Lets talk CBD legality, veterinary professionals

August 1, 2019
Dawn Merton Boothe, DVM, MS, PhD, DACVIM, DACVCP

Dr. Dawn M. Boothe is a professor of physiology and pharmacology at Auburn University College of Veterinary Medicine. She also serves as the director of the Clinical Pharmacology Laboratory, which offers therapeutic drug monitoring services to veterinary practices throughout the country and across the globe.

dvm360, dvm360 October 2019, Volume 50, Issue 10

While some in the veterinary world might be raring to throw a CBD is legal! parade, there are a few caveats keeping you from tossing confetti. Lets walk through it.

Newspapers and other advertisements are claiming that, with passage of the 2018 Farm Bill, “CBD is now legal.”

Not quite yet.

Regulatory barriers have made it difficult to access marijuana or its medically relevant constituents. While it is true that cannabidiol (CBD) is likely to become legally accessible by our clients, this is not without caveats.

The changes in legality of CBD actually began with the 2014 Agricultural Act (Farm Bill). It was in this bill that Congress defined “industrial hemp” as “… the plant Cannabis sativa L. and any part of such plant, whether growing or not, with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3% on a dry weight basis.”

This means there are now two legally defined cultivars of Cannabis sativa: marijuana, defined by the Controlled Substances Act, and industrial hemp, defined by the 2014 Farm Bill. They are genetically and chemically distinct. Industrial hemp (IH) products will be largely void of psychoactive cannabinoids-that is, THC. The 2014 Farm Bill allowed for legalization of IH only in limited circumstances, specifically, at institutions of higher education and only if the state in which the crop was being grown approved crops. It also allowed limited research with IH.

Because the legal definition is for industrial hemp, the use of the term “hemp” may be confusing since the term has been used to refer to marijuana.

The 2018 Farm Bill changed several things. Notably, it extended the legalization of IH, as previously defined, to any state interested in it as a product. Further, and perhaps most importantly, IH and any of its derivative products, including CBD, are no longer subject to the DEA Controlled Substances Act.

However, this does not mean that CBD is legal.

Here's what's raining on your parade

Several caveats exist in making CBD legal. To start, the 2018 Farm Bill does not change the fact that the federal government still considers all state programs that have legalized marijuana (not IH) cannabis products to be illegal. Although verified derived products have been removed from Schedule 1 status, and although there is now a potential for a broad expansion of commercially available CBD products, all CBD is not "legal." Only CBD that has demonstrated to be derived from IH will be legal.

This leads to the second major caveat: States that allow the growth of IH must regulate its cultivation through programs that must be approved in advance and subsequently overseen by the Secretary of the USDA. This includes verification that the seeds and the resulting plants being grown meet the definition of IH (thus avoiding the growth of marijuana). As such, although any person can grow IH, a license will be required and approved state regulations must be followed.

If a state does not promulgate protocols or regulatory plans for USDA approval, the individual can work through the USDA, but a process must still be in place. The USDA has not yet put a process for approval in place and, as such, this means none of the currently marketed products derived from an approved IH crop have gone through this “regulatory” or “approval” process.

The process will likely include methods to assure that the product being sold is derived from IH and that marijuana cannot infiltrate the system. Until such time that the USDA has put these protocols in place, no CBD has been derived from IH and thus no CBD product is legal. The USDA anticipates that these protocols will be in place by the end of 2019 and until that time, all CBD falls under the current DEA Controlled Substances Act and thus is considered a Schedule 1 Substance.

There are two exceptions to this, however. The first regards products that have already been approved as a result of the 2014 bill. However, the lack of USDA written regulations suggests that even these products are not legal. The second exception to CBD as a federally regulated Schedule 1 product is Epidiolex. This approved drug is CBD and it has been designated a Schedule V drug. However, the schedule V status agreed upon by the DEA and FDA applies only to this drug product, not CBD in general.

A related concern is the impact of pharmaceutical grade CBD in an approved drug vs CBD in IH sold as supplements. The FDA may perceive such products to be adulterated drugs, particularly if the product label includes treatment or prevention indications. It is for this reason that the labels may refer to “[industrial] hemp oil” rather than CBD, as the active ingredient. This may confound the ability of veterinarians to make dosing recommendations in the absence of a known amount of CBD per unit dose.

Finally, just because Congress has legalized IH and its products and removed these from DEA oversight does not mean that states' Controlled Substances Acts will be modified to reflect this. Many states do not recognize “industrial hemp” and thus still consider CBD, irrespective of source, to be a controlled substance.

Indeed, selected individual state boards of Veterinary Medical Examiners have either explicitly precluded or restricted what veterinarians can prescribe, dispense or even recommend in terms of CBD products. State boards of pharmacy may also weigh in on how these products are to be handled and thus, may also impact veterinarians in that state. As such, practitioners in each state are encouraged to review the relevant boards that are weighing in on the use of CBD until these caveats change.

Dr. Dawn M. Boothe is a professor of physiology and pharmacology at Auburn University College of Veterinary Medicine. She also serves as the director of the Clinical Pharmacology Laboratory, which offers therapeutic drug monitoring services to veterinary practices throughout the country and across the globe.

download issueDownload Issue : dvm360 October 2019