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Advertising health products: Rules about safety claims in advertising

Complying with the Therapeutic Goods Advertising Code 2018

3 July 2019

The Therapeutic Goods Advertising Code (No.2) 2018 prevents advertisers from claiming that therapeutic goods (including medicines and medical devices) are safe, that their use cannot cause harm, or that they have no side-effects.

Many consumers may be vulnerable because of a disease, condition or general concern about their health. This may impact on their ability to critically evaluate advertising to assess whether a particular therapeutic good is appropriate for them. Claiming these products are 'safe' could heavily influence consumer choices, could be misleading or result in inappropriate use.

Safety claims in advertising may be explicit or implicit - both are prohibited.

Explicit safety claims

Therapeutic goods are, by their nature, intended to exert an effect on the human body. However, these products may not be effective in all cases of a condition. Individual responses can vary and in some cases a therapeutic good may have unintended consequences or trigger an adverse event in an individual.

The therapeutic goods legislation specifically prohibits the advertising of therapeutic goods as 'safe' or having 'no side effects', even for specific patient populations or particular dosages. This requirement applies even if you think there is evidence to substantiate such a claim.

Implied safety claims

Advertising claims that imply a therapeutic good is safe are also prohibited.

Examples of these claims include:

  • '[The product] has a safe mode of action'
  • 'No known side effects'
  • 'Safe alternative'
  • 'Non-toxic amounts of [ingredient]'
  • 'Safe alternative to prescription medicines without the debilitating side effects'.

Natural doesn't mean safe

The Therapeutic Goods Advertising Code (No.2) 2018 prohibits claims that are misleading. Care must be taken to ensure that using the term 'natural' does not imply that a product is safe, safer than other products or that excessive use cannot cause harm. For more information on the use of 'natural' in advertising see Using 'natural' claims when advertising to the public.

Rules about safety features

While the mention of a product's safety features is not prohibited in advertising, care is needed to ensure that highlighting a safety feature (such as a safety shield on an injection device) does not imply that the product itself is 'safe'.

Top tips for compliant advertising

Advertising for therapeutic goods must:

  • be valid, accurate and substantiated
  • be truthful, balanced and not misleading or likely to be misleading
  • be consistent with the Australian Register of Therapeutic Goods (ARTG) entry for the product
  • support the proper use of the product by depicting them in a way that is consistent with their directions or instructions.

Advertising for therapeutic goods must not:

  • state or imply that other products are harmful or ineffective
  • exaggerate product efficacy or performance
  • result in consumers delaying medical attention or failing to use prescribed treatment
  • encourage inappropriate or excessive use
  • claim or imply that a product is effective or guaranteed to work in all cases of a condition
  • represent a product as infallible, unfailing, magical or miraculous, including by use of testimonials
  • claim that harmful consequences may result from failure to use the product.

Care is also needed to ensure that comparisons with other therapeutic goods do not imply that the other therapeutic goods are harmful or ineffective. For example, use of the word 'organic' may be acceptable if substantiated. However, it is not acceptable to compare the 'organic' product with non-organic products in a way that states or implies that the non-organic products could harm the consumer.

Further information