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Guidance on applying the Advertising Code rules

26 May 2022

24 December 2021: The 2021 Advertising Code takes effect on 1 January 2022 and will be subject to a 6-month transition period until 30 June 2022 where both the 2018 and 2021 Advertising Codes will apply. The Advertising Code guidance has been updated to reflect changes to the Code. Further changes will be made to advertising education and guidance material over the coming months.

Mandatory statements

Part 4 of the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code) sets out statements that must accompany the advertising of specific therapeutic goods. Mandatory statements have been simplified in the 2021 Advertising Code following consumer testing.

Therapeutic goods are available through a range of avenues other than at a pharmacy including:

  • Internet
  • Social media
  • Radio
  • Direct marketing such as mail-order
  • Supermarkets.

Regardless of the platform where the advertising of medicines, devices and other therapeutic goods is conducted, they must include mandatory statements because they provide information about the product, warnings about the product's use and guidance for consumers to seek assistance if required.

Part 4 of the Code requires certain information to be 'prominently displayed or communicated' in advertisements as defined in Part 4 of the Code. Examples of how to present information in this manner are provided in the related section of this guidance.

For written advertisements, statements must be prominently displayed on the same page that the advertisement for the therapeutic good is displayed.

If the written advertisement is on social media, the statement must be available at all times and not collapsed into a view that is only visible if the consumer selects 'see more' or similar.

For audio advertisements, this statement must be prominently communicated to be as part of the advertisement for the therapeutic good.

This principle can be applied to other variations of possible advertisements.

Pharmacist-only medicines

Pharmacist-only medicines that contain ingredients listed in both Schedule 3 and Appendix H of the Poisons Standard may be advertised to consumers. All advertisements must contain the following statement prominently displayed or communicated:

ASK YOUR PHARMACIST ABOUT THIS PRODUCT

This statement is to ensure that a consumer talks to a pharmacist about the medicine. The pharmacist can consider the needs of the consumer and if the product is right for them. Pharmacist-only medicines that are not included in Appendix H - Schedule 3 of the Poisons Standard cannot be advertised to consumers.

The statement for advertisements of medicines 'ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE' are not required for pharmacist-only medicines.

For details refer to Part 4, Section 15 of the Code.

Jill needs to purchase a medicine that contains an ingredient included in schedule 3 (appendix H) of the Poisons Standard.

Jill can only purchase this medicine at the Pharmacy.

When advertising for such medicines, the advertiser must include the statement 'ASK YOUR PHARMACIST ABOUT THIS PRODUCT' in a way that Jill can clearly see and/or hear.

This will prompt Jill to have a conversation with the pharmacist to determine if the product is right for her and, if appropriate, purchase it from the pharmacy.

Not available for purchase by the general public

Advertisements for products that are only available for supply through a health professional must contain the following statement, prominently displayed or communicated:

THIS PRODUCT IS NOT AVAILABLE FOR PURCHASE BY THE GENERAL PUBLIC

For written advertisements, this statement must be prominently displayed on the same page that the advertisement for the therapeutic good is displayed. This means that if the good is displayed on a landing webpage and its own product webpage, the mandatory statement must be included on both pages and any other pages the product is displayed.

For audio advertisements, this statement must be prominently communicated to be part of the advertisement for the therapeutic good.

For details refer to Part 4, Section 16 of the Code.

Example: in vitro diagnostic medical device

While accessing a website, Jack sees an advertisement for an in vitro diagnostic (IVD) medical device.

The advertisement does not have a purchase price or a link for purchase.

The IVD can only be purchased in Australia by certain health professionals.

As Jack can view this advertisement, the advertiser must prominently display the statement 'THIS PRODUCT IS NOT AVAILABLE FOR PURCHASE BY THE GENERAL PUBLIC' for Jack to be able to see and understand that the product is not available for him to purchase.

The other requirements of the Code must also be met, as the exemption to those requirements does not apply whilst members of the public have access to the advertisement.

Example: medical devices only sold to dentists

Jane conducted a web search for dentists and accessed a webpage for a company which sells medical devices to dentists.

The company advertises these devices on its website and Jane is interested in some of the dental devices although she is not an AHPRA registered health professional.

The advertiser has a responsibility to ensure Jane is not led to the view that she can purchase the devices.

The advertiser must prominently display 'THIS PRODUCT IS NOT AVAILABLE FOR PURCHASE BY THE GENERAL PUBLIC' so Jane is able to see and understand that the product is not available for her to purchase.

The advertisement must also comply with the other advertising requirements in the Act and Code as it is publicly accessible.

Short form advertisement

'Short form' advertisements include:

  • Radio advertisements
    • that are 15 seconds or less in duration.
  • Text only advertisements
    • that consist of 300 characters or less, and
    • there is no capacity to include a picture, logo or other imagery as part of the advertisement.

Advertisements in social media are not considered 'short form advertisements' because they either have capacity to include all the applicable mandatory statements in the advertisement itself or they can include links to all the applicable mandatory statements.

Short form advertisements must contain the following statement, prominently displayed or communicated:

ALWAYS FOLLOW THE DIRECTIONS FOR USE

Where advertisements have scope to contain pictures, videos or any other types of representations it is expected that the requirement to include the mandatory statements is fulfilled, even where the text of the advertisement consists of 300 characters or less.

A radio advertisement in its entirety must be 15 seconds or less in duration to qualify for using only the above statement.

Any reference to a website in a radio or television advertisement that must lead to content that meets all requirements of the Code.

For details refer to Part 4, Section 17 of the Code.

Advertisements about medicines

An advertisement about a medicine must contain the following statement, prominently displayed or communicated:

ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE

This does not apply to pharmacist-only medicines that contain ingredients that are captured in Schedule 3 and Appendix H of the current Poison Standard.

For details refer to Part 4, Section 19 of the Code.

Beans Pty Ltd (Beans) is the sponsor of a listed folic acid supplement 'Befol'. Befol is a listed medicine and does not contain any scheduled substances included in the Poisons Standard.

Befol is indicated for reducing the risk of having a child with spina bifida/neural tube defects.

Beans advertises Befol in a television commercial.

Beans is required to include the statement 'ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE'.

Beans understand that this statement must be prominently displayed or communicated and makes a decision about what would be easily read (if the statement appears in writing) or understood (if the statement is spoken) by the consumer viewing the advertisement.

Beans is advertising compliantly.

Advertisements about complementary medicines

An advertisement about complementary medicines that includes one or more claims based on evidence of traditional use for active ingredients in the medicine, must prominently display or communicate a statement (or words that have the same meaning):

BASED ON TRADITIONAL USE IN <insert therapeutic tradition> MEDICINE (refer to the complementary therapeutic tradition such as Western Herbal Medicine, Ayurvedic Medicine, Homeopathy etc)

The Code no longer refers explicitly to the "paradigm” as the concept of the complementary therapeutic paradigm is included within the definition for "the traditional use” of an active ingredient in the medicine.

It is not sufficient for the advertisement to only state 'based on traditional use'. The traditional use must also state the complementary therapeutic tradition in which it is used. A few examples of these traditions include homoeopathy, anthroposophy, western herbalism, Ayurveda, Rongoa and traditional Chinese medicine.

These statements may be combined where more than one ingredient is involved. It must remain clear to the intended audience of the advertisement which ingredient(s) are associated with which tradition(s).

Example:

Rachel comes across an advertisement during her regular television viewing of her favourite evening show. The advertisement is for Beanz Chesty. Beanz Chesty claims to relieve the symptoms of chest congestion by including horseradish in the formulation.

The active ingredient (horseradish) included in Beanz Chesty is traditionally used in western herbal medicine to relieve chest congestion.

TV advertisements for Beanz Chesty must prominently display the statement "Beanz Chesty can relieve chest congestion based on traditional use of horseradish in western herbal medicine" or alternatively "Horseradish is traditionally used in western herbal medicine to relieve chest congestion." for Rachel to clearly see and understand during the advertisement.

Advertisements about medical devices

An advertisement about medical devices must contain the following statement prominently displayed or communicated:

ALWAYS FOLLOW THE DIRECTIONS FOR USE

or

ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE

The first statement may be used in any advertisement of medical devices and provides a streamlined statement suitable for these types of products.

In instances where advertisers have an advertisement containing both medicines and medical devices on one page, they may choose to use the single mandatory statement 'ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE' which will apply to both the advertised medicine and device.

To be eligible to do this the medicine must not be a medicine included in Appendix H - Schedule 3 of the Poisons Standard or an analgesic as these medicines require specific mandatory statements.

For details refer to Part 4, Section 20 of the Code.

A company advertises a blood pressure monitor for consumers during a television program.

Sarah sees this advertisement during an ad break while watching The Bachelor and thinks it might be useful for monitoring her high blood pressure between GP visits.

Sarah is interested in the blood pressure monitor.

During the advertisement Sarah can clearly see and/or hear 'ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE' to ensure she is informed before purchase.

When Sarah goes to the pharmacy to buy the blood pressure monitor, she reads all the product information on the label and the directions for use.

Being unsure about her specific needs, she proceeds to talk to her pharmacist about the product to make sure its suitable for her.

Advertisements about other therapeutic goods

An 'other therapeutic good' is one that is not regulated specifically as a medicine, biological or medical device such as a:

  • sterilant
  • disinfectant
  • tampon
  • menstrual cup.

Sanitary pads and period underwear are not therapeutic goods and not subject to the Code.

Disinfectant products do not include hand sanitisers. While some hand sanitiser products are regulated by the TGA as medicines and the relevant mandatory statement for medicines must be used when advertising these products, many hand sanitisers are consumer goods which are not subject to TGA regulation.

An advertisement about other therapeutic goods must contain the following statement, prominently displayed, or communicated:

ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE

Where there is no label on, or attached to, the therapeutic good - the following statement must be prominently displayed or communicated:

ALWAYS FOLLOW THE DIRECTIONS FOR USE

For details refer to Part 4, Section 21 of the Code.

Health warnings

Summary

Some medicines, medical devices, and other therapeutic goods have associated health warnings.

Health warning information is essential for the consumer to make an informed decision about whether the product is suitable for them and their individual circumstances.

Where a therapeutic good has an associated health warning, Part 4 of the Code requires that advertisements for that good include the warning.

Health warnings are required to be prominently displayed in advertising that facilitates purchase of the good that is not available for inspection before purchase. This includes sales through the internet, through call centres and by mail order.

As long as an advertisement contains the health warnings for the good that requires them, the advertiser is able to elaborate as well, or provide further warnings. The Code sets a minimum requirement, as set out below.

When using an image also provide warnings in text form

Providing consumers with an image of the product label in online advertising assists consumers to assess and choose a therapeutic good when they cannot physically inspect it.

The Code requires product health warnings be reproduced in text form in online advertisements where there is a click-to-buy option.

This ensures that consumers can access pertinent product information even if they cannot load an image or are using screen readers due to visual impairment.

In instances where advertising leads to a purchase made by telephone, advertisers must be able to demonstrate how they have provided consumers with the health warnings before any purchase is made. This may include through the advertising itself, sales procedures or scripts or directly on order forms if appropriate.

How health warnings apply

Medicines

Many medicines have vital health warnings included on the label that are required by legislative instruments such as:

If one or more health warnings apply, either of the following must be prominently displayed or communicated in an advertisement where the consumer can purchase the medicine without physically inspecting it first:

  • A list of the health warnings in text form; or
  • A list of the health warnings provided verbally

Where a health warning is required by a legislative instrument, it is required to be replicated in the advertisement for the therapeutic good.

Beans PTY LTD (Beans) advertises Befol on the company website which facilitates the direct purchase of Befol by the consumer. The consumer can purchase Befol online and have it delivered to them directly.

Beans understands that there are 'health warnings' for Befol.

The relevant legislative instrument, the Required Advisory Statements for Medicine Labels, requires that these statements appear on the label of Befol:

'DO NOT EXCEED THE STATED DOSE EXCEPT ON MEDICAL ADVICE.'

'IF YOU HAVE HAD A BABY WITH NEURAL TUBE DEFECT / SPINAL BIFIDA, SEEK SPECIFIC MEDICAL ADVICE'

These statements are also required to be prominently displayed in the website advertisement for Befol as the advertisement has an 'add to cart' function.

While one of the required statements 'IF YOU HAVE HAD A BABY WITH NEURAL TUBE DEFECT / SPINAL BIFIDA, SEEK SPECIFIC MEDICAL ADVICE' is a 'restricted representation', as it is a statement required by the Code and labelling instrument, restricted representation approval is not required before it is used in advertising.

Jill is recommended to provide a probiotic to her young child with Irritable Bowel Syndrome (IBS).

An advertisement for Beans Probiotic says she can buy it online. The probiotic contains Bacillus coagulans as an ingredient.

The warning 'NOT SUITABLE FOR CHILDREN' appears on the label and is a health warning.

The warning must be prominently displayed in the advertisement so that Jill is aware of this before purchasing the product.

Medical devices

Sponsors of medical devices regulated by the TGA are required to hold evidence to demonstrate their device meets certain safety, quality and performance requirements known as Essential Principles. Essential Principles are specified in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002. Of note for advertisers, Essential Principle 13 pertains to information that must be supplied with the medical device on label or in the Instructions for Use.

Advertisers should check if their good has a requirement for this information be included on the label, the packaging or some other document (such as Instructions for Use or Patient Leaflets) provided with the medical device.

Where required, as the information is required by a legislative instrument, it must appear in the advertisement as a health warning.

If the medical device has one or more health warnings then any advertisement where the consumer can purchase the device without physically inspecting it first, must prominently display or communicate:

  • A list of the health warnings in text form; or
  • A list of the health warnings provided verbally; or
    • A link to the health warnings
      • The link provided to the consumer must be direct access to the warnings or a document, such as the instructions for use, which contain those warnings.

Jack has heart failure and underwent surgery to install a pacemaker.

A door to door salesman arrives selling an electronic device 'Beanz Electro Therapist' that will relieve the pain in his ankle. They offer to have a courier deliver the device tomorrow if Jack is interested in purchasing the product.

The manufacturer has included a warning on the packaging 'DO NOT USE IF YOU HAVE A PACEMAKER'.

The warning is a health warning that must be prominently (clearly) communicated to Jack before the salesman completes an order for purchase

Jill has diabetes and has just found out she is pregnant.

She hears an advertisement on the radio for a new kind of lancet coated with a fast-acting pain control ingredient. It says to ring 1300 999 999 to order the lancets.

The manufacturer is unsure about the safety of the ingredient for a foetus and includes the warning 'DO NOT USE IF YOU MAY BECOME OR ARE PREGNANT' on the label of the lancets and in the leaflet provided with the lancets.

The is a health warning and the call centre must prominently communicate this warning to Jill before taking an order for the product.

This communication should be included in the sales script used in the call centre.

Other therapeutic goods

Therapeutic goods which are not classified as medicines, medical devices or biologicals are called other therapeutic goods.

Where these have associated health warnings, advertisers must ensure the following pieces of information are prominently displayed or communicated in any advertisement where the consumer can purchase the good without physically inspecting it:

  • A list of the health warnings in text form; or
  • A list of the health warnings provided verbally; or
  • A link to the health warnings
    • The link provided to the consumer must be direct access to the warnings or a document, such as the instructions for use, which contain those warnings.

A pharmacy advertises a range of therapeutic goods on its website. The website has 'buy now' functionality.

The advertisement includes the promotion of a new tampon brand and consumers can have the tampons sent directly to them.

The website contains a link with the heading 'warnings'. That link contains prominently displayed warnings that are required by law to be included on the label, packaging or in information included with the good.

The pharmacy is compliant with the Code in this regard.

Health warnings which are restricted representations

Advertisers should note that at times there may be health warnings that contain restricted representations. It is therefore reasonable to ask whether you then need to apply to use a restricted representation in advertising.

Where a health warning statement is required by a legislative instrument to be on the label of the good, and in the advertisement that facilitates the direct purchase of the good, approval to use a restricted representation is not required.

If you are unsure what a restricted representation, please review the webpage information for this topic at restricted representations.

Therapeutic goods not available for inspection before purchase

Advertisements that facilitate purchase of therapeutic goods from online platforms, such as a website or mobile application (app), must comply with the Act and the Code. As do advertisements for those therapeutic goods, such as on social media, mail order and via call centres.

Health warnings and mandatory statements are to be prominently displayed and communicated.

An image of the product label is not sufficient to meet this requirement.

The health warnings and statements that are on the label should be reproduced in text of the advertisement.

Simona is a registered pharmacist at Theras Pty Ltd. Simona opens a new website to advertise and sell therapeutic goods from her pharmacy.

Each of the advertisements for a therapeutic good contain:

  • Image of the good
  • Name of the good
  • Size of the container/package
  • Indications
  • Ingredients
  • Mandatory statements
  • Health warnings
  • Related goods and links to those

The website is compliant as the health warnings and mandatory statements have been reproduced on the website.

Simona opens a business Facebook page to reach more customers.

She makes posts containing the image of the product. The name, pack size, link to the website, indications and mandatory statements and health warnings are also in the Facebook posts advertising each good. The hash tags are collapsed below a 'see more' expandable.

This post is considered compliant with the Advertising Code.

Paul received a call from a call centre selling medicines over the phone. Paul has been lacking energy lately and asked the call centre operator if they had anything that would help with his fatigue.

The caller centre operator told Paul they had an energy boosting vitamin product which included 50 capsules for $30.

Paul asked if the product was right for him and the call centre operator told him it would help cure his fatigue. The operator did not advise Paul of the mandatory statements, the health warnings, or the indications for the medicine.

Paul completed his purchase and was excited to try his new vitamin product to boost his energy levels.

When the product arrived, Paul read the mandatory statement and health warnings on the label and noticed that it was an iron supplement which was contraindicated for his haemochromatosis condition (high iron level).

The call centre should have provided Paul with all the required information as per the packet before he completed the purchase.

The report was referred to the TGA for investigation.

Prominently displayed or communicated

The Code requires certain information to be 'prominently displayed or communicated' in advertisements.

The 'prominently displayed or communicated' requirement has been restricted to those provisions which require important mandatory information to be communicated in advertising - i.e. the messages that are critical to the consumer when self-selecting a product for self-treatment. Advertisers should be aware that the target audience of the advertisement should be considered. For example, to meet the requirement to be prominently displayed or communicated, an advertisement directed to people with eyesight difficulties may require special consideration to ensure the message is received in its entirety.

Examples of prominently displayed and communicated mandatory information

Mandatory statements are not required to be in any particular font style, size or format when included as visual statements in an advertisement, as long as they are 'prominently displayed or communicated' within the meaning of that term as defined in section 4 of the Code. For example, font embellishments (including serifs, italicised, cursive, shadowed, calligraphic, poster) and other fancy or irregular fonts, may affect the extent to which the required statement stands out so as to be easily read and understood.

The following examples are indicative of the requirements for ensuring mandatory statements are prominently displayed or communicated:

example advertisement showing mandatory statement that: Stands out - benchmark met. Factors: Font size and type similar to the main representations in the ad; Good contrast from background; Good separatation of individual warning statement assists
example advertisement showing mandatory statement that: Stands out - benchmark met. Factors: Font size and type similar to the main representations in the ad; Good contrast from background. Separation of individual warning statements may also assist.
example advertisement showing mandatory statement that: Stands out - benchmark not met. Factors: Font is too small compared with rest of ad; Text colour and background colour provide insufficient contrast; Individual statements are not distinguishable - all appears as one line.

Testimonials and endorsements

Specific information about Part 6 if the Code can be found on the guidance on testimonials and endorsements webpage.

Included in the ARTG, not TGA approved

It is acceptable to state that your product is included in the ARTG and or provide the listed (AUST L) or registered (AUST R) number for medicines - devices do not have these numbers.

You cannot imply that it's approved or endorsed by the TGA or any government authority.

In your advertisement is directed to the public, you are not permitted to refer to the TGA, use any government logo, or imply that any government body, including those in other countries, endorses a therapeutic good.

For further information on this top view our factsheet The claim 'TGA approved' must not be used in advertising.

Note: Assessed-listed medicines and registered complementary medicines which have been assessed for efficacy by the TGA are eligible to use the 'TGA assessed' claim on their medicine label and other advertising material.

Consistent with the ARTG entry

Advertising must be consistent with the information included in the ARTG entry for the advertised therapeutic goods.

Where the therapeutic goods are exempt from inclusion in the ARTG, the advertising must be consistent with the labelling or packaging.

The requirement for consistency applies to all aspects of the full ARTG entry, including the:

  • Product name or description of the therapeutic goods
  • Dosage form or, in the case of medical devices, the GMDN code
  • Formulation of the product
  • Intended purpose
  • Conditions applied to the ARTG entry
  • Required warnings or contraindications.

While therapeutic claims made in an advertisement must be consistent with the indication or the intended purpose of the therapeutic good, it is not necessary to replicate it exactly.

This concept is used in the definition for 'accepted indication'.

Indications may be reworded or joined together to improve comprehension or presentation of indications.

These changes must not alter the meaning of the indication or add an indication not in the ARTG entry.

At least one, but not all indications for medicines are required to be included in an advertisement.

Qualifying or clarifying information attached to the therapeutic claim can be used if it is substantiated by robust evidence.

Consistency with the label

It is expected that many advertisements will contain statements and claims that do not appear on the label of the advertised good.

There is no requirement for advertisements to ONLY contain information that appears on the label of the advertised good, but any information that appears in the advertisement must not be inconsistent with the label of the good.

For example, if an advertisement depicted a small child being given a medicine, and the medicine included dosage instructions only for adults, the advertisement would be considered to contain representations that were inconsistent with the directions for use of the medicine.

For details refer to Part 3, Section 9(3) of the Code.

Wording of indications

If a medicine has a range of indications recorded on the ARTG, the advertiser must use at least one of those indications in any advertisement for the medicine.

The term 'accepted indication' in the context of the Code means that the indication is recorded on the ARTG.

The 'accepted indication' does not however mean that the indication, as it appears on the ARTG or on the label of the good has to be replicated word for word in the advertisement.

As long as the meaning and the intent of the claim made in the advertisement is consistent with the indication on the ARTG and the label, these requirements will be satisfied.

For details refer to Part 3, Section 8(2) of the Code.

Accurate, truthful, not misleading

Part 3 of the Code states that any claims made in advertising must be valid, accurate, and substantiated. The information must be truthful, balanced and not misleading.

Claims need to be substantiated before use. Advertisers do not necessarily have to hold the information supporting every claim in an advertisement but must satisfy themselves that the information can be obtained. This may be from the sponsor or is available to them before including the claim in an advertisement.

Any claim, either by omission or ambiguity of important information, that could prompt a consumer's error of judgement about the use of therapeutic goods could be misleading.

An example of this is making claims around the 'natural' properties of a product. Without sufficient explanation for these claims, the meaning of 'natural' is open to interpretation and may result in consumers being misled. Find out more about promoting your product as natural.

Claims do not necessarily have to be inaccurate to be misleading, depending on the context in which the claims are made.

If you suspect that the placement of your advertisement could impact its compliance, the TGA recommends checking with the publisher or media agency.

Before you advertise, consider the:

  • Context in which your message is presented
  • Intended audience for your message and how it could be perceived
  • Use of visual and other non-verbal cues.

Substantiation of claims

Section 8 (1)(b) of the Code requires that all information in an advertisement is substantiated by the advertiser before the advertisement is published or broadcast.

This means that the party responsible for the advertisement must satisfy themselves that all claims can be supported with evidence. Whoever publishes or broadcasts the advertisement could be held responsible for it even in circumstances where the advertising material has been provided by another party.

Retailer advertisers

In circumstances where the advertiser is a retailer as opposed to the sponsor of the therapeutic goods, the responsibility of the third-party retailer would be the check the ARTG for consistency with the therapeutic claims being made.

It is likely to be reasonable for the retailer advertiser to assume therapeutic claims are substantiated especially if the claims are consistent with the advertised good's indication or intended purpose as it appears on the ARTG.

For other claims, such as 'voted the best tasting liquid supplement in Australia' or 'starts to work in less than 20 minutes', the advertiser, whether the sponsor of the advertised good or a third party retailer, would have to ensure the claim is substantiated with an appropriate level of evidence.

What does substantiation look like?

For the sponsor of the good, ensuring a claim is substantiated may entail a well-conducted study or evidence relating to the 'onset of action'.

For the third-party retailer advertiser, this may entail the advertiser seeking confirmation from the product sponsor that these claims are substantiated and the basis of the substantiation.

For details refer to Part 3, Section 8 of the Code.

A pharmacy advertises an over the counter medicine indicated for relieving cold symptoms. The Australian sponsor of the medicine provides the pharmacy with promotional material for the medicine.

The pharmacy checks that the therapeutic claims in the promotional material are consistent with the indications for the medicine as they are recorded on the ARTG. On discovering they are, the pharmacy advertiser can be confident the therapeutic claims in their own advertisement for the medicine are substantiated.

The promotional material provided by the sponsor also includes a number of non-therapeutic claims about the medicine, including the claim 'used by more Australians than other leading brands'.

The pharmacy advertiser needs to ensure this claim is substantiated by seeking evidence from the sponsor to support such a claim. The sponsor provides the pharmacy with the survey studies it used to arrive at the claim.

The pharmacy advertiser is satisfied from this information that the claim is substantiated by the studies and therefore can be satisfied the claim is substantiated.

The pharmacy advertiser has satisfactorily ensured the claims in the advertisement it is publishing are substantiated.

A social media influencer promotes an eczema cream and claims she uses it because it is the 'most effective cream on the market'. The influencer has no evidence whatsoever to substantiate such a claim and is therefore liable under the Code for making unsubstantiated claims in an advertisement for a therapeutic good.

Safe and proper use

Advertising must support the safe and proper use of therapeutic goods. The way a good is presented must be:

  • consistent with the directions or instructions for use for the good
  • not exaggerate the good's efficacy or performance
  • not be likely to lead to consumers using the good inappropriately or excessively.

Claiming therapeutic goods are 'safe' or have 'no side effects' could influence consumer choices, be misleading or result in inappropriate use. All therapeutic goods can have side-effects and no therapeutic goods are universally 'safe'.

Claims that a good is 'safe' or have 'no side effects' are specifically prohibited.

This is true for specific patient populations or particular dosages even if you think there is evidence to substantiate such a claim.

Your advertisement must not:

  • suggest consumers delay seeking medical attention or use treatment prescribed by a medical practitioner in favour of using the advertised product.
  • encourage consumers to use therapeutic goods inappropriately or excessively for the intended purpose.
  • suggest a product is effective in all cases, offer any certain benefit from using it or imply a negative outcome if the product is not used.

For details refer to Part 3, Section 9 of the Code.

Product and service comparisons

In general, it is good practice to not compare one therapeutic good to other goods.

Where done, comparisons of the advertised good with other goods or health services should be factual, fair and not undermine the goods used as the comparator.

Comparative advertising, while permitted under the Code, must not suggest that the comparator goods or services are harmful or ineffectual, either directly or by implication.

An advertisement for an 'organic' tampon lists the chemicals included in a competitor's tampons to indicate their 'organic' tampons are safer and chemical free.

This type of advertising implies the comparator goods are harmful. This is not fair or factual and the TGA would not have approved the tampons if they were unsafe.

Broad comparisons like 'higher strength' or 'better absorbed' should not be used unless it is clear to the audience which goods are being compared.

The use of superlatives that suggest a comparison to all other goods, or in certain cases services, for example, by describing a therapeutic good as 'the best' or 'works fastest' should not be used.

For details refer to Part 3, Section 9 of the Code.

Scientific or clinical representations

Scientific or clinical terminology must be clearly explained, easily understood by consumers and consistent with the broader body of evidence relating to the product.

Using scientific claims can give credibility to representations, so it is important that studies are used correctly. The restriction on the kind of terminology used applies only to these representations.

References to scientific or clinical studies must be accompanied by sufficient and unambiguous information which will provide consumers a clear pathway to locate or request access to the study.

If your business does not make the study or data available on request, your advertising may be considered misleading.

Identifying a financial sponsor

The financial sponsor must be disclosed in certain circumstances.

Many scientific journals now require and publish this information with papers. In-house studies will have this information available from the owner of the studies. Where these are cited in an advertisement the disclosure is expected.

Textbooks and other reference sources do not usually include this information with their citations.

Studies and other materials available through the published literature must be obtained and paid for by the consumer. All other studies must be provided by the advertiser at no charge to the consumer.

Find out more about using scientific or clinical claims.

For details refer to Part 3, Section 11 of the Code.

Advertising lawfully to children

Advertisements for therapeutic goods must not be directed to children under the age of 12 years. Products containing substances included in Schedule 2, Schedule 3, Schedule 4, or Schedule 8 of the Poisons Standard may not be advertised to children of any age.

Only advertisements for certain products may be directed to children aged 12 and over. These are:

  • tampons
  • acne preparations
  • sunscreens with SPF 15+
  • condoms and personal lubricants
  • bandages and dressings
  • cold sore preparations
  • lip balm
  • unscheduled anti-dandruff preparations
  • Class 1 medical devices for the management of chronic conditions under medical supervision.

Advertisements for these products are permitted to be directed to children aged 12 and over as this audience is likely to have the maturity to make responsible decisions in relation to the advertised products.

Advertisers can apply to the TGA to have additional products added to the list by contacting the Advertising Enquiries.

For details refer to Part 3, Section 12 of the Code.

Samples

Sample means any therapeutic goods given for free. Some therapeutic good samples can be offered to consumers. They must meet certain conditions.

Therapeutic goods that advertisers can offer as samples are:

  • condoms and personal lubricants
  • continence catheter devices for self-management
  • COVID-19 rapid antigen tests for self-testing
  • disinfectants
  • face masks and gloves for preventing the transmission of disease in persons
  • hand sanitisers
  • lancets and blood glucose strips for use in connection with measuring blood glucose
  • nicotine replacement therapies administered by oromucosal or transdermal means, including sprays, patches, gums, lozenges, sachets and tablets
  • oral hygiene goods, including toothpaste, mouthwash and interdental brushes
  • oral rehydration goods
  • stoma devices for self-management
  • sunscreens and other therapeutic goods containing sunscreen
  • tampons and menstrual cups
  • wound care dressings for superficial wounds, including first aid items and antiseptics

Advertisers are not permitted to promote or distribute samples of any other therapeutic goods.

To be able to provide or advertise samples they:

  • Must be included on the ARTG, in an approved pack size, or exempt from the requirement to be included in the ARTG.
  • May be provided to children (12 years and over) for products that may also be advertised to children.
  • Must not contain substances included in Schedule 2, Schedule 3, Schedule 4 or Schedule 8 of the Poison Standard.

Restrictions on the provision of samples do not apply to healthcare professionals during the treatment of a patient.

Advertisers can apply to the TGA to have additional samples added to the list by contacting the Advertising Enquiries.

Any additional samples will be considered for suitability against the TGA's guiding principles for products that can be given as samples. The guiding principles state that any samples included need to have clear health or social welfare benefits, cannot be brand-specific, must be entered on the ARTG (as required) and must not require health professional advice for safe and appropriate use.

For details refer to Part 7, Section 25, and Annexure 2, of the Code.

Public health campaigns

Advertisers need to be aware of any public health campaigns and ensure any planned advertisements are not inconsistent with these important health and safety messages.

Government priorities in public health messaging change depending on needs within the community and developments in health policy, while others remain constant.

Advertising a product which claims to prevent or cure hangovers.

This is inconsistent with public health priorities as they potentially encourage consumers to disregard health advice about the damaging impacts of alcohol.

Other therapeutic goods related to ongoing public health campaigns include:

  • sunscreens
  • cough and cold medicines
  • smoking cessation
  • vaccines.

For details refer to Part 3, Section 10 of the Code.

Price information

Restricted scheduled goods and substances

The Act prohibits advertising of a substance, or a therapeutic good containing a substance, included in the current Poisons Standard:

  • Schedule 3 (Pharmacist-Only medicine)
    • unless the Schedule 3 substance is listed in Appendix H to the current Poisons Standard
  • Schedule 4 (Prescription-Only medicine)
  • Schedule 8 (Controlled Drug).

Substances which are listed in Schedules 3 (but not in Appendix H), 4 or 8 are collectively referred to as, restricted scheduled substances.

Therapeutic goods containing restricted scheduled substances are referred to in this part of the Guidance as restricted scheduled goods (medicines or medical devices as appropriate).

Unless the subject of an exemption, advertisements for restricted scheduled goods must not be accessible to consumers.

Therapeutic goods that do not contain restricted scheduled substances can generally be advertised to consumers. These advertisements must comply with the requirements under the Act, the Regulations, and the Code.

Advertising prices of medicines

The Code (excluding Part 9) sets out how to advertise price information for medicines other than restricted scheduled medicines.

Combined price advertising of restricted scheduled medicines and OTC or complementary medicines often fail to meet the requirements of Part 9 of the Code. Price information for restricted scheduled medical devices cannot be advertised.

There are requirements for price advertising of restricted scheduled medicines that do not apply to other advertising of therapeutic goods including that any photographs or other reproductions of the medicine are prohibited as are any references to a therapeutic use.