CBD: Not the medical, just the legal

Weed. Grass. Ganja. Hashish. Bhang. Marijuana (Cannabis sativa or Cannabis indica plant) has more names than I can count! Sometimes I am not sure if people aren’t just making up their own name for it to see if I am paying attention! But, then again, since it has been cultivated and used by humans since 500 BC (in Asia), there has been ample time for us to come up with so many names for it. These days people are using the names hemp, pot and CBD interchangeably. Are all these interchangeable? The short answer is no. The long answer is no, they are not LEGALLY all the same. And, therein lies the rub! Especially for pet owners and veterinarians searching for treatments and cures to difficult therapeutic situations ranging from cancer to arthritis to heartworm disease. Let’s try to eliminate some of the haziness surrounding Cannabis and pets these days.

Related: Get our guide to CBD

In 2018, two critical events happened that brought this issue front and center in every pet-owning household in the country. First, in September 2018, the US Drug Enforcement Agency (DEA) reclassified drugs that contained components of cannabis. Namely, FDA- approved drugs that contain CBD (cannabidiol) derived from cannabis and no more than 0.1 percent tetrahydrocannabinols (THC) in Schedule V rather than the taboo and untouchable Schedule I. Other Schedule V drugs include cough preparations with less than 200 milligrams of codeine or per 100 milliliters (Robitussin AC), Lomotil, Motofen, Lyrica, Parepectolin. Marijuana remained Schedule I along with others such as heroin, LSD, ecstasy, peyote, etc. This move was huge!

Currently, only a single cannabis-derived drug is FDA-approved, Epidiolex. Epidiolex contains a purified form of the CBD for the treatment of seizures associated with Lennox- Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.  That’s right – only for use in people. There are three cannabis-related drug products that are FDA-approved as well.

All of these FDA-approved items are for use in people and require prescriptions. Well, then why is the local gas station stocked with every flavor of CBD-containing gummy I can imagine (and some I couldn’t)? Puff, puff, pass – here comes the smoke that has hampered understanding and it has to do with who regulates what. In the land of the federal government (where a veterinarian’s license to prescribe controlled substances resides with the DEA), marijuana is still illegal.

In most states, marijuana is still illegal. However, since the DEA reclassified CBD-containing products to Schedule V, it is possible that if an FDA-approved drug for use in animals contained CBD and less than 0.1% THC, that a veterinarian could legally prescribe such a drug for use in a patient.

Since the FDA has only a single cannabis-derived drug labeled for use, and only in humans, and only with a prescription, the reclassification by the DEA only goes so far and does not allow for the gas station to expand its revenue base. Then, the second critical event took place – Congress passed, and the President signed into law, the Agriculture Improvement Act of 2018 (2018 Farm bill).

According to the US Dept. of Justice (US DOJ) the 2018 farm bill, which was signed into law on Dec. 20, 2018, “…changed the definition of marijuana to exclude “hemp”—plant material that contains 0.3 percent or less delta-9 THC on a dry weight basis. Accordingly, hemp, including hemp plants and cannabidiol (CBD) preparations at or below the 0.3 percent delta-9 THC threshold, is not a controlled substance, and a DEA registration is not required to grow or research it.” 

The 2018 farm bill explicitly legalizes the interstate transport of hemp-derived products for commercial or other purposes. The 2018 farm bill further provides no restrictions on the sale, transport, or possession of hemp-derived products, so long as those items are produced in a manner consistent with the law.

The proverbial flood-gate was opened! So, as long as that gummy contains less than 0.3% THC all is legal, right? Well, no.

According to testimony from Amy Abernethy, Md, Phd., Principal Deputy Commissioner in July 2019, “FDA’s existing authorities over foods, dietary supplements, human and veterinary drugs, and cosmetics apply to hemp products to the extent such hemp products fall within those categories.”  What is missing from that list is dietary supplements for animals. Dr. Abernathy goes on to say, “It is unlawful under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to introduce into interstate commerce a food (including any animal food or feed) to which has been added a substance that is an active ingredient in an approved drug product or a substance for which substantial clinical investigations have been instituted, and the existence of such investigations has been made public.” There’s animal food and feed! So, what are we left with?

All of this legalese and maneuvering leaves a somewhat grey area called animal dietary supplements. Animal drugs must still obtain FDA approval. But, animal supplements do not exist in the federal regulatory universe (yet) and the FDA determined in 1996, “After examining the statutory language, intent, and legislative history…the Dietary Supplement Health and Education Act (DSHEA) does not apply to animal products.”

As long as the label on the dog treat does not claim to prevent, diagnose, mitigate, treat, or cure any disease, and the CBD is hemp-derived through lawful cultivation (and has less than 0.3% THC), it is an animal dietary supplement and not subject to regulation by the FDA. Therefore, a dog supplement containing hemp (notice I avoided saying CBD) can be labeled to support the structure and function of the animal, i.e. support joint movement or serve as a calming aid, but it cannot legally be labeled to treat, mitigate or cure osteoarthritis or separation anxiety.

If it were labeled to treat, mitigate or cure osteoarthritis or separation anxiety, then it would be seen by regulators as a drug and subject to FDA regulation and approval. Yes, yes, I know, semantics, but semantics that make the difference between legal and illegal.

To add a little bit more information, since pure CBD oil is currently the active ingredient in an existing FDA-approved drug (Epidiolex), pure CBD oil may not be sold without prescription. While the DEA, FDA, and the 2018 Farm bill all combine to make a hemp-derived animal supplement legal for over-the-counter sale at the federal level, state governments still have the opportunity to put the kibosh on the whole transaction. In fact, even hemp-derived products remain illegal in Idaho unless they meet additional incredibly restrictive criteria, i.e. contain 0.0% THC, etc.

So, the next time a client comes into your practice and asks you if it is legal to give their pet a little ganja, Mary Jane, pot, or grass – the answer is still no for now, but California… However, it is legal to discuss supplements for pets that are hemp-based or hemp-derived, or contain hemp extract, etc. It would be prudent to make sure that the pet owner is aware that this is a relatively new area of research in pets and doses may or may not be accurate. It may also be prudent to remind pet owners that these supplements are unregulated – that means no government agency is verifying that what they say is in the bag is actually in the bag!

So, yes, Dr., animal supplements containing hemp (and as a consequence likely CBD) are okay, except in ID. But, pharmacokinetics, safety, bioavailability, etc...those are topics for another day!

References:

1. https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and- cannabis-derived-products-including-cannabidiol-cbd#othercbdapproved

2. https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and- cannabis-derived-products-including-cannabidiol-cbd

3. https://www.brookings.edu/blog/fixgov/2018/12/14/the-farm-bill-hemp-and-cbd- explainer/

4. https://www.fda.gov/news-events/congressional-testimony/hemp-production-and- 2018-farm-bill-07252019

5. https://www.justice.gov/opa/pr/dea-announces-steps-necessary-improve-access- marijuana-research

6. https://www.govinfo.gov/content/pkg/FR-1996-04-22/pdf/96-9780.pdf