FDA requests public input to accelerate botanical drug product development

The U.S. Food and Drug Administration issued a request for information (RFI) to collect public comments on ways to move botanical drug products forward.

Botanical drug products are derived from plant material, algae or fungi and are intended for diagnosis, treatment or prevention of disease. Their complexity and variability pose challenges for research and regulatory review.

Acting FDA Commissioner Kyle Diamantas said the agency is modernizing regulatory frameworks to evaluate promising natural health options with rigorous science. He noted the initiative is part of the administration’s effort to streamline pathways and foster medical innovation.

Marta Sokolowska, deputy center director at the FDA, highlighted that many people use botanicals for self‑treatment and that greater scientific development could create new therapeutic opportunities while maintaining safety standards.