Please visit our glossary for a list of useful definitions to these terms and others.
In brief, cannabis refers to the plant Cannabis sativa. There are thousands of varieties of the cannabis plant, which have different types and amounts of cannabinoids and other constituents (e.g., terpenes). The two main cannabinoids in the cannabis plant are CBD and delta-9-tetrahydrocannabinol (THC).
Hemp and Marijuana are legal terms that refer to cannabis plant varieties with very different compositions of THC. Hemp refers to cannabis plant varieties (and plant parts) that have very low levels of the intoxicating cannabinoid THC (less than 0.3% on a dry weight basis) whereas marijuana refers to cannabis plant varieties (and plant parts) that have higher levels of THC (from 0.3% to >30%), which is why its use is associated with an intoxicating effect (a “high”).
While hemp contains low levels of THC, it often contains higher levels of CBD. There is a lot of industry interest in CBD, and thus hemp, since research is emerging on the potential benefits of CBD in human and animal health, as further discussed below.
Naturally-occurring CBD in hemp is found in the leaves and flowering heads of the cannabis plant. In contrast, hulled hemp seeds, hemp seed protein, and hemp seed oil do not contain CBD.
What is the regulatory status of CBD in the United States?
In the U.S., there is only one approved drug product that contains CBD and that is Epidiolex, approved for use in humans for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. There are no approved CBD-containing veterinary drugs. Aside from Epidiolex, products containing CBD that claim to treat, mitigate, prevent, or cure disease – effects reserved for drugs – have not been approved by the U.S. Food and Drug Administration (FDA) and cannot be lawfully marketed.
Foods or dietary supplements intended for human or animal (including pet) consumption that include CBD are also not permissible for sale in the U.S. because the FDA has yet to determine how to regulate CBD that is not found in an FDA approved drug. However, given the growing public interest in CBD, the FDA has created an internal CBD working group that is exploring potential regulatory pathways for conventional foods and dietary supplements containing CBD to be lawfully marketed. While the FDA acknowledges the public interest in CBD, it also remains committed to evidence-based decision-making and ensuring the health and safety of humans and animals (including pets). The FDA is actively obtaining and evaluating information related to the safety of CBD, including its long-term safety, to inform its decision-making on CBD and whether a regulatory pathway for its incorporation into foods and dietary supplements is scientifically sound.
We will keep you updated on the evolving regulatory framework for CBD. Up-to-date information on the regulation of CBD in the U.S. is also made available by the FDA.
Are hemp products legal in the United States?
The Farm Bill, which was signed into law on December 20, 2018, removed hemp from the “Controlled Substances Act” (CSA). Because of this change, hemp, which refers to cannabis plants, plant parts, and derivatives of cannabis that contain very low levels of THC (no more than 0.3 percent on a dry weight basis) are no longer controlled substances under the CSA. Even with hemp’s removal from the CSA, regulations have not been established surrounding the inclusion of hemp-derived “CBD” into foods or dietary supplements intended for human or animal (including pet) consumption.
There are hemp products that can lawfully be put into human foods, such as hulled hemp seeds, hemp seed protein, and hemp seed oil. These substances have been “Generally Recognized as Safe” (GRAS), meaning the safety of these substances, when incorporated into human foods, has been reviewed by experts and the FDA has been “notified” of this GRAS assessment. Importantly, the uses of these hemp-derived ingredients have only been approved for human food and not animal (pet) food. To date, the FDA has not been notified of any GRAS assessments conducted on hemp-derived ingredients for use in animal (pet) food.
The FDA also recognizes ingredients listed in the Official Publication (OP) of the Association of American Feed Control Officials (AAFCO) as being acceptable for use in animal food. At this time, there are no approved food additive petitions or ingredient definitions listed in the AAFCO OP for any substances derived from hemp.
Thus, no hemp-derived ingredients are currently permissible in animal (pet) food.
Is it legal to recommend CBD to my clients?
Most U.S. veterinary medical licensing and pharmacy boards are advising veterinarians to avoid discussing, recommending and selling products containing CBD until further guidance is provided by the U.S. FDA. This is because, under federal law, there are no approved uses of CBD for animals (including pets). However, laws across U.S. states vary and in August 2019, the state of California proposed a Bill (California Senate Bill 627) to authorize veterinarians to recommend cannabis and cannabis products for medicinal uses in animals.
The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) permits veterinarians to prescribe extralabel uses (i.e., uses not in accordance with approved labelling) of approved human drugs for animals under certain conditions. Among other limitations, extralabel use of a drug requires the lawful order of a licensed veterinarian in the context of a valid veterinarian-client-patient relationship and only in circumstances when the health of an animal is threatened or suffering, or death may result from failure to treat.
Data on CBD safety and efficacy in animals
At this time, under federal law, there are no approved uses of CBD for animals (including pets). Nevertheless, research is being conducted on the safety and efficacy of CBD in companion animals, mainly dogs.
- A 2018 study at Colorado State University assessed the safety and pharmacokinetics of CBD (5 or 10 mg/kg twice daily for 6 weeks) in 30 healthy dogs when delivered orally in capsules (microencapsulated oil beads) or as an oil, or in transdermal form as a cream.1 2 The CBD-infused oil provided the most favorable pharmacokinetic profile. Overall, orally consumed CBD was well tolerated.
- A 2019 study at Colorado State University conducted in nine client-owned dogs with epilepsy showed that CBD (2.5 mg/kg twice daily for 12 weeks) in addition to existing antiepileptic treatments caused no adverse behavioural effects and had favorable effects on the frequency of seizures.3
- A 2018 study at Cornell University demonstrated favorable effects of CBD (2 mg/kg twice daily for 4 weeks) on pain and activity associated with osteoarthritis in sixteen client-owned dogs. The dogs were perceived to be more comfortable and active and no side effects were reported by owners.4
Based on the existing studies, dogs appear to tolerate oral CBD well. A clinically significant finding reported across these studies was elevated blood levels of alkaline phosphatase (ALP), a liver enzyme, levels of which should be monitored with CBD intake.
Discussing cannabinoids/CBD with my clients
Your clients may be interested in using CBD for their pet and it is possible they may ask you about it. Based on the results of an online survey, ~29% of U.S. veterinarians were asked about CBD products weekly.5 Interestingly, veterinarians practicing in U.S. states with legalized recreational cannabis (for human use) were more likely to be asked about CBD use in pets as compared to those practicing in states wherein cannabis use remains illegal.
Should your client initiate a conversation about cannabinoids or CBD, below are some key takeaways you may want to communicate to them.
- CBD is a cannabinoid found in cannabis plants.
- Hemp is a cannabis plant variety that contains low levels of THC.
- CBD does not produce the “high” that THC does.
- Hemp seeds and hemp seed oil do not contain CBD.
- The FDA has not approved CBD for use in pets.
- Studies conducted to date suggest that dogs tolerate CBD well.
- Cannabis, CBD, or THC products intended for human use should not be provided to pets. These products could contain other ingredients which may be harmful to pets.
The regulatory landscape for CBD is evolving. Up-to-date information on the regulation of CBD in the U.S. is made available by the FDA. We also recommend you contact your local veterinary board to understand your state’s cannabis regulations, especially as they pertain to animals (pets).
The information provided on this website does not, and is not intended to, constitute legal advice; instead, all information, content, and materials available on this site are for general informational purposes only. Information on this website may not constitute the most up-to-date legal or other information.