FDA Seeks Public Input to Advance Development of Botanical Drug Products
September 3, 2026
Dear International Colleague,
As part of the Trump Administration’s initiative to streamline regulatory pathways and foster medical innovation, the U.S. Food and Drug Administration today announced a request for information (RFI) to gather public input on opportunities to advance the development of botanical drug products.
Botanical drug products are products that include or may be derived from plant materials, algae, macroscopic fungi, or combinations of these materials and are intended to diagnose, cure, mitigate, treat or prevent disease. While there is broad interest in botanical products, their inherent complexity and variability can present unique challenges for research, product development and regulatory review.
“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.”
“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.”
To date, four botanical products have been approved for marketing as prescription drugs through the FDA’s new drug application and biologics license application pathways. Additionally, botanical active ingredients such as psyllium and witch hazel can be marketed under certain over-the-counter 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.
As part of these efforts, the FDA recently collaborated with the Reagan-Udall Foundation for the FDA on a roundtable to gather information on challenges and opportunities to advance botanical drug development. The FDA will also convene a joint workshop with the European Medicines Agency on September 25, 2026, to discuss regulatory considerations for herbal medicinal/botanical drug products intended for medicinal use.
Through the RFI, the FDA is seeking feedback on topics including challenges encountered in botanical research and drug development; innovative approaches to support and accelerate development; potential updates to FDA guidance and other resources; quality standards; appropriate study designs for complex botanical mixtures; and the potential use of real-world evidence and other scientifically credible information to facilitate development.
The public will have 60 days following publication in the Federal Register to submit comments to the docket. Stakeholders are encouraged to submit comments electronically at https://www.regulations.gov by searching for Docket No. FDA-2026-N-9550, entitled “Advancing Development of Botanical Drug Products; Request for Information.” Written/paper submissions may also be sent to: Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852
The comment period closes November 3, 2026. Late comments will not be considered.
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