Cannabis Edibles: Regulatory Updates, Risk Assessment and

Public Health Messaging Keith Warriner

Department of Food Science Center for Public Health and Zoonosis

Marijuana Production and Market

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

Production Process

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

When public try to extract resin Blasting – pressurized butane

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

Edibles

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

Bhang

First Edibles 1100 AD

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

On-line Edibles

Edibles in Ontario are only a bus ride away

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

Main players in the edible marijuana space

No need to stamp or imprint symbol of edibles

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

Where will edibles come from?

Cook Books

Celebrity Blogs

Internet Pop-up restaurants

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

Biz as usual?

Farmers Markets and Food Service

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

By accident or purpose? Entering food chain to attract new users?

Market value: $140 per bag

Risk Analysis of Edible Cannabis

Jenitta Shanmugaraj MSc FSQA • Establish a foundation for Risk Analysis for edibles • Identify knowledge gaps

Most Popular in Colorado

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?