FDA Opens Public Comment Period on Botanical Drug Development

On September 3, 2026, U.S. Food and Drug Administration (FDA) issued a request for information (RFI) inviting public comment on how the agency might better support the development of botanical drug products.¹ The announcement tied the move to the current administration's broader push to simplify regulatory pathways and promote medical innovation.

The agency defines botanical drugs broadly: products made from or containing plant material, algae, or macroscopic fungi—alone or in combination—that are meant to diagnose, treat, mitigate, cure, or prevent disease. Interest in this category is widespread, but the natural variability of plant-derived ingredients continues to complicate areas from research to the regulatory review process.

FDA's current framework for evaluating these products traces back to its December 2016 guidance, "Botanical Drug Development: Guidance for Industry," which addresses characterization, quality control, clinical investigation, and other regulatory considerations.²

What's Driving FDA's Interest in Botanical Drugs?

Acting Commissioner Kyle Diamantas framed the initiative as an effort to update how the agency evaluates natural health products. “Under the Trump Administration, we are committed to modernizing regulatory frameworks to ensure promising, natural health options are evaluated through rigorous science,” he stated. “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.”

Marta Sokolowska, who oversees substance use and behavioral health matters within FDA's drug center, pointed to a practical reality driving the RFI. “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,” she explained. “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.”

So far, only 4 botanical products have cleared FDA's prescription drug pathways (new drug applications and biologics license applications), though some botanical ingredients, including psyllium and witch hazel, are already permitted in over-the-counter monograph products.

What Feedback Is FDA Seeking, and by When?

The agency is asking for input on a range of issues: obstacles encountered during botanical R&D, ways to speed development, whether existing FDA guidance needs updating, quality benchmarks, how to design studies for mixtures with many active constituents, and the use of real-world evidence to support development. Comments are due within 60 days of the RFI's Federal Register publication—the window closes November 3, 2026—and can be filed at regulations.gov under Docket No. FDA-2026-N-9550.

What Did the Reagan-Udall Roundtable Find?

Ahead of the RFI, FDA partnered with the Reagan-Udall Foundation for the FDA on a roundtable bringing together former regulators, consultants, manufacturers, researchers, and standards experts to identify where botanical drug development gets stuck.² Findings were grouped around five areas: regulatory process, research design, production and quality, funding, and education.

Participants said while the existing pathway is functional, it is applied inconsistently across review divisions, often not treating the whole botanical substance as active, as guidance intends. Batch-to-batch consistency in raw plant material was cited as a manufacturing hurdle, and closer alignment with pharmacopeial standards was suggested as a fix. On funding, participants said investors view botanical drugs as riskier and costlier than conventional ones, with some proposing longer market exclusivity as an incentive. Other recommendations included earlier FDA engagement on trial design and clearer informed-consent language distinguishing botanical drugs from products with a history of traditional use. Participants also called for more visible public signaling from FDA that botanical drug development is a genuine priority, along with greater clarity around how dietary supplement requirements differ from those for drug development.

What's Happening at the FDA/EMA Workshop?

FDA and the European Medicines Agency will jointly host a workshop on September 25, 2026, comparing the two agencies' approaches to regulating herbal medicinal and botanical drug products.³ The event, "Regulatory Perspectives on Herbal Medicinal/Botanical Drug Product Development," takes place at EMA headquarters in Amsterdam and will also be available online.

References

1. U.S. Food and Drug Administration. FDA seeks public input to advance development of botanical drug products. US Food and Drug Administration; September 3, 2026. Accessed September 3, 2026. https://www.fda.gov/news-events/press-announcements/fda-seeks-public-input-advance-development-botanical-drug-products
2. Reagan-Udall Foundation for the FDA. Botanical drug development – learnings from expert discussions. Accessed September 3, 2026. https://reaganudall.org/sites/default/files/2026-07/Botanical%20Drug%20Development%20-%20Learnings%20from%20Expert%20Discussions%20-%20Summary%20Slides_FINAL.pdf
3. US Food and Drug Administration. Regulatory perspectives on herbal medicinal/botanical drug product development – joint FDA/EMA workshop. Updated June 12, 2026. Accessed September 3, 2026. https://www.fda.gov/drugs/news-events-human-drugs/regulatory-perspectives-herbal-medicinalbotanical-drug-product-development-joint-fdaema-workshop