The U.S. Food and Drug Administration (FDA) has announced a request for information (RFI) to gather public feedback on advancing the development of botanical drug products. The announcement, made on September 3, 2026, is part of the Trump Administration’s initiative to streamline regulatory pathways and foster medical innovation.

Botanical drug products are defined as those that include or may be derived from plant materials, algae, macroscopic fungi, or combinations of these materials intended to diagnose, cure, mitigate, treat, or prevent disease. The FDA notes that while there is broad interest in these products, their inherent complexity and variability present unique challenges for research and regulatory review.

Acting FDA Commissioner Kyle Diamantas J.D. stated that the agency is committed to modernizing regulatory frameworks to ensure promising natural health options are evaluated through rigorous science. Deputy Center Director for Substance Use and Behavioral Health Marta Sokolowska, Ph.D., emphasized the potential for scientific development to create new opportunities for patients who currently use botanicals for self-treatment.

As of the announcement, 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 feedback on several specific topics, including challenges encountered in botanical research and drug development, innovative approaches to accelerate development, potential updates to FDA guidance, quality standards, appropriate study designs for complex botanical mixtures, and the use of real-world evidence.

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 submissions may also be sent to the Dockets Management Staff (HFA-305) at the FDA’s headquarters in Rockville, MD. The public comment period closes on November 3, 2026.