---
title: "FDA Requests Public Input to Advance Development of Botanical Drug Products"
id: "fda-news-releases-0-fda-seeks-public-input-to-advance-development-of-botanical-drug-products"
canonical_url: "https://medichelpline.com/clinical-feed/fda-news-releases-0-fda-seeks-public-input-to-advance-development-of-botanical-drug-products"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "FDA News Releases"
source_url: "http://www.fda.gov/news-events/press-announcements/fda-seeks-public-input-advance-development-botanical-drug-products"
published_at: "2026-09-03T12:52:49.000Z"
evidence_level: "Agency Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# FDA Requests Public Input to Advance Development of Botanical Drug Products
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/fda-news-releases-0-fda-seeks-public-input-to-advance-development-of-botanical-drug-products
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** FDA News Releases
- **Source URL:** [Original Journal Publication](http://www.fda.gov/news-events/press-announcements/fda-seeks-public-input-advance-development-botanical-drug-products)
- **Published At:** 2026-09-03T12:52:49.000Z
- **Evidence Rating:** Agency Feed
## Executive GIST (TL;DR)
- The U.S. Food and Drug Administration (FDA) issued a public request for information (RFI) on September 3, 2026, to gather stakeholder input on accelerating development of **botanical drug products**. - The RFI seeks feedback on scientific, regulatory and practical barriers in botanical research, development, quality standards, study design, and potential use of **real-world evidence**. - Botanical drug products include materials derived from plants, algae, macroscopic fungi, or combinations intended to diagnose, treat, cure, mitigate or prevent disease. - The FDA noted complexity and variability of botanical materials can create unique challenges for research and regulatory review. - Four botanical products have been approved previously through the FDA’s new drug application and biologics license application pathways; some botanical actives (e.g., psyllium, witch hazel) are marketed under OTC monographs. - The FDA collaborated with the Reagan-Udall Foundation on a roundtable to gather information and will hold a joint FDA–European Medicines Agency workshop on September 25, 2026, on regulatory perspectives for herbal medicinal/botanical drug development. - The RFI invites comments on potential updates to FDA guidance, innovative approaches to accelerate development, appropriate study designs for complex mixtures, and quality considerations. - Comments must be submitted within 60 days of Federal Register publication to the docket FDA-2026-N-9550 (Advancing Development of Botanical Drug Products); the comment period closes November 3, 2026. - Stakeholders may submit comments electronically at regulations.gov or by written/paper submission to Dockets Management Staff. - Contact points and media/consumer lines were provided; additional background about FDA’s mission and regulated products is included in the release.
## Clinical Analysis & Structured Key Points
FDA Seeks Public Input to Advance Development of Botanical Drug Products | FDA Skip to main content Skip to FDA Search Skip to in this section menu Skip to footer links Home News & Events FDA Newsroom Press Announcements FDA Seeks Public Input to Advance Development of Botanical Drug Products Press Announcements In this section More Press Announcements For Immediate Release: September 03, 2026 As part of the Trump Administration’s initiative to streamline regulatory pathways and foster medical innovation, the U.S. Food and Drug Administration today announced a request for information (RFI) to gather public input on opportunities to advance the development of botanical drug products. Botanical drug products are products that include or may be derived from plant materials, algae, macroscopic fungi, or combinations of these materials and are intended to diagnose, cure, mitigate, treat or prevent disease. While there is broad interest in botanical products, their inherent complexity and variability can present unique challenges for 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. “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 Marta Sokolowska, Ph.D., Deputy Center Director for Substance Use and Behavioral Health in the FDA Center for Drug Evaluation and Research . “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.” To date, 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 to build on the agency’s experience with these products and other botanical drug development programs to help accelerate development through additional scientific and stakeholder engagement. As part of these efforts, FDA recently collaborated with the Reagan-Udall Foundation for the FDA on a roundtable to gather information on challenges and opportunities to advance botanical drug development. The FDA will also convene a joint workshop with the European Medicines Agency on September 25, 2026, to discuss regulatory considerations for herbal medicinal/botanical drug products intended for medicinal use. Through the RFI, the FDA is seeking feedback on topics including challenges encountered in botanical research and drug development; innovative approaches to support and accelerate development; potential updates to FDA guidance and other resources; quality standards; appropriate study designs for complex botanical mixtures; and the potential use of real-world evidence and other scientifically credible information to facilitate development. The public will have 60 days following publication in the Federal Register to submit comments to the docket. 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/paper submissions may also be sent to: Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 The comment period closes November 3, 2026. Late comments will not be considered. Media: FDA Request for Comment 202-690-6343 Consumer: 888-INFO-FDA ### Boilerplate The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products. Content current as of: 09/03/2026 Regulated Product(s) Drugs Follow FDA Follow @US_FDA on X Follow FDA on Facebook Follow @FDAMedia on X Feedback Back to Top
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