Complaints Register

COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2009-12-013 French Bentonite Clay

Meeting held 15 April 2010

1.      The complaint concerned an internet advertisement published at the website www.biodistributors.com.au.

2.      The advertisement included claims that “taken internally clay goes straight to the site of a disorder to draw out toxins and evacuate them from the body”, “clay emits or transmits such powerful radiations that thin glasses are sometimes shattered”, “clay helps to stimulate tissue repair, soothe pain, and prevent scarring”, “apply paste to burns, sores, cuts and bites to retard the growth of bacteria and stimulate the growth of healthy tissue”,  and “clay may also be beneficial in the treatment of arthritis, varicose veins, migraines, acne, and other skin eruptions”.

3.      An excerpt of the advertisement can be viewed in the relevant Appendix to this determination.

4.      The advertisement promoted the product French Bentonite Clay.

5.      The advertiser was Bio-Distributors.

6.      The complainant was anonymous.

7.      The complainant alleged that the advertisement breached sections 4(2)(a), 4(2)(c), and 4(2)(h) of the Code.

8.      The advertiser provided documentary material in response to the complaint, and asked that these be considered by the Panel when dealing with the complaint.

9.      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.”

10.  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”.

11.  The Panel reviewed the material provided by the advertiser in support of the claims made in the advertisement. The Panel found that the material did not include any persuasive or authoritative published material, and could not be regarded as adequate to support claims made in an advertisement for therapeutic goods, such as the claims that “taken internally clay goes straight to the site of a disorder to draw out toxins and evacuate them from the body”, “clay emits or transmits such powerful radiations that thin glasses are sometimes shattered”, “clay helps to stimulate tissue repair, soothe pain, and prevent scarring”, “apply paste to burns, sores, cuts and bites to retard the growth of bacteria and stimulate the growth of healthy tissue”,  and “clay may also be beneficial in the treatment of arthritis, varicose veins, migraines, acne, and other skin eruptions”, or any other claims that the advertised product is for therapeutic use.

12.  The Panel was therefore satisfied that the advertisement breached sections 4(2)(a), and 4(2)(c) of the Code, and found these aspect of the complaint to be justified.

13.  Section 4(2)(h) of the Code prohibits advertisements for therapeutic goods that “contain any claim, statement or implication that it is effective in all cases of a condition”. The Panel did not find words in the advertisement that appeared to convey such a claim or implication. This aspect of the complaint was therefore not justified.

14.  The Panel also noted, without making any formal finding, that the advertisement appeared likely to breach section 42DL(1)(g) of the Act by promoting therapeutic goods that are not included in the Register.

15.  The Panel requests Bio-Distributors, 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 the advertised clay product has benefits in relation to toxins,  stimulating tissue repair, soothing pain, preventing scarring, or in relation to burns, sores, cuts, and bites, retarding the growth of bacteria,  stimulating the growth of healthy tissue,  arthritis, varicose veins, migraines, acne, or other skin problems, together with any other claims that the advertised product is for therapeutic use;

c)      not to use the representations in (b) above in any other advertisement unless Bio-Distributors 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.

16.  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.

Dated 31 May 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).