On September 3, 2026, the U.S. Food and Drug Administration (FDA) issued a formal request for information (RFI) to solicit public comment on opportunities to advance development of botanical drug products. The RFI is intended to gather input from researchers, clinicians, industry, patient groups and other stakeholders about barriers and practical approaches that could help bring safe and effective botanical drugs to patients.
The FDA framed this action as part of broader efforts to modernize regulatory pathways and support medical innovation while maintaining safety and efficacy standards. The announcement reiterates the agency’s interest in applying rigorous science to the evaluation of natural-origin medicinal products.
The FDA defines botanical drug products 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. This includes complex mixtures of botanical constituents rather than single isolated chemical entities.
The agency noted that botanical materials have inherent complexity and variability that can pose unique challenges for research, product development and regulatory review. These characteristics drive the need for specialized approaches to quality control, study design and evidence generation.
The FDA highlighted its prior experience: to date, four botanical products have been approved for marketing as prescription drugs through the new drug application and biologics license application pathways. In addition, certain botanical active ingredients, such as psyllium and witch hazel, are marketed under applicable over-the-counter monographs. The agency intends to build on that experience and other botanical development programs to identify ways to accelerate development.
The announcement underscores that wide public use of botanicals for self-treatment increases the importance of generating rigorous evidence to support safe and effective therapeutic options. At the same time, scientific and regulatory challenges linked to product complexity require stakeholder engagement to identify feasible, scientifically credible solutions.
As part of preliminary engagements, the FDA collaborated with the Reagan-Udall Foundation for the FDA on a roundtable to gather information on challenges and opportunities in botanical drug development. The RFI supplements those efforts by opening a broader public comment process.
The FDA also announced plans to convene a joint workshop with the European Medicines Agency (EMA) on September 25, 2026, to discuss regulatory considerations for herbal medicinal and botanical drug products intended for medicinal use. These activities reflect a multipronged approach to gather scientific input and regulatory perspectives domestically and internationally.
Through the RFI, the FDA seeks feedback on multiple topic areas, specifically including:
Challenges encountered in botanical research and drug development, including scientific and practical barriers to advancing programs.
Innovative approaches that could support or accelerate botanical product development.
Potential updates to FDA guidance or other resources that would help stakeholders navigate development and regulatory requirements.
Quality standards appropriate for complex botanical mixtures, and analytical strategies to manage variability.
Appropriate clinical study designs and methodologies tailored to complex mixtures and mixed constituents.
The potential use of real-world evidence and other scientifically credible information sources to facilitate development and regulatory decision-making.
These topic areas are presented to help focus stakeholder comments on actionable scientific and regulatory considerations.
The public will have 60 days following the RFI’s publication in the Federal Register to submit comments to the docket. Stakeholders are encouraged to submit comments electronically via regulations.gov by searching for Docket No. FDA-2026-N-9550, entitled “Advancing Development of Botanical Drug Products; Request for Information.”
The FDA also accepts written or paper submissions mailed to the Dockets Management Staff (HFA-305) at the Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The press release states the comment period closes on November 3, 2026, and that late comments will not be considered.
Contact information for media and consumer lines was provided in the announcement for additional inquiries.
The FDA will hold a joint workshop with the EMA on September 25, 2026, titled Regulatory Perspectives on Herbal Medicinal/Botanical Drug Product Development. This workshop is one of several planned engagements to discuss regulatory considerations and to gather input that may inform future guidance or resources.
The agency indicated it will use input from the RFI, stakeholder roundtables and international workshops to consider potential actions to support botanical drug development, including possible updates to guidance documents, quality frameworks and recommendations on evidence-generation strategies.
The announcement reiterates the FDA’s broader mission to protect public health by assuring the safety, effectiveness and security of drugs and other regulated products. The release provides links and contact points for submitting comments and for media or consumer inquiries.
If stakeholders require further details beyond what is included in the RFI announcement, those specifics would be found in the Federal Register notice and the regulations.gov docket for Docket No. FDA-2026-N-9550.