CBD in Consumer Products
Cannabis contains several phytocannabinoid compounds, including the well-known THC (delta-9-tetrahydrocannabinol), CBD (cannabidiol), and non-cannabinoid compounds, such as terpenoids and flavonoids.
While structurally similar to THC, CBD is a non-intoxicating phytocannabinoid. CBD has been studied for its therapeutic treatment potential for neuropathic pain, cancer pain, multiple sclerosis, inflammation, and more.1-5
CBD’s regulatory status in Canada is the subject of much interest and debate, and there are differences between expectations and what ultimately came to pass.
In November 2017, Health Canada published a consultation paper Proposed Approach to the Regulation of Cannabis, forecasting various supply chains for CBD-rich products.
The document implied that CBD would be permitted within the natural health products (NHP) regulatory framework, if applicants provided “robust safety and efficacy evidence” for the ingredient, and the product contained less than 10 parts per million THC.
At the time, it was believed the licensing of CBD as an NHP would eventually pave the way for CBD in cosmetics and supplemented foods, also known as functional foods. This would have been a major win for the Canadian nutraceutical and cosmeceutical industries, by opening many doors for CBD in consumer products.
In July 2018, the federal government introduced the Cannabis Act and Cannabis Regulations, as the foundations for legalization of recreational cannabis. However, contrary to what had been proposed, the act and regulations contained amendments that added cannabis and cannabis preparations to Schedule 2 of the Natural Health Product Regulations – the list of ingredients explicitly not permitted in NHPs.
Presence on Schedule 2 means isolated or concentrated phytocannabinoids, including CBD, are excluded from the definition of a natural health product, and cannot be present in this class of product. Even further, phytocannabinoids from cannabis were added to the Prescription Drug List (PDL), further excluding CBD from any other non-prescription health product.
Note that CBD is still permitted in cannabis products, as they fall under the Cannabis Act and Cannabis Regulations, but these products are not permitted to make health claims.
This restriction of CBD to cannabis products limits consumer CBD access to the oils, capsules, and dried flowers from federally licensed medical cannabis sellers, and provincially and territorially licensed recreational cannabis retailers until October 2019.
Health Canada is set to increase the types of cannabis products permitted to include cannabis topicals with no health or cosmetic claims, cannabis extracts, and cannabis edibles after October 2019.
While market access for these products will borrow heavily from the regulated frameworks of cosmetics, natural health products, and foods, their availability will continue to be limited to federally licensed medical cannabis sellers and provincial and territorial recreational cannabis retailers.
Legalization has opened many doors for research and development of cannabis products, including CBD. Hopefully this research will pave the way for CBD’s removal from Schedule 2 of the Natural Health Product Regulations and the Prescription Drug List. This would then allow CBD in natural health products, consumer products such as cosmetics and supplemented foods, and in veterinary health products (VHPs).
This regulatory change would enable these industries to participate in a market that is poised to grow exponentially. U.S. annual market value projections range from $2 billion to $22 billion by 2025!
Perhaps more importantly, it will expand consumer access to CBD, a move supported by the Canadian Health Food Association (CHFA) in their Get Well. Not High initiative.
If your company is thinking about the use of CBD in consumer health products, now is the time to prepare for the future. CCI consultants can help you understand the current framework and adapt for changing regulations.
Written By: Adrian Rodriguez, Cannabis Retail Licensing Manager
References
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 Clinical 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. Current Drug Safety. 2011 Oct 10; 6(4).
