CHFA WEST 2019 WHAT YOU NEED TO KNOW ABOUT CBD REGULATIONS - PRESENTED BY: LEWIS RETIK, LAURA GOMEZ, AND DR. JON -PAUL POWERS
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
CHFA WEST 2019
WHAT YOU NEED TO KNOW
ABOUT CBD REGULATIONS
PRESENTED BY: LEWIS RETIK, LAURA GOMEZ, AND DR. JON -PAUL POWERS
This presentation is not legal advice
February 22, 2019
AGENDA
• What is cannabis and how to market it
• Understanding industrial hemp and the CBD regulatory
framework
• CBD as a possible Natural Health Product
• Questions
The content of this presentation is provided for general information purposes only and does not constitute
legal or other professional advice or an opinion of any kind. Participants are advised to seek legal advice
by contacting legal counsel regarding any specific legal issues. Participants are encouraged to consult the
Cannabis Act and the applicable Regulations, and any other legislation that may apply to them or their
activities, such as any applicable provincial or territorial legislation.
2 This presentation is not legal advice
PART 1: WHAT IS
CANNABIS AND
HOW TO MARKET IT
PRESENTED BY:
LEWIS RETIK, PARTNER
3 This presentation is not legal advice
WHAT IS LEGAL CANNABIS?
• Recreational Cannabis:
Until O c tober 17, 2018 “ c annabis , its preparations and derivatives ” were “c ontrolled s ubs tanc es ” under the
Controlled Dr ugs and Subs tanc es Ac t (“CDSA”) and “narc otic s ” under the Narc otic Control Regulations
• Industrial Hemp:
Sinc e 1998, the Indus tr ial Hem p Regulations have authorized the produc tion, pos s es s ion, im port and s ale of low -
T HC c annabis f or indus tr ial us e via a s ys tem of lic ens ed, perm its and authorizat ions
Indus trial Hem p Regulations wer e updated to ref lec t new c annabis regim e ef f ec tive O c tober 17, 2018
• Medical Cannabis:
Legal ac c es s to dr ied c annabis f or m edic al purpos es was f irs t perm itted in 1999 us ing CDSA ex em ptions
Marihuana Medic al Ac c es s Regulations (2001): pres c ription - bas ed ac c es s to c annabis f or m edic al purpos es ; hom e
produc tion or pur c has e gover nm ent s upply
Marihuana f or Medic al Pur pos es Regulations (2013): c om m erc ial s ale of c annabis f or m edic al purpos es
Ac c es s to Cannabis f or Medic al Purpos es Regulations (2016 - 2018): lic ens ing regim e f or c om m erc ial indus try; hom e
produc tion
4 This presentation is not legal advice
WHAT IS LEGAL CANNABIS?
• The Cannabis Act (the “Act”) removes “cannabis, its preparations and
derivatives” from the CDSA to provide legal access to cannabis for recreational,
industrial and medical purposes
• Controls and regulates the production, distribution, promotion and sale of
cannabis
• Persons 18+, subject to additional provincial restrictions, can legally:
• Possess a total of 30 g of dried cannabis or equivalent in public
• Distribute up to 30 g of dried cannabis or equivalent to other adults
• Cultivate, propagate or harvest a maximum of f our cannabis plants per
household f or personal use, licensed seeds or seedlings f rom licensed
suppliers
• Purchase limited amounts of cannabis f rom retailers authorized by the
provinces and territories
• Consume cannabis in locations authorized by local jurisdictions
• Make legal cannabis -containing products at home, such as f ood and
drinks, provided that dangerous organic solvents are not used in making
them
5 This presentation is not legal advice
CANNABIS REGULATIONS
• On July 11, 2018, the Cannabis Regulations w ere finalized to support the coming into force of the Act
• Provide additional regulation w ith respect to commercial activities:
Licensing (f or cultivation, processing, research, medical cannabis, cannabis drugs, analytical testing)
Security
Quality
Product standards
Packaging and labelling
Retention of documents
Reporting and disclosure
• Regulate medical cannabis:
Access to cannabis f or medical purposes
Drugs containing cannabis and cannabis drug/device combination products (additional Food and Drugs Act and
Food and Drug Regulations requirements)
• Does not regulate the production of industrial hemp (new Industrial Hemp Regulations promulgated)
6 This presentation is not legal advice
REGULATED CANNABIS
• Under the Act, cannabis is:
“Any part of a cannabis plant, including the phytocannabinoids produced by, or f ound in, such a plant, regardless
of whether that part has been processed or not […]”;
“Any substance or mixture of substances that contains or has on it any part of such a plant”; and
“Any substance that is identical to any phytocannabinoid produced by, or f our in, such a plant, regardless of how
the substance was obtained”
• Expressly exempted:
Non-violable seed of a cannabis plant or a mature stalk without any leaf , f lower, seed or branch (and f iber f rom
such a stalk) and the root (or any part of the root) of such a plant.
Industrial Hemp Regulation exemptions enable natural health products and consumer products containing
low THC (10 µg/g or less) industrial hemp derivatives (e.g. hemp protein, hemp seed oil, cosmetics, etc .)
• IMPORTANT:
Health products containing phytocannabinoids (e.g. THC & CBD) and duplicates of phytocannabinoids are regulated
as prescription drugs.
7 This presentation is not legal advice
LEGAL SALE OF CANNABIS
• Classes of cannabis legal for sale include:
Dried cannabis
Cannabis oil
Fresh cannabis
Cannabis plants
Cannabis plant seeds
• Anticipated legal sale after October 17, 2019 (subject to regulatory
amendment):
Edibles containing cannabis (solid and liquid)
Cannabis extracts
Cannabis topicals
8 This presentation is not legal advice
NEW CLASSES OF CANNABIS - THC LIMITS
1. Edible cannabis: a limit of 10 mg of THC per discrete unit and per package.
• For example, a package could contain one discrete unit of edible cannabis that contains 10 mg or two
discrete units that each contain 5 mg.
2. Cannabis extracts: a limit of 10 mg of THC per discrete unit intended to be ingested or for nasal,
rectal, or vaginal use, such as a capsule. And, a limit of 1,000 mg of THC in a single package.
• For example, a package could contain 100 capsules of an extract that each contain 10 mg; or 200
capsules of an extract that each contain 5 mg.
3. Cannabis topicals: a limit of 1,000 mg of THC per package.
9 This presentation is not legal advice
CATEGORIZATION OF CANNABIS PRODUCTS
Non-Medical Medical Health Products with Cannabis
(Cannabis Act) (Cannabis Act) (Cannabis Act &
Food and Drugs Act)
• Limited classes initially • Same limited classes as non- • No restrictions on product classes
• Health care practitioner medical that may be approved under FDA
authorization not required • Health care practitioner (e.g., dosage forms for
• No pre-market review for safety authorization required prescription drugs)
and efficacy • No pre-market review for safety • Practitioner oversight
• Quality and security requirements and efficacy • Pre-market review for safety,
under Cannabis Act • Quality and security requirements efficacy and quality under FDA
• Cannot make health claims under Cannabis Act • Manufacturing subject to quality
• Cannot make health claims and security requirements under
the FDA and Cannabis Act
• Can make health claims, if
authorized
Health Canada, “Health products containing cannabis or for use with cannabis: Guidance for the Cannabis Act, the Food and Drugs Act, and related regulations” (July 11, 2018)
10 This presentation is not legal adviceKEY CONSIDERATIONS
• Licensing
Sale and Distribution:
• Provincial/Territorial authorization required
‾ Patchwork of 12 different regimes with varying degrees of public/private involvement
• Medical cannabis sale requires federal licence
• Business-to-business distribution and sale authorized among licensees
Cultivation and processing cannabis and cannabis products:
• Federal licence required but facilities subject to municipal restrictions
• Micro-processing and micro-cultivation licences available
Research and Analytical Testing:
• Federal licence required for R&D
‾ Health Canada’s stated policy is that licensees are be permitted to research within the scope of another licence (e.g. cultivation) but this is not
found in the legislation
Cannabis Drug Licence:
• For drugs containing cannabis
• Security Requirements
• Good Production Practice and Record Keeping Requirements
• Import and Export
Federal authorization required to import and export cannabis for medical or scientific purposes
No import or export of recreational cannabis
11 This presentation is not legal adviceADVERTISING, BRANDING AND PROMOTION
• Cannabis Act:
Unless authorized by the Act, no promotion of cannabis, cannabis accessories and services related to cannabis
Informational or Brand-preference promotion – permitted by persons authorized to produce, sell or distribute cannabis and must be:
• In a communication addressed and sent to a person who is 18 years of age or older
• In a place where persons under 18 years of age are not permitted by law
• In a telecommunication where the person responsible of the content of the promotion has taken reasonable steeps to ensure that
such promotion cannot be accessed by a young person
• In a prescribed place
• In a prescribed manner
Brand element promotion permitted on things that are not associated with or appealing to persons under 18, or that are associated with a
way of life that includes glamour, recreation, excitement, vitality, risk or daring
Brand element includes a brand name, trademark, tradename, distinguishing guise, logo, graphic arrangement, design or slogan that is
reasonably associated with, or that evokes,
(a) cannabis, a cannabis accessory or a service related to cannabis; or
(b) a brand of any cannabis, cannabis accessory or service related to cannabis.
12 This presentation is not legal adviceADVERTISING, BRANDING AND PROMOTION
• Promotion limited at point of sale (price and availability)
• Permitted informational/brand-preference promotion cannot be
accessible by or appealing to persons under 18
• Prohibited to display a brand element or name of cannabis
producer, seller etc, as part of the name of the facility or
otherwise, if the facility is used for a sports or cultural event or
activity
• Sponsorship and giveaway restrictions
• Additional provincial restrictions
• Packaging and labelling restrictions
13 This presentation is not legal adviceADVERTISING IN BRITISH COLUMBIA
• Under the Cannabis Control and Licensing Act and associated regulations:
• A person who markets, advertises or promotes cannabis must not allow a minor to take part in
those activities
• An unlicensed person must not promote cannabis for the purpose of selling it
• A person must not market, advertise or promote any place as a place to consume cannabis or to
spend time after consuming cannabis.
• Unless authorized to sell cannabis in BC, a person must not use any words, phrases, designs,
domain names or other branding elements or indicia that could indicate that the person owns or
operates a business that sells cannabis.
• The Cannabis Licensing Regulations create a Marketing Licence which authorizes the licensee to
promote cannabis from Licensed Producers to licensed cannabis retail stores.
14 This presentation is not legal adviceADVERTISING IN ONTARIO
• In addition to Federal restrictions and prohibitions, the Registrar's Standards for Cannabis Retail Stores contains additional
requirements for retailers in Ontario:
Licensees must have signage clearly identifying their business on the exterior of the authorized store.
Language and images on exterior signage may not:
‾ communicate information about the price or distribution of cannabis or cannabis accessories
‾ appeal to young persons
‾ contain testimonials or endorsements
‾ depict a person, character, or animal, whether real or fictional
‾ present cannabis or a cannabis accessory in a manner that associates it with or evokes a positive or negative emotion or image of a way of life
such as one that includes glamour, recreation, excitement, vitality, risk, or daring
‾ promote cannabis or cannabis accessories in a way that is false, misleading, or deceptive
‾ be associated with medicine, health, or pharmaceuticals
‾ associate consumption of cannabis with driving a motorized vehicle, or with any activity that requires care and skill or has elements of danger.
15 This presentation is not legal adviceADVERTISING IN ONTARIO
• Licensees may promote cannabis and cannabis accessories within the store only under the following circumstances:
the promotion is limited to factual information about:
‾ Cannabis or a cannabis accessory and its characteristics
‾ a service related to cannabis
‾ the availability or price of cannabis, cannabis accessories, or a service related to cannabis.
the promotion focuses on brand characteristics of cannabis or cannabis accessories.
• Licensees may not provide cannabis or cannabis accessories free of charge or provide any other thing or benefit,
including a discounted price, as an inducement for the purchase of cannabis or a cannabis accessory.
• Licensees may not accept or request material inducements from Licensed Producers, their representatives, or
suppliers of cannabis accessories.
16 This presentation is not legal adviceADVERTISING IN QUEBEC
• Cannabis Regulation Act contains additional restrictions and prohibitions that
go beyond the federal regulations.
• In Quebec, the promotion of cannabis is permitted only in:
Printed newspapers and magazines addressed to a person 18 years of age or older
On signage inside of a cannabis retail store, which cannot be viewed from outside of such
store
On the website of the Société Québecoise du Cannabis (“SDQC”) – the only authorized
provincial retailer
17 This presentation is not legal adviceADVERTISING IN QUEBEC
• The French (primary) version of the law prohibits direct and indirect “publicité en faveur du
cannabis” (in English “advertising for the promotion of cannabis”), which suggests that
prohibitions may extend beyond promotional advertising to any advertising “in favour” of
cannabis.
• No sale of objects with images directly associated with cannabis
“The operator of a business or a cannabis producer may not sell or give an object that is not cannabis or
supply such an object as part of an exchange if a name, logo, distinguishing guise, design, image or slogan
that is directly associated with cannabis, a brand of cannabis, the Société québécoise du cannabis or a
cannabis producer appears on the object.”
18 This presentation is not legal adviceCHALLENGES & POTENTIAL COMPLICATIONS FOR GROWTH
• Limitations on importation
• Limitations on trade:
Inter-provincially
Internationally
• Municipal restrictions on production facilities
• Patchwork of inconsistent provincial laws
• Challenges for collaborations and joint ventures where licensing is a requirement
• Cross-border issues for individuals involved in the legal cannabis industry in Canada
• Supply vs. demand for recreational cannabis
19 This presentation is not legal adviceCURRENT TRENDS
• Consolidat ion – M&A within the indus tr y
• Product Innov at ion – Novel s trains , deliver y, etc .
• Inconsist ent Regulat ion – Multi- j ur is d ic t iona l with res pec t to s ale and us e
• G lobal O pport unit y – Canadian indus try pos itioned to bec om e global leader in the
c om m er c ial pr oduc tion of r ec r eational c annabis
• Safer and M ore Responsible Consumption – Inc reas ed f oc us on em piric al data and s ound
evidenc e
• New Businesses – Em er ging c om m erc ial opportunities anc illar y to c annabis produc tion and
s ale
• Edibles, Concent rat es and T opicals – W hile not c urrentl y legal f or s ale, m aj or f oc us on
produc tion of edibles , c onc entr ates , and phytoc annab ino i d c ontaining topic al produc ts
20 This presentation is not legal adviceCOMPLIANCE & ENFORCEMENT – CANNABIS ACT &
CANNABIS REGULATIONS
• It is prohibited to possess and distribute any cannabis that you know is illicit cannabis.
• Illicit cannabis means cannabis that is or was sold, produced, distributed or imported by a person prohibited from
doing so under the Cannabis Act or any provincial legislation
• Includes criminal offences, for example:
• Possession offences: depending on type of offence, up to 5 years in prison, and no limit on fine, for contravening
possession limits and possessing illicit cannabis
• Distribution offences: depending on type of offence, up to 14 years in prison, and no limit on fine, for distributing to an
underage person, to an organization, more than 30 grams, or illicit cannabis
• Various other selling, importing, exporting, and producing offences
• Includes authority to issue Administrative Monetary Penalties for certain types of offences:
• Current maximum fine set at $1,000,000 but will be subject to other maximums introduced by regulation and whereby
offences would be classified as minor, serious, or very serious and would have associated maximum fines for each
21 This presentation is not legal advicePART 2: UNDERSTANDING
INDUSTRIAL HEMP
& THE CBD
REGULATORY FRAMEWORK
PRESENTED BY:
LAURA GOMEZ, PARTNER
22 This presentation is not legal adviceWHAT DO THE INDUSTRIAL HEMP REGULATIONS DO?
• The old Industrial Hemp Regulations were promulgated under the Controlled Drugs and
Substances Act – the old regulations were repealed when the Cannabis Act came into force,
October 17, 2018
• The new Industrial Hemp Regulations operate in parallel to the Cannabis Regulations, both
promulgated under the Cannabis Act
• Licence the sale, import, export, processing and cultivation of industrial hemp plants, seeds and
grains
• Authorize or exempt certain activities that would otherwise be illegal under the new cannabis
regulatory framework
• Specify that only certain varieties of hemp may be cultivated for industrial hemp purposes
• Set standards for industrial hemp, THC content, testing, storage…etc.
23 This presentation is not legal adviceWHAT IS INDUSTRIAL HEMP?
• Industrial hemp means a cannabis
plant – or any part of that plant – in
which the concentration of THC is 0.3%
w/w or less in the flowering heads and
leaves
• Only seeds of approved industrial hemp
varieties, THC level lower than 0.3% in
their leaves and flowering heads, can be
planted (List of Approved Cultivars)
• Industrial hemp also includes the
derivatives of industrial hemp plants
and plant parts
24 This presentation is not legal adviceDIFFERENT REQUIREMENTS FOR DIFFERENT PARTS
Industrial hemp derivatives
• Only a product made by processing of the grain of industrial hemp is exempted from the Cannabis Act if
the derivative or product contains less than 10 µg/g of THC
• Derivatives that are considered industrial hemp include e.g. hemp seed oil (oil derived from seed or
grain) and hemp flour
Flowering heads, leaves and branches
• A holder of a licence that authorizes sale may only sell the flowering heads, leaves and branches of
industrial hemp to a holder of a licence under the Industrial Hemp Regulations or the Cannabis
Regulations
• Derivatives made by the processing of flowering heads, leaves and branches are not exempted from
Cannabis Act
Stalk, fibre & non-viable seeds
• Non-viable cannabis seeds, mature cannabis stalks, when those stalks are stripped of their leaves,
flowers, seeds, and branches, and fiber derived from such mature cannabis stalks, are exempted from
the Cannabis Act
• Fibre from stalks can be used in making paper, textiles, rope or twine, and construction materials
25 This presentation is not legal adviceINDUSTRIAL HEMP DERIVATIVES
• Natural Health Products, cosmetics and
foods can include industrial hemp derivatives
with a THC content of 10 µg/g or less
• e.g. hemp seed, hemp seed oil, hemp seed
protein
• Derivatives must come from the grain of
industrial hemp, not other parts
• Isolated or concentrated phytocannabinoids are
excluded (i.e. no concentrated CBD even from
industrial hemp)
26 This presentation is not legal adviceREMEMBER…
ONLY SPECIFIC ACTIVITIES ARE EXEMPTED
• No blanket exemption for industrial hemp
• A plant part, derivative or product made from a
derivative must fall within one of the specific
exemptions in the Industrial Hemp Regulations,
or be exempted from the Cannabis Act
altogether, otherwise the Cannabis Act applies
• e.g. hemp seed oil (CBD – TARGETED AMENDMENTS
• On October 17, 2018, upon the coming in force of the Cannabis Act, Health Canada
implemented two changes targeted at excluding isolated or concentrated phytocannabinoids
(e.g. CBD) from being sold as a Natural Health Product
Health Canada added phytocannabinoids to the Prescription Drug List (PDL):
o Phytocannabinoids produced by, or found in, the cannabis plant and substances that are duplicates
of such phytocannabinoids
Health Canada added phytocannabinoids to Schedule 2, of the Natural Health Product
Regulations (Excluded Natural Health Product Substances):
o Anything referred to in Schedule 2 to the Cannabis Act that contains more than 10 μg/g THC, an
isolated or concentrated phytocannabinoid or a synthetic duplicate of that phytocannabinoid
28 This presentation is not legal adviceCBD – ADDED TO PRESCRIPTION DRUG LIST
• The PDL is a list of medicinal ingredients that, when found
in a drug, require a prescription to purchase
A substance or combination of substances is not considered
to be a NHP if its sale is required to be pursuant to a
prescription
• The PDL includes an exemption for derivatives of cannabis
exempted under the Industrial Hemp Regulations (e.g.
hemp seed oil) and anything exempted from the Cannabis
Act (e.g. fibre from mature stalk)
Exemption only applies if the product DOES NOT contain an
isolated or concentrated phytocannabinoid
29 This presentation is not legal adviceCBD – EXCLUDED FROM THE DEFINITION OF NHP
• Schedule 2 of the Natural Health Products Regulations, lists
substances that are excluded from the definition of an NHP
[an NHP] does not include a substance set out in Schedule 2,
any combination of substances that includes a substance set out
in Schedule 2 or a homeopathic medicine or a traditional
medicine that is or includes a substance set out in Schedule 2
• Schedule 2 includes an exemption for industrial hemp
derivatives exempted under the Industrial Hemp Regulations
(e.g. hemp seed oil) and anything exempt from the Cannabis
Act (e.g. fibre from mature stalk)
Exemption only applies as long as the ingredient DOES NOT
contain an isolated or concentrated phytocannabinoid
30 This presentation is not legal advicePART 3: CBD AS A
POSSIBLE NATURAL
HEALTH PRODUCT
PRESENTED BY:
DR. JON-PAUL POWERS, PARTNER
31 This presentation is not legal adviceCBD PRESCRIPTION DRUG STATUS
• When the Cannabis Act cames into force, the Prescription Drug List was amended to include
phytocannabinoids produced by, or found in the cannabis plant, including any product
containing an “isolated or concentrated phytocannabinoid” or a synthetic duplicate
• Health Canada has taken a precautionary approach, due to scientific uncertainty and limited
market experience with phytocannabinoid health products
• To be removed from the Prescription Drug List, Health Canada indicates it needs new
evidence to show that these products can be used safely for the intended therapeutic benefit
and patient population without a practitioner's oversight
• CBD is currently NOT permitted in NHPs, foods or cosmetics. The only route to market
is currently via the recreational cannabis market or a prescription drug.
32 This presentation is not legal adviceOVERVIEW OF THE NATURAL HEALTH PRODUCTS
REGULATIONS
• In Canada, Natural Health Products (“NHPs”) are a
subset of drugs
• NHPs are governed by the Food and Drugs Act (the
“FDA”), the Food and Drug Regulations (the “FDR”),
and the Natural Health Products Regulations (the
“NHPR”)
• A product will be classified as an NHP as a result of
its composition and representation. This is because
the definition of an NHP has both a “substance
component” and a “function component”.
33 This presentation is not legal advicePRODUCT LICENCE REQUIREMENTS
• The NHPR require that each NHP receives a product licence before it can be sold in Canada
(NPN, DIN-HM)
• To obtain a product license, a product licence application (PLA) must be submitted to the
Natural and Non-prescription Health Products Directorate (the “NNHPD”) of Health Canada
• The NNHPD must receive sufficient data to allow the evaluation of the safety, efficacy and
quality of the NHP when used according to the recommended conditions of use
• Safety and efficacy of NHPs are largely supported through the following evidence: NNHPD
Monographs, Traditional evidence, Clinical studies
34 This presentation is not legal adviceCBD EVIDENCE - NHP
Evidence Comments
NNHPD Monographs There are currently no monographs covering CBD and/or Cannabis
(other than Hemp seed, seed protein and seed oil)
Traditional Evidence Not likely applicable to isolated and purified CBD or CBD rich extracts
Clinical Studies Published or otherwise
NHP PLAs supported by clinical evidence are considered as class III PLAs (with an associated, and
not guaranteed, 210 day review period; 30 day administrative screening, 180 day assessment time)
35 This presentation is not legal adviceEVIDENCE REQUIREMENTS - SAFETY
• Must demonstrate the ingredient is safe, at the propose dose, in the respective population, for
the specified duration of time
• e.g. a study in which healthy adults orally consumed 200 mg/day CBD for 6 months without
significant adverse events would support a PLA for a product providing the same
• Use in special/high risk populations (e.g. children, and pregnant and breast feeding women)
would require clinical evidence collected from the same populations
• e.g. a clinical study in adults would not typically support use in children
• The duration of the clinical study may affect the licensed duration of use of the product.
Generally the NNHPD requires clinical studies of a 6 month duration, without significant
adverse events, to license a product without a specified duration of use (i.e. for chronic use).
36 This presentation is not legal adviceEVIDENCE REQUIREMENTS - EFFICACY
• Must demonstrate the ingredient imparts a beneficial health effect
• The measure of the effect must be meaningful and statistically significant when
compared to placebo. In general, the measures should be:
• Scientifically recognized/validated
• Relevant to the population the product is intended for
• Investigator administered
• The claim must be consistent with the beneficial health effect and worded in a health context
• e.g. a study demonstrating a reduction in knee pain associated with osteoarthritis would not support a claim such as
“Reduces pain”
• e.g. “Reduces biomarker A” vs “Reduces biomarker A, a factor associated with inflammation”
• With respect to efficacy, the higher level the claim, the higher level of evidence required for support (e.g.
antioxidant vs. cardiovascular health)
37 This presentation is not legal advicePOPULAR CBD CLAIMS
• A review of popular news, health and other industry sites reveals a wealth of conditions that purportedly may benefit
from the use of CBD. Some examples include (and as one site notes “just to name a few”):
• Depression
• Anxiety
• Pain Important Considerations:
• Epilepsy • NHPs are intended for self-care
• NHPs may not be represented as a
• Seizures
treatment, preventative or cure for any of
• Cancer the diseases, disorders or abnormal
• ALS physical states referred to in Schedule A of
• MS the FDA
• Arthritis
• Headaches
• Nausea
• Insomnia
38 This presentation is not legal adviceCBD CLAIMS VS REGULATION
Claim/Condition Issue
Cancer; Acute anxiety; Acute, inflammatory and Schedule A Conditions
debilitating arthritis; Depression; Nausea (due to
pregnancy)
Epilepsy; Seizures Schedule A Diseases (Synonymous with
convulsions)
ALS; MS Conditions likely deemed outside the realm of self-
care
Nausea; Insomnia; Pain; Headache Possibly permitted NHP claims
39 This presentation is not legal adviceEVIDENCE REQUIREMENTS - QUALITY
• The NNHPD has been requesting the following quality related information as part of
product license applications including hemp:
1. Specifications indicating testing and tolerance limits for THC and CBD:
• The determination of THC must take into account the potential to convert THCA into THC
• The determination of CBD must take into account the potential to convert CBDA into CBD
• Testing must be conducted via a validated method (suitable to detect 10 ppm THC and CBD) and competent
laboratory as per the IHR
2. Documentation must be provided which indicates the specific hemp cultivar (which must be compliant
with the IHR List of Approved Cultivars)
• Should the NHP route become possible, the above would likely be required as part of a
product license application including CBD.
1. It remains to be seen what possible CBD source materials would be permitted in a NHP if any (e.g. Hemp
as per the IHR, Cannabis as per the Cannabis act, etc.)
40 This presentation is not legal adviceSUMMARY
• Should CBD be removed from the Prescription Drug List and permitted
for use in NHPs:
1. Unlikely to be a blanket removal as some conditions are not appropriate for
self care (e.g. L-Carnitine acceptable ingredient in NHPs, remains on the
prescription drug list for when sold for the treatment of primary or
secondary L-Carnitine deficiency)
2. A product licence (NPN) would be required for sale
3. A product licence application (PLA) would need to be submitted to support
the safety, efficacy and quality of the product
4. Claims (efficacy) must be supported by clinical studies, must not be
represented as a treatment, preventative or cure for a Schedule A disease,
and must be appropriate for self-care
41 This presentation is not legal adviceTHE CONTENT OF THIS PRESENTATION IS PROVIDED FOR GENERAL
INFORMATION PURPOSES ONLY AND DOES NOT CONSTITUTE LEGAL OR
OTHER PROFESSIONAL ADVICE, OR AN OPINION OF ANY KIND.
PARTICIPANTS ARE ADVISED TO SEEK LEGAL ADVICE BY CONTACTING
LEGAL COUNSEL REGARDING ANY SPECIFIC LEGAL ISSUES.
PARTICIPANTS ARE ENCOURAGED TO CONSULT THE CANNABIS ACT AND
THE APPLICABLE REGULATIONS, AND ANY OTHER LEGISLATION THAT
MAY APPLY TO THEM OR THEIR ACTIVITIES, SUCH AS ANY APPLICABLE
PROVINCIAL OR TERRITORIAL LEGISLATION.
42 This presentation is not legal adviceQUESTIONS? 43 This presentation is not legal advice
PRESENTERS
LEWIS RETIK DR. JON-PAUL POWERS
Partner Scientific Advisor
Business Law Business Law
lewis.retik@gowlingwlg.com Jon-
paul.powers@gowlingwlg.com
+1 613 7838849
+1 613 786 0123
LAURA GOMEZ FOOD, NHP & COSMETICS
Partner
Business Law LAW NEWSLETTER
Laura.gomez@gowlingwlg.com Featuring special Cannabis Editions
+1 613 786 0149 – to subscribe visit:
www.gowlingwlg.com/subscribe
This presentation is not legal advice
gowlingwlg.com Gowling WLG (Canada) LLP is a member of Gowling WLG, an international law firm which consists of independent and
autonomous entities providing services around the world. Our structure is explained in more detail at
gowlingwlg.com/legalYou can also read
