4746 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Notices 

1See 86 FR 5596, https://www.fda.gov/newsevents/public-health-focus/fda-regulation-cannabisand-cannabis-derived-products-includingcannabidiol-cbd (see Question 2). 

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 CannabisDerived 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, 

Katherine.Breed@fda.hhs.gov. 

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/113thcongress/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


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Notices 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 hempderived 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 delta9 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 hempderived 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 hempderived 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 hempderived cannabis products and other 

medications? For purposes of this 

information request, we are interested in 

interactions with any product used for 

medical purposes, including FDAapproved 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 hempderived 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 


ddrumheller on DSK120RN23PROD with NOTICES1
4748 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Notices 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5933] 

Proposal to Refuse to Approve a New 

Drug Application for TRADIPITANT; 

Opportunity for a Hearing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Director of the Center for 

Drug Evaluation and Research (Center 

Director) at the Food and Drug 

Administration (FDA or Agency) is 

proposing to refuse to approve a new 

drug application (NDA) submitted by 

Vanda Pharmaceuticals, Inc. (Vanda), 

for TRADIPITANT capsules, 85 

milligrams (mg), in its present form. 

This notice summarizes the grounds for 

the Center Director’s proposal and offers 

Vanda an opportunity to request a 

hearing on the matter. 

DATES: Either electronic or written 

requests for a hearing must be submitted 

by February 18, 2025; submit data, 

information, and analyses in support of 

the hearing and any other comments by 

March 17, 2025. 

ADDRESSES: You may submit hearing 

requests, documents in support of the 

hearing, and any other comments as 

follows. Please note that late, untimely 

filed requests and documents will not 

be considered. The https://

www.regulations.gov electronic filing 

system will accept hearing requests 

until 11:59 p.m. Eastern Time at the end 

of February 18, 2025, and will accept 

documents in support of the hearing 

and any other comments until 11:59 

p.m. Eastern Time at the end of March 

17, 2025. Documents received by mail/ 

hand delivery/courier (for written/paper 

submissions) will be considered timely 

if they are received on or before these 

dates. 

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–5933 for ‘‘Proposal To Refuse 

To Approve a New Drug Application for 

TRADIPITANT; Opportunity for a 

Hearing.’’ 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. 

• 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 

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: 

Tereza Hess, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 202– 

768–5659, tereza.hess@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Proposal To Refuse To Approve NDA 

218489 

Vanda submitted NDA 218489 for 

TRADIPITANT capsules, 85 mg, on 

September 18, 2023, pursuant to section 

505(b)(1) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

355(b)(1)). Vanda proposed that 

TRADIPITANT capsules be indicated 

for ‘‘the treatment of [symptoms of] or 

[nausea in] in gastroparesis.’’ 

To support a demonstration of 

substantial evidence of effectiveness, 

Vanda referred to two randomized, 

double-blind, placebo-controlled studies 

(Study 2301 and Study 3301, Group 1), 

and the following additional data 

submitted as confirmatory evidence: (1) 


ddrumheller on DSK120RN23PROD with NOTICES1