The U.S. Food and Drug Administration is seeking public input on ways to advance the development of botanical drug products as part of the Trump administration’s initiative to streamline regulatory pathways and foster medical innovation, a news release said.

The FDA announced a request for information Sept. 3 asking researchers, clinicians, industry representatives and other stakeholders to identify challenges in botanical research and drug development and suggest practical approaches for addressing them.

Botanical drug products include products that contain or may be derived from plant materials, algae, macroscopic fungi or combinations of those materials, the release said. They are intended to diagnose, cure, mitigate, treat or prevent disease.

Although interest in botanical products is widespread, their complexity and variability can create unique challenges in 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. in the release. “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 Deputy Center Director for Substance Use and Behavioral Health in the FDA Center for Drug Evaluation and Research Marta Sokolowska, Ph.D. “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.”

The FDA said four botanical products have so far been approved for marketing as prescription drugs through the agency’s new drug application and biologics license application pathways. Botanical active ingredients including psyllium and witch hazel can also be marketed under certain over-the-counter monographs.

The agency said it hopes to build on its experience with those products and other botanical drug development programs through additional scientific research and engagement with stakeholders.

The FDA recently worked with the Reagan-Udall Foundation for the FDA on a roundtable focused on challenges and opportunities in advancing botanical drug development. The agency also plans to hold a joint workshop with the European Medicines Agency on Sept. 25 to discuss regulatory considerations for herbal medicinal and botanical drug products intended for medicinal use.

Through the request for information, the FDA is seeking feedback on several areas, including challenges in botanical research and drug development, innovative approaches to accelerate development, possible updates to FDA guidance and other resources, quality standards and appropriate study designs for complex botanical mixtures.

The agency is also seeking input on whether real-world evidence and other scientifically credible information could be used to facilitate botanical drug development.

The public will have 60 days after the request is published in the Federal Register to submit comments to the docket. Stakeholders can submit comments electronically at www.regulations.gov by searching for Docket No. FDA-2026-N-9550, titled “Advancing Development of Botanical Drug Products; Request for Information.” Written comments can also be mailed to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The comment period closes Nov. 3, and the FDA said late comments will not be considered.