Complaints Register

COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2009-10-010 BioCeuticals

Meeting held 15 April 2010

1.      The complaint concerned a television advertisement.

2.      The advertisement related to a product range and did not name specific products. It directed consumers to a website ostensibly related to locating a suitable healthcare practitioner; this website also included extensive and readily accessible information relating to a number of specific, named products.

3.      In describing the advertised product range, the advertisement made reference to “cheaper brands of retail vitamin supplements”, but recommended the advertised range to avoid such risks as “compromis[ing] our family’s health” and “gambl[ing] with my daughter’s life”.

4.      An excerpt of a transcript of the advertisement can be viewed in the relevant Appendix to this determination.

5.      The advertisement promoted the BioCeuticals range of products, without naming specific products.

6.      The advertiser was FIT-BioCeuticals Pty Ltd.

7.      The complainant requested anonymity but acknowledged representing a commercial competitor of the advertiser..

8.      The complainant argued that the advertisement constituted an advertisement for therapeutic goods, despite referring only to the BioCeuticals brand and not to specific, named products.

9.      The complainant argued that in consequence the advertisement breached section 42C of the Act, and sections 4(1)(b), 4(2)(c), 4(2)(d), 4(2)(f), 4(6)(b), 6(3)(a), 6(3)(b), and 6(3)(d) of the Code. (The complainant in fact referred, apparently in error, to sections “4(1)(b)(c)(d)” of the Code; for clarity, the Panel formally raised possible breaches of sections 4(1)(b), 4(2)(c), and 4(2)(d) of the Code with the complainant as noted below.)

10.  The Panel gave preliminary consideration to the complaint at its meeting of 18 February 2010. As a result of this preliminary consideration the Panel advised the advertiser that it considered the advertisement to constitute an advertisement for therapeutic goods, namely BioCeuticals products.

11.  Under sub-regulation 42ZCAH(1), the Panel is empowered to raise matters other than those specified in the complaint, where the Panel is satisfied that the advertisement to which the complaint relates contains matter that is not mentioned in the complaint, which may contravene the Act, Regulations, or the Code in other ways. The Panel was so satisfied and raised the following additional matters:

a)      Possible breaches of sections 4(1)(b), 4(2)(a), and 4(2)(c) of the Therapeutic Goods Advertising Code, in relation to factual claims made in the advertisement;

b)      Possible breaches of sections 4(2)(b), 4(2)(d), and 4(5) of the Therapeutic Goods Advertising Code through the use of words such as “compromise our family’s health”, “gamble with my daughter’s life”, and “sure I can buy cheaper brands of retail vitamin supplements”, together with other words found in the advertisement;

c)      Possible breaches of section 4(2)(f) of the Code; and,

d)     Possible breaches of sections 6(3) of the Therapeutic Goods Advertising Code, in that the advertisements may not include required information.

12.  The advertiser initially responded by arguing that the advertisement did not constitute an advertisement for therapeutic goods, but rather was a “company identity branding promotion” the “ultimate message” of which was “to visit a healthcare practitioner in a clinic setting.”

13.  After receiving the Panel’s advice that the advertisement was, in the Panel’s view, an advertisement for therapeutic goods, the advertiser responded that they “now concur that this advertisement has transgressed from the requirements of the Code” and that they had amended their company processes such that their marketing department would not be “signing off any advertisements in the future”.

14.  An advertisement for therapeutic goods is defined in the Act to include “any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.”

15.  As noted above, the Panel made a preliminary finding at its meeting of 18 February 2010 that the advertisement did in fact constitute an advertisement for therapeutic goods, namely BioCeuticals products. The Panel confirmed this preliminary finding when giving final consideration to the complaint. The Panel noted that the advertisement clearly directed the minds of consumers to products, directed consumers to a website which contained extensive product information, and made explicit comparison with “cheaper brands of retail vitamin supplements”.

16.  Section 42C of the Act makes it an offence to publish certain advertisements for therapeutic goods in specified media that does not have an approval number, or to publish an advertisement without its approval number, and through reference to the Regulations, applies to “advertisements for designated therapeutic goods published or inserted, or intended to be published or inserted, for valuable consideration, in specified media.”

17.  The advertisement therefore ought to have been approved under section 42C of the Act, and ought to have contained a reference to the approved/permitted indication(s) for the use of the goods advertised (section 6(3)(b) of the Code),  and the words “use only as directed” and “if symptoms persist see your doctor/healthcare professional” (section 6(3)(d) of the Code). The advertisement had not been approved and did not include these mandatory statements. These aspects of the complaint were therefore justified.

18.  Section 4(1)(b) of the Code requires that advertisements for therapeutic goods “contain correct and balanced statements only and claims which the sponsor has already verified.” Section 4(2)(a) of the Code prohibits representations that are “likely to arouse unwarranted and unrealistic expectations of product effectiveness”. Section 4(2)(c) of the Code prohibits representations that “mislead directly or by implication or through emphasis, comparisons, contrasts or omissions”.

19.  In the absence of a relevant submission from the advertiser, the Panel was satisfied that the representations that other brands of retail therapeutic goods could be harmful, risky, or inferior had not been verified, were likely to arouse unwarranted expectations in relation to the advertised products, and were misleading, in breach of sections 4(1)(b), 4(2)(a), and 4(2)(c) of the Code. These aspects of the complaint were therefore justified.

20.  The Panel did not find words in the advertisement that appeared likely to breach section 4(2)(b) or 4(2)(f) of the Code, and these aspects of the complaint were therefore not justified. The Panel noted, however, that the www.mypractitioner.net.au website, to which the advertisement directed consumers, contained information which was readily accessible by consumers, as the website required no verification that a visitor was a healthcare practitioner before accessing the "product" section of the website. The Panel noted that the product information at the website included claims that appeared likely to breach these sections of the Code, such as references to lowering cholesterol.

21.  Section 4(2)(d) of the Code prohibits advertisements which “abuse the trust or exploit the lack of knowledge of consumers or contain language which could bring about fear or distress.”

22.  The Panel was satisfied that the representations that “cheaper brands of retail vitamin supplements” could promote such risks as “compromis[ing] our family’s health” and “gambl[ing] with my daughter’s life” abused the trust of consumers, and were likely to cause fear and distress among consumers of other brands of therapeutic goods. This aspect of the complaint was therefore justified.

23.  Section 4(6)(b) of the Code prohibits representations that therapeutic goods are endorsed by healthcare professionals. The Panel found that the advertisement represented the advertised goods to be endorsed by healthcare professionals. This aspect of the complaint was therefore justified.

24.  Section 4(5) of the Code requires that comparisons made in advertisements must be balanced and must not be misleading or likely to be misleading, and prohibits the inclusion in advertisements of comparisons that “imply that the therapeutic goods, or classes of therapeutic goods, with which comparison is made, are harmful or ineffectual.”

25.  The Panel was satisfied that the references to “cheaper brands of retail vitamin supplements”, and to such risks as “compromis[ing] our family’s health” and “gambl[ing] with my daughter’s life” breached section 4(5) of the Code by implying that other brands of therapeutic goods could be harmful or ineffectual.

26.  The Panel considered the references to “compromis[ing] our family’s health” and “gambl[ing] with my daughter’s life” to be matters of grave concern, as they conveyed a representation that “cheaper brands of retail vitamin supplements” could be harmful, ineffectual, or even deadly, such that the advertisement very nearly warranted a broadcast retraction.

27.  The Panel requests FIT-BioCeuticals Pty Ltd, in accordance with subregulation 42ZCAI(1) of the Therapeutic Goods Regulations 1990:

a)      to withdraw the advertisement from further publication;

b)      to withdraw any representations that other brands of therapeutic goods may be harmful or ineffectual, or that their use may involve risk to the health of those who use them, together with any representations that the advertised therapeutic goods are endorsed by healthcare professionals;

c)      not to use the representations in (b) above in any other advertisement unless FIT-BioCeuticals Pty Ltd satisfies the Panel that the use of the representation would not result in a contravention of the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 or the Therapeutic Goods Advertising Code;

d)     where the representation has been provided to other parties such as retailers or website publishers, and where there is a reasonable likelihood that the representation has been published or is intended to be published by such parties, to advise those parties that the representation(s) should be withdrawn; and,

e)      within 14 days of being notified of this request, to provide evidence to the Panel of its compliance, including a response in writing that they will comply with the Panel’s sanctions, and where appropriate, supporting material such as copies of instructions to advertising agents or publishers, or correspondence with retailers and other third party advertisers.

28.  The advertiser’s attention is drawn to the provisions of sub-regulations 42ZCAI(3) and (4) which permit the Panel to make recommendations to the Secretary in the event of non-compliance with this request, including a recommendation that the inclusion of the goods on the Register be cancelled.

Dated 21 July 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).