cannabis edibles: regulatory updates, risk assessment and ... seminar cannabis edibles dec 18...
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Cannabis Edibles: Regulatory Updates, Risk Assessment and
Public Health Messaging Keith Warriner
Department of Food Science Center for Public Health and Zoonosis
Marijuana is an Orchestra of Compounds
Tetrahydrocannabinol (THC) Psychoactive Pain relief Sleep inducing Increase appetite
Cannabidiol (CBD, CBD, CBN, CBC) Analgesic Anti-inflammatory Anti-anxiety
Terpenes (100+ types) Flavor Odor Antimicrobial Preservative
Extraction
• Dry Sieve: Extraction of trichomes • Ice water: Break off trichomes
Hash oil • Carbon dioxide (critical carbon dioxide) • Solvent extraction
• Ispropyl alcohol:hexane • Butane:Propane
Grow at home
• 4 plants per residency (ban in Manitoba and Quebec)
• Indoor or outdoor • Challenges
• Policing • Odor • Pesticide management • Safety hazards
• Mould • Pesticides • Solvents
Extracts
Why extract? • Concentrate THC
• Use of cuttings and shake
• Ease of use – edibles, topicals
Domestic incidents 2012-2017 • 37 Ontario • 57 British Columbia • 29 Colorado • 101 California
Risk management in domestic production and processing • Allow purpose built equipment • Encourage lower-risk equipment in cultivation- LEDs • Extraction
• Limit raw materials – butane, acetone, toluene • Educate on alternatives – ice water extraction, carbon dioxide • Provide central facility of processing
Forms of Marijuana • Shake (<18% THC) • Marijuana dried buds (<28%
THC)
• Hash oil (up to 60% THC)
• Shatter (80% THC)- Popular
• Hashish (Pure resin; 90% THC)
https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/canadian-cannabis-survey-2019-summary.html
Market is moving to oversupply • Legal production at
beginning was restricted
• Legal supply increasing
• Supply shortages resolved by 2020
• Illegal market to be
maintained
• Demand has flat-lined (4.4% population)
• Over-valued
• High investor expectations
• Limited outlets
• Shortages
• Overpriced
• Quality issues
Supply management issues – investments up in smoke
THC and CBD require decarboxylating (activating) before consuming
THC: Psychoactive CBN: Sedative • Over-heating • Oxidation (exposure to air) • UV (sunlight)
Decarb
• Decarboxylation of marijuana
• Activation of THC and CBD
• 100 - 200°C for 40-60 mins • Decarb units: Maximize decarboxylation
• Ingredient in heat sensitive foods • Activation prior to addition into baked product
• Decarb decreases half-life of THC and CBD
Not all Marijuana is Decarboxylated
Raw marijuana
• Low active THC
• High in antioxidants
• Enhanced pain relief
Alice B Toklas : Inventor of the Fudge Brownie
By design or accident
• Decarboxylation of THC • High fat
• Increase solubility • Increased potency of THC
• High sugar • Faster acting
• Shelf-stability
Regulations: Canada Gazette Part II June 2019
• Edible Cannabis • Cannabis Extracts • Cannabis Topicals
• 6800 responses to public comments • 350 written submissions (not many taken on board)
Foundation
Themes • Minimizing harm to users • Establishing a safe and
responsible supply chain • Enforcing public safety and
protection • Medical Access • Implementation
Purpose • Protect health of young • Reduce illegal activities • Deter use and sale • Reduce burden on justice system • Quality control • Health risks associated with use
Regulations restricting edible types
• CBD omitted from edible regs • Low dose THC • Individual serving/pack (<10 mg THC) • Plain packaging – marketing • No nutritional supplements • Treated as a food product
• Nutritional label • Ingredient list • Allergens
• Shelf-stable – no refrigerated products • Limits on caffeine • No alcohol
Regulations
• Produced in separate processing facility • Plain packaging • Containers that cannot be directly drank from • Health warnings
Health Canada: Case-by-Case
• Its shape. Is it shaped like a bear? • Its colour. Is it a bright primary colour? Is it fluorescent? • Its smell. • Its flavour • What it's called • How it's packaged • How it's labelled • How it is presented to consumers Loosening the reins with time?
V2 Day: Oct 17th 2019 : 17th Dec 2019
• Delay in edibles reaching shelves (ON, QC, AB) – avoid Xmas rush • CBD infused product to be a vanguard • Topicals and extracts (vap cartridges) Health Canada U turn on regs • Infused barley based beverage with hops – beer substitute • Fruit infused beverages – grape juice/wine substitute • Infused alkali water • Brownies • Confectionary
https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/canadian-cannabis-survey-2019-summary.html
How regulations have missed the mark
• Designed with new users – low dose? (typical user 15-30mg THC) • Strain of cannabis (THC:CBD ratio) • Host related factors • Degree of decarboxylation
• Confusion to industry • Passing control to the illegal market • No consideration on what is happening in the real world • Passing responsibility to Municipal Public Health
Domestic Kitchen
• Risk of over-dosing increased • Uncontrolled Decarb • Heterogeneous distribution of THC • Temperature abuse • Sanitation • Cross-contamination Need for edible cannabis food guide
• Sourcing • Preparation • Storing • Food safety
Social Marketplace
• Craigslist • Facebook Marketplace • Amazon Marketplace • Ebay (allows CBD)
• Unlikely
• Avoid regulatory focus • Canada a spec in the marketplace world • Against philosophy of companies
Risk Analysis of Edible Cannabis
Jenitta Shanmugaraj MSc FSQA • Establish a foundation for Risk Analysis for edibles • Identify knowledge gaps
Most popular recipes from the internet
• Cannabis oil (Cannon oil) • Magic butter • Weed milk • Infused vodka (Crossfade) • Garlic cheese pasta • Cookies • Ice cream
Fraud
• THC inflation
• Edibles containing low THC or CBD
• THC levels 20% lower then stated
• Mislabeled • Cannabinoid type and concentration
• Requires close surveillance
Not concerned about regulations why would they worry about food safety
Company Date Amount recalled Reason Aphria 08-Mar-17 1 lot code THC labelled higher than actual content
Emblem Cannabis Corp
07-Apr-17 4 lot codes CBD labelled higher than actual content
Aurora Cannabis 16-Nov-17 1 lot code THC labelled higher & CBD labelled lower than actual content
Bonify 24-Dec-18 5883 units Record keeping issues with production Zenabis Ltd. 24-Jun-19 204 units THC & CBD labelled higher than actual content
Broken Coast Cannabis Ltd
30-Apr-19 11 units THC & CBD labelled higher than actual content
Blissco Holdings Ltd 24-Apr-19 720 units THC & CBD labelled higher than actual content
Tweed Inc 07-Mar-19 13575 units THC labelled lower & CBD labelled higher than actual content
High Parks Farm Ltd. 30-Apr-19 1872 units THC & CBD labelled lower than actual content
Recalls for Weed Fraud
Outbreaks and Recalls Year Hazard Cases/Action 1975 Hepatitis B 3 1982 Salmonella 85 (cut with dried manure) 1987 Hepatitis A 4 1988 Aspergillosis 1 2014 April Unsanitary conditions Recall 2014 May Coliforms Recall 2014 Sept Temperature abuse/Sanitation Recall 2014 Aug Mould Recall 2015 March Coliforms Recall 2015 July Temperature abuse Recall 2015 Aug - Dec Pesticide 16 Recalls 2016 April Pesticide 176 2017 May Pesticide Recall
Year Hazard Action Dec 2019 Mold Recall Nov 2019 Mold Recall Sept 2019 Distributing non-licensed
product License Suspended
Feb 2019 THC instead of CBD Recall Jan 2019 High mold counts Recall Jan 2019 Lack of testing Recall Jan 2019 Mold Recall Dec 2018 Falsified test results Recall Dec 2018 Escherichia coli Recall Nov 2018 Mold Recall July 2018 Pesticide residue Recall
Opportunistic Pathogens Recovered from MM
• Escherichia hermannii • Raoultella planticola • Enterobacter hormaechei • Enterobacter cloacae • Citrobacter freundii • Cronobacter turicensis • Escherichia vulneris
Legal vs Gray Market
Legal Sales • Regulator overview • Testing • Controlled growing conditions • Convenient • Expensive • Variable quality • Mold/pesticide contamination
Illegal Sales • Relationship with supplier (trust) • Less expensive • Less risk of pesticides
• Variable quality • Potential contaminants
(fentanyl) • Fraud/mislabeling
https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/canadian-cannabis-survey-2019-summary.html
https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/canadian-cannabis-survey-2019-summary.html
Risk Identification Hazard Consequence Severity Likelihood
Legal Likelihood Illegal
Pesticides (Chemical) Intoxication, carcinogenic Major Strong Intermediate
High THC (Chemical) Intoxication Major Strong Strong
Solvents (Chemical) Intoxication, carcinogenic Major Minor Intermediate
Heavy Metals (Chemical) Neurotoxicity Major Intermediate Intermediate-high
Mycotoxin (Chemical) Carcinogenic Major Minor Minor
Moulds (Microbial) Infection, intoxication Medium Intermediate Intermediate
Salmonella (Microbial) Infection Major Minor Minor
Clostridium botulinum (Microbial)
Intoxication Major Minor Minor
Listeria monocytogenes (Microbial)
Infection Major Intermediate Minor
Staphylococcus aureus (Microbial)
Intoxication Medium Intermediate Minor
Hair (Physical) Complaint Low Low Intermediate
Fingernail clippings (Physical)
Complaint Low Low Intermediate
Risk Communication: The US Experience
• Doreen Elis FSQA MSc student
• California, Colorado, Michigan, Oregon
• Advisory committee membership and objectives • Organization and messaging • Recommendations
Committee members and objectives
• Committees required by State Law • Create regulations and guide lines
• To protect the health of the population
• Youth • Parents • Pregnant Woman • Tourists (Colorado)
• Safe food handling and training
Committee Membership
• Scientific knowledge about Cannabis and its health effects • Experts in various aspects of public health • Law enforcement • Department of Labor • Revenue/tax department • Liquor commission/board • Tribes (indigenous) • Cannabis growers, producers and retailers • Public (including users)
Lessons Learnt
• Transparency in decisions and actions • Frequent meetings • Avoid too many chefs in the kitchen • Create focus groups and subcommittees
• Advertising and labelling • Edibles • Retail cannabis
• Focus campaigns • Start Low and Go Slow • Marijuana during pregnancy • How to keep marijuana out of reach
State of Oregon: 90% Capture of Youth and Young Adults
Health Canada Messaging in Canada
Health Warning messages • 34% users recall seeing
warnings
• 54% increased knowledge from warnings
Final Thoughts
• Edibles will be a significant sector in cannabis business • Consumers prefer legal sources • Regulations more flexible than initially envisaged • Absence of choice will lead to alternative sources
• Domestic • On-line • First nations
• Lack of control will lead to threats to health • Health Canada Policy focused on export market- valued added
products?