Matters to Consider when Advertising Therapeutic Goods – Consistency with the Accepted Indication/Accepted Intended Purpose

Sponsors of therapeutic goods must ensure that they advertise their products in accordance with the indications accepted in relation to inclusion on the Australian Register of Therapeutic Goods (ARTG).

A person commits an offence under section 22(5) of the Therapeutic Goods Act 1989 (NSW) (Act) if:

(a) the person, by any means, advertises therapeutic goods for an indication; and

  • (b) the therapeutic goods are included in the Register; and
  • (c) the indication is not an indication accepted in relation to that inclusion.

A person commits an offence under section 41ML of the Act if:

(a) the person, by any means, advertises a medical device as being for a purpose; and

  • (b) the device is of a kind included in the Register; and
  • (c) the purpose is not a purpose accepted in relation to that inclusion.

Contravention of either of the above provisions of the Act will incur a penalty of 60 penalty units, that is $12,600.

Sponsors of a registered/listed medicine/medical device must also hold evidence to support all the indications they make for their product at the time they register/list the medicine/medical device in the ARTG. The evidence they hold must adequately support all indications and demonstrate all claims made for the medicine/medical device are true, valid and not misleading.

If you advertise an indication other than as accepted for use in the ARTG which is also misleading and deceptive, then you will also be in breach of the Australian Consumer Law (ACL).

Contraventions of the ACL in respect to false or misleading conduct will attract a pecuniary penalty. The maximum penalty for false or misleading and unconscionable conduct and breaches of relevant product safety provisions is $1.1 million for corporations and $220,000 for individuals.

In ACCC v Reckitt Benckiser (Australia) Pty Ltd [2016] FCAFC 181, the Full Federal Court has upheld an appeal by the Australian Competition and Consumer Commission against the penalty imposed on Reckitt Benckiser (Australia) Pty Ltd for contravening the ACL. The Full Court ordered Reckitt Benckiser to pay a revised penalty of $6 million (up from $1.7 million) for making misleading representations about its Nurofen Specific Pain products.

Set out below are a sample of relevant cases from the Therapeutic Goods Administration Complaints Resolution Panel (Panel). The cases indicate that the Panel will:

  • review each advertisement in its context to ensure that the advertisement is consistent with the Accepted Indication/Accepted Intended Purpose in the ARTG;
  • in checking for consistency, be quite strict in interpreting the wording of the advertisement against the Accepted Indication/Accepted Intended Purpose in the ARTG; and
  • not require perfect reproduction of the wording of an indication in advertising.      

Caroline’s Cream

In 2014/06/007 Caroline’s Cream (Health Writer Hub and Caroline’s Skincare Pty Limited), the advertisement included representations about the therapeutic use of the product that did not correlate to any of the indications stated on the ARTG entry for the product, for example, curing the 25 listed conditions, claims regarding the relief and management of frostbite and stretch marks and the management of haemorrhoids.

The Panel held that section 22(5) of the Act does not in the Panel’s view amount to a requirement that the accepted indications for therapeutic goods must be reproduced in entirety in each advertisement for those goods. The question of whether an advertisement complies with section 22(5) of the Act must be decided for each advertisement in context.

XL(S) Medical

In 2016-02-011 XL(S) Medical (Orion Laboratories Pty Limited trading as Perrigo Australia), the complainant alleged that the advertisement, through the inclusion of the product label within it, breached section 22(5) of the Act because it used the words “lose up to 3x more weight than with dieting alone”, while the indications on the ARTG for the advertised product were qualified with the word “help”.

The Panel did not find this aspect of the complaint justified, for two reasons:

(a) the advertisement as a whole clearly qualified the indication, so that the complainant’s allegation was not sound; and

(b) in any event, promoting the advertised product for weight loss, when an indication on the ARTG was for weight loss, did not breach section 22(5) of the Act. Section 22(5) of the Act does not require perfect reproduction of the wording of an indication in advertising; rather, it requires that therapeutic goods be advertised only for uses consistent with their indications and not for uses that are not indicated.

Caroline’s Lip Balm

In 2015-04-003 Caroline’s Lip Balm (Caroline’s Skincare Pty Limited and Doward International Pty Limited) the Panel found that the advertisement advertised the product for the prevention of cold sores because of the words “the formula is especially useful for those who typically suffer from extremely dry skin which can often result in the onset of conditions such as Cold Sores”.

While the intended purpose for the product made some reference to cold sores, it did not in the Panel’s view extend to the prevention of cold sores, only to the use of the product by sufferers of cold sores for symptomatic relief.


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