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Restricted and prohibited representations

12 November 2020

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

Referring to serious forms of a disease, condition, ailment or defect in advertising therapeutic goods is restricted. These references are known as restricted representations.

Serious forms are those which require a suitably qualified health professional to diagnose and/or treat them and exclude those conditions that are suitable for self-treatment once medically diagnosed.

In particular circumstances, the TGA may allow advertisers to refer to these serious forms if it's considered to be in the public interest. Unless granted to a specific person or business, these permissions apply to all advertisers promoting the specified goods.

All current permissions are detailed as notices of approved and restricted representations.

Find out more about restricted representations.

For details refer to Section 28 of the Code, which also references related sections in the Act.

Requesting to use a restricted representation

If you're intending to refer to a restricted representation in your advertising and no permission exists or your claims or goods are not captured by the terms of an existing permission, you'll need to make an application to TGA. This includes representations made on the product's labels, packaging and accompanying information.

Prior to commencing an application, advertisers should familiarise themselves with the related guidance and checklist.

Complete an application for approval to use a restricted representation in advertising.

Prohibited representations

Referring to diseases including neoplastic diseases (i.e. all types of cancer), sexually transmitted diseases, HIV/AIDS, Hepatitis C virus, mental illness or an abortifacient action in advertising therapeutic goods is prohibited. These references are known as prohibited representations.

Other prohibited representations apply to particular types of therapeutic goods, including analgesics, disinfectants and antiseptics, plus vitamins and minerals.

Representations that:

  • Taking analgesics is safe, or that they will relax, relieve tension, sedate or stimulate.

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.

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.

In particular circumstances, the TGA may allow advertisers to use prohibited representations if it's considered to be in the public interest or necessary for product usage.

All current permissions are detailed as notices of approved and restricted representations.

For details refer to Schedule 2 of the Regulations and Section 30 of the Code, which also references related sections in the Act.