Health Essentials Australia Pty Ltd (Complaint No. 2010-10-016)
6 August 2012
Therapeutic Goods Act 1989
Therapeutic Goods Regulations 1990
Decision under regulation 9 of the Therapeutic Goods Regulations 1990 in relation to an advertisement about the product "Happy Feet Detox Patches"
(Complaint No 2010-10-016)
On 17 February 2012, the delegate of the Secretary to the Department of Health and Ageing (the Delegate) for the purposes of section 9(1) of the Therapeutic Goods Regulations 1990 (the Regulations) issued an order to Health Essentials Australia Pty Ltd in relation to a print advertisement published in Edition 3, 2010 Natural Health Trader magazine and representations made on the website www.healthessentials.com.au in relation to "Happy Feet Detox Foot Patches".
The decision to issue the order was made by the Delegate after a recommendation was made to the Secretary of the Department of Health and Ageing (the Secretary) by the Complaints Resolution Panel (the Panel) under section 42ZCAI(3) of the Regulations on 8 July 2011 in relation to the "Happy Feet Detox Foot Patches" advertisement referred to above, the subject of Complaint No 2010-10-016. The recommendation was made as Health Essentials Australia Pty Ltd had not fully complied with the Panel's determination issued on 21 March 2011.
The Panel's findings
The Panel found that the "Happy Feet Detox Foot Patches" print advertisement breached sections 4(2)(a), 4(6)(b) and 6(3) of the Therapeutic Goods Advertising Code 2007 (the Code1). The discussion of these breaches can be found in relation to the Panel's findings at paragraphs 12–21 of the Panels determination which may be accessed from the Panel's Complaint Register at Complaint No. 2010-10-016.
1 Please refer to the webpage http://www.tga.gov.au/consumers/advertising-complaint-consumer-guide.htm for a summary of the advertising provisions that are commonly breached.
The Delegate was of the view that the "Happy Feet Detox Foot Patches" print advertisement that appeared in the Edition 3, 2010 of Natural Health Trader magazine breached sections 4(2)(a), 4(6)(b) and 6(3) of the Code. The Delegate was also of the view that the advertising on the Health Essentials Australia website at www.healthessentials.com.au as at 9 December 2011 and 13 February 2012, continued to breach those provisions of the Code.
The Delegate reviewed the determination No 2010-10-016 and agreed with the Panel that the representations made implied the product might assist with such conditions as headaches, lethargy, fatigue, constipation, bad breath and acne, or that the product may improve circulation, increase metabolism and boost the immune system, all of which are continuing to be used in the advertising of this product through the 'YouTube' videos which are accessed via a link on the website.
The Delegate found that the advertisement breached section 4(2)(a) of the Code in that the representations described above on the Health Essentials website at www.healthessentials.com.au as at 9 December 2011 and 13 February 2012, were likely to arouse unwarranted expectations as to the effectiveness of the advertised product through unsubstantiated claims.
The delegate of the Secretary also agreed with the Panel's determination and found that the advertisement breached, section 4(6)(b) of the Code because of the statement "TGA listed", and that it breached section 6(3) of the Code because of the absence of mandatory statements.
In considering this matter the Delegate noted that Health Essentials Australia had submitted an "expert clinical evaluation" to the Panel. However, the Delegate agreed with the Panel that this material "could not reasonably be regarded as adequate evidence to support any claims in advertising." Although that document was described as an "expert clinical evaluation" to the Panel, that document did not conclusively provide adequate scientific support for the claims about therapeutic benefits.
Accordingly, the Delegate considered it necessary to issue the order under regulation 9 of the Regulations to Health Essentials Australia Pty Ltd requiring it to comply with all the actions set out in the order.
The delegate of the Secretary ordered Health Essentials Australia Pty Ltd to:
- to withdraw any representations that the advertised product can detoxify the body, remove or "draw out" toxins from the body, help the body function more effectively, or offer therapeutic benefits in relation to stress, excessive alcohol intake, nicotine consumption, poor diet, environmental contaminants, pollutants or harmful chemicals;
- to not use the representations described in (a) in any other advertisement unless Health Essentials Australia Pty Ltd satisfies the Therapeutic Goods Administration (TGA) that the use of the representations would not result in a contravention of the Therapeutic Goods Act 1989 (the Act), the Regulations or the Therapeutic Goods Advertising Code 2007; and
- where the representations have been provided to other parties such as retailers or website publishers, and where there is a reasonable likelihood that the representations have been published or is intended to be published by such parties, to advise those parties that the representations should be withdrawn.
Conditions imposed on the order
Pursuant to section 9(2) of the Regulations, the order is subject to the following conditions:
- That within ten (10) working days of being notified of this order, Health Essentials Australia Pty Ltd must provide evidence to the delegate of the Secretary of compliance by Health Essentials Australia Pty Ltd with the order set out in paragraphs (a) – (c) above, including, where appropriate, by providing copies of instructions to advertising agents or publishers and relevant correspondence with other third party advertisers; and
- Within ten (10) working days of being issued with the order, Health Essentials Australia Pty Ltd is required to provide to the delegate a response in writing indicating that Health Essentials Australia Pty Ltd will abide by the order set out in paragraph (d) of the order
As of 4 April 2012 Health Essentials Australia Pty Ltd advised that they have complied, and will continue to comply, with the order.
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