Research in CBD and Market Opportunities
By Anuja Siwakoti, Quality & Regulatory Consultant
Since I joined the field of cannabis research in 2011, I frequently hear cannabidiol (CBD) being described as “a molecule that works like THC but doesn’t get you high”. This statement largely underscores the potential therapeutic effect of CBD. A repressive policy on the study of cannabis and cannabinoids have made it difficult to study the roles of the cannabinoid compounds including CBD, but this could change with the changing regulatory landscape in cannabis and cannabinoid compounds.
Today, we wait for a historic moment for CBD. The FDA could decide as early as June 27 whether Epidiolex- a CBD oral solution, could be prescribed to patients with rare epilepsy conditions. Epidiolex has already received a unanimous recommendation from an FDA advisory committee. Currently, in Canada, there are 5 active clinical trials on CBD and its effect on various medical conditions such as drug addiction, Tourette’s syndrome, Dravet syndrome, refractory epileptic encephalopathy, advanced cancer and pain.
Before delving into much details, it is crucial to understand how CBD works at an intracellular level. CBD, unlike THC, has a low affinity for cannabinoid receptors and binds to other receptors such as the vanilloid and serotonin receptors1,2. CBD acts as a homeostatic modulator and anti-inflammatory agent by activating the TRPV-1 receptor1. CBD agonist has been shown to stimulate the 5-HT1a serotonin receptors suggesting it has properties similar to anti-depressants2. CBD has also been shown to be a negative allosteric modulator (interferes with the activity of THC on CB1 receptor) with the possibility of limiting cannabis side effects such as pyschoactivity, anxiety and rapid heart beat3.
Currently cannabis is a controlled substance under the CDSA. Possession, trafficking, import, export and production of all varieties of cannabis regardless of the THC content are prohibited unless authorized according to regulations or an exemption. CBD is a Schedule 2 drug in Canada. That does not mean that CBD is something that is unavailable for product development, though. There are various ways in which a manufacturer can get a handle of CBD in the present market, such as applying for a Dealer’s Licence and/or applying for a Licensed Producer status.
But with the onset of Canada’s new cannabis regulatory framework, how will these various licensing categories that exist today integrate into the new framework? As per Health Canada’s consultation paper entitled Proposed Approach to the Regulation of Cannabis published in November, 2017, it is forecasted there will be various supply chains for CBD-rich plants/products such as cultivation licence (standard, micro-cultivation, industry and nursery licence), processor licence (standard and micro-processing), analytical testing, research and import/export authorization. The consultation paper offers two exciting insights as it relates to CBD:
1) There is an indication that Standard Cultivators of hemp will be permitted to harvest plant material such as CBD-rich flowers and leaves for further processing. This represents a massive shift from current regulations which obligate Industrial Hemp Licensees (IHLs) to destroy all plant material other than seeds, grain and mature stalks and
2) There is also initial indication that a new pathway could emerge for Natural Health Products (NHPs), cosmetics and veterinary NHPs for products derived from cannabis flowers containing cannabinoids such as CBD with a limit of 10 ppm for THC.
According to The Hemp Business Journal, the CBD-based product market is expected to grow to $2.1 Billion by 2020. There is a myriad of opportunities for CBD-based products ranging from pharmaceuticals, cosmetics, edibles market, NHP products, veterinary products and many more.
CCI’s team of experts understands what regulations apply to your business now, and for transition into the new framework. Whether you are interested in applying for a cultivation licence, Dealer’s licence, industrial hemp licence, clinical trial applications (CTA), NHP Product licence or NHP site licence to work on cannabinoid-based products, we can help you get started.
- Costa B., Giagnoni G. et al., Vanilloid TRPV1 receptor mediates the antihyperalgesic effect of the nonpsychoactive cannabinoid, cannabidiol, in a rat model of acute inflammation, British Journal of Pharmacology, 2004, 143(2):247-250.
- Russo EB, Burnett A, Hall B, Parker KK. Agonistic properties of cannabidiol at 5-HT1a receptors. Neurochem Res. 2005; 30:1037–1043.
- Laprairie RB, Bagher AM, Kelly ME, et al. Cannabidiol is a negative allosteric modulator of the type 1 cannabinoid receptor. Br J Pharmacol. 2015;172(20):4790–4805.