Health Canada Considers New Regulatory Pathway for CBD Products
Health Canada is pursuing input on its Discussion Paper Towards a Pathway for Health Products Containing Cannabidiol. The paper aims to explore a new regulatory pathway for authorizing CBD products that consumers can access without a prescription. Health Canada is the primary regulatory agency implementing and managing the Cannabis Act. The goal is to align CBD regulations with those in place for non-prescription health products, reducing current regulatory burdens while protecting quality and safety.
At present, CBD products are regulated under cannabis-specific laws, and CBD and phytocannabinoids have been on Canada’s Prescription Drug List since 2018. However, due to CBD’s safety and nonpsychoactive nature, there is a proposal to reclassify a product containing CBD as a Natural Health Product (NHP), allowing for its non-prescription sale. This reclassification is currently not possible under the existing regulations.
There are several additional proposals in the Discussion Paper.
- THC would continue to be limited to 10 ppm (10 milligrams per kilogram)
- CBD products would require pre-market approval before they could be advertised and sold, with approval based on a complete safety and efficacy assessment, as required now for other NHPs
- Since CBD would be considered a novel medicinal ingredient in NHPs, Health Canada will require solid scientific evidence for market approval, i.e., phase 3 clinical trials
- CBD products must comply with all NHP regulations concerning licensing, labeling, packaging, etc.
Health Canada is also seeking opinions on which types of businesses should be allowed to sell CBD. Currently, CBD products require a prescription and are only sold through pharmacies.
The Discussion Paper also addresses veterinary drugs containing CBD. These products are also considered prescription drugs, and hemp-based animal products are only available through a veterinarian. Health Canada is asking for input on changing veterinary drugs containing CBD to non-prescription while keeping their sale limited to veterinary clinics.
“For businesses in the CBD space, understanding this consultation and its potential impact is crucial…Understanding and engaging in this consultation is key for industry stakeholders who want to influence the final regulatory framework,” explains the research organization Dicentra.
Any organization or stakeholder can submit feedback. Should the new rules be adopted, people will have easier access to CBD products, potentially leading to increased sales and a promising future for the CBD industry in Canada.
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