CBD is medicine. All but three states have accepted the medical use of CBD under state law. Let’s take this bull by the horns and protect the intra-state medical use of CBD, instead of looking for regulatory loopholes that will make it possible to turn a profit at the expense of our patients.
Thanks to the 2018 Federal Farm Bill there are now four types of CBD
State Medical Use CBD
CBD produced under Hawaii’s Medical Use of Cannabis Act is exempt from federal Schedule I regulation because Hawaii has established that Cannabis has accepted medical use, and the federal Controlled Substances Act says that a substance cannot be in Schedule I if it has accepted medical use. CBD can only be produced for medical use in Hawaii by registered patients and licensed dispensaries, and cannot be exported to other states because it is not FDA-approved for interstate marketing. However, the State could certainly provide other avenues for the production of CBD for medical use in Hawaii, such as allowing Hawaii hemp farmers to contract with Hawaii dispensaries for the sale of hemp material that cannot meet the 0.3% cut off for THC, or even create a separate regulatory structure for the intra-state production of CBD only products for medical use, which could be a huge savings for local insurance companies compared with the cost of FDA-approved CBD drug products.
As a result of the FDA’s approval of Epidiolex (GW’s pharmaceutical grade CBD Oil), and the DEA’s decision to place Epidiolex in federal Schedule V, there will soon be available for the first time in the United States a plant-derived FDA-approved cannabis drug product. Epidiolex has been approved for the treatment of two severe pediatric forms of epilepsy (Lennox-Gastaut and Dravet Syndromes) in children over two years old, and will likely be available in Hawaii’s pharmacies the end of 2019, once FDA-approved CBD drug products are placed into Schedule V of Hawaii’s Uniform Controlled Substances Act (UCSA). SB1263 is the bill currently sitting on the Governor’s desk that would place Epidiolex into state Schedule V. Epidiolex carries an annual estimated cost of around $32K, which is expected to be covered mostly by medical insurance, depending on how it is being used. Physicians can certainly prescribe Epidiolex for off-label use, but pre-authorizations for uses other than the FDA-approved indications will be unlikely given the cost of this medication. The FDA approval of Epidiolex also means that unapproved CBD cannot be used as a food additive or marketed as a dietary supplement.
With the signing of the 2018 Federal Farm Bill, any parts of the cannabis plant, including the seeds, extracts, cannabinoids, and their derivatives, that are 0.3% THC or less on a dry weight basis, are defined as “hemp”, instead of “marihuana”, and are no longer regulated under the federal Controlled Substances Act, as long as they come from a state-licensed producer of a USDA-approved state hemp program, and as long as scheduled substances within hemp, such as THC, are not being extracted and sold on the open market. The Secretary of the USDA is now responsible for promulgating regulations that will allow for the implementation of the hemp provisions of the 2018 Federal Farm Bill, which will include USDA approval of state plans to regulate local hemp production. The industrial hemp provisions of the 2014 Federal Farm Bill will expire one year after the date that the USDA establishes a plan for regulating state hemp programs under the 2018 Federal Farm Bill. It is entirely possible that the USDA will defer to the FDA regarding the regulation of CBD, because the 2018 Federal Farm Bill preserves the authority of the FDA to regulate unapproved drug substances found in hemp, including CBD. If FDA-approved CBD will be in state and federal Schedule V, then it would be unreasonable to assume that unapproved CBD can be any less controlled.
Schedule I CBD
Any CBD that does not fall under one of the categories above is still considered a Schedule I controlled substance by the DEA. Which makes sense if you consider that the state and federal definition of “Tetrahydrocannabinols” includes CBD. This includes CBD from unlicensed hemp producers, even if such CBD comes from plants that meet the federal definition of hemp. This also includes CBD from state-licensed hemp pilot program producers who are not complying with the cultivation and marketing research provisions of the 2014 Federal Farm Bill. Possession, use, production, distribution, and transportation of a Schedule I controlled substance without DEA Schedule I research registration or without state-accepted medical use is a violation of federal law.
Because hemp has phytoremediation properties, which is why it is being used in Chernobyl to eliminate soil radiation there, we have to be very careful about where CBD-hemp is being grown. One way to protect against consuming contaminated hemp-CBD is to make sure that the hemp from which CBD is being extracted is being grown organically. Another way is to make sure that hemp-CBD products are being tested by an accredited third-party analytical lab that has validated testing methods for heavy metals, pesticides, bacteria, and mold/fungi. This will be especially important for synthetic CBD that is reportedly now being made in uncertified labs in China and making its way into the U.S. CBD market.
However, because the scheduling status of CBD in Hawaii remains unknown, because CBD products being sold in Hawaii are currently completely unregulated, and because most CBD manufacturers do not provide lab testing results for their products, the only way to know for sure whether a hemp-CBD product is free of contaminants, and contains the amount of CBD being advertised, is to have such products tested for yourself. Luckily, there is an accredited state-licensed cannabinoid analytical lab in Hawaii that is able to legally accept samples directly from patients and the general public and performs testing at a reasonable cost.
CBD has been shown to inhibit CYP3A4, a liver enzyme found in humans that is responsible for metabolizing a significant number of commonly used pharmaceutical medications. Some of the more dangerous potential drug-interactions include prescription medications such as Coumadin, Hydrocodone, Ambien, Amlodipine, Losartan, Viagra, and Xanax. One study has shown that as little as 25 mg of CBD can inhibit CYP3A4 function.
Potential interactions with CBD can be checked using Medscape’s Online Drug Interaction Checker, by first inputting “grapefruit”, which also inhibits CYP3A4, and then inputting the medication of interest. Potential interactions will be displayed along with the associated warnings.
Because of these potential drug interactions, all certification examinations should include a review of current prescription medications and their potential interaction with CBD. Products containing CBD should also include a drug interaction warning. Patients wishing to take CBD on a daily basis need to be followed by their Primary Care Physician in order to monitor for potential drug-interaction side effects and to consider adjusting the dose of the affected prescription medications if side effects occur.
While CBD-drug interactions could be potentially life threatening depending on the dose of CBD, close supervision of patients using CBD on a daily basis may allow for dosages of the affected medications to be reduced while still having the same therapeutic benefit, thereby reducing the associated side effects that these prescription medications can have by themselves.
Most medical use of cannabis states recognize Glaucoma as a qualifying condition for their medical use of cannabis programs. There are also still a few remaining patients in the FDA’s Compassionate Investigational New Drug Program, one of whom qualified for this federal program based upon her glaucoma.
Unfortunately, very little research has been done on the effect of CBD on intraocular pressure (IOP). Even the clinical trials that were conducted for the FDA approval of Epidiolex, did not look at changes in IOP in their study subjects (personal communication). However, a recent study looking at the effect of topically applied THC and CBD in mice not only found that THC significantly lowered IOP, but that CBD also seemed to block the IOP lowering effect of THC, and caused an elevation of IOP when given alone.
What this means is that we now need to look at the possible effect of CBD on IOP in humans, especially with the number of people who are using locally available unregulated CBD products to treat a variety of medical conditions without proper medical supervision. Until such data is available, patients who are taking CBD on a daily basis should consult with their certifying physician and their PCP about this potential side effect, and consider having their IOP followed by a licensed Optometrist or Ophthalmologist while taking CBD.
Disclaimer: The information on this website is for educational purposes only, and is not intended as legal or medical advice. This website is also an exercise in freedom of speech, and is afforded all the rights and protections of our Constitution. Furthermore, we have no commercial interests in any of the products or companies mentioned on this website.
Please consult with a lawyer for professional legal advice on the Medical Use of Cannabis in Hawaii.