Final Regulations for New Cannabis Products Edible Cannabis, Cannabis Extracts and Cannabis Topicals June 14, 2019 1 Highlighting the key elements of the new regulations Understanding the health effects of the new products 2 Highlighting the key elements of the new regulations Amended Cannabis Regulations to permit the legal production and sale of a diversity of cannabis product types  The regulations allow for a broad variety of product forms, consistent with the Government’s objective of displacing the illegal market, subject to regulatory controls to reduce public health and public safety risks  The amendments to the Cannabis Regulations control the production and sale of three new cannabis products: i. Edible cannabis, such as baked goods and beverages ii. Cannabis extracts, such as vaping liquids, tinctures, wax, hash and cannabis oil iii. Cannabis topicals, such as creams, lotions and balms, and similar products that are meant to be applied to a person’s skin, hair or nails 3 Highlighting the key elements of the new regulations Strict THC limits to reduce the risk of overconsumption and harm in the event of accidental consumption  Maximum of 10 mg of THC per package of edible cannabis  Maximum of 10 mg of THC per unit (such as capsule) or dispensed amount of ingested cannabis extract AND maximum of 1000 mg of THC per package of cannabis extract (ingested or inhaled)  Maximum of 1000 mg of THC per package of cannabis topical 4 Highlighting the key elements of the new regulations Controls to reduce appeal to youth  Prohibited to sell any cannabis product that can reasonably be considered appealing to a young person  Cannabis must be packaged in child-resistant containers  Plain packaging to reduce appeal of products  Standardized cannabis symbol for products containing THC  Mandatory health warning messages  Prohibited to brand cannabis products with alcohol or tobacco-related terms  Prohibited to use sugar, other sweeteners, and colourants in cannabis vaping products and other cannabis extracts 5 Highlighting the key elements of the new regulations Controls to reduce the risk of contamination and food-borne illness, and support the production of quality-controlled cannabis products  Drawn heavily from Canada’s existing regulatory frameworks for food safety, vaping, and cosmetics, the amended regulations set rules for: a. proper handling and storage of ingredients b. restrictions on the use of certain ingredients (e.g., shelf-stable, must not cause injury to health) c. preparation and implementation of preventive control plans d. prohibition of cannabis production in a facility where conventional food is manufactured 6 Highlighting the key elements of the new regulations Timing of product availability June 26, 2019 Regulations published in Canada Gazette, Part II July 15, 2019 Licence holders can begin to submit requests for licence amendments October 17, 2019 Regulations come into force; licence holders can begin to submit new product notifications December 16, 2019 Earliest date new products could be available for purchase online and/or in stores 2020 onward Greater variety of legal products become available in stores and online 7 Highlighting the key elements of the new regulations Understanding the health effects of the new products 8 Understanding the health effects of the new products Health effects of consuming cannabis  Short-term effects of consuming THC:  experiencing euphoria or a high  drowsiness  anxiety  impaired ability to remember, concentrate or react quickly  Long-term effects associated with daily or near-daily use can include:  increased risk of problematic cannabis use and addiction  harm to memory and concentration  impaired ability to think and make decisions  Populations at greater risk of harms 9  teenagers and young adults  individuals who are pregnant or breastfeeding Understanding the health effects of the new products What you need to know if you choose to consume cannabis  Everyone’s response to cannabis can differ  And it can vary from one time to the next  It can take longer to feel the effects of eating or drinking cannabis and the effects can last longer than when it is smoked or vaporized  The higher the THC content in a product, the more likely one will experience adverse effects and greater levels of impairment 10 Understanding the health effects of the new products How to lower the risks  Start low, go slow  Choose a product with a low amount of THC and equal or higher level of CBD  If consuming edibles, look for products that contain 2.5 mg of THC or less, and wait to feel effects before taking more  Avoid smoking cannabis  Avoid frequent use  Avoid consuming with nicotine, alcohol, other drugs or health products  Store all cannabis products securely and out of the reach of children and pets  Don’t drive high 11 Understanding the health effects of the new products An updated consumer information sheet and health warning messages provides information on the health effects of cannabis use  Updated Consumer Information Sheet is intended to be provided to consumers whenever they purchase cannabis  Updated health warning messages are required to be displayed on the labels of cannabis products 12 Understanding the health effects of the new products Research  The Canadian Institutes of Health Research has invested $32 million over 9 years through its Integrated Cannabis Research Strategy  Budget 2018 included $10 million over 5 years to the Canadian Centre on Substance Use and Addiction and $10 million over 5 years to the Mental Health Commission of Canada to support research on cannabis and examine the impacts of legalization  The Government has a number of tools to monitor the impacts of legalization and regulation of cannabis, including surveys, health service databases and information from poison centres 13 Annex full-size images Earliest date new preduete may,r be came available far purchase 051.201? leaf Greater variety of products became available in stores and anline ZDZD onward I'l'l CANADA.CMCANNABIS Canada [:anna his use can cause adverse effects. Adverse effects can include rapid heart rate, dizziness, varying levels of anxiety, disorganized thoughts, memorv loss, nausea, or vomiting. Serious adverse effects can also include episodes lahnormal hehaviour, hallucinations, loss of touch with reality, and delu sionsl, and seizures. Disclaimr: This inlorrnaiien sh euld not he considered legal or medical advice- Consumers, palients and healthcare are encouraged to report side ellecls [adverse reactions] lrom cannabis products to the producer of the product. Side effe cis mav also he reported In Health Canada's Eenada Yigilanco Program. '3 Her MajestyI the Queen in Flightof Canada, 2019 ISBN: Fuh.: Government Gouvsmemsnt ol Canada ciu Canada WHAT YOU NEED TO KNOW IF YOU CHOOSE TO CONSUME CANNABIS Canad? CANNABIS: LOWER YOUR RISKS If you choose to consume cannabis, how much you consume and how guic kly you consume can influence whether or not you experience adverse effects. Take your time to understand howyour hooy reacts to cannaois as eueryone's response is different- Until then, start low and go slow to minimize health risks and the risks of ore rconsumotion. Start with a low amount of THC and wait to feel the effects before taking more. h- Look tor products that contain 2.5 mg Start with 1 or 2 putts of a trade or iotnt ol THC or less with 10% or loss THE Effects fell within an minutes to 2 hours i- Effects felt In seeon do to minutes Ir It can take up to :1 hours to feel the h- lt can take up to Ell] minutes to feel full effects the full effects Remember; the total amount of THE in the package of edible cannabis can be up to 10 mg. The concentration [tif- or ol THC can he found on the label. Always read the label to Always read the tonetto understo no the strength or the product. Choose products With i understand the strength of the product. Choose products with a low amount towomount of THE and on emsl or higher amount of can. of THC and an equal or higheramount of CB D. Certain cannabis extracts like hash, kief, wait, or shatter contain a high concentration of THC. To minimize your risk, particularlyr if you are a new or occasional use r, atroicl using cannaois extracts as higher amounts of THE can ca use greater levels of imoair me ht and increase your risk of ettoe rie ncing serious adverse effects. asses? ?estas? Canada CONSUMER INFORMATION CANNABIS Cannabis contains Substances that affect the brain and body. including THC and CEIEI. THC causes the intoxicating eifects of cannabis. CED is not intoxicating and may reduce some of the effects of however. it does have an effect on the brain. veryone's response to cannabis differs and can vary from one time to the next. To minimize your risk or if you are a new consumer. look for a product con taming 2.5 mg of THC or less or two THC flit? mgfg.I or less. and an equal or higher amount of CED. COMMON IMMEDIATE EFFECTS OF THC - Euphoria l"high"]; drowsiness; anxiety; impaired ability to remember. concentrate or react quickly. IMPORTANT NOTES ABOUT EATING OR DRINKING CANNABIS AND CONSUHING PRODUCTS WITH HIGH THC - It can take up to at hours to feel the full effects from eating or drinking cannabis. Consuming more within this time period can result in adverse effects that may require medical attention. - The higher the THC content of a product. the more likely you are to experience adverse effects and greater levels of impairment. - Store all cannabis Iparticularly edible cannabisl securely and out of reach of children and pets. - Ifyou or someone you know has accidently consumed cannabis or consumed too much cannabis and is not well. contact your local poison centre or seek medical attention. Ways of using cannabis 1i'ihen effects could begin How long effects could last Smokingivaporizing Seconds to minutes Up to 45 hours' SD rninutes to2 hours Upto 12hours' some effects could last as long as hours WHAT ARE SOME HARMS AND HOW TO LOWER THE RISKS - Delay using cannabis to later in life. Teenagers and young adults are at greater risk of harms because the brain continues to develop until around the age of 25. - Don't drive or operate heavy equipment after using cannabis. Cannabis can cause drowsiness and impair your ability to concentrate and make quick decisions. - Avoid frequent use. Frequent and prolonged use daily or near? daily use across months pryearsl increases the risk of dependence and may bring on or worsen disorders related to anxiety and depression. - Avoid smoking cannabis. The smoke from cannabis contains the same harmful chemicals found in tobacco smoke. - Avoid combining cannabis with alcohol an dr'or other substances. Using cannabis at the same time as alcohol andior other drugs can cause more severe Levels of impairment and adverse effects. KNOW THE RULES - It is your responsibility to know the rules and to follovir them. To find out more about the rules for cannabis. visit Ca nada.caica nnabis - Talk to your health care practitioner if you have any questions or concerns regarding cannabis use and your health. - For questions or concerns about a product. or to report adverse reactions. contact the manufacturer. ?fpu can also report concerns. complaints or adverse reactions to Health Canada. Ivl Govern ment Gouvernemert of Canada ciu Ganacia caIlada. Part 1: All of the cannabis health warning messages in this Part apply to cannabis products of all classes of cannabis listed in Schedule 4 to the Cannabis Act, with the exception of cannabis topicals. WARNING: The smoke from cannabis is harmful. Toxic and carcinogenic chemicals found in tobacco smoke such as polyaromatic hydrocarbons, aromatic amines, and N-heterocyclics are also found in cannabis smoke. WARNING: Do not use if pregnant or breastfeeding. Substances in cannabis are transferred from the mother to child and can harm your baby. WARNING: Do not drive or operate heavy equipment after using cannabis. Cannabis can cause drowsiness and impair your ability to concentrate and make quick decisions. WARNING: Frequent and prolonged use of cannabis containing THC can contribute to mental health problems over time. Daily or near-daily use increases the risk ofdependence and may bring on or worsen disorders related to anxiety and depression. WARNING: Adolescents and young adults are at greater risk of harms from cannabis. Daily or near-daily use over a prolonged period oftime can harm brain development and function. WARNING: The higher the THC content of a product. the more likely you are to experience adverse effects and greater levels of impairment. THC can cause anxiety and impair memory and concentration. WARNING: It can take up to 4 hours to feel the full effects from eating or drinking cannabis. Consuming more within this time period can result in adverse effects that may require medical attention. WARNING: The effects from eating or drinking cannabis can be long-lasting. The effects can last between 6 and 12 hours following use. Part 2: The cannabis health warning message in this Part applies only to cannabis products that are cannabis topicals. WARNING: Do not swallow or apply internally or to broken. irritated or itching skin. There may be health effects and risks associated with cannabis topicals that are not fully known or understood.