Canada Considers New “Cannabis Health Products” Category
Canadian citizens and industry stakeholders are being invited by Health Canada to take part in a new consultation launched by the healthcare regulator last week.
The consultation is set up to discover if there is an appetite for the creation of a new “Cannabis Health Products” product category, which would allow cannabis-containing products to be sold for therapeutic use without the need for a prescription from a doctor.
Current Canadian cannabis product law
In a document provided alongside the basic consultation information, it is explained that Health Canada previously conducted a cannabis product consultation during the creation of the Cannabis Act, which legalized cannabis use in Canada when it came into force in late 2018. In the final summary report from that consultation, the Canadian Government committed to maintaining access to medical cannabis products and devices on prescription, with the possible regulation of non-prescription cannabis health products, of CHPs, to be given further consideration at a later date. This current consultation is that such future consideration.
Under the current framework of the Cannabis Act and the Food and Drugs Act, it is currently illegal to sell a cannabis product that is marketed as having some kind of health benefit in humans or animals without the oversight of a doctor. This means that recreational cannabis products cannot be marketed and sold with any accompanying medical claims, and medical cannabis cannot be sold without a prescription.
In the adjoining consultation document, Health Canada say that they are aware of interest from some Canadians in bringing non-prescription CHPs to the country’s legal market. The healthcare regulator also noted that cannabis products, and particularly cannabidiol (CBD) products, with unauthorized health claims are already being sold through unregulated channels, where they are marketed as a treatment for minor ailments, such as muscle and joint pain and inflammation.
While the consultation exists to gather feedback from the public in order to shape any future regulations, Health Canada has said that any future market for CHPs will be required to meet certain expectations. Namely, a new market pathway should have in place strict controls that will protect the youth, displace the illegal market, restrict the promotion of cannabis use, and encourage a firmly evidence-based approach to regulation.
What might be proposed?
Legally, CHPs would be required to meet controls set out by the Cannabis Act, as they are still cannabis products at their core; but CHPs would also be assessed for quality and safety using measures from the Food and Drug Act.
The approach currently being proposed would not permit general health claims to be made about CHPs, but would allow more specific ones. These more specific claims would also need to be backed up by modern scientific evidence, not just a history of traditional use.
Cannabis would need to be listed as an active ingredient for the CHP in question, and evidence would need to sufficiently demonstrate the association of cannabis — through a specific phytocannabinoid component — with the health claim being made.
It is expected that Health Canada will be seeking expert advice with regard to what should qualify as satisfactory scientific evidence that demonstrates safety and efficacy.
While Health Canada does not want the packaging of CHPs to be appealing to youth, they have suggested that young people may be able to access CHPs through the intermediary of a responsible adult, such as a parent or guardian. The adult would be allowed to purchase CHPs on behalf of the young person, with the understanding that they would be responsible for overseeing the sensible consumption of the CHP for treating minor ailments.
Fulfilling a need for clarity
The proposal for a legal path to market for CHPs has been praised by many in the industry. The new rules proposed by Health Canada would provide significant clarity and will save people from unintentionally breaking the law, said Sherry Boodram, CEO of Toronto-based regulatory consulting firm CannDelta, to Marijuana Business Daily.
“Currently, there are a lot of conversations and misinformation among the general public in regards to cannabidiol, specifically if CBD products can be freely imported/exported, can it be sold in health food stores, in beauty stores,” she said.
Lucas McCann, the chief scientific officer at CannDelta also gave comment, saying that the proposals from Health Canada would be a welcome sight to those who feel trapped between the cracks of the adult-use and medical cannabis markets.
“What Health Canada is doing with the consultation is setting the framework for these CHPs to come into existence and to tie scientifically founded, evidence-based claims to cannabis health products,” he said.
“These are baby steps, but let’s not forget that legalization is a big ship to steer.”
The consultation is currently open for comment and will close on September 3, 2019. Canadians who are interested in one day purchasing CHPs and companies who may consider manufacturing or selling CHPs are the main focus of the consultation, though other interested parties are also being encouraged to respond.