```

[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]

[[Page 4746]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \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).

---------------------------------------------------------------------------

[[Page 4747]]

    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

[[Page 4748]]

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
```