin B12 version 2 (health professional).
  • Fact sheets updated: Botanical Dietary Supplements, Calcium (health professional), Iodine (health professional and consumer), Magnesium (health professional), Omega-3 Fatty Acids (health professional and consumer), Probiotics (health professional), Vitamin B12 (health professional and consumer), and Vitamin E (health professional and consumer).
  • New fact sheets completed: Dietary Supplements in the Time of COVID-19 (health professional), Boron (health professional and consumer), Chromium version 2 (health professional and consumer), Fluoride (health professional and consumer), What You Need to Know, version 2.
  • All nutrient fact sheets were updated with the new daily values for nutrient intakes as provided by theFDA, and the percent dietary value for each food listed in our tables was correspondingly adjusted.
  • New webpages were added for the CARBON Program and the Trans-NIH Resilience Working Group.
  • ODS staff presentations and publications in 2020 included 9 presentations at national/international conferences and 25 publications.
  • Staff developed ODS’s 25th Anniversary graphics and the Anniversary Webpage with a calendar of ODS events, social media messages, and an ODS timeline. Anniversary events were launched in September of 2020 (ODS Update) and an anniversary scientific symposium has been rescheduled for 2021.