Limitations apply to the use of certain representations in the advertising of therapeutic goods.
These include serious forms of a disease, condition, ailment or defect and some particular conditions like cancer, sexually transmitted diseases and mental illness.
Using references to these representations in your advertising requires TGA approval.
Restricted representations
'Restricted representations are representations which refer to a serious form of a disease, condition, ailment or defect.
Restricted representations cannot be used in advertising without prior approval or permission from the TGA with the exception of restricted representations that are legally required to be included on the product label.
Serious forms are those which require a suitably qualified health professional to diagnose and/or treat them. The TGA excludes those conditions that are suitable for self-treatment once medically diagnosed.
Approval to use a 'restricted representation' can be given to individual applicants or, in particular circumstances, to all advertisers. More information is presented at the webpage titled restricted representations.
For details refer to Part 8, Section 28 of the Code, which also references related sections in the Act.
Applying to use a restricted representation
If you intend to use a restricted representation in advertising and the representation is not covered by an existing permission, advertisers need to make an application to the TGA.
Prior to commencing an application, advertisers should familiarise themselves with the related guidance and checklist.
To complete an application to use a restricted representation in advertising: Apply for approval to use a restricted representation
Prohibited representations
'Prohibited representations' in advertising must not be used unless such use has been expressly permitted by the TGA.
A prohibited representation is a representation regarding the treatment, cure, prevention, diagnosis (including screening) or monitoring of, or the susceptibility or pre disposition to, one or more of the following:
- neoplastic diseases (i.e. all types of cancer)
- sexually transmitted diseases
- human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)
- hepatitis C virus (HCV)
- mental illness.
Representations regarding abortifacient action are also prohibited representations.
Other prohibited representations apply to particular types of therapeutic goods, including analgesics, disinfectants and antiseptics, and vitamins and minerals. All prohibited representations are set out in Part 1 of Schedule 2 of the Regulations.
The TGA may permit advertisers to use prohibited representations if the use is is necessary for public health reasons or for the appropriate use of the good.
The TGA publishes approval and permissions for both 'restricted' and 'prohibited' representations on its website at Notices of approved and permitted restricted representations.
Analgesics
Representations that:
- Taking analgesics is safe, or that they will relax, relieve tension, sedate or stimulate.
Antiseptics and disinfectants
Representations that:
- Antiseptics promote healing.
Representations about the:
- Bacteriostatic activity regarding disinfectants without also referring to bactericidal activity.
Representations that refer to the:
- Rideal Walker test or the Phenol Coefficient
- Results of laboratory tests on micro-organisms on the label only, other than within a leaflet or on a label within product packaging
- Achievement of sterility except without TGA approval
- An effect against viruses or Mycobacterium tuberculosis and related acid fast bacteria without TGA approval
- Disinfection of inaccessible parts of drains.
Representations that:
- Contradict or conflicting with the common name
- Are not more specific than the common name as a description or measure of activity against micro-organisms.
Vitamins or minerals
Representations about the:
- Amount of a vitamin or mineral present in a product, expressed as a percentage or proportion of the recommended daily or dietary intake or allowance
- Recommended daily or dietary intake or allowance of a vitamin or a mineral, unless current and sourced from the National Health and Medical Research Council.
Representations that vitamin products are:
- A substitute for good nutrition or a balanced diet
- Superior to or more beneficial in any way than dietary nutrients.