Health officials in Canada have launched a public consultation seeking feedback on a regulatory framework that could open up the market for over-the-counter CBD products.
Currently regulated like marijuana under the Cannabis Act of 2018, CBD is limited to sales through licensed cannabis dispensaries under strict rules. The proposed framework would change all that by making CBD products available through grocery stores, pharmacies, and health food retailers.
While the regulated market has already reached nearly a half-billion U.S. dollars, if CBD were reclassified as a natural health product or dietary supplement, it could drastically expand the market. Under the current rules, forecasts show only modest growth for CBD.
Lowering costs
A reclassification would also streamline distribution, lowering costs for producers and retailers. With fewer regulatory hurdles, prices could drop, and more companies could enter the market, leading to innovation and increased competition, stakeholders have suggested.
Health Canada, the government health agency, opened the consultation March 7; it runs through June 5. The consultation invites input from industry stakeholders, health professionals, researchers, Indigenous partners, consumer organizations, and the general public.
The suggested pathway would permit CBD to be included as a medicinal ingredient in natural health products (NHPs), with a strict THC limit of 10 parts per million (ppm). Products would undergo comprehensive safety and efficacy assessments, aligning with existing NHP approval processes, according to the proposed changes. Activities such as manufacturing, packaging, labeling, and importing CBD-containing products would require specific licensing, and import/export regulations under the Cannabis Act would still apply.
Key questions
In the consultation, stakeholders are asked if drug licenses and enhanced security controls are necessary for CBD and whether additional raw material good manufacturing practices (GMP) standards should apply to CBD suppliers.
There is also a discussion around the need for a certificate of analysis to support product quality, and whether the products should carry warning labels due to potential interactions with prescription drugs. Feedback is also sought on clinical trials, sales locations, and packaging considerations to optimize consumer safety and promote informed usage.
Pet products included
Health Canada is also considering regulating CBD health products for animals as non-prescription veterinary drugs under the Food and Drug Regulations.
Stakeholders are encouraged to share views on whether a streamlined regulatory pathway is appropriate for pet products. Specific questions include the level of scientific evidence required for manufacturing processes, and the need for certificates of authorization to ensure product quality. There are also considerations on the sale and promotion of CBD pet products, particularly in veterinary clinics and pet stores, along with post-market safety monitoring.