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FY2022 Referral Guidelines: The Office of Dietary Supplements (ODS) Research Scholars Program

Table of Contents

The Office of Dietary Supplements (ODS) Research Scholars Program is a one-year competitive scholarship opportunity for NIH intramural scientists to study the role of dietary supplements and/or their ingredients in health promotion and disease prevention. This program is targeted towards early career scientists, including tenure-track investigators, independent research scholars, early independent scientists, assistant clinical investigators, research fellows, staff fellows, and postdoctoral fellows with at least one year of postdoctoral research experience. All applicants must have obtained their terminal degree within the last 10 years. Senior Investigators, Senior Scientists, and Senior Clinicians are not eligible to apply. These referral guidelines have been prepared for use by NIH in determining projects within the scope of ODS, identifying requirements for application submission, and describing the expectations of funded scholars. For further information, please contact Karen Regan at  Information about previously funded ODS scholars can be found below.

I. Purpose of Funding Opportunity

The mission of ODS is to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for the U.S. population.

ODS supports all types of biomedical research, including pre-clinical, clinical, behavioral, and epidemiological, in which the primary emphasis is the investigation of dietary supplements and/or their ingredients*. ODS research interests are not limited to specific health conditions, organ systems or populations groups.

Primary consideration for support will be given to proposals that stimulate dietary supplement research where it is lacking or lagging to clarify gaps, investigate the balance between health benefits and risks where data are in conflict, target special population groups where additional science on supplements is needed, and focus on the use of supplements and/or their ingredients in improving or maintaining health and reducing the risk of chronic disease.

Another ODS funding priority is to enhance collaborations between multidisciplinary researchers from different NIH laboratories or institutes. ODS encourages applications where the scholar would have the opportunity to learn and apply new methodology to his or her research.

Due to constrained budgets, ODS mission-relevant research will be focused on the above areas. ODS will not accept grant applications that have disease treatment as a focus.

*As defined by Congress in the 1994 Dietary Supplement Health and Education Act, a dietary supplement is a product (other than tobacco) that is intended to supplement the diet; contains one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and other substances) or their constituents; and is intended to be taken by mouth as a pill, capsule, tablet, or liquid.?

Examples of research projects that are within the mission of ODS:

  • Investigations of the role of dietary supplements in maintaining a healthy immune system and promoting resilient health outcomes in healthy and at-risk populations.
  • Intervention studies that examine the role of the microbiome in mediating the beneficial health effects of botanical dietary supplements.

  • Utilization of "omics" technologies such as metabolomics or proteomics to evaluate biomarkers of total nutrient intake (from diet and dietary supplements) in cohort studies or projects that add novel biomarkers to randomized controlled trials of dietary supplements.

  • Studies that investigate the contrasting effects of dietary supplements on certain diseases or health conditions (e.g. folic acid and its effects on neural tube defects and colon cancer).

  • Intervention studies that examine the effects of dietary supplements on maintenance of optimal health or reduction of disease risk where supplement interventions alter physiological endpoints or other health outcomes (e.g., a study that examines the physiologic or mechanistic effects of St. John’s wort on depression or a study assessing the effects of calcium supplements on bone mass density and the reduced risk of osteoporosis).

  • Studies of single ingredients or complex mixtures that examine the transport, metabolism, mechanism of action, associated enzymes, binding sites, regulatory mechanisms or excretion of dietary supplements in order to elucidate their physiological or biochemical role (e.g., a study to investigate the transport and metabolism of orally administered folic acid or a study to evaluate the mechanism of action of the various components in Panax ginseng).

Examples of research projects that typically fall outside the scope of ODS:

  • Studies that do not give the supplement by mouth  (e.g. i.v. or dermal).

  • Studies that administer the supplement to treat a disease process or outcome such as atherosclerosis or depression without evaluation of the supplement’s effect on the underlying mechanism of action, bioavailability, or metabolic pathways.

  • Human, animal, or laboratory studies that correlate physiological levels of dietary supplement ingredients, their metabolites, or marker compounds with disease risk, physiological endpoints, or other health outcomes without the administration of a dietary supplement (e.g., a human study correlating serum levels of 25-hydroxyvitamin D and risk of hip fracture or a human study correlating serum levels of folate and cardiovascular disease).

  • Studies evaluating the effect of whole foods that could be considered “functional foods” such as broccoli and other cruciferous vegetables, garlic, soy, and flaxseed. However, if a food ingredient in a defined form is being investigated (e.g., a garlic capsule, a soy or phytoestrogen supplement, EGCG in a green tea supplement, or dried ginger root in a tea bag), then the study could be within the scope of ODS.

  • Studies that involve dietary ingredients used to treat inborn errors of metabolism, such as a study investigating the use of tyrosine to treat phenylketonuria.  However, if the research is focused on identifying the mechanism of action, it could be considered within scope.

  • Studies of compounds that are classified as drugs, such as the hormones estrogen, progesterone, and insulin.

II. Key Dates

  August-September, 2021     Email to Karen Regan at with brief description
  October 1, 2021   Full applications submitted to Karen Regan at      
  October 22, 2021   Proposal review by ODS
  October 29, 2021   Notification of ODS funding decision
  Fall-Winter, 2022   Participation in ODS Scholars Symposium if applicant is funded

III. Requirements for Application Submission

A. General Guidelines

  1. Support is available for NEW projects, including pilot or feasibility studies; collection of preliminary data; secondary data analysis of existing data; small, self-contained research projects, and development of new research technologies. ODS co-funding is intended to stimulate new avenues of research within the NIH. Collaborative studies between different NIH institutes or different laboratories is encouraged.

  2. ODS funding of intramural projects is designed for research projects that can be carried out in a year with limited resources.

  3. Projects are generally limited to one year of funding and cannot exceed $100,000. Funds will be for FY2022. They may be used for supplies, equipment, and analyses. ODS funding is not meant to replace salary support currently being provided through an NIH stipend.

  4. The proposal should be written by the scholar candidate.

  5. Submitted project applications should be within the Guidelines for the Conduct of Research.

  6. For clinical studies investigating dietary supplements and/or supplement ingredients, the supplement should be administered in physiologically relevant forms and concentrations and must be administered orally.

  7. In studies employing dietary assessments or surveys, questions about dietary supplement use must be included, and the survey instruments should be validated.

  8. A rationale for how the proposed research fits within the mission of ODS should be included in the application (See ODS Strategic Plan Goals).

  9. Investigators conducting clinical studies must contact the Center for Drug Evaluation and Research at FDA to determine whether an Investigational New Drug (IND) application is required.

  10. Information demonstrating that the dietary supplement and controls or placebos adhere to the Policy for Natural Products Integrity of the National Center for Complementary and Integrative Health (NCCIH) will be required prior to funding. (An ODS summary of the policy is provided for your reference. See Minimum Criteria: Assessment of Dietary Supplement Ingredient Integrity.) Additional requirements for characterizing dietary supplements and/or their ingredients for clinical trials, animal studies, and the special case of probiotics can be found at

  11. For studies that measure 25-hydroxyvitamin D [25(OH)D] in biological samples, the PI will be required to use National Institute of Standards and Technology (NIST) standard reference materials to assure clinical data integrity and are encouraged to participate in the Vitamin D External Quality Assessment Scheme (DEQASexternal link disclaimer). For large clinical trials, the laboratory making the measurement should participate in the Center for Disease Control and Prevention (CDC) Vitamin D Certification Programexternal link disclaimer.  

  12. Analytic methods must be adequately described and must be demonstrated to be scientifically valid (accurate and precise) and suitable for their intended purpose.

  13. Applications will not be accepted without approval of the email request to submit.

B. Request for Submission (August-September 2021)

In place of the letter of intent, ODS is requiring an email request to submit which should include a brief description of the project. There is no preferred format, ODS just wants to review for relevance to the mission of ODS. This email should be sent to Karen Regan at as soon as possible. Notification by ODS that the applicant is encouraged to submit a full proposal is required before proposal submission.

C. Submission of Materials (Must be received by 5:00 pm on October 1, 2021):
 There is no required or preferred format.

1. Intramural requests for support should include a description of the Research Plan, not to exceed 10 pages, including tables, graphs, figures, and diagrams and charts. This will be critically reviewed for its scientific premise, experimental clarity and rigor, and reporting transparency.

The Research Plan should include:

  • Introduction (one-page limit): Describe how this proposed study supports the ODS mission. What is the hypothesis under investigation?

  • Background and significance. Address the scientific premise of the proposed research, including a discussion of the strengths and weaknesses of prior research crucial to support the application.

  • Clearly defined specific aims. Identify preliminary studies if available.

  • Experimental design and methods. Describe what you propose and how your design and methods will achieve robust and unbiased results. Specific details should include:
    • Statistical procedures used to determine appropriate group sizes

    • Plans for data analysis

    • Methods to reduce bias
      • Procedures to ensure independent and blinded measurements
      • Procedures to improve precision and minimize variability
      • Methods for randomization
    • Subject inclusion and exclusion criteria

    • Plans to address loss to follow-up and missing data

    • The chemical/biological composition and standardization of the intervention (both the dietary supplement and any experimental diets)

    • Relevant biological variables, such as sex

2. Supporting documents, in addition to the 10-page Research Plan, should include:

  • Abstract

  • Budget

  • Biosketches for the Principal Investigator (scholar candidate) and mentor

  • Training Plan for applicants who are not Principal Investigators. It is not to exceed two pages, excluding publications. The candidate and the mentor are jointly responsible for preparing the training plan. It must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the young scientist’s career goals. The sponsor/mentor may form an advisory committee to assist in developing a program of study or to monitor the candidate’s progress through the training. The training plan should include:
    1. A statement of the candidate’s objectives and long-term career goals.

    2. A description of the candidate's prior training and how it relates to his/her objectives and long-term career plans.

    3. A description of the candidate’s professional responsibilities in his/her current NIH research position.

    4. A description of the candidate’s research efforts to date, including any publications, prior research interests, and experience.

    5. A statement of how the proposed new training and research experience logically evolves from prior training and experience and how they will facilitate the young scientist’s transition to independent-investigator status.

    6. Mentor’s description of his/her oversight role in the training experience as well as expectations and deliverables for the trainee.

    7. Note if other mentors will be engaged in the trainee’s research.

    8. A timeline is helpful.

    9. An explanation of how research and educational resources of the institution will be utilized to promote the candidate’s independence. 
  • Appropriate product integrity information as well as any additional material related to the authentication of key biological and/or chemical resources.

3. Cover letter containing the signatures of the scholar, mentor, division or branch chief, and the IC scientific director or IC director. For submission from an applicant who is not a Principal Investigator, include a letter of approval from the applicant’s Principal Investigator.

IV. Expectations of Funded Scholars

A. Present his/her research findings at the ODS Scholars Symposium which will occur in the fall of 2022 (date to be determined);

B. Acknowledge that ODS has co-funded the project. In addition, the Principal Investigator should acknowledge such co-funding in any publications, reports or presentations resulting from the award;

C. Provide ODS with copies of any abstracts or publications pursuant to the work encompassed by the co-funding award;

D. Provide a final report within six months of project completion;

E. Participate in the Dietary Supplement Scientific Interest Group;

F. Participate in the ODS Mary Frances Picciano Dietary Supplement Research Practicum.

Direct inquiries and submit requests to Karen Regan at or call her at 301-640-0133.

Assessment of Dietary Supplement Ingredient/Product Integrity - Minimum Criteria 

(Adapted from NCCIH Guidance on Natural Product Integrity)

  1. Establish the identity, composition, and purity of test article(s).  Manufacturer provided lot- or batch-specific certificates of analysis (CoAs), with quantitative analytical results, may be acceptable; product specification sheets and safety data sheets are NOT adequate.
    1. Characterize the test article composition, including ingredient content and quantity, and report results of the laboratory analysis to confirm information on the certificate of analysis, if applicable.
    2. For complex test article(s) derived from living organisms, the complete taxonomic/scientific name along with the common name and source of the plant/animal material/extract/phytochemical.
    3. For all test articles, provide documentation demonstrating both chemical and isomeric purity (when appropriate), including the methodology used in purity determination.
    4. State the constituent(s), if any, to which the test article is standardized.
    5. Assure test article(s) is/are free of impurities (accidental or deliberate), e.g., pesticides, drugs, microbes, or metals. 
    6. Identify the manufacturer or distributor (if any) by name and address and contact information along with product brand name, if applicable.
  2. Establish stability and reproducibility of the test article preparation.
    1. Provide documentation that demonstrates stability of test article(s) for at least the duration of the study and explain how the test article(s) will be monitored for stability throughout the project period.
    2. Provide documentation that demonstrates reproducibility of test article(s) characteristics, especially if more than one batch is used in the study.
  3. If the test article is administered via a vehicle other than a tablet/capsule, provide information on the source and composition of the vehicle (diet, etc.) and assure that the test article(s) remain stable and bioavailable (e.g., probiotic added to porridge, EGCG added to animal diet) throughout the study.
  4. For placebo, verify that it matches the test article on sensory characteristics, that the sensory characteristics are stable, and that it contains no bioactive materials.

Reference Resources

Contact Information

Direct inquiries and submit requests regarding the ODS Scholars Programs to:
Karen S. Regan, M.S., R.D. 
ODS Grants and Extramural Activities