The federal government recently 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 the current regime, products that contain cannabis and make health claims are considered prescription drugs (subject to prescription drug pre-market authorization requirements) and can only be sold with a prescription from a health-care practitioner. Cannabis that is subject to the Cannabis Act and Cannabis Regulations is not currently 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 (relief of headaches, muscle pain, etc.)
Much like NHPs, 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 precise 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. Scientific evidence would need to be provided to demonstrate that the interaction of the different ingredients would be both safe and effective.
- 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, similar to 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. CHPs would also be subject to existing prohibitions regarding promotion, packaging and labelling appealing to young persons under the Cannabis Act.
- 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).
It remains to be seen how Health Canada will determine what types of health claims will be permitted. Health Canada has indicated that it intends to gather external scientific advice regarding appropriate evidence standards for CHPs before drafting regulations for consultation. It also remains to be seen how Health Canada 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). Health Canada is accepting comments from industry, consumers and all interested parties until September 3, 2019.
For further information on how this may affect your business, please contact:
Laura Weinrib 416-863-2765
Pei Li 416-863-4265
or any other member of our Cannabis group.
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