Consumer guide to commonly noted advertising breaches

3 August 2011

The following list is a summary of commonly recorded breaches of the therapeutic goods advertising requirements and is provided as a guide only.

Tables 1 and 2 list the frequently noted sections of the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Advertising Code 2007 (the Code) respectively that are breached.

It should be noted that exceptions may apply to some of these provisions and that the exceptions have not been included in this summary. Please refer to the Act and the Code for the full detail of the provisions.

Table 1 - Frequently noted sections of the Therapeutic Goods Act 1989
Section The TG Act states that advertisements:
22(5)
  • must not refer to an indication not included on the Australian Register of Therapeutic Goods (ARTG) for the advertised goods.
42C(1)
  • must be approved (an exception applies for internet advertising and advertisements for medical devices) if published or broadcast (for valuable consideration) in specified media.
42C(2)
  • must not differ from the approved version of the advertisement.
42C(4)
  • must display a valid approval number (an exception applies for broadcast media and internet advertising).
42C(6)
  • must comply with all conditions for advertising approval.
42DL(1)(a)
  • must not contain a prohibited representation (see also Code section 5(1) below).
42DL(1)(c)
  • must not contain a restricted representation without prior approval (see also Code section 5(2) below).
42DL(1)(f)
  • must not refer to scheduled (S3, 4 & 8) poisons, unless excepted.
42DL(1)(g)
  • must not promote therapeutic goods that are not included in the ARTG for sale in Australia.
42DM(1)
  • must comply with the Code (section 42DP applies to generic information.)
41FN(5)
  • for a kind of medical device included in the ARTG, must be consistent with the certified intended purpose.
41ML
  • must not refer to an intended purpose not included on the ARTG for the advertised medical device.
Table 2 - Frequently noted sections of the Therapeutic Goods Advertising Code 2007
Section The Code states that advertisements
4(1)(a)
  • must comply with Australian law.
4(1)(b)
  • must contain only correct and balanced statements which the product sponsor has verified.
4(2)(a)
  • must not be likely to arouse unrealistic or unwarranted expectations of product effectiveness.
4(2)(b)
  • must not be likely to lead to self-diagnosis or inappropriate self-treatment of potentially serious diseases.
4(2)(c)
  • must not mislead or be likely to mislead.
4(2)(d)
  • must not exploit the lack of knowledge of consumers or abuse their trust.
  • must not use language that causes fear or distress.
4(2)(e)
  • must not cause people to believe that they have a serious ailment.
  • must not cause people to believe that harm will result from not using the advertised product.
4(2)(f)
  • must not encourage excessive or inappropriate use of the advertised product.
4(2)(g)
  • must not claim that the advertised product is magical or infallible.
4(2)(h)
  • must not claim that the advertised product is effective in all cases.
4(2)(i)
  • must not claim that goods are safe, harmless, or free of side-effects.
4(2)(j)
  • must not be directed to minors (subject to exceptions.)
4(4)
  • must identify the researcher when research results are published.
  • must use appropriate and understandable language when providing scientific information.
4(5)
  • if making comparisons, must make only balanced and accurate comparisons.
  • must not imply that the therapeutic products being compared are ineffective or harmful.
4(6)(b)
  • must not claim that the product advertised is endorsed by hospitals or any government body, including the TGA.
  • if referring to sponsorship of a healthcare facility or government body, must not imply that the sponsorship is also an endorsement.
  • must not claim the product advertised is endorsed by a by a healthcare professional.
4(6)(c)
  • if containing an endorsement by a healthcare professional association or healthcare body, must include the name of the endorser and acknowledge any payment or other valuable consideration.
4(7)
  • where testimonials are included, must contain only typical and genuine testimonials and must not be misleading.
4(8)
  • must not offer samples of therapeutic goods.
5(1)
  • must not refer to prohibited representations such as cancer, sexually transmitted diseases, or mental illness (subject to exceptions).
5(2)
  • must not refer to serious forms of diseases or conditions such as cardiovascular disease, dental disease, bone disease, liver, endocrine, gastrointestinal, haematological, infectious, immunological, metabolic, renal, or respiratory diseases, substance dependence, without prior approval by the TGA.
6(3)(a)
  • must contain the trade name of the goods advertised.
6(3)(b)
  • must contain a reference to the ARTG indications for the advertised product.
6(3)(c)
  • must include the words "ALWAYS READ THE LABEL" or a full list of the active ingredients.
6(3)(d)
  • must include the words "USE ONLY AS DIRECTED" and "IF SYMPTOMS PERSIST SEE YOUR DOCTOR/HEALTHCARE PROFESSIONAL."
6(4)
  • must include a valid approval number, prominently displayed in the bottom right-hand corner of the advertisement (subject to exceptions.)
7(3)
  • if advertising weight loss, size loss, weight control, or similar effects, must have an appropriate balance between the claim and references to healthy lifestyle and diet.