Opportunity Information: Apply for RFA FD 21 010
This funding opportunity is a renewal cooperative agreement from the U.S. Food and Drug Administration (FDA), specifically the Center for Food Safety and Applied Nutrition (CFSAN), focused on strengthening national work around botanical natural products used in foods, dietary supplements, and cosmetics sold in the United States. The overall purpose is to support and speed up the development, organization, and sharing of reliable scientific information on botanicals, in a way that complements ongoing efforts across government, academia, and industry. The award is set up as a cooperative agreement (U01), which usually means the FDA expects substantial scientific involvement and coordination during the project rather than simply providing funds and stepping back. Clinical trials are not allowed under this announcement, so the emphasis is on research infrastructure, reference materials, methods, and public health-focused scientific exchange rather than testing interventions in people.
A central part of the project is helping FDA build and maintain a prioritized list of botanical ingredients that deserve attention based on potential safety concerns, marketplace trends, and existing knowledge gaps. In practice, that means continuously scanning what botanical ingredients are being used, how they are being marketed, what adverse event or safety signals may exist, and where the evidence base is weak or inconsistent. The goal is to support FDA's ability to focus limited scientific and regulatory resources on the botanicals most likely to affect public health, whether due to toxicity concerns, contamination/adulteration risks, interactions, vulnerable population exposure, or rapid growth in consumer use.
Another major focus is the acquisition and scientific characterization of authenticated reference materials. This includes raw plant materials, processed plant materials, and purified natural products that FDA can rely on when evaluating safety, identity, and composition. The intent is not just to collect samples, but to validate them and characterize them so they can serve as dependable benchmarks for laboratory testing and method development. Having well-authenticated reference materials matters in botanical science because species can be misidentified, chemical composition can vary by geography and processing, and products can be adulterated with other botanicals or synthetic substances. Reliable reference materials help ensure that laboratory results across different groups are comparable and that safety evaluations are based on correctly identified and well-characterized substances.
The opportunity also emphasizes active exchange of technical and scientific information with FDA scientists and other stakeholders. That includes sharing analytical methods, data, and reference materials, and helping spread best practices for botanical identification and characterization. This kind of exchange is meant to improve consistency and quality across the broader research and public health community, so that scientists and regulators are working from the same playbook when they assess botanical ingredients. The cooperative structure suggests regular coordination with FDA, potentially including joint planning, method harmonization, and collaborative problem-solving around emerging botanical issues.
Collaboration with FDA scientists in research areas of mutual interest is another explicit goal. Rather than being a purely independent academic research program, the work is expected to align closely with FDA's public health needs, such as improving tools for evaluating botanical safety, understanding chemical profiles relevant to toxicity or exposure, and addressing issues like identity testing, contaminants, and adulterants. Because the announcement is positioned as a renewal, it is likely intended to continue an established partnership and maintain continuity in expertise, resources, and outputs that FDA already uses.
Finally, the award supports coordination of scientific workshops, training activities, and conferences on botanical topics that have clear public health relevance. These events are intended to convene researchers, regulators, and other stakeholders to address high-priority scientific questions, share new findings and methods, and identify gaps that need attention. Training and convening functions can be especially important in botanical natural products because the field spans botany, chemistry, toxicology, analytical methods, and regulatory science, and the science can move quickly as new ingredients enter the market.
From an administrative standpoint, the opportunity is issued by the Department of Health and Human Services (HHS) through FDA, listed under CFDA 93.103, and categorized under agriculture, consumer protection, and food and nutrition. It anticipated a single award, with an award ceiling of $3,500,000. The funding opportunity number is RFA-FD-21-010, created December 14, 2020, with an original closing date of February 12, 2021. Eligibility is listed as "Others" with additional clarification referenced in the full announcement, which typically means applicants may include certain organizations beyond standard academic institutions depending on the terms in the eligibility section.
In plain terms, this grant is designed to reinforce the scientific backbone FDA relies on for botanical ingredient oversight: deciding what botanicals are most important to evaluate, ensuring there are trustworthy reference materials to support identity and safety testing, collaborating on shared research priorities, and bringing the community together through structured information-sharing and training. The expected deliverables are less about clinical outcomes and more about practical, reusable scientific resources and coordination that improve how botanical ingredients are evaluated for safety in real-world U.S. markets.Apply for RFA FD 21 010
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Renewal - Research, Education, and Outreach on Botanical Natural Products (U01) Clinical Trial Not Allowed" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Dec 14, 2020.
- Applicants must submit their applications by Feb 12, 2021. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $3,500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs)
What is the main purpose of this FDA funding opportunity?
This opportunity supports national work to strengthen the development, organization, and sharing of reliable scientific information on botanical natural products used in foods, dietary supplements, and cosmetics sold in the United States. The emphasis is on practical scientific resources and coordination that help protect public health and complement existing efforts across government, academia, and industry.
Which FDA center is sponsoring the work?
The opportunity is issued by the U.S. Food and Drug Administration (FDA), specifically through the Center for Food Safety and Applied Nutrition (CFSAN).
What type of award is this, and what does that imply?
This is a renewal cooperative agreement (U01). A cooperative agreement typically means FDA expects substantial scientific involvement and coordination during the project, rather than providing funds with minimal ongoing interaction.
Are clinical trials allowed under this announcement?
No. Clinical trials are not allowed. The focus is on research infrastructure, reference materials, methods, and scientific exchange intended to support public health-focused evaluation of botanicals, rather than testing interventions in people.
What kinds of products and markets does the project focus on?
The work focuses on botanical natural products used in foods, dietary supplements, and cosmetics that are sold in the United States.
What are “botanical natural products” in the context of this opportunity?
Based on the description, this includes botanical ingredients and related natural products derived from plants that appear in foods, dietary supplements, and cosmetics, including raw plant materials, processed plant materials, and purified natural products.
What does the project do with a prioritized list of botanical ingredients?
A central function is to help FDA build and maintain a prioritized list of botanical ingredients that merit attention. Prioritization is driven by factors such as potential safety concerns, marketplace trends, and gaps or inconsistencies in existing scientific knowledge.
How is the prioritized list expected to be informed?
The description indicates the work involves continuously scanning which botanical ingredients are being used and marketed, identifying adverse event or safety signals, and pinpointing areas where evidence is weak or inconsistent.
Why does FDA need a prioritized list of botanicals?
The goal is to support FDA’s ability to focus limited scientific and regulatory resources on botanicals most likely to affect public health. This can include concerns such as toxicity, contamination or adulteration risk, interactions, exposure in vulnerable populations, and rapid growth in consumer use.
What are “reference materials,” and why are they important for botanicals?
Reference materials in this opportunity include authenticated raw plant materials, processed plant materials, and purified natural products that FDA can rely on when evaluating safety, identity, and composition. They matter because botanical identity and chemistry can vary due to misidentification, geography, and processing, and products can be adulterated with other botanicals or synthetic substances. Well-characterized reference materials help ensure laboratory testing and method development are comparable and trustworthy.
Is the project just collecting samples, or is there more expected?
More is expected than collecting samples. The opportunity emphasizes acquisition and scientific characterization of authenticated reference materials, meaning samples should be validated and characterized so they can serve as dependable benchmarks for laboratory testing and method development.
What kinds of scientific activities are emphasized if clinical trials are not allowed?
The emphasis is on research infrastructure and shared scientific tools, including reference materials, analytical methods, data exchange, method harmonization, and other public health-focused scientific coordination that supports evaluation of botanical ingredient identity, composition, and safety.
What role does scientific exchange and information-sharing play in this award?
Active exchange of technical and scientific information is a major component. This includes sharing analytical methods, data, and reference materials and promoting best practices for botanical identification and characterization so that researchers and regulators can work from consistent approaches.
How does the cooperative agreement structure affect collaboration with FDA?
The cooperative structure suggests regular coordination with FDA scientists, potentially including joint planning, method harmonization, and collaborative problem-solving around emerging botanical issues. The work is expected to align closely with FDA public health needs.
What research topics are specifically highlighted as aligning with FDA needs?
Highlighted areas include improving tools for evaluating botanical safety, understanding chemical profiles relevant to toxicity or exposure, and addressing issues such as identity testing, contaminants, and adulterants.
Does the opportunity support workshops, conferences, or training events?
Yes. The award supports coordination of scientific workshops, training activities, and conferences on botanical topics with clear public health relevance. These events are intended to convene researchers, regulators, and other stakeholders to share methods and findings and identify high-priority scientific gaps.
Why are training and convening activities emphasized for botanical science?
The description notes that botanical natural products work spans multiple disciplines (such as botany, chemistry, toxicology, analytical methods, and regulatory science) and that the science can evolve quickly as new ingredients enter the market. Workshops and training help improve consistency and quality across the broader community.
Which federal department issues this opportunity?
It is issued by the Department of Health and Human Services (HHS) through the FDA.
What is the CFDA listing for this opportunity?
The opportunity is listed under CFDA 93.103.
How is this opportunity categorized?
It is categorized under agriculture, consumer protection, and food and nutrition.
How many awards are anticipated?
The announcement anticipates a single award.
What is the maximum (ceiling) award amount mentioned?
The award ceiling is $3,500,000.
What is the funding opportunity number?
The funding opportunity number is RFA-FD-21-010.
When was the opportunity created, and what was the original closing date?
It was created on December 14, 2020, and the original closing date was February 12, 2021.
Who is eligible to apply?
Eligibility is listed as “Others,” with additional clarification referenced in the full announcement. This generally indicates that eligible applicants may include certain organizations beyond standard academic institutions, depending on the eligibility terms in the full notice.
What kinds of deliverables are implied by the opportunity description?
Implied deliverables focus on reusable scientific resources and coordination, such as a maintained prioritized list of botanicals of concern, authenticated and characterized reference materials, shared analytical methods and data practices, collaborative work products aligned with FDA needs, and workshops/training/conferences that support consistent scientific approaches across stakeholders.
Is this opportunity intended to create continuity with prior work?
Yes. It is described as a renewal cooperative agreement, and the description indicates it is likely intended to continue an established partnership and maintain continuity in expertise, resources, and outputs that FDA already uses.
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