Office of Dietary Supplements Strategic Plan Annual Report October 2016–December 2017

The history of ODS is rooted in legislation by the U.S. Congress that forms the basis of the ODS mission and activities. ODS was created in 1995 at National Institutes of Health (NIH) to meet the requirements of the Dietary Supplement Health and Education Act (DSHEA) of 1994. According to DSHEA, the purpose of ODS is to explore the role of dietary supplements as a significant part of U.S. efforts to improve healthcare and to promote scientific study of dietary supplements in maintaining health and preventing chronic disease. Since its inception, several congressional mandates have directed ODS to add new or to enhance existing activities including to establish a botanical research center program (1999), conduct evidence-based reviews of the efficacy and safety of dietary supplements (2001), accelerate the validation of analytic methods and reference materials for dietary supplements (2004), and develop a dietary supplement label database (2004).

Exhibits 1, 2, and 3 below summarize the ODS mission, goals, and areas of focus.

Exhibit 1: ODS Mission, Goals, and Areas of Focus; The mission of ODS is 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. DSHEA Mandate 1-4: 1. Conduct and coordinate scientific research within NIH relating to dietary supplements. 2. Coordinate funding relating to dietary supplements for the NIH. 3. Collect and compile the results of scientific research relating to dietary supplements; develop a database. 4. Serve as the principal advisor to HHS on issues relating to dietary supplements.  ODS Goals 1-4: 1. Support and Stimulate Dietary Supplement Research (spans DSHEA Mandates 1-3). 2. Support and Conduct Training (Mandate 1). 3. Develop and Disseminate Resources (Mandates 3-4). 4. Translate Dietary Supplement Research for All (Mandates 3-4). ODS Area of Focus (AF) 1: Research and Training (supports goals 1-2). AF 2: Population and Nutrient Initiatives (goal 1). AF 3: Research Resources (goal 3). AF 4: Collaborations with Federal Agencies (goals 1-3). AF 5: Translating Research Findings (goal 4).

The responsibilities delineated by DSHEA are directly addressed by at least one of the four main ODS goals presented in Exhibit 2.

Exhibit 2: ODS Goals
Goal 1:  Expand the scientific knowledge base on dietary supplements by stimulating and supporting a full range of biomedical research and by developing and contributing to relevant initiatives, workshops, meetings, and conferences.
Goal 2: Enhance the dietary supplement research workforce through training and career development.
Goal 3: Foster development 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.

Exhibit 3 presents an organization of ODS's 16 programs and activities and their primary categorization within one of ODS's areas of focus (research and training, population and nutrient initiatives, research resources, collaborations, and translating research findings). Although the overall emphasis of each program or activity relates to its assigned area of focus, there is frequent collaboration. In fact many programs or activities could be included in more than one area of focus.

Exhibit 3: Areas of Focus and Related Programs and Activities; Area of Focus (AF) 1: Research and Training; contains: Dietary Supplement Research, CARBON*, Training & Career Development, Dietary Supplement Research Practicum. AF 2: Population and Nutrient Initiatives; contains: Nutrient Initiatives for Vitamin D, Folate, Vitamin B12, Iron, and Iodine, Develop Tools/Analytical Models for Population Studies, and IEM/Primary Mitochondrial Diseases. AF 3: Research Resources; contains: AMRM*, Dietary Supplement Databases*, and Systematic Reviews*. AF 4: Collaborations with Federal Agencies; contains: Federal Working Group on Dietary Supplements and NIH/Federal Agency Collaborations & Consultations. AF 5: Translating Research Findings; contains: Communications, Publich Health Policy & Clinical Practice, Workshops, and Publications & Presentations. * = Congressionally Mandated Program

Innovation 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 among its roles as a facilitator of research, developer of resources, trainer of researchers, collaborator with academics and federal and other agencies, and communicator of existing and new knowledge.

The ODS Strategic Plan 2017–2021 provides a detailed description of each of the 16 ODS programs and activities that fall into the categories depicted in Exhibit 3 above. However, the reality of the work done by ODS and its programs is not so neatly categorized. Programs tend to be interwoven between areas of focus, satisfying different goals, and the collaborative nature of ODS staff helps to build strong connections within ODS, NIH, federal agencies, academic institutions, and other stakeholders within the dietary supplement community. The following are 3 examples of how ODS staff have worked together across their programs and activities to achieve the overall mission and goals as stated above.

Identifying a Research Gap: The Vitamin D Paradox

Since 2004, the Office of Dietary Supplements (ODS) has actively been engaged in developing an in-depth understanding of vitamin D's impact, effectiveness, and safety in relation to health, particularly bone health, through its sponsorship of several workshops and the establishment of the ODS Vitamin D Standardization Program (VDSP). Through this work, ODS has contributed substantially to the updated Vitamin D Dietary Reference Intakes and recommended levels of 25-hydroxyvitamin D [25(OH)D] in blood as a measure of vitamin D status.

At the 2014 ODS conference "Vitamin D: Moving Toward Evidence-based Decision Making in Primary Care," questions were raised about the efficacy of vitamin D supplementation among Black American populations and the potential risks associated with assuming a "normal" range of serum 25(OH)D levels without adequately assessing health outcomes in various subpopulations. These questions were based on findings showing that although there is a correlation of serum 25(OH)D levels with bone mineral density and fracture risk in White and Mexican-American populations, serum 25(OH)D levels do not correlate with the same health outcomes in some other populations, particularly Black Americans. In that group, bone density measures are high despite markedly low or deficient serum levels of 25(OH)D.

To address these and other questions pertaining to this vitamin D paradox, ODS, the National Institute on Minority Health and Health Disparities (NIMHD), the National Institute on Aging (NIA), and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) co-sponsored an expert panel meeting titled "A Systems-Based Approach to Investigating the Vitamin D Paradox in Black American" as a forum to: (1) explore the paradox through various multidisciplinary lenses (genetics, epigenetics, molecular mechanisms, and behavior) to determine the factors affecting vitamin D requirements in Black Americans; (2) identify potential unintended consequences of current clinical practices and public health polices (e.g., vitamin D supplementation, food fortification) on minority health and health disparities; and (3) aid in determining whether additional input from the scientific community via a subsequent workshop is needed to advance the understanding of the vitamin D paradox and bone health in the Black American population. A publication of the meeting proceedings will be forthcoming.

Developing Resources: Working Collaboratively to Accurately Measure Nutrient Intake

Data on food and nutrient intake have been collected for decades. Collecting data on dietary supplement use is more recent and has grown in importance with increased use of dietary supplements. Dietary supplements now contribute substantially to intakes of several essential nutrients. Food and supplement intakes must be used together for assessing and planning total dietary intakes for individuals and groups and for developing dietary recommendations at the federal and local levels.

In the past, the Office of Dietary Supplements (ODS) has supported the development of a dietary supplement database to be used with data from the National Health and Nutrition Examination Survey (NHANES) to address population dietary supplement intakes. Two more recent databases developed by ODS are used to assess the intake of ingredients in dietary supplements: the Dietary Supplement Ingredient Database (DSID) and the Dietary Supplement Label Database (DSLD). They were developed in collaboration with federal experts from National Institutes of Health (NIH), U.S. Department of Agriculture (USDA), U.S. Department of Commerce, Food and Drug Administration (FDA), and U.S. Department of Defense (DoD). The DSLD provides information on product ingredients and other information from dietary supplement labels; more than 72,000 labels are now included. The DSID provides chemically analyzed values in key nutrients for a representative sample of some of the most common dietary supplements sold in the United States and provides the capacity for comparisons to be made between label values and analyzed values. Both web-based public-use databases were updated in 2017 to increase accessibility and usability.

The development of these databases and ODS's other work in supporting collection and analysis of dietary supplement use in NHANES now permit population-based estimates of total dietary intake. However, obtaining accurate information on the composition and use of dietary supplements continues to be an issue. Throughout 2017 ODS staff, in collaboration with other federal agencies, have produced prevalence estimates and reviewed existing and developed new data collection and analysis methods and resources. They are doing this for two purposes. The first is to assess dietary supplement quality (through studies of disintegration of supplements) with particular focus on nutrients and supplements of current public health concern (iron, iodine, prenatal and infant and child multivitamins, and herbal supplements). The second is to accurately collect prevalence data from high-risk target populations (infants, toddlers, pregnant and lactating women, and older adults). The work on the databases and on methods for data collection and analysis has been accomplished by staff from various ODS program areas and through collaborations with FDA, National Library of Medicine (NLM), National Cancer Institute (NCI), the Uniformed Services University of the Health Sciences (USUHS), the Centers for Disease Control and Prevention (CDC), the USDA, Department of Commerce, and DoD.

Informing Policy and Public Knowledge: Dietary Supplement Fact Sheets

A majority of people who access the Office of Dietary Supplements (ODS) website come to view the ODS dietary supplement fact sheets. ODS staff have prepared almost three dozen fact sheets on ingredients in dietary supplements (primarily nutrients such as vitamin D and calcium) and on categories of products, such as multivitamin/mineral supplements and dietary supplements for weight loss and for exercise and athletic performance. Most fact sheets are available in three formats: a detailed and fully referenced version for healthcare professionals and a more basic easy-to-understand version directed to consumers in both English and Spanish. All fact sheets have a similar format for easy access to their contents. Consumer fact sheets are available in PDF format for printing and distribution by health educators and others who wish to make paper copies.

New fact sheets are always being developed so the ODS library continues to grow. Beginning with the healthcare professional version, one nutritionist studies the ingredient and performs the literature review, ultimately preparing a preliminary draft that is revised until a complete interim version is completed and edited. This draft is then reviewed by ODS scientific staff and revised accordingly. It then undergoes one more review by three outside subject matter experts, typically from academia. This dietary supplement fact sheet for health professionals is then finalized, edited, and published on the ODS website. It then becomes the basis for preparing a nontechnical consumer version—an effort involving the work of ODS nutrition staff and an editor—followed by a review by nutrition experts within the Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA) to ensure its contents conform to the federal government's dietary and nutrition guidelines.

Once a fact sheet is on the ODS website, it is updated as needed to incorporate new information, such as to add an important new study or fact. Furthermore, ODS staff strive to thoroughly review and update each fact sheet every three years to keep them as up to date and scientifically detailed as possible. Many stakeholders use the ODS fact sheets to inform their decisions about whether or not to take dietary supplements and about choosing appropriate products. Also, many media outlets expand the reach of these fact sheets as they use them to develop their news stories about nutrients, other dietary components, and dietary supplements.

In 2017, four new fact sheets were developed, two fact sheets were completely revised and updated, and three fact sheets were revised with new information. In addition, all fact sheets were revised to allow users to see the last date on which the information was updated and the text changes that were made at that time.

ODS Accomplishments (October 2016–December 2017)

ODS's staff initiate effective collaborations across government and constituent communities. Such collaborations are key to fulfilling the ODS mission. The value of ODS efforts is evident in its ability to engage and manage the wide range of expertise required to accomplish its goals.

GOAL 1: Expand the scientific knowledge base on dietary supplements by stimulating and supporting a full range of biomedical research and by developing and contributing to relevant initiatives, workshops, meetings, and conferences.

  • ODS co-funded 69 grants valued at $10.9 million for new and continuing projects across 12 NIH Institutes and Centers.
  • ODS supports the Centers for Advancing Research on Botanical and Other Natural Products (CARBON) Program, run jointly by ODS and the National Center for Complementary and Integrative Health (NCCIH). The CARBON Program is responsible for 26 publications in two areas of focus (rigorous research elucidating mechanisms of action and the development of methods).
  • ODS has increased the understanding of the microbiome with respect to food, dietary supplements, nutritional status, energy balance, and risk of disease. ODS co-funded two R01 grants and two administrative supplements related to the microbiome. ODS also helped plan two workshops and participated in three trans-NIH and trans-federal working groups related to the microbiome. Two of the CARBON Centers include projects researching the role of the gut microbiome in modulating the biological effects of orally consumed botanicals.
  • ODS staff collaborated with various NIH Institutes and Centers and other federal agencies (Centers for Disease Control and Prevention [CDC], Department of Health and Human Services [HHS] Office of the Secretary, Food and Drug Administration [FDA], and U.S. Department of Agriculture [USDA]) on obtaining accurate data on supplement use and total nutrient intake from food and supplements in pregnant and lactating women and infants up to 24 months.
  • ODS staff evaluated differences in strategies used for assessing dietary supplement use in the main food frequency questionnaires used in large epidemiologic studies and presented their results at the 2017 Experimental Biology meeting. A draft of the paper is forthcoming.
  • ODS staff worked closely with National Health and Nutrition Examination Survey (NHANES) staff to determine how best to evaluate biomarkers for iron and iodine status in pregnant women, infants, and children.
  • ODS staff published a manuscript and presented findings describing dietary supplement use in older Americans.
  • ODS staff reviewed the current literature related to supplement use among cancer patients, particularly breast cancer patients, and researched how industry markets their supplements to cancer patients.
  • ODS directed the preparation of a review manuscript that (1) evaluated clinical evidence of efficacy and safety of nutritional interventions in primary mitochondrial disorders and (2) characterized cellular and animal model systems for investigating nutritional intervention mechanisms of action and efficacy (accepted for publication in Annual Reviews of Pathology: Mechanisms of Disease in early 2018).
  • ODS staff contributed to development and support of an Agency for Healthcare Research and Quality (AHRQ) systematic review related to sodium, potassium, and health outcomes. The review will be available by spring 2018 and will be used by a National Academies of Science, Engineering, and Medicine (NASEM) expert committee to review the Dietary Reference Intake values for sodium and potassium.
  • An ODS workshop titled "Iron Screening and Supplementation in Iron-Replete Pregnant Women And Young Children" resulted in the publication of a report on the workshop proceedings (including 23 manuscripts) in the December 2017 American Journal of Clinical Nutrition.
  • The Vitamin D Standardization Program (VDSP) hosted a meeting in November 2017 titled "The Road Ahead" focused on its achievements based on input from the program's stakeholders. In addition, future plans were discussed for an evaluation of VDSP performance criteria for 25-hydroxyvitamin D [25(OH)D], the promotion of the standardization of 24,25(OH)2D3 and vitamin D binding protein, and the development of a rickets registry.
  • ODS staff, in collaboration with the National Institute on Minority Health and Health Disparities (NIMHD), organized an expert panel meeting titled "A Systems-Based Approach to Investigating the Vitamin D Paradox in Black Americans" to explore why, despite markedly low or deficient measures of vitamin D status in Black Americans, the incidence of falls, fractures, and osteopenia is significantly lower when compared to White American counterparts with similar vitamin D status. A report on the meeting proceedings is forthcoming. For more information, please see Identifying a Research Gap: The Vitamin D Paradox under the section on Innovation and Collaboration.

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

  • Among the 69 funded grants mentioned above, ODS funded seven applications for the 2018 ODS Scholars Program and 22 administrative supplements in 2017 allowing investigators, including junior scientists, to expand the scientific scope of their NIH-funded projects to include work related to dietary supplements. In addition, ODS funded two Milner fellows and hosted a metrology postdoctoral fellow and an academic researcher on sabbatical. The CARBON Program contributed directly to the training of 16 postdoctoral fellows and 15 graduate students.
  • ODS again offered its Dietary Supplement Research Practicum, a 2.5-day course to provide fundamental knowledge of dietary supplements, to 91 academic faculty, Ph.D. students, and postdoctoral fellows; healthcare practitioners; and other professionals with advanced biomedical degrees. To offer the practicum to a wider audience, the 2017 Practicum was recorded and is available on the ODS website.

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

  • As part of the ODS Analytical Methods and Reference Materials (AMRM) Program, ODS contracted with AOAC International for method development and validation. Stakeholders helped to define, identify, and review analytical methods for characterizing eight dietary ingredients through their participation in consensus-based standard-setting meetings.
  • As part of an ongoing interagency collaboration between AMRM and the National Institute of Standards and Technology (NIST), ODS support permitted NIST scientists to develop new analytical methods for dietary supplements and allowed them to create and maintain 25–30 dietary supplement-specific Standard Reference Materials (SRMs) or calibration standard solutions throughout FY2017, including six newly issued or updated SRMs.
  • NIST completed two Dietary Supplement Quality Assurance Program (DSQAP) exercises and initiated two more that are in progress.
  • AMRM funding, through an ongoing Interagency Agreement between ODS and the Food Composition and Methods Development Laboratory at USDA, resulted in the development of innovative methods to identify, authenticate, and characterize botanical supplements including echinacea, black cohosh, and maca.
  • The CARBON Program supported new methodologies that improve the usability of the crystalline sponge method for organic structure determination and rapidly optimize solvent systems for separation of natural product constituents. It also supported the development and publication of a method for quantitative chemical standardization of complex natural products using quantum mechanical quantitative proton nuclear magnetic resonance for red clover extract.
  • A new Interagency Agreement was initiated with the USDA Nutrient Data Laboratory to develop a database on the iodine content of salt, foods, beverages, and dietary supplements. Activities will include studies on the stability of iodine in table salt, evaluation of iodine in commonly eaten foods, and (in collaboration with CDC Atlanta) assessment of the iodine content of standard dairy products and nondairy "milks" made from nuts, grains, or legumes. Outputs will include addition of iodine values to the USDA Standard Reference Database, the Dietary Supplement Ingredient Database (DSID), and related databases as used for NHANES and other surveys.
  • The Dietary Supplement Label Database (DSLD), DSID, and Computer Access to Research on Dietary Supplements (CARDS) databases were all updated to improve their look and usability.
  • The DSLD added 1,000 new labels per month and now contains more than 72,000 labels. This database is now both web and mobile friendly.
  • The DSLD project team received the 2017 NIH Office of the Director Honor Award in November in recognition of the next-generation DSLD deployment.
  • Several papers were prepared and national and international presentations were made throughout the year using data available in the DSLD. This research presented data previously not available to practitioners and researchers, thus contributing to current knowledge about prescription and nonprescription prenatal supplements and the forms of iron used in these products. A paper on the characteristics of prescription and nonprescription prenatal supplements was published in the September 2017 issue of the Journal of the Academy of Nutrition and Dietetics.
  • The DSID was updated in August 2017 and an article on national estimates of the analytical content of nutrients in adult multivitamin supplements in the DSID was published in the American Journal of Clinical Nutrition.
  • The DSID includes botanicals for the first time, along with levels of vitamins A and D and chromium in adult multivitamin/mineral supplements. Dietary supplement products in four studies were tested for disintegration, with failure rates ranging from 25 to 45 percent for capsules and tablets, respectively.
  • Along with presentations, ODS staff have completed two journal supplements to be published in early 2018. The Nutrients journal special issue on dietary supplements will include papers on iodine, vitamin D, omega-3 fatty acids, iron, and scientific and regulatory challenges in dietary supplement research. For the Journal of Nutrition, a supplement was prepared (along with federal partners) to include seven papers on dietary supplement databases.

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

  • The ODS website, which averages more than 1.4 million visits and more than 8 million page views per month, has been updated. As part of its continuous content review and development, four new fact sheets were developed and five existing fact sheets were revised.
  • In 2017, more than 25 interviews were given to a wide variety of consumer and health professional media outlets.
  • ODS has 6,261 likes on Facebook and 13,829 Twitter followers.
  • ODS hosted eight research investigators through its seminar series and an additional eight other workshops or expert panel meetings throughout the year.
  • ODS organized three meetings of the Federal Working Group on Dietary Supplements (October 2016, March 2017, and October 2017) that included presentations and discussions on the NIH Office of Nutrition Research and the National Institute on Aging (NIA), DSID, activities of the Food and Nutrition Board and its Dietary Reference Intake effort, the ODS Workshop on Iron Screening and Supplementation, the ODS Strategic Plan 2017–2021, the ODS AMRM Program, and the microbiome.
  • ODS staff participated on the Joint U.S.-Canada Dietary Reference Intake Working Group comprising officials from HHS and USDA agencies and Health Canada to develop and support a NASEM report on use of chronic disease endpoints in establishing Dietary Reference Intakes, an AHRQ systematic review of sodium and potassium, and initiation of a NASEM review of Dietary Reference Intakes for sodium and potassium.
  • ODS staff contributed to the development of a Nutrition Research Strategic Plan as part of the NIH Nutrition Research Task Force.
  • Along with numerous ODS-sponsored presentations by staff, there were 65 ODS staff presentations at national and international workshops, meetings, and conferences and 62 staff publications between October 2016 and December 2017.