This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.
The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.
The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.
FederalRegister.gov retrieves relevant information about this document from Regulations.gov to provide users with additional context. This information is not part of the official Federal Register document.
Food and Drug Administration, HHS.
Notice; request for information; establishment of a public docket.
The Food and Drug Administration (FDA or Agency) is opening a public docket to solicit comments on FDA's efforts to advance development of botanical drug products (BDPs). FDA is publishing this request for information 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).
Submit either electronic or written comments, data, or information by November 3, 2026.
You may submit comments, data, and information as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 3, 2026. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2026-N-9550 for “Advancing Development of Botanical Drug Products; Request for Information.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
Caroline Huang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6117, Silver Spring, MD 20993-0002, 855-543-3784, botanicaldrugproducts@fda.hhs.gov.
There is broad public interest in botanical products among consumers, researchers, clinicians, industry, the U.S. Federal Government, and international regulators. Consumers report widespread use of botanical products for self-treatment of a variety of conditions. In light of this, FDA seeks to facilitate additional research on botanicals, with the goal of accelerating drug product development and review of clinical treatments in this space.
In this notice, the terms “botanicals,” “botanical drug products,” and “BDPs” refer to 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.[1] BDPs may be available as, but are not limited to, solutions ( e.g., tea), powders, tablets, capsules, tinctures, topicals, or injections.
The inherent heterogeneity of botanicals creates unique challenges in research, product development, and regulatory review. In recognition of these unique considerations, FDA published the guidance for industry “Botanical Drug Development” on December 29, 2016 (81 FR 96018) (available at https://www.fda.gov/media/93113/download ),[2] outlining recommendations related to characterization, quality control, clinical investigation, and regulatory considerations for BDPs. Despite increasing interest in plant-based medicines, researchers and developers of botanicals report a variety of challenges, such as clinical trial design and implementation, production quality and consistency, and other development considerations.
To date, four botanical products have been approved for marketing as prescription drugs under the new drug application (NDA) and biologics license application (BLA) pathways. The three NDAs include drug products containing the active ingredients sinecatechins, crofelemer, and birch triterpenes, respectively. The BLA contains the active ingredient anacaulase-bcdb. Additionally, botanical active ingredients such as psyllium and witch hazel can be marketed under certain over-the-counter (OTC) monographs.[3]
Building on the lessons learned from these marketed products and the Agency's experience with other BDP development programs, FDA seeks to accelerate development of BDPs. As part of this effort, FDA recently collaborated on a roundtable to gather information on challenges and opportunities for development of BDPs.[4] External roundtable participants identified several potential opportunities to accelerate the development and review of BDPs, such as incorporating real-world evidence to inform fit-for-purpose BDP development programs, identifying and applying appropriate quality frameworks to address batch-to-batch variability and ensure reproducibility, and increasing education and outreach to align understanding across the development ecosystem.
FDA seeks information and comments from researchers, clinicians, industry members, and other interested parties on the following questions:
1. Research and BDP development experience:
a. What challenges, if any, have you encountered in botanical research or drug product development programs which you have led or to which you have contributed? For example, have you encountered specific challenges in studies in healthy volunteers compared to studies in patient populations, or vice versa? Provide detailed information and comments on the progress of and challenges for these programs. ( printed page 56889)
b. How are you using existing FDA resources to advance development of BDPs, if at all?
c. What systems, processes, and/or standard practices do you have in place as part of your drug product development program that facilitate gathering the information required by the FD&C Act and the implementing regulations in Title 21 of the Code of Federal Regulations (21 CFR)?
2. General challenges:
a. What challenges have you experienced or do you foresee for BDP development ( e.g., scientific and economic)?
b. What are the challenges, regulatory or otherwise, in developing minimally purified or whole plant products versus highly purified or isolate products?
3. General opportunities:
a. What innovative approaches can FDA and/or industry take to support and accelerate BDP development?
b. What approaches have been successful in streamlining BDP development without impacting safety, efficacy, or quality of the BDP?
c. Which specific updates ( e.g., to guidance or other materials) would provide clarity on FDA's approach to botanicals?
d. What opportunities exist for standards development ( e.g., quality standards) outside of FDA to support advancements in BDP development and review?
e. What scientifically credible study designs are best suited for complex botanical mixtures, and how should those be assessed ( e.g., with respect to safety, efficacy, and quality)?
f. How could information from botanicals with well-established use, generally accepted scientific knowledge, and/or real-world evidence be utilized to facilitate development?
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
1. See section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)) for the definition of the term “drug”. For more information on BDPs, see FDA's web page “What is a Botanical Drug?” at https://www.fda.gov/about-fda/cder-offices-and-divisions/what-botanical-drug.
Back to Citation2. The draft guidance for industry “Botanical Drug Products” was issued in August 2000, finalized in June 2004, and later revised in August 2015, at which point the title was revised to “Botanical Drug Development.” This revised draft guidance was finalized in December 2016. Available at https://www.fda.gov/media/93113/download.
Back to Citation3. OTC monograph drugs can be marketed without an approved drug application under section 505 of the FD&C Act (21 U.S.C. 355) if they meet the requirements of section 505G of the FD&C Act (21 U.S.C. 355h), including applicable conditions in an OTC monograph and other applicable requirements. An OTC monograph establishes conditions, such as active ingredients, uses (indications), doses, routes of administration, labeling, and testing, under which an OTC drug in a given therapeutic category is generally recognized as safe and effective for its intended use.
Back to Citation4. For more information on this roundtable, see https://reaganudall.org/projects/botanical-drug-development-roundtable.
Back to Citation[FR Doc. 2026-18133 Filed 9-3-26; 8:45 am]
BILLING CODE 4164-01-P
This document has a comment period that ends in 26 days. (11/03/2026) Submit a public comment