FDA Seeks Public Input to Advance Botanical Drug Product Development
核心洞察
The FDA issued a Request for Information (RFI) seeking public comment on advancing botanical drug product development, published September 3, 2026, with comments due November 3, 2026.
The RFI solicits feedback across six areas, including research barriers, quality standards, study designs, and the potential use of real-world evidence in regulatory submissions.
Only four botanical products have received marketing approval through NDA or BLA pathways to date, while ingredients like psyllium and witch hazel are marketed under OTC monographs.
The U.S. Food and Drug Administration has issued a Request for Information (RFI) seeking public input on how to advance the development of botanical drug products — therapeutics derived from plant materials, algae, macroscopic fungi, or combinations thereof intended to diagnose, treat, mitigate, cure, or prevent disease. Published to the Federal Register on September 3, 2026, under Docket No. FDA-2026-N-9550, the action was framed as part of an administration initiative to streamline regulatory pathways and foster medical innovation. The comment period closes November 3, 2026.
"Under the Trump Administration, we are committed to modernizing regulatory frameworks to ensure promising, natural health options are evaluated through rigorous science," said Acting FDA Commissioner Kyle Diamantas, J.D. "Botanical drug products represent a critical area where greater scientific development can unlock new therapeutic opportunities for American patients while maintaining the highest safety standards."
Scope of the Request for Information
The RFI solicits feedback across six substantive areas: barriers in botanical research and drug development; innovative approaches to accelerate development; potential updates to FDA guidance documents and other agency resources; quality standards for complex botanical mixtures; appropriate clinical and nonclinical study designs; and the potential use of real-world evidence (RWE) and other scientifically credible data sources in regulatory submissions.
"Given that many people use botanicals for self-treatment, botanical drug products represent an area where greater scientific development could create new opportunities for patients," said Marta Sokolowska, Ph.D., Deputy Center Director for Substance Use and Behavioral Health in the FDA Center for Drug Evaluation and Research. "We want to hear directly from researchers, clinicians, industry and other stakeholders about the barriers they face and practical approaches that could help bring safe and effective botanical drugs to patients."
Current Regulatory Landscape
To date, four botanical products have received marketing approval through the new drug application (NDA) or biologics license application (BLA) pathways. Additionally, certain botanical active ingredients — including psyllium and witch hazel — are already marketed under over-the-counter (OTC) monographs. The FDA is seeking to build on the agency's experience with these products and other botanical drug development programs to help accelerate development through additional scientific and stakeholder engagement.
The persistent regulatory challenges stem from the inherent complexity and variability of plant-derived materials, including characterization, standardization, and clinical evidence generation. By soliciting input on study design, quality standards, and RWE, the FDA is exploring ways to address persistent development barriers for complex botanical products, including possible updates to guidance and other agency resources.
Stakeholder Engagement and Upcoming Milestones
The RFI follows a recent Reagan-Udall Foundation (搜索) roundtable on botanical drug development challenges, which gathered information on challenges and opportunities to advance botanical drug development. The FDA will also convene a joint workshop with the European Medicines Agency (搜索) (EMA) on September 25, 2026, to discuss regulatory considerations for herbal medicinal and botanical drug products intended for medicinal use.
The comment period gives developers, academic researchers, and trade associations an opportunity to influence how the FDA approaches future guidance, standards, and development policy for botanical drugs. The upcoming FDA-EMA workshop may also provide indications of where U.S. and European approaches to herbal and botanical medicines overlap or diverge.
What to Watch
Several developments warrant attention. Comments on study design, quality standards, and use of RWE are likely to be particularly relevant given the FDA's emphasis on these issues in the RFI. The FDA-EMA joint workshop outcomes may signal where the two agencies are converging on evidentiary standards and oversight frameworks for herbal and botanical products.
Notably, the RFI carries no commitment to a specific rulemaking or guidance update schedule; follow-on draft guidance publications or program announcements would indicate how the agency intends to act on input received. The FDA's explicit inclusion of RWE as a topic of inquiry aligns with broader agency-wide efforts to expand its use across therapeutic areas, and any botanical-specific RWE framework that emerges could have precedent value for other complex or natural-product-derived drug categories.