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Purpose
This guidance outlines the factors we generally consider when assessing if materials and activities are advertisements for therapeutic goods or vaping goods. This guide does not deal with whether such advertisements would contravene the Therapeutic Goods Act 1989 (the Act).
Whether something is an advertisement must be assessed on a case-by-case basis and includes whether it promotes, directly or indirectly, the use or supply of therapeutic goods or vaping goods.
The factors described in this guidance are not exhaustive. The presence or absence of a factor in a particular scenario is not necessarily conclusive in assessing whether particular conduct amounts to advertising. Entities who disseminate content about therapeutic goods and vaping goods must assess their materials carefully.
Materials and activities that advertise therapeutic goods or vaping goods are subject to the relevant advertising requirements in the Act. This includes the requirement to comply with the Therapeutic Goods Advertising Code (the Code). For more information see Advertising legal framework.
Legislation
Definition of advertise
Under section 3 of the Act, advertise in relation to therapeutic goods or vaping goods, includes making:
any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design:
- is on the label of the goods; or
- is on the package in which the goods are contained; or
- is on any material included with the package in which the goods are contained.
The definition of ‘advertise’ encompasses material with promotional characteristics.
The definition is intended to have a broad meaning and includes both direct and indirect promotions of the use or supply of therapeutic goods or vaping goods.
Whether a statement, pictorial representation or design is intended to promote the use or supply of the goods is determined not by the actual intentions of the person responsible for making or transmitting the content, but by whether the relevant content on its face appears to be designed or calculated to promote the supply or use of the relevant goods.
Conversely, content that describes the features or benefits of a therapeutic good is not necessarily advertising if it is clear on its face that it was not designed or calculated to promote the supply or use of the relevant goods.
We have outlined general principles for assessing whether material and activities are advertising below.
Examples
The examples below illustrate how the principles in this guidance apply in practice. They are not exhaustive and do not prescribe a definitive outcome. Instead, they show how different types of material may be assessed for the intent to promote the use or supply of therapeutic goods or vaping goods, and how the context guides that assessment.
Example - Advertising where promotional intent is clear
A pharmacy website provides details about each of the complementary medicines it offers for sale. The website includes the name of each medicine, one or more accepted indications as well as the relevant advisory statements. The website may have a ‘buy now’ capability or it might not. In either scenario it is an advertisement and must comply with the advertising legislation.
Note: advertising is generally permitted for complementary medicines provided the advertisement complies with the Act, Regulations and Code.
Example - Information material where intent is non-promotional
A peer‑reviewed article appearing in a scientific journal evaluates the effectiveness of omega‑3 supplementation, using data from a controlled trial. The article presents both positive and negative findings, outlines methodological limitations, and avoids persuasive or emotive language. It is published within an academic research context with no references to commercial availability or consumer use.
The article is intended to be analytical and informational, rather than to promote the use or supply of the goods.
Identifying the entity responsible for advertising
Under the Act, a person can commit an offence or be liable for a civil penalty if the person advertises or causes the advertising of therapeutic goods or vaping goods, by any means, and the advertisement does not comply with applicable requirements in the Act or the Code.
Scenarios where a person causes the advertising include where:
- the promotional material is disseminated on their behalf or at their request, or
- where they have control over the content of the material.
This is regardless of whether there is a payment or other valuable consideration for the dissemination of the material.
Examples of persons who might advertise, or cause the advertising of, therapeutic goods include, but are not limited to, the following:
- the person in relation to whom the goods are included in the Australian Register of Therapeutic Goods.
- any person in the supply chain for the therapeutic goods (for example manufacturers, wholesalers, retailers, franchisees, multi-level marketers) who advertises the goods
- a person publicly endorsing the goods
- a health practitioner or health service advertising therapeutic goods or promoting the use of specific goods in promoting its services.
Advertisers, for example online retailers, should be aware that they are responsible for the material they publish, regardless of whether they have copied that material from product packaging or other websites.
All forms of communication can be advertising
The definition of ‘advertise’ applies to all forms of communication and all types of media, including (but not limited to):
- traditional media (such as television, radio and print media)
- electronic media (such as websites, emails, blogs, discussion forums and social media posts), including user generated content
- articles published in magazines and newspapers, displays on posters and notices, photographs, film, broadcast material, video recording, electronic transmissions and material posted on the internet
- point-of-sale materials, leaflets, posters, displays, booklets and other promotional materials that include specific product claims and which are supplied separately from the product
- advertorials and infomercials
- product reviews/testimonials and endorsements
- the supply of product samples
- business/company materials such as media releases
- material presented to the public through other means (e.g. workshops and other face-to-face sessions, webinars and podcasts, words forming part of a soundtrack or video recording, exhibitions, billboards, shopfronts and signage).
Product labels may also be an advertisement if they contain a claim (such as an indication or intended purpose) or any other promotional information. If a label is an advertisement, it must comply with all applicable parts of the Act, Regulations and Code.
In addition, businesses should also carefully consider whether the name they use for their products, business or service promotes the use or supply of therapeutic goods or vaping goods. For example, in the past the Administrative Review Tribunal (formerly the Administrative Appeals Tribunal) has found that the name of a medicine advertised a therapeutic good for weight loss because the name of the medicine referred to this therapeutic use.
General principles for assessing whether material and activities are advertising
When deciding whether something is an advertisement, we assess material on a case-by-case basis, having regard to:
- the context in which the material is viewed.
- whether the material or activity has promotional characteristics.
No single factor will determine if a particular statement, pictorial representation or design is promotional. Advertising can be formed from the combination of separate elements that, taken together, are intended to promote the use or supply of the goods. Linkages to content related to the material will also be considered.
The context in which the material is viewed
When we assess whether particular material is advertising, we consider the context in which it is viewed. The context includes:
- the words used (written or verbal)
- non-verbal and unwritten messages (such as images). These may be just as important in assessing the material and can affect the audience’s take-out message
- the media or medium chosen to disseminate the material
- the audience that the material is directed to, what their likely take-out message is
- Advertisements may be targeted to:
- the masses, for example, a newspaper advertisement for cold relief products
- a specific patient group, for example, an advertisement for blood glucose meters in a magazine for diabetics
- individual consumers, for example, a letter or email to individuals that have bought certain types of products from a clinic in the last 12 months.
- Advertisements may be targeted to:
- other material in proximity to the information (or linked to it) that is likely to be seen by the viewer.
- This includes third party content, such as external websites, blogs, articles and testimonials that draw the consumers mind to particular goods.
Example - How context changes the overall impression
A website that sells medical devices includes articles about health conditions written by a health professional. The articles do not mention specific products but describe the benefits of certain medical devices for certain health conditions.
Because the website sells medical devices mentioned in the articles, it is likely the articles would be considered to form part of the advertising for those goods.
If the article is published in a newsletter for health professionals, it may not be considered an advertisement, depending on the context.
Note: advertising is permitted for a majority of medical devices provided the advertisement complies with the Act, Regulations and Code.
Promotional characteristics
Some of the factors that indicate messaging may be promotional are where it:
- prompts a call to action from potential customers to encourage them to make a purchase or seek out a product
- refers to specific therapeutic goods or vaping goods or a specific class of goods, including a brand of goods, in a manner that:
- creates a favourable impression
- gives publicity or raise awareness of the good or brand
- contains a therapeutic claim, recommendation or suggestion that a specific therapeutic good is beneficial for a particular health condition
- includes representations about the goods which on their face appear designed to persuade consumers, such as by:
- referring to its benefits and features, including through words, non-verbal and unwritten messages (such as images)
- using descriptive adjectives or statements that are emotive such as describing a therapeutic good or vaping good as 'brilliant' or 'life changing' or a ‘break through’
- using superlatives such as 'the best', ‘effective’, 'works faster', or ‘new improved formulation’
- making a favourable comparison to other therapeutic goods or vaping goods
- emphasises the benefits, features and positive aspects of a therapeutic good, vaping good or class of goods, including where the content also omits or downplays their risks or limitations
- provides information for how particular therapeutic goods or vaping goods can be purchased or obtained such as:
- price and point of sale information
- availability of goods from a business
- offers, discounts and competitions
- refers to effects of the goods and is disseminated by or on behalf of a party with a financial interest in the sale of the goods, such as manufacturers, sponsors or retailers.
These factors are not exhaustive. Other factors or circumstances will be taken into account when considering whether information is intended to promote the use or supply of a therapeutic good or vaping good.
Non-promotional material
Not all material about therapeutic goods is advertising.
Examples of non-promotional information include:
- certain content relating to human health or diseases. For more information see Advertising guidance for providers of disease education activities
- advertising for health services that does not refer, either directly or indirectly, to therapeutic goods or vaping goods. For more information see Advertising health services
- correspondence with a potential customer, possibly accompanied by material of a non-promotional nature, to answer a specific unsolicited question about a therapeutic good, for example allergy information
- operational information about a company that does not promote the use or supply of particular therapeutic goods or vaping goods or a class of goods.
Page history
Major update and re-write of content to more clearly articulate when content relating to therapeutic goods and vaping goods is likely to be regulated as advertising, including new examples and outline of some of factors that indicate messaging may be promotional.
Minor update to 'Promotional activities' section.
Original publication.
Major update and re-write of content to more clearly articulate when content relating to therapeutic goods and vaping goods is likely to be regulated as advertising, including new examples and outline of some of factors that indicate messaging may be promotional.
Minor update to 'Promotional activities' section.
Original publication.