FDA seeks public input to advance development of botanical drug products
Key Insights
The FDA issued a request for information seeking public input on how to advance development of botanical drug products derived from plant materials, algae or macroscopic fungi.
The agency cites the inherent complexity and variability of botanicals as challenges for research, product development and regulatory review, and asks about barriers stakeholders face.
Four botanical products have been approved as prescription drugs via NDA and BLA pathways, and the FDA will hold a joint workshop with the European Medicines Agency (search) on September 25, 2026.
The FDA has announced a request for information (RFI) to gather public input on opportunities to advance development of botanical drug products, described as 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. The agency said the inherent complexity and variability of botanical products can present unique challenges for research, product development and regulatory review.
Acting FDA Commissioner Kyle Diamantas said the agency is committed to modernizing regulatory frameworks so that natural health options are evaluated through rigorous science. Marta Sokolowska, deputy center director for substance use and behavioral health in the FDA Center for Drug Evaluation and Research, said many people use botanicals for self-treatment and that the agency wants to hear from researchers, clinicians, industry and other stakeholders about barriers and practical approaches.
The RFI seeks feedback on challenges in botanical research and drug development, innovative approaches to 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. To date, four botanical products have been approved for marketing as prescription drugs through the new drug application and biologics license application pathways, and botanical active ingredients such as psyllium and witch hazel can be marketed under certain over-the-counter monographs. The FDA recently collaborated with the Reagan-Udall Foundation for the FDA (search) on a roundtable and will convene a joint workshop with the European Medicines Agency (search) on September 25, 2026, on regulatory considerations for herbal medicinal and botanical drug products. The public has 60 days following publication in the Federal Register to comment via Docket No. FDA-2026-N-9550.