From the AVMA’s, “Frequently Asked Questions About Cannabis, Cannabis-Derived, and Cannabis-Related Products.”
Has FDA approved any veterinary (animal) drugs containing cannabis or cannabis-derived compounds such as
CBD?
No, there are currently no approved animal drugs that contain cannabis, are derived from cannabis, or are
related to cannabis.FDA has, however, approved one cannabis-derived and three cannabis-related human drug products. Epidiolex contains a purified form of CBD. Marinol and Syndros include the active ingredient dronabinol (a synthetic THC),
and Cesamet contains the active ingredient nabilone (a chemical that is similar to THC and is also synthetically
derived).
What about the numerous cannabis-derived products, including various types of CBD, being marketed for
pets? As a veterinarian, should I be administering, prescribing, dispensing, or recommending them?
As veterinarians, when we look to administer, prescribe, or recommend products, we are generally doing so
with intent to prevent, mitigate, treat, or cure a disease or condition. Products for animals for which therapeutic
claims are made that have not been evaluated and approved by the FDA are unapproved animal drugs.
Unapproved animal drugs are considered to be “unsafe” under the FDCA, because they have not been shown to
meet FDA standards for safety and efficacy for their intended use.
The FDA approval process assures that drugs are evaluated as to whether they work, what the proper dosage
might be if they do work, how they could interact with other drugs, and whether they have dangerous side
effects or other safety concerns.
Examples of what FDA has indicated1 it considers to be therapeutic claims associated with the marketing of CBD
products for animals include the following:
“…CBD and other chemicals found in cannabis have an antitumor effects and could be used to improve
standard treatments…”
“…Due to its anti-inflammatory effect, cannabinoids may provide relief of joint pain and swelling, and
decrease joint destruction and disease progression…”
“…how [product] may help your dog or cat…reduce cancer-associated symptoms, aid in decreasing
severity of dementia, reduce bronchial spasm in asthmatics…”
“…for all pets, but especially for those with arthritis, allergies, anxiety or behavior issues, compromised
immune systems, diabetes, digestive issues, nausea, chronic pain, cancer, seizures…”
There are currently no approved animal drugs derived from cannabis. Animal drugs must generally receive
premarket approval by FDA via the New Animal Drug Application (NADA) process. The manufacture and
marketing/sales of drugs in interstate commerce that have not been FDA approved is a violation of federal law.
The use of unapproved drugs can put patients at risk and may create legal risk for veterinarians who administer,
prescribe, dispense, or recommend them because they have not been evaluated for efficacy and safety by the
FDA. Risk may be heightened when approved treatments are available and are not utilized, or when patients for
which unapproved drugs have been administered, prescribed, dispensed, or recommended are adversely
impacted (either side effects or treatment failures).
My state has laws that allow cannabis to be sold for medical use without FDA approval. Doesn’t that mean, as
a veterinarian, that I can legally use and/or recommend them for my patients?
No. To date, laws that have been passed by states that remove state restrictions on the use of cannabis for
medical or recreational use by people do not apply to their use in animals.
A veterinarian’s use of cannabis and its products for their patients may additionally be regulated at the state
level via state veterinary medical practice acts or state pharmacy laws. A 2018 law2 passed in California
amended section 4883 and added section 4884 to the Business and Professions Code that allows veterinarians
(other than those employed by or having an agreement with a cannabis licensee) to discuss cannabis within the
veterinarian-client-patient relationship and sets a deadline of January 1, 2020 for that state’s veterinary medical
board to develop guidelines for those discussions. However, that law also expressly prohibits a licensed
veterinarian from administering or dispensing cannabis or cannabis products for an animal patient. With respect
to state pharmacy laws, in Maryland a statement3 issued on March 1, 2019 by the State Board of Veterinary
Medical Examiners indicates, “Although the General Assembly may change state law at some point, right now, in
Maryland, all products containing cannabidiol, except for Epidiolex, are Schedule 1 Controlled Substances.”
These are just a couple of examples as to why it is always important for veterinarians to understand their
responsibilities and obligations under both federal and state law.
Can CBD or THC products be marketed for animals as dietary supplements?
No. Technically there is no such thing as a ‘dietary supplement’ for animals, because the Dietary Supplement
and Health Education Act of 1994 (DSHEA) does not apply to products intended for use in animals. What this
means is that the only evaluative route for veterinary products is as ‘drug’ or ‘food’ under the FDCA.
Additionally, with respect to products for human use, FDA has concluded based on available evidence that CBD
and THC products are excluded from the dietary supplement definition under the FDCA (21 USC § 321(ff)(3)(B)(i)
and (ii)). Under that section, if a substance is an active ingredient in a drug product that has been approved
under the FDCA (21 USC § 355), or has been authorized for investigation as a new drug for which substantial
clinical investigations have been instituted and for which the existence of such investigations has been made
public, then products containing that substance are excluded from the definition of a ‘dietary supplement’.
Click Below For Complete Report: 2019_AVMA_Cannabis-FAQ
