Notice2026-18133
Advancing Development of Botanical Drug Products; Request for Information
Primary source
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Published
September 4, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 91 Issue 171 (Friday, September 4, 2026)</title>
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[Federal Register Volume 91, Number 171 (Friday, September 4, 2026)]
[Notices]
[Pages 56887-56889]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18133]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-9550]
Advancing Development of Botanical Drug Products; Request for
Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for information; establishment of a public
docket.
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SUMMARY: 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).
DATES: Submit either electronic or written comments, data, or
information by November 3, 2026.
ADDRESSES: You may submit comments, data, and information as follows.
Please note that late, untimely filed comments will not be considered.
The <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and
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Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
FOR FURTHER INFORMATION CONTACT: 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, <a href="/cdn-cgi/l/email-protection#f0929f84919e9993919c9482859780829f9485938483b0969491de989883de979f86"><span class="__cf_email__" data-cfemail="dbb9b4afbab5b2b8bab7bfa9aebcaba9b4bfaeb8afa89bbdbfbaf5b3b3a8f5bcb4ad">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
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.
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\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 <a href="https://www.fda.gov/about-fda/cder-offices-and-divisions/what-botanical-drug">https://www.fda.gov/about-fda/cder-offices-and-divisions/what-botanical-drug</a>.
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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 <a href="https://www.fda.gov/media/93113/download">https://www.fda.gov/media/93113/download</a>),\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.
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\2\ 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 <a href="https://www.fda.gov/media/93113/download">https://www.fda.gov/media/93113/download</a>.
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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\
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\3\ 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.
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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.
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\4\ For more information on this roundtable, see <a href="https://reaganudall.org/projects/botanical-drug-development-roundtable">https://reaganudall.org/projects/botanical-drug-development-roundtable</a>.
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II. Topics for Public Input
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.
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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.
[FR Doc. 2026-18133 Filed 9-3-26; 8:45 am]
BILLING CODE 4164-01-P
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