NIH Highlighted Topic: New Approach Methodologies (NAMs) for Dietary Supplement and Nutrition research
Below is a brief summary. Please check the full solicitation before applying (link in resources section).
Executive Summary:
The National Institutes of Health (NIH) is encouraging innovative research proposals focused on developing and validating New Approach Methodologies (NAMs) for dietary supplement and nutrition research. This highlighted topic supports multidisciplinary projects aimed at replacing or complementing traditional animal models with more human-relevant systems capable of improving prediction of dietary supplement safety, efficacy, metabolism, and long-term health outcomes across the lifespan.
NIH is particularly interested in projects leveraging advanced human-based systems such as organoids, tissue chips, microphysiological systems, computational simulations, multi-omics platforms, and AI-enabled modeling tools to better understand how nutrients and bioactive compounds interact with human biology. Companies developing organ-on-chip systems, nutrition analytics platforms, AI-driven computational biology tools, dietary supplement testing systems, precision nutrition technologies, metabolomics platforms, or translational toxicology systems may be strong candidates for funding.
Areas of interest include nutrient absorption and metabolism, bioavailability and bioaccessibility modeling, microbiome interactions, chronic disease prevention, personalized nutrition, dietary supplement-drug interactions, aging-related nutrition changes, multi-organ physiology simulation, developmental nutrition impacts, and systems biology approaches for nutrition science. NIH is also encouraging projects focused on reproducibility, interoperability, longitudinal exposure modeling, and integration of genetics, sex, age, health status, and environmental factors into nutrition-related predictive systems.
Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on project scope and translational impact.
This highlighted topic is supported by multiple NIH Institutes and Offices including ODS, NCCIH, NEI, NHLBI, NIA, NIDDK, and ONR, all of which are seeking transformative innovations that improve dietary supplement evaluation, nutrition science, precision health, aging research, chronic disease prevention, and human-relevant biomedical modeling systems.
How much funding would I receive?
Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.
What could I use the funding for?
Funding may support the research, development, validation, and commercialization of nutrition science technologies, organoid systems, computational modeling platforms, multi-omics analytics tools, and human-relevant NAMs for dietary supplement and food research.
Eligible activities may include:
Organoid, tissue-chip, and microphysiological systems for nutrition and dietary supplement research
AI and machine learning platforms for nutrition modeling and bioactive compound prediction
Multi-omics, metabolomics, proteomics, and systems biology analytics technologies
Computational simulations of nutrient absorption, metabolism, and longitudinal exposure
Precision nutrition and personalized dietary intervention platforms
Bioavailability and bioaccessibility testing systems for dietary supplements and processed foods
Human-relevant toxicology and safety assessment technologies
Microbiome and gut-brain interaction modeling platforms
Chronic disease prevention and metabolic health nutrition technologies
Aging-related nutrition and resilience prediction systems
Ocular nutrition and vision-health modeling technologies
Diet-related obesity, diabetes, GI, kidney, and endocrine disease simulation systems
Nutrient-drug interaction and polypharmacy assessment platforms
Biomarker discovery and validation systems for nutritional status and disease risk
Food matrix interaction and multi-ingredient supplement evaluation technologies
Real-world data integration and longitudinal nutrition analytics platforms
Prototype development, translational studies, and validation research
Commercialization planning, regulatory preparation, and manufacturing scale-up activities
Funding may also support personnel, laboratory testing, software engineering, cloud infrastructure, AI model development, bioinformatics analysis, organoid research, analytical chemistry, toxicology testing, translational modeling, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable nutrition science or biotechnology solution aligned with NIH priorities.
Are there any additional benefits I would receive?
Beyond the formal funding award, awardees gain several strategic advantages:
Government Validation and Credibility:
Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.Enhanced Visibility and Market Recognition:
Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.Access to the Federal Innovation Ecosystem:
Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.Stronger Commercial and Exit Potential:
By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.
What is the timeline to apply and when would I receive funding?
Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.
Where does this funding come from?
Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.
Who is eligible to apply?
Applicants must be U.S. small business concerns (SBCs) that:
Are organized for profit with a U.S. place of business.
Have ≤ 500 employees including affiliates.
Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.
What companies and projects are likely to win?
Projects that demonstrate:
A clear unmet medical or public-health need,
Strong scientific rationale and feasibility,
High commercialization potential, supported by a realistic market and regulatory strategy, and
Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).
Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.
Are there any restrictions I should know about?
Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.
Foreign entities are not eligible.
Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.
How long will it take me to prepare an application?
For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.
How can BW&CO help?
Our team specializes in complex federal R&D proposals and can:
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