FDA Seeks Public Input on Botanical Drug Development
The FDA has launched a public request for information to identify challenges and opportunities in developing botanical prescription drugs, aiming to
The U.S. Food and Drug Administration is asking for public feedback to help advance the development of botanical drug products. The request for information, announced today, seeks input from researchers, clinicians, and industry stakeholders on the unique hurdles faced in this field.
Botanical drug products include or may be derived from plant materials, algae, or macroscopic fungi and are intended to diagnose, cure, mitigate, treat, or prevent disease. The agency notes that while interest in these products is broad, their inherent complexity and variability present distinct challenges for research, development, and regulatory review.
Regulatory Context and Past Approvals
Acting FDA Commissioner Kyle Diamantas J.D. Stated the administration's commitment to modernizing frameworks. "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," he said.
To date, only four botanical products have been approved for marketing as prescription drugs through the FDA's standard application pathways. Also, certain botanical active ingredients like psyllium and witch hazel can be marketed under specific over-the-counter monographs. The FDA aims to build on its experience with these products to accelerate future development.
Seeking Stakeholder Perspectives
Marta Sokolowska, Ph.D., Deputy Center Director for Substance Use and Behavioral Health in the FDA's Center for Drug Evaluation and Research, highlighted the public health angle. "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," she said. The agency wants to hear directly about the barriers stakeholders face and practical approaches that could help bring safe and effective botanical drugs to market.
The FDA recently collaborated with the Reagan-Udall Foundation on a roundtable to gather initial information. A joint workshop with the European Medicines Agency is also scheduled for September 25, 2026, to discuss regulatory considerations for these products.
Scope of the Request for Information
Through this formal request, the FDA is seeking feedback on a wide range of topics. These include the specific challenges encountered in botanical research and drug development. The agency is also interested in innovative approaches to support and accelerate development, potential updates to FDA guidance documents, and establishing appropriate quality standards.
Other key areas for comment involve designing suitable clinical studies for complex botanical mixtures. The FDA is also exploring the potential use of real-world evidence and other scientifically credible information to help the development process.
Submission Process and Deadline
The public will have 60 days following the notice's publication in the Federal Register to submit comments. Stakeholders are encouraged to submit comments electronically via the Regulations.gov website by searching for Docket No. FDA-2026-N-9550. The docket is titled "Advancing Development of Botanical Drug Products; Request for Information."
Written or paper submissions may be sent to the Dockets Management Staff in Rockville, Maryland. The agency has set a firm deadline of November 3, 2026, for all comments, noting that late submissions will not be considered.
