Transcript Food & Drugs Act - University of Waterloo

Product Classification by Health Canada
Alysyn Smith
Manager, Product Assessment Division
Bureau of Product Review and Assessment
Natural and Non-prescription Health Products Directorate
Health Products and Food Branch
Health Canada
University of Waterloo – December 4, 2015
Outline
• Provide guidance on the classification of a
product

Regulation of products under the Food and Drugs
Act

Regulation under another Health-related Acts
such as
• Canada Consumer Product Safety Act (CCPSA)
• Controlled Drugs and Substances Act (CDSA)
• Pest Control Products Act (PCPA)
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Acts
• Classification is the first step in any regulatory process – you need to
determine which legislation or regulations (if any) apply to the product
or activity in question.
• Each classification should be assessed based on legislative authorities
set out in the Acts.
• It is recommended that applicants always consult the current
consolidated versions of the Acts and regulations from the Justice
Canada website. http://laws.justice.gc.ca/eng/
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Food and Drugs Act - Definitions
•
“Drug” includes any substance or mixture of substances manufactured, sold or
represented for use in

the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal
physical state, or its symptoms, in human beings or animals,

restoring, correcting or modifying organic functions in human beings or animals, or

disinfection in premises in which food is manufactured, prepared or kept;
•
“Food” includes any article manufactured, sold or represented for use as food or drink
for human beings, chewing gum, and any ingredient that may be mixed with food for any
purpose whatever;
•
“Cosmetic” includes any substance or mixture of substances manufactured, sold or
represented for use in cleansing, improving or altering the complexion, skin, hair or
teeth, and includes deodorants and perfumes;
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Food and Drugs Act - Definitions
•
•
“Device” means any article, instrument, apparatus or contrivance, including any
component, part or accessory thereof, manufactured, sold or represented for use in
a)
the diagnosis, treatment, mitigation or prevention of a disease, disorder or
abnormal physical state, or its symptoms, in human beings or animals,
b)
restoring, correcting or modifying a body function or the body structure of human
beings or animals,
c)
the diagnosis of pregnancy in human beings or animals, or
d)
the care of human beings or animals during pregnancy and at and after birth of the
offspring, including care of the offspring,
e)
preventing conception in human beings or animals;
however, it does not include such an instrument, apparatus, contrivance or article, or a
component, part or accessory of any of them, that does any of the actions referred to in
paragraphs (a) to (e) solely by pharmacological, immunological or metabolic means or
solely by chemical means in or on the body of a human being or animal.
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Regulations under the Foods and Drugs Act
Food and Drugs Act
defines
Cosmetic, Device, Drug, Food
Cosmetics
Regulations
Medical Devices
Regulations
Revises definition to
exclude animals
“Drug” is
broken down in the
Regulations
NHP
Regulations
Since 2004
Food and Drug
Regulations
Part B – Foods
Food and Drug
Regulations
Part C – Drugs
Div. 1 – “old drugs”
Div. 3 – Radiopharmaceuticals
Div. 4 – Biologicals
Div. 8 – New Drugs
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Cosmetic Regulations
•
All cosmetics sold in Canada must be safe to use and must not pose any health risk. They must meet
the requirements of the Food and Drugs Act and the Cosmetic Regulations.
•
Under the Food and Drugs Act, a cosmetic includes "any substance or mixture of substances,
manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin,
hair or teeth and includes deodorants and perfumes." This includes cosmetics used by professional
esthetic services, bulk institutional products (such as hand soap in school rest rooms), as well as
"handmade" cosmetics sold at craft sales or home-based businesses.
•
The Cosmetic Regulations and the Food and Drugs Act require that cosmetics sold in Canada be
manufactured, prepared, preserved, packed and stored under sanitary conditions. The manufacturer
and importer must notify Health Canada that it is selling the product and provide a list of the product's
ingredients.
•
Additionally, cosmetics are subject to the requirements of the Consumer Packaging and Labelling Act
and Regulations and any chemicals found in cosmetics may be subject to the Canadian
Environmental Protection Act.
•
Additional guidance on the difference between therapeutic claims and cosmetic claims can be found
in the Guidelines for the Non-prescription and Cosmetic Industry Regarding Non-Therapeutic
Advertising and Labelling Claims published by Advertising Standards Canada
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Cosmetic Regulations continued
“Cosmetics” with health claims are regulated as Part C-drugs or as NHPs
e.g., antiperspirants, sunscreens with SPF, fluoride toothpaste
Guidelines for the Non-prescription and Cosmetic Industry Regarding NonTherapeutic Advertising and Labelling Claims published by Advertising Standards
Canada
http://www.adstandards.com/en/Clearance/Cosmetics/Guidelines-for-theNonprescription-and-Cosmetic-Industry.pdf
Guidance on Classification of Products at the Cosmetics-Drug Interface
http://www.hc-sc.gc.ca/cps-spc/cosmet-person/interface-frontiere/index-eng.php
Cosmetic Ingredient Hotlist (list of restricted or prohibited substances in
cosmetics)
http://www.hc-sc.gc.ca/cps-spc/cosmet-person/hot-list-critique/hotlist-liste-eng.php
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Medical Device Regulations
• These regulations apply to

(a) the sale and advertising for sale of a medical device; and

(b) the importation of a medical device for sale or for use on individuals,
other than importation for personal use.
• These regulations also apply to an in vitro diagnostic product that is a
drug or that contains a drug, as if the product were an in vitro
diagnostic device.
• Medical devices are classified into one of Classes I to IV by means of
the classification rules set out in Schedule 1, where Class I represents
the lowest risk and Class IV represents the highest risk.

If a medical device can be classified into more than one class, the class
representing the higher risk applies.
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Definition of Natural Health Product (NHP) in the NHP Regulations
"natural health product" means a substance set out in Schedule 1 [to the
NHP Regulations], a homeopathic medicine or a traditional medicine,
that is manufactured, sold or represented for use in
a)
the diagnosis, treatment, mitigation or prevention of a disease,
disorder or abnormal physical state or its symptoms in humans [i.e.,
not in animals];
b)
restoring or correcting organic functions in humans; or
c)
modifying organic functions in humans, such as modifying those
functions in a manner that maintains or promotes health.”
Includes substances on Schedule 1 to the NHP Regulations
Excludes substances on Schedule 2 to the NHP Regulations
Excludes drugs listed on the Prescription Drug List
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Schedule 1 to the NHP Regulations–Inclusions
Included natural health products substances
•
Plant, alga, bacterium, fungus, non-human animal
material
•
Extract or isolate of the above
•
Vitamins
•
Amino acids
•
Essential fatty acids
•
Synthetic duplicates of the above
•
Minerals
•
Probiotics
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Schedule 1 to the NHP Regulations–Exclusions
Excluded natural health product substances
•
in Schedule C (radiopharmaceuticals) or D (biologics from
micro-organisms or homeopathic pharmacy) to the Food &
Drugs Act
•
under the Tobacco Act
•
in Schedules I-V of the Controlled Drugs & Substance Act
•
administered by puncturing the skin
•
antibiotics
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Food and Drug Regulations Part C- Drugs
•
As outlined in the Food and Drugs Act “Drug” includes any substance or mixture of
substances manufactured, sold or represented for use in

the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal
physical state, or its symptoms, in human beings or animals,

restoring, correcting or modifying organic functions in human beings or animals, or

disinfection in premises in which food is manufactured, prepared or kept;
Part C of the Regulations
•
Division 1 - Old drugs
•
Division 3 – Radiopharmaceuticals
•
Division 4 – Biologicals
•
Division 8 – New Drugs
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Food and Drug Regulations Part A - Food
“Food” includes any article manufactured, sold or represented for use as
food or drink for human beings, chewing gum, and any ingredient that
may be mixed with food for any purpose whatever.
Classification of Products at the Food-Natural Health Product Interface:
Products in Food Formats
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/food-nhpaliments-psn-guide-eng.php
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Consumer Product Safety Act
The purpose of this Act is to protect the public by addressing or preventing dangers to
human health or safety that are posed by consumer products in Canada, including those
that circulate within Canada and those that are imported.
•
Under the Canada Consumer Product Safety Act (CCPSA) a "consumer product" is
defined as a product, including its components, parts or accessories that may
reasonably be expected to be obtained by an individual to be used for non-commercial
purposes, including for domestic, recreational and sports purposes, and includes its
packaging.
•
Section 4 of the Act outlines the consumer products to which the CCPSA does not apply,
including those listed in Schedule I. These include products that are covered under other
legislation such as food, cosmetics, medical devices, drugs, natural health products,
pest control products, fertilizers and vehicles. Tobacco products are also excluded,
except with respect to their ignition propensity - i.e., their flammability properties.
•
There are 36 sets of Regulations under the including the Toy Regulations, Ice Hockey
Helmet Regulations, Hazardous Products (kettles) Regulations, Cribs, Cradles and
Bassinets Regulations
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Controlled Drugs and Substances Act
• Schedules I – VIII of the Act describe the different substances that are
regulated under this Act
• There are 10 sets of Regulations under this Act including the
Controlled Drugs and Substances Act (Police enforcement)
Regulations, the Narcotic Regulations and the Marihuana for Medical
Purposes Regulations
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Pest Control Products Act
• From the Pest Control Regulations

(a) a device that is manufactured, represented, distributed or used to
directly or indirectly control, destroy, attract or repel a pest or to mitigate or
prevent the injurious, noxious or troublesome effects of a pest; and

(b) a compound or substance that is not an ingredient of a pest control
product described in paragraph (a) of that definition but is added to or used
with such a product to enhance or modify its physical or chemical
characteristics or to modify an effect on host organisms in connection with
which the product is intended to be used.

Exempted products that fall under the Food and Drugs Act
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Classification of Health products
- Classification is the first step in regulatory review process.
- When unclear, the Therapeutic Products Classification Committee
(TPCC) may be consulted.
- TPCC makes recommendations on the classification of a product as
either a drug (pharmaceutical, biological, or natural health product),
medical device, or combination product.
- If a product does not readily meet one of the definitions provided in the
Food and Drugs Act, other regulatory areas of Health Canada are asked
to participate in the committee's discussion.
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Classification of Health products
TPCC membership and representation:
•
•
•
•
•
Biologics and Genetic Therapies Directorate;
Pharmaceuticals; Medical Devices Bureau;
Natural and Non-prescription Health Products Directorate;
Veterinary Drugs Directorate;
Health Products and Food Branch Inspectorate.
Areas represented ad hoc when products may affect their area:
• Pest Management Regulatory Agency;
• Cosmetics;
• Consumer Product Safety;
• Tobacco;
• Food Directorate
Legal Services are consulted for advice when needed.
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Our classification webpages
Classification of Health Products at the Device-Drug Interface
http://www.hc-sc.gc.ca/dhp-mps/dev-drug-instr-drogue/index-eng.php
What are products at the device-drug interface?
Products that do not readily fall within the definition of "device" or "drug" as set out in the
Food and Drugs Act. Three sets of regulations may apply under the Act:
• Medical Devices Regulations;
• Food and Drug Regulations; or
• Natural Health Products Regulations.
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How to contact us
• Natural and Non-Prescription Health Products Directorate
[email protected]
• Cosmetics [email protected]
• CDSA [email protected]
• Drug Prescription Status-Statut D'ordonnance Des [email protected]
• Drug-device classification [email protected]
• Health Products Food Branch Inspectorate [email protected]
• Border Integrity [email protected]
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Useful Links – to Acts
Canada Consumer Product Safety Act
http://laws-lois.justice.gc.ca/PDF/C-1.68.pdf
Controlled Drugs and Substances Act
http://laws-lois.justice.gc.ca/eng/acts/C-38.8/index.html
Food and Drugs Act
http://laws-lois.justice.gc.ca/eng/acts/F-27/index.html
Pest Control Products Act
http://laws-lois.justice.gc.ca/eng/acts/P-9.01/
Tobacco Act
http://laws-lois.justice.gc.ca/eng/acts/T-11.5/index.html
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Useful Links – to Regulations
Cosmetic Regulations
http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._869/index.html
Food and Drug Regulations
http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._870/index.html
Medical Devices Regulations
http://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/index.html
Natural Health Products Regulations
http://laws-lois.justice.gc.ca/eng/regulations/SOR-2003-196/
Pest Control Products Regulations
http://laws-lois.justice.gc.ca/eng/regulations/SOR-2006-124/
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