[Federal Register Volume 90, Number 10 (Thursday, January 16, 2025)]
[Notices]
[Pages 4746-4748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00945]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5976]
Use of Cannabis-Derived Products, Including Cannabidiol, in
Veterinary Practice; Request for Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for information.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
soliciting comments from the public, particularly veterinarians,
related to the use of cannabis-derived products (CDPs) in animals, with
an emphasis on cannabidiol (CBD) products and general trends associated
with those products, including information about: usage trends (e.g.,
product selection, indications, etc.), quality standards, benefits of
use, potential drug interactions, adverse events and safety problems,
and toxicological concerns. This information will enhance the Center
for Veterinary Medicine's (CVM's) knowledge of potential safety signals
associated with these products, in addition to aiding our understanding
of veterinarians' experiences related to the use of CDPs for their
animal patients.
DATES: Either electronic or written comments on the request for
information must be submitted by April 16, 2025.
ADDRESSES: You may submit comments 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 April 16, 2025. 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:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
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 https://www.regulations.gov.
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:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
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-2024-N-5976 for ``Use of Cannabis-Derived Products, including
Cannabidiol, in Veterinary Practice; Request for Information.''
Received comments 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.
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.'' We will review
this copy, including the claimed confidential information, in our
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 https://www.regulations.gov. 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:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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.
FOR FURTHER INFORMATION CONTACT: Katherine Breed, Center for Veterinary
Medicine, Food and Drug Administration, 12225 Wilkins Ave., Rockville,
MD 20852, 301-796-9361, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The CDP marketplace has grown significantly in the past few years
as the U.S. Government removed certain restrictions related to specific
aspects of the Cannabis plant's use and distribution. The Agricultural
Act of 2014 (also known as the 2014 Farm Bill (https://www.congress.gov/bill/113th-congress/house-bill/2642)) specifically
defined ``industrial hemp'' as any part of the Cannabis sativa L. plant
with a delta-9 tetrahydrocannabinol (THC) concentration of not more
than 0.3 percent on a dry weight basis, allowing its use in limited
situations for research purposes only. The Agricultural Improvement Act
of 2018 (also known as the 2018 Farm Bill (https://www.congress.gov/bill/115th-congress/house-bill/2)) further relaxed certain Federal
restrictions on hemp, which resulted in allowing interstate commerce of
hemp and removing hemp from the Controlled Substances Act statutory
definition of marijuana, among other changes. The 2018 Farm Bill also
explicitly preserved FDA's authority to regulate products containing
cannabis or cannabis-derived compounds, including hemp, under the
Federal Food, Drug, and Cosmetic Act and section 351 of the Public
Health Service Act (see 7 U.S.C. 1639r(c)).\1\
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\1\ See 86 FR 5596, https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd (see Question 2).
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CVM is particularly interested in input from practicing
veterinarians, whose expertise and experience can help inform FDA
regarding the use and effect of CDPs in animals. FDA is gathering
information relating to the use of CDPs in animals, with an emphasis on
CBD products and other hemp-derived products and general trends
associated with those products. For purposes of this request for
information, ``cannabis'' refers to plants that can be further defined
as either ``hemp'' or ``marijuana,'' depending on their delta-9 THC
concentration. The focus of this request for information is hemp-
derived products, and we use the term ``hemp'' to refer to the plant
species Cannabis sativa L. and any part of that plant, including the
seeds and all derivatives, extracts, cannabinoids, isomers, acids,
salts, and salts of isomers, whether growing or not, with a delta-9 THC
concentration of not more than 0.3 percent on a dry weight basis. We
are interested in information about the use of hemp-derived products
(typically labeled as products containing CBD) and not marijuana-
derived products.
Firms marketing CBD products for use in (non-human) animals often
make claims regarding a wide variety of diseases or conditions. Some
products are also purported to enhance general wellness and promote
longevity. Products are marketed in many different formulations, such
as tinctures/oils, treats/chews, pellets for large animals, capsules,
and sometimes as food toppers or infused in foods such as peanut
butter; topical products infused with CBD, such as balms and shampoos,
are also available for pets. Products that are intended for use in the
cure, mitigation, treatment, or prevention of diseases in animals are
animal drugs.
Currently, no FDA-approved, conditionally approved, or indexed
animal drugs contain CBD. However, with respect to human drugs, FDA has
approved one cannabis-derived drug product: EPIDIOLEX (cannabidiol),
and three synthetic cannabis-related drug products: MARINOL
(dronabinol), SYNDROS (dronabinol), and CESAMET (nabilone). Under the
Animal Medicinal Drug Use Clarification Act of 1994 and its
implementing regulations at 21 CFR part 530, under certain conditions,
veterinarians can lawfully prescribe approved human drugs for use in
animals in an extralabel manner.
FDA has made the regulation of the CBD market a priority, including
products marketed for animals. While there is some limited published
information about use of CDPs in animals, significant data gaps exist
surrounding many aspects of CBD and other CDPs in animals, and further
research is necessary to assess the safety and effectiveness of these
products. FDA is seeking a better understanding of what veterinarians
are experiencing related to CDPs in their patients, such as: general
patterns of use (i.e., animal species, brands, formulations, doses,
indications for use), quality standards, benefits of use, potential
drug interactions, adverse events and safety problems, and
toxicological concerns.
II. Questions for Consideration
We are particularly interested in input on the following questions
regarding veterinarians' experiences related to CDPs in their patients
(Note: You may submit your comment anonymously if you do not wish to
provide your name along with your response. CVM will fully consider all
comments. (https://www.regulations.gov/faq)):
1. Are you a veterinarian licensed to practice veterinary medicine
in the United States? If so, in which State(s) do you hold an active
license? Please indicate how many years of experience, as a practicing
veterinarian, you have. Please indicate the type of community (i.e.,
urban, suburban, or rural) that best describes where you work.
2. Are you in clinical practice, meaning, do you have physical
contact with client-owned animals? If so, what species does your
practice see (e.g., food-producing species such as cattle, poultry,
etc., and/or nonfood-producing species such as dogs, cats, etc.)?
3. Have clients asked you about using products derived from
cannabis in their animals? If so, please describe approximately how
often (weekly, monthly, quarterly, annually) your clients ask and
describe for which animal species and for what indications your clients
are using (or are interested in using) cannabis-derived products.
4. When clients ask about products derived from cannabis, do they
generally distinguish between products derived from hemp versus those
derived from marijuana (i.e., do they ask about hemp products,
marijuana products, or do they not specify)? What brands (if known) and
formulations or types of products do clients ask about (e.g.,
tinctures, treats, capsules, topical products, etc.)?
5. Have you prescribed or dispensed EPIDIOLEX, MARINOL, SYNDROS, or
CESAMET for use in any of your patients? If so, which drug(s) for what
species, and what was the reason or indication for which you prescribed
or dispensed these drugs for animal patients?
6. Do you use or recommend hemp-derived cannabis products for your
animal patients? If so, are you confident that the products you use or
recommend are labeled accurately (e.g., concentration, ingredients,
etc.)? What factors influence your decision on which brand of hemp-
derived cannabis product to use or recommend (e.g., certificate of
analysis, research, continuing education lectures, etc.)? What CBD:THC
cannabinoid ratio in hemp-derived cannabis products do you use or
recommend for your animal patients (if known)?
7. Describe your practices surrounding recommendations of hemp-
derived cannabis products for your animal patients including: for what
indications do you use or recommend hemp-derived cannabis products; for
which species; and which dosage forms (e.g., oral, topical,
inhalation), dose, brand, and cannabinoid(s) do you prefer? What
information sources do you use to make these treatment decisions
(continuing education, specialist recommendations, industry
recommendations, etc.)? Describe any benefits of use related to hemp-
derived cannabis products in your patients.
8. Related to hemp-derived cannabis products only: Have clients
reported to you, or have you observed, adverse effects following an
animal being administered a hemp- derived cannabis product (i.e., after
a client intentionally administered a hemp-derived cannabis product,
not accidental ingestion of adult recreational use products)? If so,
please describe each event(s) including animal species, clinical signs
and severity of the adverse event, product/dose/route of exposure (if
known), whether veterinary intervention was needed, and whether the
animal recovered, or the adverse event resulted in death. Did you
report any adverse events to FDA?
9. Do you have questions or concerns about drug interactions
between hemp-derived cannabis products and other medications? For
purposes of this information request, we are interested in interactions
with any product used for medical purposes, including FDA-approved
drugs, United States Department of Agriculture-licensed biologics, and
other products, such as veterinary nutraceuticals and veterinary
phytotherapy (plant-derived) products. Are you concerned about, or have
you seen potential drug interactions (e.g., reduction in the
effectiveness, safety margin, or both, of either the hemp-derived
cannabis products or the other medications) between hemp-derived
cannabis products and other medications?
10. If you do not use or recommend hemp-derived cannabis products
for
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your animal patients, what factors have influenced your decision (e.g.,
legal issues surrounding cannabis, safety concerns, effectiveness
concerns, product quality concerns, not found a need, etc.)? If you do
not use or recommend hemp-derived cannabis products for your animal
patients for reasons other than effectiveness concerns, are there any
indications and species for which you believe they could be effective
and why?
Dated: January 10, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-00945 Filed 1-15-25; 8:45 am]
BILLING CODE 4164-01-P