Complaints Register

COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2009-09-005 Essence Emergency Oral Spray

Complaint 2009-09-006 Essence Woman Oral Spray

Meeting held 4 February 2010

1.      The complaint concerned two print advertisements published in Issue 122 of Wellbeing magazine.

2.      The first advertisement was headed “Help! Emergency” and included claims such as “balance in a bottle”, “not coping, uptight, panic, public speaking, tantrums, traffic”.

3.      The second advertisement was headed “Emergency Essence” and included claims such as, “a fast-acting natural formulation”, “whether it’s a visit to the dentist, a big exam, public speaking, or you’re just not coping, reach for ‘Balance in a Bottle’.”

4.      An excerpt of the advertisements can be viewed in the relevant Appendix to this determination.

5.      The advertisement promoted the products Emergency Oral Spray and Essence Woman Oral Spray.

6.      The advertiser was Bush Biotherapies Pty Ltd.

7.      The complainant requested anonymity but acknowledged representing a commercial competitor of the advertiser, and was the same individual in relation to both complaints.

8.      The complainant alleged that both of the advertisements breached section 42C of the Code through lack of a required approval number.

9.      The advertiser stated that they had received advice that their products were not regarded as therapeutic goods from a regulatory standpoint. On this basis, the advertiser questioned whether the Panel had the jurisdiction to determine the complaint.

10.  Products such as the advertised product are not regarded as therapeutic goods under current regulatory arrangements, provided that they fall outside the definition of therapeutic goods found in the Act.

11.  Therapeutic goods are defined in the Act to include goods that are represented in any way to be for therapeutic use. Therapeutic use is defined to include use in or in connection with influencing, inhibiting, or modifying a physiological process in persons.

12.  From this definition, it is clear that goods which are not otherwise therapeutic goods may be brought within the definition if they are represented to be for therapeutic use. If they are so represented – in advertising, for example – then they are therapeutic goods within the scope of the Act. Generally speaking, it follows from this that they are required to be included in the Register, that they are subject to the advertising approval requirements found in section 42C of the Act as well as to other requirements of the Act, Regulations and Code, and that advertisements promoting them fall within the Panel’s jurisdiction.

13.  In practice, this means that sponsors of products such as the advertised product may, by advertising their products as being for therapeutic use, place themselves in the position of promoting illegal therapeutic goods (in breach of section 42DL(1)(g) of the Act), and of publishing an advertisement without approval in breach of section 42C of the Act.

14.  In the present case, the primary question for the Panel was whether the advertisements represented the advertised products as being for therapeutic use. If the advertisements did so represent the products, then the complaint would fall within the Panel’s jurisdiction and would, most likely, be justified. If the advertisements did not represent the products as being for therapeutic use, then the complaint would fall outside the Panel’s jurisdiction, section 42C of the Act would not pertain to the advertisement, and the complaint would not require further consideration.

15.  The Panel noted that the complainant, who requested anonymity, acknowledged representing a commercial competitor of the advertiser. Given this, the Panel was of the view that the complainant ought to have presented a clear argument as to how the advertisements could bring the advertised products within the definition of therapeutic goods. The complainant presented no argument to this effect.

16.  The Panel considered the advertisements at some length, and, in the absence of any clear argument from the complainant, concluded that they did not represent the advertised products as being for therapeutic use. The complaint therefore fell outside the jurisdiction of the Panel (except insofar as it was necessary to consider whether the matter fell within its proper jurisdiction), and was given no further consideration.

17.  The Panel noted, however, that it considered the advertisements – in particular the first advertisement, which included words such as “distressed” and “anxious” in conjunction with the words “balance in a bottle” – to bring the advertisement vanishingly close to making representations that the advertised product was for therapeutic use.

Dated 28 April 2010

For the Panel

Jason Korke

Chairman

In this determination, unless otherwise specified:

a)      “the Act” means the Therapeutic Goods Act 1989;

b)      “the Regulations” means the Therapeutic Goods Regulations 1990;

c)      “the Code” means the Therapeutic Goods Advertising Code;

d)     “the Register” means the Australian Register of Therapeutic Goods;

e)      “any other advertisement” appearing in sub-regulation 42ZCA1(1)(d) is not confined to advertisements in specified or broadcast media (in relation to which complaints may be made to the Panel under Regulation 42ZCAB).