OMA Submission on Health Canada s Proposed Regulations for Additional Cannabis Products February 2019
OMA Submission on Health Canada s Proposed Regulations for Additional Cannabis Products The Ontario Medical Association (OMA) appreciates the opportunity to comment on the proposed regulations for additional cannabis products, namely edible cannabis (including beverages), cannabis extracts and cannabis topicals. This submission intends to propose recommendations to the key issues and questions identified by the federal government. The OMA s recommendations on the proposed regulations are based on public health and harm reduction approaches. Recommendations and key learnings from other stakeholders, including other jurisdictions and the Canadian Medical Association were considered when this submission was written. As an overarching principle, the OMA would like to reiterate that despite its popularity, recreational cannabis is associated with several negative health risks, especially for those who use it frequently or begin to use it at an early age. These health impacts include addictive consequences, a range of respiratory and circulatory diseases and disorders, cognitive effects as well as harmful effects on the mental health of some individuals. The health risks caused by recreational cannabis use can best be avoided by abstaining from cannabis use. The OMA supports much of the proposed regulations and the intent of the regulations to establish protection around the legalization of additional cannabis products. The federal government, for the most part, has introduced appropriate safeguards given the evidence that is currently available regarding recreational cannabis. That said, the OMA feels it is important to note that there is a need for more research on recreational cannabis and at this time there is a gap in knowledge. As such, greater research is needed. The content of this submission will focus on specific sections of the proposed regulations (and will be divided as such), namely: THC limits, Product Ingredients and Flavouring, Packaging and Labelling, and Additional Considerations. Page 1 of 7 November 2018
THC Limits Legalizing additional recreational cannabis products gives the federal government an opportunity to regulate the substance as well as mitigate some of the associated health risks. A key element to regulating recreational cannabis is to set a limit on the amount of THC allowed in each product. Canada has a unique opportunity in regulating recreational sales as it can implement progressive regulations based on lessons learned from other jurisdictions that have legalized cannabis. The proposed regulations from the federal government do outline strict THC limits for each new class of cannabis products. While, the OMA supports the proposed implementation of restrictions on THC limits, stricter limits would be more in line with a harm reduction approach. If we look to other jurisdictions for lessons learned, we would predict that cannabis-infused edibles will have a strong hold in the cannabis market share. Since legalizing cannabis in both Colorado and Washington states, they have seen continued growth in sales of cannabis edibles (1). In fact, sales of cannabis-infused edibles had increased by 134% in the first quarter of 2015 compared to the same period in 2014 (1). Cannabis-infused edibles have a broad appeal for several reasons. First, novice cannabis users often find cannabis-infused edibles such as brownies and cookies attractive (1). Secondly, restrictions on where cannabis can be smoked in both public and private spaces may increase interest in the edible market (1). This is noteworthy as it is not yet clear if the same restrictions on where cannabis can be smoked will apply to edible cannabis. Lack of regulation around edible products in Colorado s initial phase of legalization led to several unintended public health consequences, including accidental overconsumption and overdoses, increased emergency room visits and calls to poison control lines (1). A key lesson learned from other jurisdictions to best avoid the unintended consequences is to implement strict THC limits and portion sizes for cannabis-infused products (1). Should the proposed regulations be passed, no more than 10 mg of THC will be permissible per package of edible cannabis product and 1000 mg of THC per package of cannabis extracts. No guidance on serving size is outlined in the proposed regulations other than a limit of 10 mg per unit of cannabis extracts intended for ingestion. While the proposed THC limits per serving size are within the limits of other jurisdictions, they are higher than what many cannabis advocates would suggest for first time users when applying a harm reduction approach. This is critical given that no guidance for serving or dosage sizes is outlined in the proposed regulations. Should the THC limit be set at 10mg for edible cannabis products and 1000 mg per package of cannabis extracts, guidance should be outlined for dosage and serving size. The recommended serving size for both edible cannabis products and cannabis extracts should be 5 mg of THC, which is in line with a harm reduction approach. Recommendation 1: The recommended serving size for edible products (solid or beverage) should be 5 mg of THC/serving. Page 2 of 7
Product Ingredients and Flavouring Parameters around product ingredients and product flavours are also key elements that must be regulated to mitigate some of the negative health impacts of recreational cannabis use. The federal government has introduced appropriate safeguards to restrict caffeine, nicotine, alcohol, added vitamins and minerals, sugar, colours and sweeteners to the new classes of cannabis products. The OMA supports the federal government s decision to implement restrictions on certain flavours, such as dessert or confectionary flavours, that are often appealing to youth. The flavouring restrictions are outlined to be consistent with rules that apply to vaping products under the Tobacco and Vaping Products Act. That said, there is evidence that banning all flavoured tobacco, including menthol, has shown to be an effective public health measure to reduce uptake in regular use. The federal government should apply lessons learned from banning flavoured tobacco to underpin the flavouring ban for cannabis products. Recommendation 2: All flavouring should be restricted for cannabis extract (ingested or inhaled) products. Labelling and Packaging In addition to regulations on THC limits, product ingredients and flavours, labelling and packaging are key components to ensuring the negative health impacts of recreational cannabis use are mitigated. The federal government has introduced proposed regulations for the new classes of cannabis to have specific label requirements on top of the already required primary plain packaging and labelling requirements. The OMA is in support of the additional requirements set out in the proposed regulations. If passed, these regulations will necessitate edible cannabis products to have similar labelling requirements to food, including a cannabis-specific Nutrition Facts Table, will prohibit the new classes of cannabis to associate with alcoholic beverages and from making health and cosmetic benefit claims and/or claims of being part of a specific diet. That said, there is no guidance in the proposed regulations to ensure serving size and/or dosage is included in the label. As noted in the THC Limits section of this submission, suggested serving and dosage sizes are recommended and should be clearly marked on product labels. Further, the way in which cannabis is consumed will impact when the user feels the effect. This is especially important when considering individuals consuming cannabis-infused edible products where it can take several hours for THC to take full effect. In some cases, this has led to users consuming more cannabis when the desired effect has not been felt and resulted in stacked dosing of cannabis and consequently accidental overconsumption or overdoses. Warning labels on products where a delayed effect is likely should outline that a postponed result is expected to best avoid users from overconsuming THC or overdoses. Moreover, with additional classes of cannabis legalized, there is room for consumer confusion on the quantity of the product in Page 3 of 7 November 2018
question. This could also lead to overconsumption and overdoses for individuals using new classes of cannabis products. To avoid or limit such incidents, labels should include an equivalency factor, that outlines the quantity of the given cannabis product that is equivalent to one gram of dried cannabis. Finally, the proposed regulations include allowances for small product packages to have the ability to use peel-back or fold-out labels to display certain required information. The OMA believes that public health warnings on recreational cannabis products should be a core component to public education. Front of the label packaging should be standard regardless of the product package size. Recreational cannabis products labelling regulations should be in line with federal tobacco products labelling regulations that state that 75% of the front and back of cigarette and little cigar packages be covered in health warning messages. Recommendation 3: Serving size (for edible products) and recommended dosage (for cannabis extract and topical products) should be included on the product label. Recommendation 4: Edible product warning labels should outline that there may be a delayed effect or that the user may not feel the full effect of consuming cannabis immediately. Recommendation 5: A gram equivalency factor is considered as an additional requirement for labels. Recommendation 6: Recreational cannabis product labelling regulations should be in line with federal tobacco products labelling regulations that state that 75% of the front and back of cigarette and little cigar packages be covered in health warning messages. Additional Considerations Minimum age for possessing, using and purchasing recreational cannabis The federal government has outlined that one of the key reasons for legalizing cannabis is to protect youth and to establish safeguards so that illegal cannabis is not accessible to underage individuals. In order to achieve this goal, a minimum age to purchase, possess, and use recreational cannabis has been set at 18 with the ability for provinces and territories to adjust the minimum age upward. Establishing a minimum age has been an important control measure for both alcohol and tobacco in Canada. Regarding a minimum age for recreational cannabis, the government must focus first and foremost on health risks. There is strong evidence showing recreational cannabis use impacts brain development. It is known that the brain continues to develop through early adulthood, until the age of 25 (3,4). Adopting a minimum age of under 25 for recreational cannabis use ignores scientific evidence around the negative health impacts on brain development. Therefore, the OMA advocates that the federal government reconsider the minimum age for purchase, possession and use of cannabis and adjust it to 25. Page 4 of 7
Recommendation 7: The minimum age for purchasing, possessing and using recreational cannabis should be reconsidered and set at 25, given the negative impact that recreational cannabis can have on health, particularly on brain development. Regulating recreational cannabis sales There must be strict regulations implemented on the marketing of recreational cannabis, using the current regulations for marketing tobacco as the minimum. Regulatory frameworks that address marketing for tobacco, vaping products and recreational cannabis should be updated in lockstep. Recommendation 8: There must be strict regulations implemented on the marketing of recreational cannabis, using current regulations for marketing tobacco as the minimum. Planning public education and research It is critical that the federal government integrate the additional cannabis products into existing public education campaigns and or develop new campaigns for edible cannabis and cannabis extracts and topicals. Regardless of whether the government expands its current campaign or develops a new one, any public education campaign should use a public health approach that focuses on prevention and increasing awareness of the risk factors associated with recreational cannabis use. General education and awareness campaigns should be geared toward the general public. More focused public education should be developed to target youth as well as specific populations that are more at risk for cannabis use and its adverse effects (5). Current public education materials should be updated, and revised campaigns and materials should be deployed before the new classes of cannabis become legal. Successful campaigns used in the past have increased awareness of the health impacts of tobacco and alcohol and have led to greater public knowledge around the issues as well as a decrease in the number of users. Principles from these campaigns could serve as a foundation to underpin current and future work around public awareness of the harmful risks of recreational cannabis use, no matter the consumption method. Physicians play a critical role in planning and executing education on harmful health impacts that cannabis can have. Patients turn to physicians as a trusted voice on a wide array of health issues, including the impacts of cannabis in all forms of consumption. However, to date, there have been insufficient resources allocated to properly research cannabis use at a national level. This lack of evidence-based information poses a public health risk and leaves physicians ill-equipped to inform and best support patients. Recommendation 9: Public education campaigns should be developed or updated to integrate additional cannabis products. Public education campaigns should focus on prevention and increasing awareness of the risk factors associated with recreational cannabis use and should be deployed before additional cannabis products become legal. Recommendation 10: The federal government should invest in necessary research to inform physicians and health care providers about the health impacts of recreational cannabis use. Page 5 of 7 November 2018
Summary of Recommendations 1. The recommended serving size for edible products (solid or beverage) should be 5 mg of THC/serving. 2. All flavouring should be restricted for cannabis extract (ingested or inhaled) products. 3. Serving size (for edible products) and recommended dosage (for cannabis extract and topical products) should be included on the product label. 4. Edible product warning labels should outline that there may be a delayed effect or that the user may not feel the full effect of consuming cannabis immediately. 5. A gram equivalency factor is considered as an additional requirement for labels. 6. Recreational cannabis product labelling regulations should be in line with federal tobacco products labelling regulations that state that 75% of the front and back of cigarette and little cigar packages be covered in health warning messages. 7. The minimum age for purchasing, possessing and using recreational cannabis should be reconsidered and set at 25, given the negative impact that recreational cannabis can have on health, particularly on brain development. 8. There must be strict regulations implemented on the marketing of recreational cannabis, using current regulations for marketing tobacco as the minimum. 9. Public education campaigns should be developed or updated to integrate additional cannabis products. Public education campaigns should focus on prevention and increasing awareness of the risk factors associated with recreational cannabis use and should be deployed before additional cannabis products become legal. 10. The federal government should invest in necessary research to inform physicians and health care providers about the health impacts of recreational cannabis use. Page 6 of 7
References 1. A framework for the legalization and regulation of cannabis in Canada: the final report of the Task Force on Cannabis Legalization and Regulation Government of Canada; Dec, 2016. Available from: https://www.canada.ca/en/health-canada/services/drugsmedication/cannabis/laws-regulations/task-force-cannabis-legalizationregulation/framework-legalization-regulation-cannabis-in-canada.html#a2.4 2. Banning flavoured tobacco products - Canadian Cancer Society [Internet]. www.cancer.ca. [cited 2019Jan28]. Available from: http://www.cancer.ca/en/get-involved/take-action/whatwe-are-doing/tobacco-control/banning-flavoured-tobacco-products-sk/?region=sk 3. Lebel C, Beaulieu C. Longitudinal Development of Human Brain Wiring Continues from Childhood into Adulthood [Internet]. Journal of Neuroscience. Society for Neuroscience; 2011 [cited 2019Feb4]. Available from: http://www.jneurosci.org/content/31/30/10937 4. Caballero A, KY Seng. Association of cannabis use during adolescence, prefrontal CB1 receptor signaling, and schizophrenia. 2012. Frontiers in Pharmacology. 3:101 5. Cannabis Policy Framework. (2014). [ebook] Toronto: Centre for Addiction and Mental Health. [cited 2019Feb4]. Available from: https://camh.ca/en/hospital/about_camh/influencing_public_policy/documents/camhcann abispolicyframeowrk.pdf Page 7 of 7 November 2018