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Advertising to the public

Complying with the Therapeutic Goods Advertising Code (No. 2) 2018

2 January 2019

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Part 4 - Restricted representations and prohibited representations

Guidance on specific Code provisions

The numbering of the sections corresponds to the numbering of the Code provisions for ease of cross-reference. However, this guidance does not cover all sections of the Code so the numbering may not be sequential.

28 Restricted representations - serious form of disease, condition, ailment or defect

This section identifies a serious form of a disease, condition, ailment or defect for the purposes of section 42DD of the Act.

However, if a reference to a disease, condition, ailment or defect is qualified in such a way that it does not meet any of the criteria, it will not be considered a serious form of the disease, and will not be a restricted representation (for example mild osteoarthritis).

Under certain circumstances, the use of 'restricted representations' may be appropriate, however, the use of such representations requires detailed consideration by the TGA to ensure such use does not compromise individual or public health and to ensure the representations are accurate, balanced and not misleading. Consumers who know, or suspect they have, a serious disease or who may be the primary carer for such a person, are particularly vulnerable. See Restricted representations and advertising for more information.

The definition of a serious form of a disease, condition, ailment or defect (collectively, 'condition') specifically excludes those conditions that, although must be medically diagnosed, are medically accepted as being suitable for self-treatment and management.

If a form of a condition is medically accepted as a form that can be self-treated and managed after diagnosis by a health professional, the onus is on the advertiser to ensure the form is represented in the advertising as having been already medically diagnosed, otherwise the representation would meet the definition of a restricted representation. For example, while plantar fasciitis (heel pain caused by inflammation of the tissue along the bottom of the foot) can generally be self-treated and managed, if the advertisement did not make it clear that the good was only suitable for use by consumers that have already been diagnosed with the condition, the representation containing the reference to plantar fasciitis would be a restricted representation and could not be used without prior approval from TGA. However, a reference to 'medically diagnosed plantar fasciitis' would not be considered a restricted representation.

The requirement to clearly qualify such a condition in advertising is especially important for conditions that, while medically accepted to be suitable for self-treatment and self-management, share symptoms and signs with other conditions that might be more serious and require medical treatment (for example plantar fasciitis requires medical diagnosis to rule out serious underlying conditions like ankylosing spondylitis). This can be achieved by ensuring the reference to the condition is made in a way which makes it clear to the consumer that the condition must have already been definitively medically diagnosed (for example qualifying references to the condition as 'medically diagnosed').

There is a risk to consumers from attempting to self-manage a condition that they might think is a particular condition but in fact requires a medical diagnosis - this could come about due to the use of representations that did not qualify the condition as medically diagnosed.

A failure to clearly identify the need for medical diagnosis in advertising would also be likely to contravene:

  • subsection 10(b), which prohibits advertisements that would be likely to lead to people delaying necessary medical attention and/or
  • subsection 10(c) which prohibits advertising that encourages inappropriate use of the therapeutic goods
Examples of applying the definition of 'serious'
Condition s. 28(1)(a) - medically accepted that the form requires diagnosis or treatment or supervision by a suitably qualified health professional s. 28(1)(a) - exclusion for forms that have been medically diagnosed and medically accepted as being suitable for self-treatment and management s. 28(1)(b) - there is a diagnostic (including screening), preventative, monitoring, susceptibility or pre-disposition test available for the form (including a self-administered test), which requires medical interpretation or follow-up Restricted representation status
Arthritis "Arthritis" can cover a wide variety of forms and severities, like debilitating osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. These are forms that require medical diagnosis. Management is variable but likely to involve prescription medicines. The appropriate treatment must be determined by a health professional.

Arthritis meets the definition of 'serious'.

Representations in advertising that include unqualified references to arthritis are restricted representations.

Mild arthritis The more serious forms of arthritis detailed above are excluded by the qualifier 'mild'. Not applicable

'Mild arthritis' does not meet the definition of 'serious'.

Representations in advertising that include references to 'mild arthritis' are not restricted representations, as long as the mild nature is not contradicted by images, testimonials or any other aspect of the advertising.

Autism spectrum disorder (ASD) Clinically accepted that an experienced paediatrician or a child psychiatrist should confirm the diagnosis Management may involve prescription psychotropic medicines. Allied health professionals may also be needed. Not applicable

ASD meets the definition of 'serious'.

Representations in advertising that include references to ASD are restricted representations.

Cystic fibrosis (CF) A serious condition that requires diagnostic tests ordered by a specialist medical practitioner for its definitive diagnosis. Management of CF includes antibiotic therapy and other prescription medicines and treatment by physiotherapist. In Australia, CF is usually detected through a newborn screening test and/or a sweat test. The results require medical interpretation and follow-up.

CF meets the definition of 'serious'.

Representations in advertising that include references to CF are restricted representations.

Headlice It is generally medically accepted that headlice infestations can be self-diagnosed and self-treated. Not applicable Not applicable

Headlice does not meet the definition of 'serious'.

Therefore, representations in advertising that include references to headlice are not restricted representations.

Irritable bowel syndrome (IBS) Clinically accepted to require medical diagnosis to rule out serious conditions like malignancy, inflammatory bowel disease and Coeliac disease There are no long-term sequelae from IBS without medical treatment and it can be self-managed. While people can self-manage IBS following medical diagnosis, to attempt to manage symptoms that have not been definitively diagnosed as IBS puts the consumer at risk. For that reason, representations that refer to unqualified references to IBS are restricted representations.
Medically diagnosed Irritable bowel syndrome Clinically accepted to require medical diagnosis to rule out serious conditions like malignancy, inflammatory bowel disease and Coeliac disease There are no long-term sequelae from IBS without medical treatment and it can be self-managed.

The ability to self-manage IBS following diagnosis excludes it from meeting the definition of 'serious'.

However, it must be qualified as medically diagnosed in advertising, as medical diagnosis is required to rule out serious forms of diseases which would require medical treatment.

29 Restricted representations - public interest criteria

Section 42DF of the Act requires that the Secretary (or their delegate) take into consideration the public interest criteria set out in the Code when deciding whether to approve or refuse to approve the use of a restricted representation in advertising.

The public interest criteria asks whether the reference to a serious form of a disease in an advertisement would:

  • be likely to take advantage of the vulnerability of consumers or particular groups of consumers, when faced with the disease, condition, ailment or defect
  • be likely to result in consumers not seeking medical advice at an appropriate time (also refer to section 10(b) of the Code)
  • be likely to have a negative impact on public health

The Secretary (or their delegate) can also take into account other aspects of the public interest that appear to be appropriate.

The public interest criteria provide a framework against which the Secretary (or their delegate) can assess the suitability of the restricted representation for use in advertising to consumers.

An application for approval to use restricted representations should include a statement from the applicant setting out how the public interest criteria apply to their advertisement and goods. See Application for approval to use a restricted representation in advertising for more information.

30 Prohibited representations

Section 42DJ of the Act and subregulation 6B(1) of the Regulations enable the Code to specify which representations are prohibited representations. The Code provides that representations relating to the treatment, cure, prevention, diagnosis (including screening), monitoring or susceptibility of, or pre-disposition to:

  • neoplastic diseases (i.e. all types of cancer)
  • sexually transmitted diseases
  • HIV/AIDS
  • Hepatitis C virus and
  • mental illness

are prohibited representations. Any representation about abortifacient action is also a prohibited representation.

The Secretary (or their delegate) may permit the use of a prohibited representation under section 42DK of the Act where it is necessary for one of the following:

  • public health interests
  • the appropriate use of the goods (applies to packaging and/or labelling only)

In addition, advertisers should be aware that there are other prohibited representations specified in Schedule 2, Part 1 of the Regulations, including the following:

  • antiseptics and disinfectants - certain representations about bacteriostatic activity and other claims about activity and tests are prohibited representations
  • goods that are, or contain, vitamins or minerals - representations such as expressing the quantity of a vitamin or a mineral contained in a preparation as a percentage or proportion of the recommended daily or dietary intake or allowance are prohibited representations
  • analgesics - representations that analgesic consumption is safe; or will relax, relieve tension, sedate or stimulate are prohibited representations

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