FDA Request for Input on Botanical Drugs (2026)

On Thursday 3 September 2026 the U.S. Food and Drug Administration announced a request for information on what stands in the way of developing plant-based prescription drugs. The formal notice, titled “Advancing Development of Botanical Drug Products; Request for Information,” was published in the Federal Register the next day, Friday 4 September 2026, at 91 FR 56887 (FR Doc. 2026-18133), and it opened a public docket, number FDA-2026-N-9550, that accepts comments until 3 November 2026.

This page reports what the two FDA documents say: what the agency announced, how it defines a botanical drug, which botanical products it says have reached the market as drugs, the development problems it describes, the guidance it already has, the meetings around the notice, the questions it asks, what the notice does not do, how comments are submitted, its status as of 11 October 2026, and how it fits the FDA’s earlier work on botanical drugs. The notice concerns botanical drug products — products intended to diagnose, treat or prevent disease — and the herbs, algae and mushrooms described elsewhere on this site are covered here only in that context.

Table of Contents

  1. What the FDA Announced
  2. What the FDA Means by a Botanical Drug
  3. Botanical Products Already Marketed as Drugs
  4. The Development Problems the Documents Describe
  5. The Existing Guidance: Botanical Drug Development (2016)
  6. The Roundtable and the Joint FDA–EMA Workshop
  7. The Questions the FDA Is Asking
  8. What the Notice Does Not Do
  9. How and Until When the Public Can Comment
  10. Dates and Status as of 11 October 2026
  11. How the Notice Fits the FDA’s Earlier Work on Botanical Drugs
  12. Primary Documents
  13. Key Research Papers
  14. Connections

1. What the FDA Announced

The FDA news release, “FDA Seeks Public Input to Advance Development of Botanical Drug Products,” is dated 3 September 2026. It states that, “as part of the Trump Administration’s initiative to streamline regulatory pathways and foster medical innovation,” the agency “today announced a request for information (RFI) to gather public input on opportunities to advance the development of botanical drug products.” A request for information is a formal invitation to the public to send in comments and data; it is not a rule and does not by itself change any requirement.

The release quotes two officials. The Acting FDA Commissioner, Kyle Diamantas, J.D., said: “Under the Trump Administration, we are committed to modernizing regulatory frameworks to ensure promising, natural health options are evaluated through rigorous science. 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.” The Deputy Center Director for Substance Use and Behavioral Health in the FDA Center for Drug Evaluation and Research, Marta Sokolowska, Ph.D., said: “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. 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.”

The Federal Register notice, published 4 September 2026 on pages 56887–56889 of volume 91, carries the action line “Notice; request for information; establishment of a public docket.” A docket is the public file, kept on regulations.gov, where the notice and every comment received are stored under one number. The notice is signed by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs, and names Caroline Huang of the Center for Drug Evaluation and Research as the contact. Its summary says the FDA wants “to better understand stakeholders’ perspectives on the state of BDP development in the United States, challenges encountered, and potential solutions to gathering the information required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).”

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2. What the FDA Means by a Botanical Drug

In the notice, “botanicals,” “botanical drug products” and “BDPs” all mean drug products “that include or may be derived from plant materials, algae, macroscopic fungi, or combinations thereof and that are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans.” Macroscopic fungi are fungi large enough to see, such as mushrooms. The press release gives the same definition in plainer words.

Two parts of that definition matter. The first is the source material: plants, algae, mushrooms, or mixtures of them. The second is the intended use: the product is meant to diagnose, treat or prevent disease, which is what makes it a drug under section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)), the definition the notice cites. The same plant can therefore appear in different regulatory categories depending on what the product is for and how it is marketed; this notice addresses only the drug category.

The notice lists the forms a botanical drug may take, “but are not limited to”: solutions (for example, tea), powders, tablets, capsules, tinctures, topical products and injections. It points readers to the FDA web page “What is a Botanical Drug?” for more information.

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3. Botanical Products Already Marketed as Drugs

Both documents state that, to date, four botanical products have been approved for marketing as prescription drugs. A prescription drug reaches the U.S. market through one of two applications: a new drug application (NDA) for most drugs, or a biologics license application (BLA) for biological products. The Federal Register notice identifies the four by active ingredient only:

Four approvals is the whole tally the FDA gives for the prescription route. The notice’s background opens by noting “broad public interest in botanical products” and that “consumers report widespread use of botanical products for self-treatment of a variety of conditions”; the gap between that use and the small number of approved botanical drugs is the setting for the request.

There is a second, non-prescription route. Both documents state that botanical active ingredients “such as psyllium and witch hazel” can be marketed under certain over-the-counter (OTC) monographs. The notice explains what that means: an OTC monograph sets the conditions — active ingredients, uses, doses, routes of administration, labeling and testing — under which an OTC drug in a given category is “generally recognized as safe and effective for its intended use.” A product that meets those conditions and the other requirements of section 505G of the FD&C Act (21 U.S.C. 355h) can be sold without its own approved drug application. (Background on the plant is on the site’s Psyllium page.)

The FDA says it is “building on the lessons learned from these marketed products and the Agency’s experience with other BDP development programs.”

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4. The Development Problems the Documents Describe

The notice states that “the inherent heterogeneity of botanicals creates unique challenges in research, product development, and regulatory review.” Heterogeneity here means that a plant-derived product is usually a complex mixture whose make-up can vary with the plant, where and how it was grown and harvested, and how it was processed — unlike a single, purified chemical. The press release puts it as “their inherent complexity and variability.”

According to the notice, “despite increasing interest in plant-based medicines, researchers and developers of botanicals report a variety of challenges,” and it names three kinds:

The notice also reports what outside participants at a recent roundtable (section 6) identified as opportunities to speed development and review: incorporating real-world evidence to inform “fit-for-purpose” development programs; identifying and applying quality frameworks “to address batch-to-batch variability and ensure reproducibility”; and more education and outreach “to align understanding across the development ecosystem.” Real-world evidence is information about a product’s use and effects gathered outside controlled clinical trials, for example from health records or registries.

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5. The Existing Guidance: Botanical Drug Development (2016)

The FDA already has a guidance document for this field. The notice describes the guidance for industry “Botanical Drug Development,” announced in the Federal Register on 29 December 2016 (81 FR 96018), as “outlining recommendations related to characterization, quality control, clinical investigation, and regulatory considerations for BDPs.” A guidance document sets out the agency’s current thinking; it is not a binding regulation.

The notice gives the guidance’s history in a footnote:

The 2016 Federal Register announcement (Docket No. FDA-2000-D-0103) adds that the guidance describes the FDA’s thinking on development plans for botanical drugs submitted in NDAs and on the investigational new drug applications (INDs) — the filings that let a sponsor test an unapproved drug in people — that support them. It also gives general information on the OTC monograph system for botanical drugs, and it states that while it does not give recommendations specific to botanical drugs marketed under BLAs, many of its scientific principles may also apply to those products.

One of the 2026 notice’s questions asks which specific updates, “e.g., to guidance or other materials,” would make the FDA’s approach to botanicals clearer; the press release lists “potential updates to FDA guidance and other resources” among the topics.

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6. The Roundtable and the Joint FDA–EMA Workshop

The roundtable. The notice says the FDA “recently collaborated on a roundtable to gather information on challenges and opportunities for development of BDPs,” and the press release names its partner: the Reagan-Udall Foundation for the FDA. The notice reports the participants’ suggestions (real-world evidence, quality frameworks for batch-to-batch variability, education and outreach), summarized in section 4. Neither document gives the roundtable’s date.

The workshop. The press release states that 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.” The European Medicines Agency (EMA) is the European Union’s medicines regulator. The two FDA documents this page draws on were published before that date, and this page does not report the workshop’s proceedings.

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7. The Questions the FDA Is Asking

The notice asks “researchers, clinicians, industry members, and other interested parties” to answer questions in three groups. They are reported here as the notice words them, lightly shortened.

  1. Research and development experience.
    • What challenges have you met in botanical research or drug development programs you led or contributed to — for example, specific challenges in studies in healthy volunteers compared with studies in patient populations, or the reverse? The notice asks for detailed information on the progress of and challenges for these programs.
    • How are you using existing FDA resources to advance development of botanical drugs, if at all?
    • What systems, processes or standard practices in your program help you gather the information required by the FD&C Act and its regulations in Title 21 of the Code of Federal Regulations?
  2. General challenges.
    • What challenges have you experienced or do you foresee, for example scientific and economic ones?
    • What are the challenges, regulatory or otherwise, in developing minimally purified or whole-plant products compared with highly purified or isolated products?
  3. General opportunities.
    • What innovative approaches can the FDA and/or industry take to support and accelerate development?
    • What approaches have streamlined development “without impacting safety, efficacy, or quality”?
    • Which specific updates, for example to guidance or other materials, would clarify the FDA’s approach to botanicals?
    • What opportunities exist for standards development, for example quality standards, outside the FDA?
    • What scientifically credible study designs are best suited to complex botanical mixtures, and how should they be assessed for safety, efficacy and quality?
    • How could information from botanicals with well-established use, generally accepted scientific knowledge and/or real-world evidence be used to facilitate development?

The press release summarizes the same topics as: challenges in botanical research and drug development; innovative approaches; potential updates to FDA guidance and other resources; quality standards; study designs for complex botanical mixtures; and the potential use of real-world evidence “and other scientifically credible information.”

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8. What the Notice Does Not Do

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9. How and Until When the Public Can Comment

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10. Dates and Status as of 11 October 2026

Legal status on 11 October 2026: open. The document is a request for information with a public docket still accepting comments. It is not a proposed rule, a final rule or guidance, and it has no effective date. Any later step — such as revised guidance — would be a separate FDA action.

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11. How the Notice Fits the FDA’s Earlier Work on Botanical Drugs

2000–2016: one guidance, revised. The FDA’s written approach to botanical drugs began with the August 2000 draft “Botanical Drug Products,” finalized in June 2004, revised in draft in August 2015 as “Botanical Drug Development,” and finalized in December 2016 (section 5). The 2026 notice treats that guidance as the current baseline and asks what in it, or around it, needs updating.

Approvals so far. Over that period, the FDA counts four botanical prescription-drug approvals — three NDAs and one BLA — plus botanical ingredients such as psyllium and witch hazel in OTC monographs (section 3). The notice presents these, and other development programs, as the experience it is building on.

2026: roundtable, request and workshop. In 2026 the FDA worked with the Reagan-Udall Foundation on a roundtable, published this request for information in September, and scheduled a joint workshop with the EMA for 25 September. The press release places the request within an administration initiative “to streamline regulatory pathways and foster medical innovation.”

A pattern of 2026 requests for information. The same Deputy Commissioner who signed this notice, Grace R. Graham, also signed the FDA’s 6 October 2026 request for information on clinical trials of ibogaine, a plant alkaloid (see FDA Ibogaine Research Notice (2026)). Both use the same instrument — a notice, a public docket and a list of questions — to gather input before any guidance is written. The botanical notice differs in scope: it asks about a whole class of products and about obstacles in general, where the ibogaine notice sets out a specific candidate trial design for one compound.

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12. Primary Documents

  1. U.S. Food and Drug Administration (2026). FDA Seeks Public Input to Advance Development of Botanical Drug Products. FDA News Release, 3 September 2026 — fda.gov press announcement
  2. Food and Drug Administration, HHS (2026). Advancing Development of Botanical Drug Products; Request for Information. Federal Register 91:56887–56889, 4 September 2026. Docket No. FDA-2026-N-9550 — FR Doc. 2026-18133 (official PDF, govinfo.gov)
  3. Food and Drug Administration, HHS (2016). Botanical Drug Development; Guidance for Industry; Availability. Federal Register 81:96018, 29 December 2016. Docket No. FDA-2000-D-0103 — FR Doc. 2016-31627 (guidance text: fda.gov/media/93113)
  4. U.S. Food and Drug Administration. What is a Botanical Drug? (web page cited in the 2026 notice) — fda.gov
  5. Reagan-Udall Foundation for the FDA. Botanical Drug Development Roundtable (project page cited in the 2026 notice) — reaganudall.org

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Key Research Papers

  1. Wu C, Lee SL, Taylor C, Li J, Chan YM, Agarwal R, Temple R, Throckmorton D, Tyner K (2020). Scientific and regulatory approach to botanical drug development: a U.S. FDA perspective. Journal of Natural Products 83(2):552-562 — PubMed PMID: 31977211
  2. Park JK, Lee D, Rui L, Gao X, Furness MS, Wu C (2025). Analysis of regulatory botanical submission profile for cancer management from the U.S. FDA perspectives. Therapeutic Innovation & Regulatory Science 59(5):1129-1137 — PubMed PMID: 40468097
  3. Grimstein M, Huang SM (2018). A regulatory science viewpoint on botanical-drug interactions. Journal of Food and Drug Analysis 26(2S):S12-S25 — PubMed PMID: 29703380
  4. Kulpa J, Pruyn SA, Hodgin G (2026). Letters from the field: challenges and opportunities in the development of botanical drugs from cannabis. Clinical Therapeutics 48(1):38-45 — PubMed PMID: 41421888
  5. Macarthur RD, Hawkins TN, Brown SJ, Lamarca A, Clay PG, Barrett AC, Bortey E, Paterson C, Golden PL, Forbes WP (2013). Efficacy and safety of crofelemer for noninfectious diarrhea in HIV-seropositive individuals (ADVENT trial): a randomized, double-blind, placebo-controlled, two-stage study. HIV Clinical Trials 14(6):261-273 — PubMed PMID: 24334179
  6. Schöfer H, Tatti S, Lynde CW, Skerlev M, Hercogová J, Rotaru M, Ballesteros J, Calzavara-Pinton P (2017). Sinecatechins and imiquimod as proactive sequential therapy of external genital and perianal warts in adults. International Journal of STD & AIDS 28(14):1433-1443 — PubMed PMID: 28566057
  7. Gibson CJ, Mueller SW, Dorgan EA, Endorf FW, Halevi AE, Wiktor AJ (2026). Real-world experience of anacaulase-bcdb debridement in burns. Journal of Burn Care & Research 47(2):432-436 — PubMed PMID: 41208022

The first four papers discuss how botanical drugs are developed and reviewed; papers 5–7 study three of the active ingredients the Federal Register notice names. None of the seven is cited by the notice itself.

PubMed Topic Searches

  1. PubMed: botanical drug development and regulation
  2. PubMed: botanical drug quality and batch variability
  3. PubMed: clinical trial design for herbal medicines
  4. PubMed: botanicals and real-world evidence

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Connections

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