The unusual addition of CBD and other phytocannabinoids to the prescription drug list
By Jon-Paul Powers, Ph.D., and Victor Zhao
As food products containing phytocannabinoids such as cannabidiol (CBD) continue to be introduced into the U.S. marketplace, there is an increasing interest as to the Canadian regulatory requirements for such products. Coinciding with legalization of recreational cannabis in October 2018, Health Canada unexpectedly added phytocannabinoids to the Prescription Drug List (PDL) and also revised Schedule 2 of the Natural Health Products (NHP) Regulations to specifically exclude isolated or concentrated phytocannabinoids for use in NHPs. This effectively prohibits their inclusion in foods and non-prescription consumer products in Canada. Health Canada has stated it was necessary to add these substances to the PDL as a measure of safety. While protecting Canadians is paramount, this is an unusual rationale as there were already robust regulatory mechanisms in place which would prevent the inclusion of cannabis, and associated phytocannabinoids, in Canadian consumer goods.
Based on the number of media reports, it seems apparent that Canadians are interested in purchasing products, food or otherwise, that contain phytocannabinoids, perhaps most notably CBD, and Canadian industry would certainly like to oblige. While Health Canada may very well be correct in the position that there is simply not enough evidence to support the safety of long-term, daily use of phytocannabinoids, a robust regulatory framework was already in place to assess the safety of such products. This framework includes pre-market reviews for novel foods and health products such that Health Canada will not authorize the sale of an ingredient or product, depending on the framework, until it is convinced of its safety.
With respect to foods, based upon historical use, it is likely that Health Canada would consider the majority of the cannabis plant, apart from common parts such as hemp seed and its derivative hemp seed oil, as being a novel food. As such, the majority of the plant, including derivatives such as concentrated or isolated phytocannabinoids, would be subject to the novel food requirements set out in Division 28 of the Food and Drug Regulations. As per this section, no person shall sell or advertise for sale a novel food unless they are in possession of a notice from the Minister of Health permitting them to do so. Obtaining such a notice is dependent upon a rigorous safety assessment of the food performed by Health Canada. In addition to novel foods, both the NHP and over the counter drug licencing streams provide Health Canada with sufficient control in its regulation of these products, and all associated ingredients. Under these streams, all products must undergo a thorough pre-market assessment in support of safety, efficacy and quality, and cannot be sold until Health Canada has issued a product licence.
The existing regulatory frameworks for foods and drugs would have sufficed to prevent the addition of phytocannabinoids to foods and health products until such time they were deemed safe and authorized for use by Health Canada. This calls into question the need to add these compounds to the PDL simply out of an abundance of safety. Setting this safety rationale aside, one may wonder whether there were other considerations that perhaps played a role in Health Canada’s decision to proceed in this fashion. One thought that comes to mind is, by specifically including phytocannabinoids on the PDL, products containing these ingredients fall outside Health Canada’s importation for personal use policy. For those not familiar, this policy permits Canadians to purchase and import, via mail or courier, a 90 day supply of a non-prescription health product. This policy has long been an irritant to Canadian manufacturers and distributors of such products as they view it as a means for foreign products to enter Canada without being subject to the costs associated with complying with Canadian regulatory requirements.
Put simply, if phytocannabinoids are ultimately permitted for inclusion in foods and health products in other jurisdictions, they would not be eligible for Canadians to purchase online and import for personal use so long as they remain on the PDL. Whether preventing personal importation of products containing phytocannabinoids was a consideration in modifying the PDL, or this is simply a consequence of a restrictive policy that happened to close the personal importation loophole, remains to be seen.