Agency’s call for feedback intended to support advancement of botanical drugs to expand beyond the four currently approved products in the US market.
The US Food and Drug Administration (FDA) is seeking public comment to modernise its regulatory approach for botanical drug products and support development of these therapies to treat diseases.
Botanical drug products include or can be derived from plant materials, algae, macroscopic fungi, or combinations.
While there is broad interest in these products— to date, four have been approved by the FDA— “their inherent complexity and variability can present unique challenges for research, product development and regulatory review”, according to the US agency.
Marta Sokolowska, PhD, Deputy Center Director for Substance Use and Behavioral Health in the FDA Center for Drug Evaluation and Research explained: “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.
“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.”
“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”
Marta Sokolowska, PhD, Deputy Center Director for Substance Use and Behavioral Health in the FDA Center for Drug Evaluation and Research
Specifically, the FDA is seeking feedback around R&D challenges, accelerating development innovation for botanical drugs, potential updates to FDA guidance and quality standards, as well as appropriate study designs for complex botanical mixtures and the potential use of real-world evidence to aid development of these treatments.
Acting FDA Commissioner Kyle Diamantas J.D. said: “Under the Trump Administration, we are committed to modernizing regulatory frameworks to ensure promising, natural health options are evaluated through rigorous science.
“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.”
Stakeholders can submit comments here under Docket No. FDA-2026-N-9550: ‘Advancing Development of Botanical Drug Products; Request for Information’ until 3 November 2026.
In addition to this request for information, the FDA continues to work on enhancing its regulatory frameworks for natural health options. The US agency is participating alongside the European Medicines Agency on 25 September in a joint workshop to discuss regulatory considerations for herbal medicinal/botanical drug products intended for medicinal use.
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