All phytocannabinoids, with several exceptions, are listed on the Prescription Drug List. If you wish to manufacture and sell a health product containing CBD that makes a health claim, you require approval for the product as a prescription drug under the Food and Drug Regulations.
Under the Cannabis Act activities with phytocannabinoids (including CBD) remain illegal, unless authorized.
This licence could be:
Cannabidiol (CBD) is one of these cannabinoids. CBD is not intoxicating and may reduce some of the effects of tetrahydracannabinol (THC); however, it does have an effect on the brain.
CBD and prescription drugs
Before the Cannabis Act came into force, CBD was:
CBD is currently a controlled substance under the Single Convention. CBD products may therefore only be imported or exported under very specific conditions. Any import or export must meet all of these criteria and may only be done:
An industrial hemp licence holder may cultivate hemp to produce a number of different products. They may:
How we regulate CBD in Canada
It was not legal to produce, sell, import or export CBD unless authorized for medical or scientific purposes.
Hemp-seed oil is oil made from pressing the grain of hemp plants. It is processed like other oil seeds, such as canola. In order for hemp-seed oil to be exempt from the Cannabis Act, it can’t contain more than 10 parts per million of THC.
The first CBD-based product was just recently registered for the treatment of treatment-resistant epilepsies (27). Meanwhile, the patients are using non-registered hemp extracts and derivative products that are considered “nutritional supplements” with high CBD content and often unknown THC concentration. These products are not considered controlled substances at the production countries and are being distributed in many countries via exceptional import mechanisms.
Meta-Analysis Search Strategy
The systematic search took place in February/2017 and updated on the 13th of December 2017 using the keywords “child” and “epilepsy” or “Dravet” or “Lennox-Gastaut” or “CDKL5” combined with “Cannabis,” “cannabinoid,” “cannabidiol,” or “CBD” resulting in 199 papers. From these, 138 were duplicates and were removed. The remained 61 records were screened and 42 of these studies were excluded. Nineteen (19) papers were assessed for eligibility and 6 papers were excluded due to lack of observational clinical data (ex: preclinical studies). The qualitative assessment of 13 articles resulted in 11 valid references for analysis, with an average impact factor of 8.1 (ranging from 1.4 to 47.8) (Figure (Figure1 1 ).
Treatment of Clinical Data and Statistical Analysis
The natural source of CBD is a variety of Cannabis plants called “hemp” or “fiber-type Cannabis,” where one can find a high ratio between CBD and THC compounds, sometimes around 30:1 (CBD:THC), with negligible amounts of THC (16, 17). Fiber-type Cannabis are, by definition, Cannabis with < 0.3% THC content, which is not considered controlled substance by the United Nations Office on Drugs and Crime (18). Hemp extracts became an internet buzz (19), with several anecdotal descriptions of therapeutic effects in children with treatment-resistant epilepsies, especially Dravet syndrome, starting to appear since 2013 (11, 20, 21). Preclinical evidence support anti-convulsant properties of CBD [reviewed in Hill et al. (22) and Devinsky et al. (23)]. Furthermore, a number of observational papers suggested good tolerability and therapeutic benefits in seizure control, with patients experiencing low frequency of side effects (6–15). Few randomized control trials in specific diseases have followed (24, 25) and the putative neuronal mechanism of action is still to be established, with the more likely candidates being inhibition of endocannabinoid uptake, allosteric modulation of CB1 receptors, activation of 5-HT1A serotoninergic receptors anti-inflammatory/anti-oxidant effects [reviewed in Bih et al. (26)].