Hashish incorporates a number of phytocannabinoid compounds, together with the well-known THC (delta-9-tetrahydrocannabinol), CBD (cannabidiol), and non-cannabinoid compounds, equivalent to terpenoids and flavonoids.
Whereas structurally much like THC, CBD is a non-intoxicating phytocannabinoid. CBD has been studied for its therapeutic therapy potential for neuropathic ache, most cancers ache, a number of sclerosis, irritation, and extra.1-5
CBD’s regulatory standing in Canada is the topic of a lot curiosity and debate, and there are variations between expectations and what in the end got here to cross.
In November 2017, Well being Canada revealed a session paper Proposed Method to the Regulation of Hashish, forecasting varied provide chains for CBD-rich merchandise.
The doc implied that CBD could be permitted inside the pure well being merchandise (NHP) regulatory framework, if candidates supplied “sturdy security and efficacy proof” for the ingredient, and the product contained lower than 10 elements per million CBD.
On the time, it was believed the licensing of CBD as an NHP would finally pave the best way for CBD in cosmetics and supplemented meals, often known as purposeful meals. This might have been a significant win for the Canadian nutraceutical and cosmeceutical industries, by opening many doorways for CBD in client merchandise.
In July 2018, the federal authorities launched the Hashish Act and Hashish Rules, because the foundations for legalization of leisure cannabis. Nevertheless, opposite to what had been proposed, the act and laws contained amendments that added cannabis and cannabis preparations to Schedule 2 of the Pure Well being Product Rules – the record of elements explicitly not permitted in NHPs.
Presence on Schedule 2 means remoted or concentrated phytocannabinoids, together with CBD, are excluded from the definition of a pure well being product, and can’t be current on this class of product. Even additional, phytocannabinoids from cannabis have been added to the Prescription Drug Record (PDL), additional excluding CBD from every other non-prescription well being product.
This restriction of CBD to cannabis merchandise limits client CBD entry to the oils, capsules, and dried flowers from federally licensed medical cannabis sellers, and provincially and territorially licensed leisure cannabis retailers till October 2019.
Well being Canada is ready to extend the forms of cannabis merchandise permitted to incorporate cannabis topicals with no well being or beauty claims, cannabis extracts, and cannabis edibles after October 2019.
Whereas market entry for these merchandise will borrow closely from the regulated frameworks of cosmetics, pure well being merchandise, and meals, their availability will proceed to be restricted to federally licensed medical cannabis sellers and provincial and territorial leisure cannabis retailers.
Legalization has opened many doorways for analysis and growth of cannabis merchandise, together with CBD. Hopefully this analysis will pave the best way for CBD’s removing from Schedule 2 of the Pure Well being Product Rules and the Prescription Drug Record. This might then permit CBD in pure well being merchandise, client merchandise equivalent to cosmetics and supplemented meals, and in veterinary well being merchandise (VHPs).
This regulatory change would allow these industries to take part in a market that’s poised to develop exponentially. U.S. annual market worth projections vary from $2 billion to $22 billion by 2025!
Maybe extra importantly, it would increase client entry to CBD, a transfer supported by the Canadian Well being Meals Affiliation (CHFA) of their Get Properly. Not Excessive initiative.
If your organization is considering using CBD in client well being merchandise, now could be the time to organize for the longer term. CCI consultants may help you perceive the present framework and adapt for altering laws.
Written By: Angela Park, Supervisor Licensing and Compliance
1. Hampson A J, Grimaldi M, Axelrod J, et al. Proc Natl Acad Sci USA. 1998 Jul 7; 95 (14): 8268-8273.
2. Olah A, Toth BI, Borbiro I, et al. The Journal of Scientific Investigation. 2014 Sep; 124(19): 3713-3724.
3. lessing E M, Steenkamp M M, Manzanares J, et al. Neurotherapeutics. 2015 Sep 4; 12: 825-836.
4. Nagarkatti P, Pandey R, Rieder S A, Hedge V, et al. Future Med Chem. 2009 Oct; 1 (7): 1333 – 1349.
5. Bergamaschi M M, Queiroz R H C, Alexandre J S, et al. Present Drug Security. 2011 Oct 10; 6(4).