Testimonials and Endorsements
When redrafting the provision for testimonials, why was the status quo implemented by the TGA when there were submissions in favour of change?
The TGA carefully considered the views expressed in the consultation submissions about the new Code, as well as the advice of members of the Therapeutic Goods Advertising Consultative Committee. In relation to testimonials these views were markedly divergent and ranged from support for outright prohibition on the use of testimonials through to support for reduced regulation.
It is acknowledged that testimonials can provide useful insights for consumers about others' experience using the product so long as controls are in place to ensure testimonials are genuine and unbiased. Therefore, an outright prohibition of testimonials was not implemented.
The new Code clarifies the type of testimonials that can be used in advertising and as far as is possible, ensures that testimonials are unbiased and cannot be influenced by commercial interests or personal gain.
Are we required to amend old social media posts that were published prior to 1 January 2022?
Yes, however a transition period applies until 30 June 2022 during which advertisements may comply with either the 2018 or the 2021 Code.
Can advertisers 'lift' positive reviews about their product from review websites and publish these on their own website as testimonials?
Advertisers are obligated to ensure that advertisements do not contain a testimonial, unless the advertiser has verified the content of, and identity of the person making, the testimonial.
Mandatory statements
When a one-page advertisement contains multiple therapeutic goods, and each of the products requires a distinct mandatory statement, do I need to include each mandatory statement with each good?
The mandatory statements (including health warnings when these are required) are a critical component of the safety information in an advertisement.
Where advertisements include multiple products with each requiring the same mandatory statement, the mandatory statement can appear once but must be clearly visible in conjunction with the relevant product. For example, in online advertising the mandatory statement must be prominently displayed and communicated in the same screen shot as the product. For a hard copy catalogue the relevant statements must appear on each page.
Where health warnings are also required, these must be presented so that it is unambiguous that the warning relates to a particular product. A health warning at the bottom of a page of multiple products is unlikely to be compliant with the Code.
The 2021 Code has taken into account that a single advertisement might include a medicine and medical device, and the mandatory statement requirements for these product categories have been aligned so that a single statement can be used where appropriate.
Note that the requirement for prominence of the statements must be met. Techniques based on using footnotes or similar, are unlikely to be compliant with the Code.
Can the mandatory statement in an advertisement for a medical device or other therapeutic good (OTG) have a FULL STOP between 'label' and 'follow' instead of AND?
ALWAYS READ THE LABEL. FOLLOW THE DIRECTIONS FOR USE.
In place of
ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE.
The wording as set out in the Code must be used.
Health warnings
What health warnings are required to be included in advertisements that can result in the direct supply to consumers of medicines that are not able to be physically inspected by the consumer before supply?
If a medicine is legally required to include on its label a statement that is a warning, contra-indication, precaution or restriction, then the statement must be included in an advertisement for the medicine where the consumer can make a purchase of that product from the advertisement.
It is important that when a consumer is making a purchase of a product online or via telephone, that they have access to the same health warnings that are available when purchasing a product in person following visual inspection.
Health warnings are essential information when making a purchasing decision in relation to health products, and must be prominently displayed or communicated in the advertisement.
For call centres, the use of scripts is recommended to ensure the health warnings for each medicine are clearly communicated to the consumer before their purchase.
Short form advertisements
For short form advertisements, do I still need to include a product name and intended purpose?
Yes, short form advertisements must comply with the general requirements set out for the type of advertised good.
Restricted representations
If a health warning contains a restricted representation, do I need to apply for approval to use the health warning in an advertisement?
No, not if the health warning is required by a legislative instrument.
Approval to use a restricted representation in advertising under section 42DF of the Therapeutic Goods Act 1989 is not required where a legislative instrument, including the Therapeutic Goods Advertising Code, requires that the health warning be displayed on the label and in advertising.
Any warnings that include a restricted representation that a sponsor chooses to include in their advertising that are not required by a legislative instrument, will require TGA approval.
Why was the list of prohibited representations removed from the Code? Are use of these in advertising no longer prohibited?
A prohibited representation is an advertising claim or reference that must not be used in any circumstances except with the express permission of the TGA.
Previously, prohibited representations were listed in Schedule 2 of the Therapeutic Goods Regulations as well as in the 2018 Code. This duplication was addressed by removing prohibited representations content from the 2021 Code. The Therapeutic Goods Regulations continue to prohibit certain representations in advertising.
Therefore, using a prohibited representation without prior permission from the TGA remains an offence under sub-section 42DL(5) of the Act.
Note. Representations that are prohibited are listed in Part 1 of Schedule 2 of the Therapeutic Goods Regulations 1990 compilation. Item 10 refers to the prohibited representations that were included in the 2018 Code.
Provisions relating to prohibited representations about vitamins and minerals, and analgesics, are not included in the 2021 Code. Does this mean that the specified warning statements are now only required on the label?
No.
The prohibitions on using certain representations about analgesics, vitamins and minerals have been moved to the Therapeutic Goods Regulations 1990.
The warning statement:
INCORRECT USE COULD BE HARMFUL
- is still required in advertising of analgesics.
Social media advertising
When is a social media post is considered advertising over educational content?
Any post on social media that promotes the supply OR use of a therapeutic good is likely to be considered advertising. Whether something is promotional is assessed by what a reasonable member of the public or consumer would take away from the post. For example, do they come away encouraged to seek out the good for purchase.
The post must also be considered in the context of the surrounding posts or content. For example, a link in the post taking the viewer to where they can purchase the good, or find promotional material for the good, would make the post an advertisement.
Information that is factual, balanced and not misleading, including information that is disseminated for the appropriate use of the goods (for example, Consumer Medicine Information, instructions for use) is unlikely to be considered promotional.
Further information on social media is in the TGA social media advertising guide.
Further information that may assist in distinguishing advertising from other material is also published on the TGA website.
How do I advertise my business on social media or practice website if I cannot name a specific therapeutic good?
The guidance Advertising for health services will assist practice and business owners to promote their business in a way that complies with the regulatory requirements for advertising therapeutic goods including the Code.
Checklists and educational items
- What summary materials will TGA provide to assist advertisers in compliance? For example, Checklists that cross-reference the Code.
- Can absolute clarity be provided?
Materials available to assist advertisers include:
- Fact sheets on a range of topics.
- A Consumer advertising compliance checklist.
- Guidance to assist advertisers to comply with the Code - Complying with advertising requirements.
- Guidance to assist advertisers comply with the broader regulatory framework for advertising therapeutic goods - Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG). The TGA plans to update and republish this by mid-2022.
Advertising examples are also published on our Learning resources webpage.
You may wish to seek advice from a regulatory affairs consultant, advertising advisory service or lawyer.
The TGA undertakes continuous improvement of online guidance material, often in consultation with the Therapeutic Goods Advertising Consultative Committee. If you would like to request changes or additions to our published material, please contact us via the enquiries portal form.
Contacting the advertising area of TGA
How do I submit a post-webinar question?
Please submit advertising questions via:
- the Enquiries portal
How do I contact the TGA about advertising?
You can find relevant forms at the bottom of the TGA website page titled Complying with advertising requirements
OR
- Please follow these links:
Guidance and resources
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Reference materialThis guidance explains part 6 of the Code, which outlines requirements for using endorsements and testimonials in advertisements about therapeutic goods.