Preparing for Cannabis Health Products: Implications for consumer health products and foods
By David Skinner, Senior Associate, and Sam Turgeon-Brabazon, Consultant, within GPA’s Health & Life Sciences Practice Group
As the policy framework for cannabis products continues to mature in Canada, there continues to be growing interest among Canadians about the potential therapeutic benefits of cannabis. Many Canadians are already utilizing cannabis for medicinal purposes under the supervision of a medical practitioner, but any potential therapeutic benefits of these products have not been assessed by Health Canada.
Cannabis products continue to be managed through the regulator’s longstanding ‘do no harm’ lens as no regulatory framework exists to approve cannabis products to treat specific ailments outside the prescription drugs framework. This is why the Cannabis Act does not currently permit health claims for any cannabis products; trusted, evidence-based information on therapeutic benefits have yet to be determined by the regulator. The only exception pertains to prescription drugs containing cannabinoids. Nonetheless, there is a growing demand for access to regulated cannabis products which are approved for therapeutic use.
In response, Health Canada launched a general consultation in 2019 to begin examining the potential to create a tailored pathway for consumer health products containing cannabis, also known as cannabis health products (CHPs). Following the consultation, Health Canada struck an external Science Advisory Committee on Health Products Containing Cannabis in November 2020 with a mandate to provide the Department with recommendations on appropriate evidentiary requirements that should accompany the filing of a CHP application. The vision of a potential CHP pathway is to permit the sale of cannabis products which carry a Health Canada approved health claim for the treatment of self-manageable conditions.
The Committee’s recommendations are now expected in Winter 2021 / Spring 2022, following which Health Canada will need time for assessment and to develop a response. Any subsequent regulatory pathway proposed will be drafted for stakeholder input. Once the regulatory pathway is finalized, additional regulatory and administrative steps will need to be taken before CHP applications can be received. This lengthy development process means that the regulatory pathway for CHPs will likely not be finalized until the latter half of 2022 at the earliest.
Once manufacturers are permitted to file a CHP application, there are two possible pathways to consider. First, a product that combines an existing non-prescription drug ingredient with a cannabis-based ingredient (e.g. an analgesic with a cannabinoid) would be eligible to make an application immediately because the category for non-prescription drugs falls under the Food and Drug Regulations. However, any product that combines Natural Health Product (NHP) ingredients with cannabis-based ingredients would not be granted an application review until the current definition under the NHP Regulations is amended to delete the cannabis prohibition.
The CHP framework is likely to be accompanied by a companion document that sets out ingredients and their associated claims and dose. Overtime, as CHP applications increasingly provide satisfactory evidence for distinct health claims, Health Canada may update relevant product monographs accordingly. As the evidence base matures, an increasing number of products will be eligible to obtain a Drug Identification Number (DIN) or Natural Product Number (NPN) thus broadening the accessibility of therapeutic cannabinoids.
It is noteworthy that cannabis-infused foods have not been included within the scope of CHPs at this time. In practice, this means that food products containing cannabis will not have a regulatory pathway to make any health claims following the implementation of the CHP framework. While it may seem like a good fit to include cannabis-based ingredients in the Supplemented Foods (SF) Regulations currently under development, there is no provision in the proposed regulations to include cannabis in foods and allow a health claim.
Under the Food and Drugs Act, health claims are generally placed under drug provisions of the Food and Drug Regulations unless the claims are specifically permitted under the food provisions (e.g., calcium and bone health). This raises practical challenges of inequitable treatment between the identical product being permitted to make a claim in dosage form but not in an edible form. The SF regulations are intended to close that gap but the government is being very cautious in its approach. Extending the claims permission for cannabis in food may take considerably longer.
Finally, the future distribution and sales channels for CHPs remains an outstanding question. There are several possible scenarios. One determining factor is whether CHPs will be classified as NHPs or non-prescription drugs. Non-prescription drugs are currently subjected to the conditions of sale set out in the provincial drug schedules, and these may or may not limit their distribution to pharmacies only. Any scheduled non-prescription drug ingredient combined with a cannabinoid could be limited exclusively to pharmacy sale. But importantly, NHPs are not subject to the provincial schedules and there are no corresponding restraints on place of sale for NHPs.
A second determining factor in respect to distribution and sales will be to the extent to which CHPs face duplicative regulatory burden, and remain subject to the provisions of both the Cannabis Act and the Food and Drug Act. Provisions under the former legislation could place additional controls on these health products, such as licensing, labelling, conditions of sale and promotion.
Observers will continue to track developments in this area closely. While still in the very early stages, a potential regulatory pathway to permit CHPs could increase Canadians’ access to trusted information on the therapeutic benefits of some regulated products.