Click to access mobile menu
Print PDF
  • Share:

ODS Strategic Plan 2017-2021 & Annual Report

Office of Dietary Supplements Strategic Plan 2017-2021

Message from the Director 

Beginning in 1998 and continuing every 5 years since, the National Institutes of Health’s (NIH's) Office of Dietary Supplements (ODS) has created and implemented a strategic plan 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." In furtherance of the ODS and NIH missions, 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 2021 and illustrates how ODS staff work together across their programs to meet ODS's mission and goals. As was the case last year, the accomplishments described in this report were achieved while all staff were teleworking due to the global SARS-CoV-2 pandemic.

This year's annual report marks the final update on accomplishments achieved in the last year of the 2017–2021 strategic plan. Next year's report will reflect the accomplishments of the first year of the new 2022–2026 plan. As with previous iterations, the strategic planning process is well underway and as with previous iterations began 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.

This year was a landmark year for ODS. In addition to being the final year in the fourth ODS Strategic Plan, ODS marked the 25th Anniversary of its existence with a series of events culminating in a 25th Anniversary Scientific Symposium. The ODS looks forward to its future role in fulfilling our mission "to support, conduct, and coordinate scientific research and provide intellectual leadership for the purpose of strengthening the knowledge and understanding of dietary supplements to foster an enhanced quality of life and health for the U.S. population."

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

 
 

ODS Annual Report 2021

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

The 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 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. In this law, 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 Office currently resides in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) within the Office of the Director (OD) of NIH.

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 and
  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 80,000 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 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, 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 FY2021.

Exhibit 2:
ODS Co-Funded Grants in FY2021 by Research Area
(65 grants valued at $10M across 14 NIH Institutes and Centers [ICs])

Pie chart describing the research areas of the 65 co-funded grants from ODS to 14 different NIH Institutes and Centers in FY 2021, valued at a total of $10 million. The research areas, ordered from highest to lowest funding levels, include Botanicals ($4,467,841), General Nutrition ($969,535), Amino Acids ($929,401), General Dietary Supplement ($792,677), Probiotics or Prebiotics ($634,845), Minerals ($594,000), Vitamin D ($458,465), Other Vitamins ($420,000), Other Fatty Acids ($312,267), Omega-3 Fatty Acids ($153,052), Iron ($100,000), Other Supplements ($87,500) and Vitamin E ($75,000).


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. 
 

Assisting Scientific Study: New and Improved ODS Supported Databases

DSLD logo - line drawing of supplement bottle and magnifying glass

ODS supports several databases that provide a continuously increasing amount of detailed information on dietary supplements and their ingredients as well as on research being done on these supplements. In addition, ODS supports the development of other databases focused on essential nutrients and dietary compounds of concern for the U.S. population. In 2021 ODS continued to expand and improve these databases to enhance the available tools for use in clinical, epidemiological, and other types of population-scientific research. The following describe these developments..

Dietary Supplements and Their Ingredients 
The need for data on the content of dietary supplements has grown in importance with the increased prevalence of dietary supplement use. A 2004 Congressional Directive encouraged ODS to develop the Dietary Supplement Label Database (DSLD) and it did so in collaboration with federal experts from NIH, the National Health and Nutrition Examination Survey (NHANES) of the National Center for Health Statistics (NCHS), CDC, the FDA, the U.S. Department of Agriculture (USDA), the Department of Commerce, and the Department of Defense (DOD). DSLD catalogs all information from product labels, all ingredients, and all claims and manufacturers and displays a photograph of the label. Revamped in 2021, the updated version includes both a desktop and mobile-friendly version of DSLD. It now contains more than 136,000 labels, with enhanced search and download features, including a more visible indicator of on- and off-market labels and the ability to download the entire database to meet the needs of small business and app developers. The label information in the DSLD is used by scientists, healthcare providers, and consumers. Fifty percent of DSLD users are return users and more than 200 publications in the scientific literature cite the database.

The Dietary Supplement Ingredient Database (DSID) provides statistically derived estimates—based on direct chemical assays—of the nutrient content of selected ingredients in popular dietary supplement products and compares them to ingredient levels reported on labels. It currently includes estimates of vitamin and mineral content in adult, child, and prenatal multi-vitamin/mineral (MVM) dietary supplements. Prescription prenatal supplement products, along with cranberry and turmeric/curcumin supplement products are currently being analyzed and results will be included in the database. The database also includes estimates of constituents of selected non-nutrient dietary supplements, such as omega-3 and green tea supplements. The DSID provides enhanced tools to aid researchers in utilizing the database. These include calculators and correction factors for the estimation of actual ingredient exposure. As noted, calculators are included for the most common types of dietary supplements, such as the MVMs, to permit consumers to compare the labels of the supplements they are taking to estimates from actual chemical analyses of representative products.

Essential Nutrients and Dietary Compounds in Foods 
Concerns about the adequacy of intake of the essential nutrient iodine in the U.S. population, particularly for pregnant and lactating women, led to the initiation of a multiagency collaboration involving ODS, FDA, and USDA to develop a novel Database for the Iodine Content of Common Foodsexternal link disclaimer and dietary supplements. Data in the most recent release include the iodine content for approximately 425 foods. Information for a selected set of dietary supplement products (such as prenatal MVMs) is provided through the DSLD and DSID databases. The iodine database values also are being linked to dietary data collected in recent NHANES, allowing estimation of total iodine intake from various dietary and supplement sources. Additionally, USDA, with ODS support, is developing a preliminary database of other dietary constituents called iodine uptake inhibitors (IUIs) that can interfere with the physiologic uptake and utilization of dietary iodine. These may include glucosinolates and other phenolic compounds, perchlorates, and thiocyanates. It is anticipated that data on IUIs will be used along with data on iodine content to improve estimates of the adequacy of iodine intake and status.

Concerns about the biological effects of understudied dietary compounds underscore the need for food and dietary supplement composition data beyond the conventional nutrients featured in currently available databases. Therefore, with ODS support, USDA has started to develop two new databases, one that will focus on the content of purines and pyrimidines in foods and dietary supplements and another focusing on nitrates and nitrites. Improved data on purines and pyrimidines will be applicable to research and patient guidance for gout and other disorders of uric acid metabolism, and data on nitrates and nitrites will help in understanding the risk-benefit relationships of these compounds to conditions such as cardiovascular disease and cancer. 

Federally Funded Dietary Supplement Research Studies
The Computer Access to Research on Dietary Supplements (CARDS) Database was the first ODS database, mandated in the founding language of the DSHEA. The database provides information on federally funded dietary supplement research for use by Congress and multiple government agencies as well as researchers, healthcare providers, industry, and the consumers. CARDS data are a subset of data available in the NIH RePORTER, but CARDS has enhanced coding capacity provides visualizations that go beyond administrative coding details. This coding enhances search capabilities by dietary supplement ingredient, health outcome or biological effect, study type, and direct (supplement taken) or indirect (biological mechanism only) relevance. This CARDS analyses return more projects than NIH RePORTER due to subject matter expert review and curation of OD projects in addition to the use of the Dietary Supplement fingerprint. Searches can use as many or as few codes as needed. To facilitate narrowly focused searches, CARDS coding is extensive, and codes are added as needed based on new focus areas in dietary supplement-related research. For example, Health Outcome code “Microbiome” was added in 2017, and Study Type code “Genetics/Epigenetics” was added in 2019. The NIH is the primary government funding source for scientific research, so most of the research projects contained in CARDS are NIH funded. Other agencies with limited historical data in CARDS are the USDA and DOD. New data from the USDA, Veterans Administration (VA), FDA, and the Agency for Healthcare Research and Quality's (AHRQ) have been added to CARDS and are targeted to be released publicly in FY2022.

Promoting Scientific Study: Improving the Knowledge Gained from Clinical Trials

variety of laboratory glassware

True to the purpose and responsibilities defined in DSHEA, ODS has focused its efforts on promoting scientific study that increases our knowledge of the impact of dietary supplements on human health and well-being. At least 80,000 products that contain an array of vitamins, minerals, botanicals, and other ingredients are available, but many questions remain about their effectiveness and safety. Through the Grant and Extramural Funding and CARBON programs, ODS has leveraged its funding to support critical research on dietary supplements to answer these questions. In past years ODS has provided support for large clinical trials to better understand the specific impacts of various nutrients and botanicals. Among these are the Selenium and Vitamin E Cancer Prevention Trial (SELECT), the Vitamin D and Omega-3 Trial (VITAL), the Antioxidants for Age-Related Eye Disease Studies (AREDS and AREDS2), and the Ginkgo Evaluation of Memory Study (GEMS).

The results of these large clinical trials have revealed that although some of the supplements studied may have positive health benefits, others demonstrate no benefit and a few present safety concerns. Examples include the following:

  • The  SELECT randomized clinical trial in healthy middle-aged men found alpha tocopherol (vitamin E) supplementation (400 IU/day) to increase the risk of prostate cancer, while selenium (200 mcg/day) had no effect on disease incidence.
  • The VITAL randomized clinical trial found that supplementation with omega-3 fatty acids (1 g/day) with or without vitamin D3 (2,000 IU/day) did not prevent cardiovascular disease or cancer events among healthy middle-aged men and women over 5 years of follow-up.
  • The AREDS and AREDS2 clinical trials tested whether taking a mix of dietary supplements (including vitamin E, vitamin C, and beta-carotene) could prevent or slow the development of cataracts and age-related macular degeneration (AMD). Although the supplement formulations tested did not prevent AMD onset or have an effect on cataracts, they did reduce the risk of progression to advanced AMD by about 25 percent. AREDS2 also found that beta-carotene increased the risk of lung cancer in former smokers.
  • GEMS, a randomized clinical trial, investigated whether supplementation with ginkgo biloba (120 mg/day twice a day) might reduce the risk of developing dementia or Alzheimer’s disease in older adults with or without mild cognitive impairment over a median of 6.1 years. Ginkgo biloba did not reduce the onset of these diseases.

Despite the findings that the supplements studied in these trials may not promote health or reduce disease, there is great value in conducting clinical trials. They provide important evidence for public health recommendations on the use and safety of specific dietary supplements and serve as resources for secondary analyses and ancillary studies. For example, an ancillary VITAL study focusing on autoimmune disease found that vitamin D supplementation (2,000 IU/day) for 5 years, with or without omega-3 fatty acids (1 g/day), reduced the development of autoimmune disease by 22 percent. Similarly, the GEMS trial led to 45 additional secondary analyses that focused on the use of herbal medicine and supplements in the elderly, mild cognitive impairment, the effects of Ginkgo biloba on cancer and blood pressure, and associations with dementia.

Understanding the importance of supporting the development of clinical trials, ODS, in collaboration with the FDA, the USDA, and 5 other NIH ICOs, held a workshop titled “Enhancing Natural Product Clinical Trials” in September 2018. The workshop addressed the challenges in moving early phase (e.g., in vitro) natural products research toward highly informative clinical trials, the latter being the gold standard for assessing the clinical efficacy of dietary supplements, diets, or other interventions. As a result of the workshop, an ebook is being completed on new research and best research practices for rigor in applying 21st century chemical, biological, and computational methods to study the health effects of foods and dietary supplements.

Communicating Science: ODS Marks 25th Anniversary Year Virtually

25th Anniversary logo

Although 2020 marked the 25th anniversary of ODS, limitations brought on by the COVID-19 pandemic delayed commemoration of this special occasion. Rising to the challenges of shifting to fully virtual stakeholder engagement, ODS celebrated its anniversary by sharing our scientific knowledge and health messages to a large and diverse audience by conducting multiple activities throughout 2021. 

The ODS Timeline, covering the office’s history and accomplishments, was developed and posted on the recently redesigned ODS website. And, for the first time since it was established in 2007, the Mary Francis Picciano Dietary Supplement Research Practicum was held virtually and was open to the public. Hundreds of attendees participated in this 3-day overview of the science, issues, concepts, and controversies about dietary supplements. The practicum recordings are available online.

Fittingly scheduled in March––National Nutrition Month––the ODS Lunchtime Seminar for NIH staff was based on the ODS brochure of the same name, Dietary Supplements: What You Need to Know. ODS nutrition scientists Carol Haggans and Paul Thomas gave their presentation to more than 500 NIH staff who viewed this seminar as a live event. We received more than 50 inquiries covering a broad array of dietary supplement topics, which we responded to either during the Q&A at the end of the seminar or via personal emails following the seminar. Most questions were similar to the types of inquires we receive from the public about various dietary supplement ingredients. A few were a bit more technical, as we would probably expect from an NIH audience. The NIH Videocast recording is available to the public on demand and has had more than 1,600 views. 

The 2-day ODS 25th Anniversary Scientific Symposium was held in October. The symposium began with opening remarks from NIH Director Francis Collins, DPCPSI Division Director James Anderson, and ODS Acting Director Joseph Betz. Featured historical commentaries were provided by past ODS Directors Bernadette Marriott and Paul Coates. The first day showcased ODS contributions to landmark scientific accomplishments in dietary supplement research, with presentations by leading researchers in the field of dietary supplement science. Day 2 of the symposium highlighted ODS’s part in training the next generation of dietary supplement researchers and discussed considerations for the future of dietary supplement research. The symposium was open to the public and nearly 1,000 people from 43 countries attended the live virtual event. Attendees included those in academia, clinicians, industry, and government. The symposium agenda, speaker bios, and recordings are available online and have had more than 1,700 views.


III.  ODS Accomplishments

The ODS Strategic Plan 2017–2021 provides a detailed description of each of the ODS programs and activities. Although they satisfy 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
ODS Total Extramural Investment in FY2021
Portfolio Total Value: $19.4M

ODS Total Extramural Investment in FY2021 Portfolio Total Value: $19.4M Pie chart describing ODS total extramural investment in FY 2021. The portfolio total value is 19.4 million dollars. There are four investment categories including extramural grants ($9,994,683 or 52 percent of portfolio), inter-agency or intra-agency agreements ($5,325,307 or 27 percent of the portfolio), research contracts ($4,048,210 or 21 percent of the portfolio, and non-grants for workshops and conferences ($25,000 or less than one percent of the portfolio).

The following are key 2021 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.

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

  • Grants and Extramural Funding
    • Objectives
      • 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 provided support to 65 extramural grants valued at $10 million across 14 NIH ICs.
      • Of these grants, 5 were related to the NIH CARBON program (total $2.6 million).
      • Of these 65 grants, 6 were training and career development grants, including 2 international training program grants, valued at $409,965.
  • Intramural Funding 
    • Objectives
      • To provide competitive scholarship funding opportunities for NIH early career intramural scientists.
      • To increase the exposure to and awareness of research on dietary supplements among early to mid-career researchers in related fields.
    • Key Accomplishments
      • ODS supported 7 junior/emerging scientists in NIH intramural laboratories across 6 Institutes through intra-agency agreements (IAAs) under the
      • ODS Research Scholars Program. The total value of ODS scholar awards was $657,338. The scholars must have mentors in their laboratories and give a presentation on their research at the end of their year-long scholarship.
      • ODS also supported 2 research projects under the Bench-to-Bedside (B2B) program through IAAs. The total value of these IAAs was $265,650. .

CARBON Program
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 a funding opportunity announcement (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
  • With the publication of the CARBON FOAs in 2019 the Botanical Dietary Supplements Research Centers (BDSRC) pilot project award eligibility was broadened. Proposed projects may now be led by others than BDSRC awardee faculty. This includes any researchers who can propose a meritorious and mutually useful pilot project with one of the awarded BDSRC. 
  • A first R03 pilot project award competed successfully for funding. Researchers at Auburn University are collaborating with the Botanicals Enhancing Neurological and Functional Resilience in Aging (BENFRA) Center to analyze potential drug interactions of the ashwagandha (Withania somnifera) extracts being used in early stage studies by the BENFRA investigators.
  •  All Centers held regular External Advisory Committee (EAC) and Internal Steering Committee meetings and are assessed as progressing by their EACs.
  • The annual meeting of all the Centers was held virtually as a closed meeting (Center Investigators and Agency staff only) with more than 120 people registered. Several Centers have initiated new collaborations or collaborative discussions as follow-ons to the meeting.
  • The annual meeting included a Resilience Roundtable in collaboration with the Trans-NIH Resilience Working Group Chair and the ODS Resilience and Health Studies Program Director. A summary of the roundtable was published in the December 2021 American Society for Pharmacognosy Newsletter.
  • The two BDSRC funded in the prior round (2015–2020) and not participating in the current CARBON published at least 8 more papers in 2021 
    • The Botanicals and Metabolic Resiliency Center at Pennington Biomedical Research Center published 4 papers on the molecular mechanisms of action of Artemisia species in modulating adipocyte physiology and systemic metabolism, and a paper, from a pilot project, on the pharmacokinetics of naringenin.
    • The Botanical Dietary Supplements for Women’s Health Center at the University of Illinois at Chicago published 3 papers from their BDSRC award in 2021, 1 describing the literature supporting functional interactions between flavonoids and ascorbic acid/Vitamin C, and 2 describing newly developed methods; 1 for the more replicable classification of flavonoids and another for analysis of Rhodiola rosea.
  • An Expert Panel review of CARBON is planned for 2022. The panel includes 8 professionals with diverse natural products expertise and backgrounds. They will respond to a set of questions with the purpose of assisting NIH in assessing components of the CARBON program and recommending future program directions.
  • There were 21 publications that resulted from prior CARBON program support.

Population Studies Program
Objectives
To conduct research, identify knowledge gaps, support, 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 supported the NHANES collection of dietary supplement data, prepares the data files for each 2-year cycle, and makes the data available to the research community.
  • ODS worked with NHANES to support prepandemic data collected during 2019 through March 2020, which included new items suggested by ODS. ODS obtained quality control data to evaluate for thyroid biomarkers and assessed the quality of the dietary supplement data collected during this time period. ODS also worked with NHANES to scale back study items of interest to the office for their new consolidated data collection that began in the summer of 2021.
  • An approach for estimation of dietary iodine intake (from foods, dietary supplements, and iodized salt) was proposed to the CDC’s NCHS and was applied during the first 3 quarters of the 2019–2020 NHANES survey cycle. NIH has worked with NHANES to gain access to the information obtained.
  • ODS staff participated 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 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 developing a series of webinars on assessing intakes and dietary supplement use across the lifespan. ODS took the lead on suggesting webinars of interest to the Dietary Guidelines Committee report for best practices for dietary assessment in pregnant women and children aged 6–11 years. The recorded webinars and full report are available at NASEM.
  • ODS is working with NASEM to develop a workshop or webinars on assessing dietary intakes in older adults for 2022. This would include the challenges of living conditions, cognitive issues, and frailty. 
  • ODS staff are working with others at NIH on topics of interest to be addressed by the NASEM Food Forums in the coming year. 
  • ODS collaborated with the AoA in designing and evaluating survey questions of participants in home-delivered and congregate meals and with the CMS in its surveys of Medicare recipients to obtain information on dietary supplement use, malnutrition, and frailty. 
  • ODS and partners at the National Institute of Child Health and Human Development (NICHD) collaborated with FDA to organize a workshop on Bioactive Ingredients for Infant Formula. The workshop was conducted in September 2021 and was highly successful; the manuscripts are under development. 
  • ODS participated in meetings with FDA about the safety of dietary supplements for body building, weight loss, and energy. The group has worked on finding and evaluating data sets that could inform the safety of these supplements.
  • Population Studies staff participate in the Joint Agency on Nutrition (JAN) working group with the FDA and several other senior nutrition staff at NIH to inform each other of recent and upcoming efforts that may be of interest and that may benefit from input from the other agency. 
  • ODS staff participate and have leadership roles in several large federal consortia, particularly related to nutrition from birth to 24 months of age, and the Human Milk Composition Consortium.
  • The program co-authored 12 publications in 2021.

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

  • 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. resilience. 
Key Accomplishments
  • ODS is working with the National Center for Complementary and Integrative Health (NCCIH) to develop a joint resilience and health program.
  • ODS collaborated with the Uniformed Services University of the Health Sciences (USUHS) Center for Health and Military Performance on dietary ingredients to minimize environmental heat injury, which resulted in 2 publications.
  • ODS established a cooperative agreement with USUHS, “Dietary Supplement Ingredients Promoted for Immune Health.” 
  • ODS developed a plan to identify and collate tools and metrics used by NIH ICOs to study resilience. 
     

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

Grants and Extramural Funding  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 contributed funding to 6 extramural training, career development, and fellowship grants. 
    • Two D43 research training programs designed for foreign professionals and students were supported in collaboration with the Fogarty International Center.  These include
      • Expanding Capacity Building in Non-Communicable Diseases: The Scholars in HeAlth Research Program (SHARP) at the American University in Beirut. The SHARP Program launched at the American University of Beirut in 2013 and aims to advance the non-communicable diseases (NCDs) agenda in Lebanon and the region.
      • International Research Training Center for Botanicals and Metabolic Syndrome (CBMS) in Tajikistan. The CBMS integrates intensive didactic training in western medical science with the strong traditional knowledge of botanical medicine to develop a sustainable mechanism for graduating doctoral- and postdoctoral-level research scientists who can merge these 2 systems for the benefit of Tajikistan.
    • One T32 institutional training grant supported NCCIH predoctoral training in innovative technologies for natural products and integrative medicine research.
    • One F31 fellowship grant supported NCCIH work on metabolomics for determining mechanism of action of botanical medicines.
    • Two career development grants (K23, K24) supported research on vitamin D, subclinical cardiovascular disease, and orthostatic hypotension in older adults with the National Heart, Lung, and Blood Institute (NHLBI) and bone metabolism in adolescents undergoing bariatric surgery, related to a bench-to-bedside project on a-lipoic acid, with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

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 prior years of the 2015–2020 CARBON awards (21 new publications in total).

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

  • To facilitate improved analytical skills through education in chemical and biological characterization of dietary supplements and their bioactive ingredients.
Key Accomplishments
  • The AMRM Program supports, mentors, and/or provides technical guidance to postdoctoral researchers and earlier career scientists at National Institute of Standards and Technology (NIST) andUSDA.
  • The AMRM program supports NIST in administering QAPs 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, doctoral students, and postdoctoral fellows; healthcare practitioners; and other professionals with advanced biomedical degrees.
Key Accomplishments
  • The annual practicum was conducted virtually and for the first time ever was open to the public. It was attended by 430 professionals. Half of the participants were from academia (faculty, research staff, students, and postdoctoral fellows) and the other half included a mix of health professionals, government employees, and industry representatives. The practicum recordings are available online.

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

CARBON Program
Objectives
To develop methods and resources to accelerate research on complex natural products such as botanicals for human health and to conduct relevant research and disseminate the results.

  • To support the competitively renewed Center for Natural Product Technology, Methodology, and Productivity Optimization (NP-TEMPO) and the Center for High-throughput Functional Analysis of Natural Products (Hi-FAN) as they continue to develop methods that will be directly applicable to the biological effects of animal- and plant-derived foods and dietary supplements and to beta test these methods via inter-institutional collaborations.
  • To award a new Natural Products NMR Open Data Exchange Center (awarded as NP-MRD [magnetic resonance database]) to establish a resource that will house the majority of the world’s natural products nuclear magnetic resonance (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 BENFRA Center received 2 administrative supplements in 2021 and published 5 papers, 1 on the chemistry of Centella asiaticai, 3 on its biological effects, and 1 on the biological effects of Withania somnifera (ashwagandha).
  • The Influence of Dietary Botanical Supplements on Biological and Behavioral Resilience Center completed all preparatory requirements and initiated their planned clinical trial. In addition, that Center published 4 papers in 2021, reporting on the characterization of the materials for the trial as well as on potential mechanisms of action via the gut-brain axis. 
  • The Spirulina Oral Supplement for Enhancing Host Resilience to Virus Infection Center finalized their clinical trial protocols, finalized the product format to be used in the trials, and is in the process of final intervention production and characterization.
  • The High-content Functional Annotation of Natural Products Center made substantial progress toward preparing their platform for broad, public availability and published 2 major methods papers. One is on the sources of variability in untargeted NMR analyses of chemically complex natural products, currently at an altmetric of 21. The other describes their newly developed platform for the analysis of data from chemically complex natural products, Metabolomics and Dereplication by Two-Dimensional Experiments (MADByTE), and its application for the prioritization of bioactive metabolites from a bacterial prefractionated extract library.
  • The NP-MRD Center is the world’s largest natural products NMR database, with every entry checked for its natural product origins and more than 20,000 unique compound entries that are not found in any other NMR database. NP-MRD investigators introduced the database in a January, 2022, paper in Nucleic Acids Research. 

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

  • ODS awarded 2 contracts in FY21 for the development of new calibration solution certified reference materials (CRMs) for chemical components of the popular dietary supplement ingredients echinacea and milk thistle.
  • ODS’s collaboration with NIST resulted in the development of 10 newly issued or updated standard reference materials (SRMs) and the maintenance of more than 35 dietary supplement-specific matrix-based SRMs.
  • ODS collaborated with NIST to optimize administration of QAPs to better focus on dietary supplement community needs and enable laboratories to improve the accuracy of their analytical measurements of foods, dietary supplements, and biological samples.
    • Two QAP exercises, with a total of 21 studies relevant to dietary supplement analyses, were offered and had results published in FY21.
    • Disseminated a feedback survey to participant labs to identify stakeholder needs and inform programmatic approaches.
  • AMRM supported outreach/educational presentations by NIST staff at 3 scientific and regulatory conferences.
  • 19 research papers and manuscripts supported by AMRM were published or submitted for peer review in FY21.
  • Published the comprehensive review “The Importance of Reference Materials and Method Validation for Advancing Research on the Health Effects of Dietary Supplements and Other Natural Products” in a special edition of Frontiers in Nutrition.

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. New work is underway to develop databases for nitrates and nitrites.
  • ODS worked with other nutrition staff at NIH to provide input for an extramural NIDDK study on gestational diabetes that did not include a dietary component. The investigators have agreed to include the dietary component but the NIH FY22 budget will determine whether NIH can support these additions.
  • ODS collaborated with NHANES on data collection methods for infant formula and iron and iodine status in pregnant/lactating women and infants.
  • ODS staff has continued as Co-Chair of an Implementation Working Group for the NIH Nutrition Strategic Plan (working group title “Nutrition Across the Lifespan”). The group developed and presented some bold initiatives for the implementation plans and continues to provide input on programs across the NIH that meet with strategic goals related to nutrition across the lifespan.
  • ODS collaborated with others within the federal government and in academia to develop a measure of total nutrient intake that included nutrient-containing dietary supplements and published the results.
  • ODS continued to publish articles in the peer-reviewed literature and made presentations at national meetings on dietary supplement use and its consequences among those of various age/life stages and risks. 
  • ODS initiated discussions and a request to the NCHS Division of Health Care Statistics to include survey questions on the periodically administered National Ambulatory Medical Care Survey (NAMCS). ODS submitted 2 questions for consideration on the survey, which will undergo cognitive testing in 2022 for possible inclusion in the 2023 survey. These survey questions, asking about the use of an electronic health record (EHR) to record dietary supplement usage, would complement the survey questions on dietary supplements collected in the NHANES survey.
  • ODS is researching different EHR programs to understand both how dietary supplement information can be collected and linked to the drug knowledge database used in an EHR and whether individual EHR systems are capable of interfacing with other EHRs. 

Dietary Supplement Database Program
Objectives
To support the development, improvement, expansion, and deployment of dietary supplement databasesa.

  • To coordinate the integration of federal databases that include dietary supplement data.

Key Accomplishments

  • ODS maintains the DSLD, the DSID, and the CARDS database in collaboration with other federal partners.
  • ODS planned and presented 
    • Workshop on standardization of nomenclature and interoperability between federal food, drug, and dietary supplement databases for the NIH Nutrition Research Coordinating Committee on January 6, 2022.
  • ODS published 3 articles in peer-reviewed journals on the DSLD and DSID. 
 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 136,000 labels and is accessible through a website and a mobile version. Servers for DSLD and DSID were moved to NIH from the National Library of Medicine (NLM). The new revamped DSLD website and download features were launched. 
  • DSLD data are being used to compare nutrient needs/dietary intake gaps with MVM and prenatal supplements. Results for child MVM supplements were published in the Journal of the American Academy of Nutrition and Dietetics in late 2021, and results for adult MVM have been submitted as an abstract to the National Nutrient Databank Annual meeting scheduled for May 2022. Results will be published in a peer-reviewed journal.
  • Staff presented at several conferences or symposiums on dietary supplements featuring the DSLD, including
    • Symposium on DSLD as part of the American Society for Nutrition annual meeting in June 2021.
    • Several abstracts and oral presentations on dietary supplement databases at the National Nutrient Databank annual meeting in November 2021.
  • ODS staff collaborated with FDA and other federal partners on use of DSLD for evaluating weight loss products and with members of DOD and USUHS to better meet needs of armed service members.
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 from dietary supplements.
  • DSID staff completed updated analyses of several popular dietary supplements.
  • DSID staff continued work on measuring dissolution and disintegration of dietary supplements.
  • ODS staff coauthored a submission with USDA staff for an AOAC International meeting on the use of DSID.
  •  DSID staff planned and executed a session on dietary supplements at the November 2021 National Nutrient Databank Conference, presenting several abstracts and oral presentations on dietary supplement databases. A similar program is planned for the 2022 conference.
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

  • FY2021 CARDS dietary supplement-related projects were reviewed, coded, and published.
  • FY2021 dietary supplement-related projects were added to CARDS and review and coding are in process.
  • Adding FDA and VA projects to CARDS is underway.

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 leads regular, monthly meetings of the Trans-NIH Resilience Working Group, which has resulted in a quarterly seminar series.  
  • ODS initiated a proposal for a Resilience Research Special Issue and identified a journal for the special issue along with topics and authors for each section. ODS is co-authoring and editing this special issue with the purpose of showcasing how the Trans-NIH Resilience Working Group resilience definition and study design tool is reflected in NIH resilience research.
  • ODS established the Resilience Research Scientific Interest Group (SIG) to expand on coordination of resilience researchers across NIH.
  • ODS resilience and health studies program staff co-authored an article titled “Physiological Need for Calcium, Iron and Folic Acid for Women of Various Subpopulations During Pregnancy and Beyond” for a Special Issue of the Journal on Women’s Health.  
  • ODS resilience and health studies program staff presented “Activities of the Trans-NIH Resilience Working Group” at an NIH Nutrition Coordinating Committee, co-presented on “Resilience and Health Restoration” at the NCCIH retreat, and presented at the Trans-NIH COVID-19 Mental Health Working Group meeting.

 
GOAL 4: Translate dietary supplement research findings into useful information for consumers, health professionals, researchers, and policymakers.

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 
  • In September, ODS launched a revised and updated website with both front-end and back-end upgrades and design changes. Changes included improved navigation tabs and choices, wider presentation, increased use of images, and streamlined administration processes, keeping with current webpage style and practices. New and revised webpages included Product Integrity, NIH Trans-Resilience Working Group, Databases, and Education & Training.
  • Average monthly users: More than 1,083,491; average monthly page views: 1,700,000. 
ODS 25th Anniversary commemorated 
  • A 2-day scientific symposium in October showcased ODS contributions to landmark scientific accomplishments in dietary supplement research and featured presentations by experts in the field of dietary supplement science. It also highlighted ODS’s part in training the next generation of dietary supplement researchers and discussed considerations for the future of dietary supplements research. It was viewed live by a diverse group of nearly 1,000 people from 43 countries, and the event recordings have had more than 1,700 views. 
  • ODS nutrition scientists presented “Dietary Supplements: What You Need to Know,” a 1-hour live seminar viewed by more than 500 NIH staff during March—National Nutrition Month. Dozens of viewer questions were answered and a recording was made available to the public after the event. 
  • An ODS Timeline was created and posted on the website to document significant accomplishments in the past and over time.
  • ODS hosted 10 virtual seminar speaker presentations and 1 meeting of the Federal Working Group on Dietary Supplements in April.
Outreach Activities and Products 
  • ODS responded to 450 public inquiries in 2021.
  • ODS received and triaged 26 media inquiries, resulting in 15 interviews with ODS experts and 11 custom responses or referrals to outside experts. ODS experts and fact sheets were quoted and referenced in dozens of media articles available online. Meltwater was engaged in August to monitor ODS’s media coverage.
  • Developed and disseminated 8 Special Supplement issues, 3 issues of the ODS Update, and 2 issues of The Scoop. ODS began sending out ODS Tweets of the Week in April and Just the Facts in July to announce new fact sheets. Since the March launch of the Granicus govDelivery email service, ODS’s subscriber audience increased significantly: ODS Update newsletter subscriptions went from 5,100 to 20,000 subscribers and The Scoop subscriptions went from 5,000 to 30,000 subscribers. 
  • Social media: ODS currently has 10,000 Facebook and 16,000 Twitter followers. Each weekday ODS posts messages on these accounts leading followers to ODS and other government resources. ODS posts once a week in Spanish. Meltwater was engaged in August to improve social media account management and monitoring.
  • Videos: An additional 15,600 views in 2021 for a total of 100,300 views since 2014.
  • ODS staff presentations and publications in 2021 included 4 presentations at national/international conferences and 27 publications.
  • ODS Fact Sheet Program (Note: Version 2 denotes a major update of an existing fact sheet.)
    • New fact sheets in progress: Calcium, Version 2 (Spanish); Carnitine (health professional); Dietary Supplements for Immunity (health professional); Dietary Supplements for Relaxation, Stress and Anxiety Relief, Calm, and Sleep (health professional); Multivitamin/Mineral Supplements, Version 2 (consumer); Vitamin A, Version 2 (health professional); Zinc, Version 2 (health professional).
    • Fact sheets updated: Dietary Supplements in the Time of COVID (health professional and consumer); Dietary Supplements for Weight Loss (health professional); Magnesium (health professional); Niacin (health professional); Omega-3 Fatty Acids (health professional and consumer); Probiotics (health professional and consumer); Riboflavin (health professional and consumer); Vitamin D, Version 2 (health professional).
    • New fact sheets completed: Calcium, Version 2 (health professional and consumer); Chromium (Spanish); Dietary Supplements in the Time of COVID (health professional, consumer, and Spanish); Fluoride (Spanish); Multivitamin/Mineral Supplements, Version 2 (health professional); Vitamin B12, Version 2 (health professional, consumer, and Spanish); Vitamin D, Version 2 (consumer and Spanish).
    • All nutrient fact sheets were updated with the dietary advice from the updated publication, Dietary Guidelines for Americans, 2020–2025. 
Internal Communications
  • ODS plays a key role in keeping the NIH OD, the 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. 
  • 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 NIH Spanish Health Information Community of Practice, the DPCPSI Communications Community, and the Nutrition Education Subcommittee of the Nutrition Research Coordinating Committee.