Last week, the World Health Organization released their opinion, or “pre-review” on Cannabidiol (CBD) and the outlook is positive. The organization reported that CBD has medical benefit and no potential for abuse. [Full PDF Report]
This goes directly against the Drug Enforcement Agency’s scheduling, which considers marihuana derived-Cannabidiol under marijuana on the controlled Substances Act.
Cannabidiol (CBD) is a major cannabinoid found in cannabis. It is non-intoxicating and has more recently been the center of medical research for diseases like epilepsy. It is naturally occurring in daisies, sunflowers, and cannabis (marijuana and hemp).
CBD was first isolated and synthesized from the cannabis plant in 1965 but the interaction of CBD with the human brain was unknown until the discovery of the human body’s endocannabinoid system in the early 1990s.
Since then, scientists, pharmaceutical firms and government officials have been analyzing these interactions, studying the effects and comparing CBD to cannabis’ other major cannabinoid, delta-9 tetrahyrdocannabinol (THC).
The World Health Organization (WHO) is responsible for directing international health within the United Nations and leading partners in global health response. WHO was created in 1946 shortly after the establishment of the United Nations.
The document released by WHO pertaining to CBD was a pre-reviewed documentation on cannabidiol, “prepared and evaluated” at the recommendation of the WHO Expert Committee on Drug Dependence. This is the first time CBD has been considered “critically reviewed.”
This step is a larger part of the process for approving the use of CBD in pharmaceuticals and exempting CBD from marijuana on the Controlled Substances Act. Exempting CBD would officially force the Drug Enforcement Agency to limit their control of the non-intoxicating form of Cannabidiol.
Earlier in 2017, the US Food and Drug Administration (FDA) requested comments from the general public for information “concerning abuse potential, trafficking, or impact of scheduling changes” for seventeen (17) drugs. CBD was one of these 17 drugs. The FDA used these comments to prepare a response from the US to WHO in regards to international restrictions. Comments from the FDA and other United Nations countries helped form the opinion of WHO in regards to CBD.
The next step in the process will be a report to the United Nations who will form an official opinion on the international restrictions of CBD. This opinion should directly impact drug scheduling of CBD on the DEA’s Controlled Substances Act.
WHO’s report provided evidence for various questions in the industry and provided both human and animal-based research for the impacts of CBD on the human body. The following are major areas of interest:
1. “[CBD] failed to produce significant effects in a human study of abuse potential…”
2. Adverse effects of CBD have occurred in some observed clinical trials when interacting with epilepsy drugs.
3. WHO recognizes “pre-clinical evidence or limited clinical evidence” of a range of conditions consistent with CBDs, “neuroprotective, antiepileptic, hypoxia-ischemia, anxiolytic, antipsychotic, analgesic, anti-inflammatory, anti-asthmatic, and antitumor properties.”
WHO also provides an “overview of disease for which CBD may have therapeutic benefits.” This was taken from published research from Pisanti et al (2017). The list of diseases includes:
(Wow! That’s an exhaustive list of major health issues for which researchers have noted CBD to have therapeutic benefit…BUT THAT’S NOT ALL!)
WHO also provides literature regarding the “therapeutic properties on opioid, cocaine, and psychostimulant addiction, and some preliminary data suggest that it may be beneficial in cannabis and tobacco addiction in humans.” However, considerable more research is needed to evaluate the potential ability of treating addiction with CBD.
1. In Petri-dish studies, CBD converted to THC in the human gut, but after trials in human clinical studies, where the patient ingested 700mg CBD/day (that’s A LOT of CBD!), zero THC was detected in the gut (this says nothing about drug testing though)
2. CBD is metabolized in the liver and similar to THC accumulates in the adipose tissues (fat cells).
3. “Findings suggest that oral CBD does not reduce the reinforcing, physiological, or positive subjective effects of smoked cannabis.”
“In general, CBD has been found to have relatively low toxicity, although not all potential effects have been explored…”
1. “It has no effect on a wide range of physiological and biochemical parameters or significant effects on animal behaviour unless extremely high doses are administered (eg, in excess of 150 mg/kg iv as an acute dose or in excess of 30 mg/kg orally daily for 90 days in monkeys)”
2. “Effects on the immune system are unclear; there is evidence of immune suppression at higher concentrations, but immune stimulation may occur at lower concentrations.”
3. “Evidence on potential hormonal changes is mixed, with some evidence of possible effects and other studies suggesting no effect, depending on the method used and the particular hormone”
4. “It has no effect on embryonic development (limited research) “
5. “CBD affects growth of tumoral cell lines, but has no effect in most nontumour cells. However, a pro-apoptotic effect has been observed in lymphocytes.”
6. “CBD has no effect on heart rate or blood pressure under normal conditions, but in animal models of stress it reduces heart rate and blood pressure.”
1. WHO describes the term Cannabidiol as an “International Nonproprietary Name.”
What does this mean? The World Health Organization uses this designation to identify a pharmaceutical substance or an active pharmaceutical ingredient. The name is considered to be public property or a generic name.
Don’t get too excited, I’m no lawyer, but the cannabis industry will still likely have issues using the term Cannabidiol in the future, unless the product they are selling is considered a pharmaceutical (**or we win an enormous and costly legal battle**)
2. WHO recognizes two trade names for Cannabidiol as Epidiolex and Arvisol, two pharmaceuticals that have completed or are in medical trials.
Epidiolex is an epilepsy pharmaceutical manufactured by GW Pharmaceuticals that is currently seeking FDA approval. Third-phase medical trials are complete and positive.
Arvisol is a pure CBD tablet intended to treat neurological diseases like schizophrenia and epilepsy. It is manufactured by Echo Pharmaceuticals B.V. in The Netherlands. It is still in medical trials.
3. Recreational cultivars contain a quantity of THC that exceeds the quantity of CBD in the dried flowers ingested orally or via smoking.
There is an interesting argument for defining hemp and marijuana by the ratio CBD : THC as opposed to the current arbitrary number of less than 0.3% THC. This gives a slight level of potential support for this case.
4. Hemp cultivars have substantially less THC and high CBD levels.
Yes, this we knew. But this is chemically the case as well. Traditionally, hemp does contain lower concentrations of THC and higher concentrations of CBD. Again, light support for the above argument.
5. Unsanctioned production of cannabis with high CBD occurs for “medical treatment rather than recreational use.”
A few points on this one…
a) For years the DEA has quietly discussed CBD and its use in medical treatment. In 2011, I interviewed Tommy LaNier, the Director of the National Marijuana Initiative, for a public policy paper for my Master’s Degree. He stated that if we could get CBD without THC, it would be legal, and there would be no problem with it.
Now there solidified proof of its medical benefit with the medical trials of Epidiolex and “limited clinical evidence” for other areas AND we know from 20 years of research of hemp foods that less than 0.3% THC isn’t a cause for concern, so let’s agree to consider 0.3% THC ,“zero THC” and call it a day.
b) Peculiar that the WHO still considers high CBD cannabis (aka hemp) production “unsanctioned,” with no reference to legal hemp production in United Nations states (Australia, France, Britain, Spain, Germany, Italy, Hungary, Romania, Russia, China, Uruguay, US…)
c) WHO does not recognize any approved marketed pure CBD products, but recognizes two in development (Epidiolex and Arvisol). This isn’t surprising given that WHO believes high CBD cannabis (hemp) is “unsanctioned production.” It also seems more geared towards pharmaceuticals as opposed to nutritional or therapeutic supplements, but again, I’m not a lawyer.
Sometime in the first half of 2018, the United Nations will convene to review the pre-review and then make an official statement regarding international restrictions of CBD. This will be an extremely important statement for the cannabis industry and pharmaceutical companies seeking FDA approval.
Agreement by the United Nations to de-schedule or re-schedule CBD within international controls will lend evidence and support for the DEA to remove barriers to CBD, excluding pure forms of CBD from the Controlled Substance Act.
This, of course, would likely do nothing for full spectrum CBD which commonly contains trace quantities of THC and other minor cannabinoids, of which very little research is done and much more is needed over the next twenty years.
Overall, this WHO report is a pretty big win for the CBD world, but there’s always lots more work to be done in this industry.