In June 2019, the federal government launched a consultation to seek feedback on the introduction of a new category of health products with cannabis, referred to as cannabis health products (CHPs). If implemented, this regime would have the potential to create a new market for cannabis products in Canada, especially given the recent interest in using cannabidiol (CBD)-based products for minor ailments.
Under Canada’s current laws, products that contain cannabis and make health claims are considered prescription drugs, which means they are subject to prescription drug licensing and can only be sold with a prescription from a health-care practitioner. Cannabis that is subject to the Cannabis Act and Cannabis Regulations, including CBD, is not permitted in over-the-counter drugs or natural health products (NHPs).
The introduction of CHPs would permit the sale of certain cannabis-based health products with health claims to be sold without a prescription. Health claims will likely be limited to minor ailments (i.e., relief of headaches, muscle pain, etc.).
Much like NHPs (such as vitamins and supplements), the proposed CHPs would be governed by the Food and Drug Act (FDA). But CHPs would also remain subject to requirements under the Cannabis Act. While the details have not yet been determined, Health Canada did provide some key parameters of a proposed regulatory framework, including:
- Health Claims: Specific health claims would need to be supported by scientific evidence. General health claims (such as claims related to general health maintenance, support and promotion) would not be permitted.
- Ingredients: CHPs would still be subject to pre-market review and the inclusion of any cannabis-based ingredients would need to be supported by scientific evidence for inclusion.
- Retail: Similar to cannabis, CHPs could be sold by a provincial, territorial or federally licensed retailer or seller. Federally licensed sellers would also be able to sell CHPs online or by phone, like the way they currently sell cannabis for medical purposes to registered clients. The federal government has also said that individual provinces and territories will have the flexibility to allow for CHPs to be sold at pharmacies, veterinary clinics, pet stores or other livestock medicine outlets, provided such locations meet the other requirements of the Cannabis Act.
- Protecting Young Persons: To restrict access to young persons and mitigate against their misuse, Health Canada is proposing to introduce the oversight of a “responsible adult intermediary” (such as a parent or guardian) for young persons to access CHPs. The intermediary could purchase CHPs from an authorized retailer and distribute CHPs to young persons for whom they are responsible.
- Packaging and Labelling: All pre-market review of labelling under the FDA would apply to CHPs, in addition to labelling requirements from the Cannabis Act (such as a standardized cannabis symbol and health warning messages, where appropriate).
While there has been a lot of interest in this new category of products, some have expressed disappointment with the substance of Health Canada’s proposal. In particular, the Canadian Health Food Association has been very vocal about its desire for a separate category of hemp-derived CBD-only health products that would be exempt from the requirements of the Cannabis Act. The Canadian Health Food Association would prefer to have such hemp-derived CBD health products be licensed and sold as NHPs and therefore available at many non-cannabis retail stores.
It remains to be seen whether Health Canada will accept the critiques of its proposal. It also remains to be seen how Health Canada will determine what types of health claims will be permitted and how it will review and pre-approve CHPs (and whether, for instance, certain CHPs may be authorized through the use of product monographs, similar to the existing NHP regime).
Laura Weinrib is a Partner at Blake, Cassels & Graydon LLP (Blakes). Her practice focuses on pharmaceutical, medical device, cannabis, natural health product, food and consumer product law, and the marketing and advertising of these products.
Pei Li is also a Partner at Blakes. Her practice focuses on food, health, cannabis, cosmetic and consumer products, and the labelling, marketing and advertising of these and other regulated products. She also provides advice in relation to consumer protection issues, access-to-information law and health-care compliance matters.