Guidance on advertising nicotine replacement therapies: Glossary
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Acronyms
- FDA
- Food and Drugs Act
- NHPs
- natural health products
- NHPR
- Natural Health Products Regulations
- NRTs
- nicotine replacement therapies
- Order
- Supplementary Rules Respecting Nicotine Replacement Therapies Order
- TMA
- terms of market authorization
Definitions
The following definitions are for the purposes of this guidance.
Advertisement: Any representation by any means for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device.
Advertising preclearance agencies: Independent entities that review and preclear advertising material before the material is used in the marketplace. Their objective is to help interested parties comply with the advertising provisions of the Food and Drugs Act and its regulations. This includes any applicable Health Canada guidance documents. These agencies also help ensure compliance with the Canadian Radio-television and Telecommunications Commission and industry codes. Some agencies also offer mechanisms to resolve complaints on advertising for authorized health products.
The board of directors or advisory bodies of these agencies may include stakeholders from academia, consumer groups, the media, advertising agencies, the pharmaceutical industry and health care practitioner associations. Health Canada acts as an ex-officio observer and advisor to some of these boards and advisory bodies, without relinquishing any part of its authority under the act and its associated regulations.
Audio advertising: An audio advertisement, such as a radio advertisement.
Audio-visual advertising: An advertisement consisting of audio and visual components (static or dynamic), such as a television or dynamic social media post advertisement.
Brand name: A name in English or French, including the name of a manufacturer, corporation, partnership and individual:
- that is used to distinguish the natural health product and
- under which a natural health product is sold or advertised
Brand recognition: The ability of consumers to recognize a brand without prompting and to recognize a brand based on a company's name, logo, colours, advertisements and any other associated elements.
Claim: Any representation made on behalf of a health product, including the indication for use and marketing claims. A marketing claim may be a statement or image that promotes the sale of a health product and highlights a specific product attribute, such as "longer lasting" or "tastes great."
Digital marketing: The use of digital technology includes web and multimedia processes for developing, distributing and promoting products and services. Digital technologies also include internet media such as websites, social media and email, and other digital media such as wireless or mobile and media, for delivering digital television (both cable and satellite).
Drug: Any substance or mixture of substances manufactured, sold or represented for use in:
- diagnosing, treating, mitigating or preventing 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
- disinfecting premises where food is manufactured, prepared or kept
Natural health product (NHP): A substance set out in Schedule 1 of the Natural Health Product Regulations, or a combination of substances where all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine that is manufactured, sold or represented for human use in:
- diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state or its symptoms in humans
- restoring or correcting organic functions in humans or
- modifying organic functions in humans to maintain or promote health
Does not include a substance set out in Schedule 2 of the Natural Health Product Regulations or 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.
Nicotine replacement therapy (NRT): A natural health product, other than a homeopathic medicine, that:
- contains nicotine or its salts and
- is for administration in the oral cavity
Product licence: A permit granted to the manufacturer of a natural health product that demonstrates the product has been assessed by Health Canada and found to be safe, effective and of high quality under its recommended conditions of use. All natural health products sold in Canada require a product licence before they can be marketed.
Real-world use: How an individual interacts with the nicotine replacement therapy in scenarios and settings that only and explicitly convey the use of the nicotine replacement therapy for the purpose of smoking cessation.
Risk: A measure of both the potential harm to human and animal health that may result from being exposed to a product under specific conditions of use, together with the likelihood that the harm will occur.
Visual (static) advertising: An advertisement consisting solely of static visual components, such as a billboard or a static social media post.
Youth appeal: Advertising targeting young persons to solicit positive or negative emotions about the product, or the settings or scenarios associated with the product.
Young person: A person under 18 years of age.
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