AHPA submits comments on botanical drug development to FDA

• By: AHPA
• On: 11/04/2026 14:07:59
• In: Regulation / Legislation

November 4, 2026

The American Herbal Products Association (AHPA) has submitted comments in response to a U.S. Food and Drug Administration (FDA) request for information regarding challenges and opportunities facing botanical drug development.

In 2004, FDA published a botanical drug guidance intended to facilitate the approval of over-the-counter (OTC) and prescription drug products derived from or consisting of botanicals. Last updated in 2016, the guidance affords drug developers significant flexibilities, reflecting the complexities of botanical ingredients, including the opportunity to satisfy Phase 1 and 2 safety evidence requirements via a documented history of use. Since the release of this guidance, however, few botanical drugs have received new drug approvals.

“The current botanical drug guidance provides a strong framework,” said AHPA President & CEO Graham Rigby. “But fulfilling the intended purpose of the guidance would require FDA to publicly communicate the availability and advantages of its approach to candidate botanical drug products. Further, realizing that purpose would require the agency to enhance institutional botanical expertise that can foster plant-based medicine candidates' progressing through the pipeline.”

In its comments, AHPA emphasizes the utility of the current botanical drug framework and the distinct benefits of botanical drugs in the marketplace, while acknowledging that FDA could do more internally to support the pathway. AHPA's comments urge FDA to take further action to promote the pathway to candidate sponsors and potential investors, including by enhancing its internal expertise through hiring reviewers with botanical expertise, including qualified pharmacognosists. The comments also emphasize that botanical drugs ultimately serve a separate, complementary role in the health system alongside herbal dietary supplements.