You are here
The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.
AcuScen - Malouf Industries Pty Ltd - Complaint No. 2010-04-022
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 "AcuScen"
(Complaint No. 2010-04-022)
On 1 September 2011, the delegate of the Secretary to the Department of Health and Ageing (the Delegate) for the purposes of subregulation 9(1) of the Therapeutic Goods Regulations 1990 (the Regulations) issued an order to Malouf Industries Pty Ltd T/A PainGoes in relation to internet advertisements about the "AcuScen" range of medical devices published on the websites www.paingoes.com.au and www.maloufindustries.com.au.
The decision to issue the order was made by the Delegate after a recommendation was made to the Secretary to the Department of Health and Ageing (the Secretary) by the Complaints Resolution Panel (the Panel) under subregulation 42ZCAI(3) of the Regulations on 2 February 2011 in relation to the "AcuScen" advertisements referred to above, the subject of Complaint No. 2010-04-022. The recommendation was made as Malouf Industries Pty Ltd had not fully complied with the Panel's determination issued on 9 December 2010.
The AcuScen product at the time of the complaint was a "class IIa medical device" included in the Australian Register of Therapeutic Goods (ARTG) with entry number 157698. This device was subsequently cancelled from the ARTG by Malouf Industries on 21 July 2011. However, the cancellation had no impact on the decision under regulation 9 of the Regulations.
The Panel's findings
The Panel found that the "AcuScen" advertisements breached paragraphs 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(d), 4(2)(g) and 4(2)(h) of the Therapeutic Goods Advertising Code 2007 (the Code1). The discussion in relation to these breaches is at paragraphs 11 to 17 of the Panel's determination which may be accessed from the Panel's Complaint Register at Complaint No. 2010-04-022).
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 "AcuScen" advertisements which appeared on the homepage and subsequent pages of the www.maloufindustries.com.au website accessed on 12 April, 5 July and 11 August 2011, and the same claims which were also on the www.paingoes.com.au website accessed on 22 April 2010 and 11 August 2011, breached paragraphs 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(d), 4(2)(g) and 4(2)(h) of the Code. The Delegate noted that the homepage for the website www.paingoes.com.au appeared to be "parked" as at 11 August 2011; however the underlying web pages containing material where the offending claims and statements were still able to be accessed and therefore continued to breach those sections of the Code.
Evidence in support of the claims made for the AcuScen devices was supplied by Malouf Industries Pty Ltd to the TGA. The Delegate reviewed this evidence and the Panel's determination No. 2010/04/022 and agreed with the Panel that the use of the words, "treating pain and other disorders or symptoms of recent origin", "fast and permanent pain relief", pain relief "in acute cases", "a life without pain", and other similar claims in the website advertisements were unverified, unsubstantiated, likely to arouse unwarranted expectations of product effectiveness, were misleading therefore in breach of paragraphs 4(1)(b), 4(2)(a) and 4(2)(c) of the Code.
The Delegate also found that the advertisements implied: that the AcuScen devices had a great effect on both chronic and acute painful conditions and injuries that may not respond to other forms of treatment; that the AcuScen products are more effective than other Scenar and TENS machine products because the other products were still using technology from 20 years ago; that the AcuScen works at a level well beyond 'TENS', ultrasound and short pulse electrotherapy devices; and, that it contained statements about the product such as, being "safe and effective", "getting rid of pain", "relieving pain", "want a life without pain" and "at last there is a simple, effective, non-invasive approach to pain relief". The Delegate found these implications and statements to be in breach of paragraphs 4(2)(d), 4(2)(g) and 4(2)(h) of the Code because they contained language that exploited the lack of knowledge of consumers and implied that the device was infallible, unfailing, and effective in all cases.
Accordingly, the delegate of the Secretary considered it necessary to issue the order under regulation 9 of the Regulations to Malouf Industries Pty Ltd to comply with all the actions set out in the order.
The delegate of the Secretary ordered Malouf Industries Pty Ltd to:
- withdraw the advertisements on the websites www.paingoes.com.au and www.maloufindustries.com.au about the "AcuScen" product range of medical devices from further publication;
- withdraw any representations that the advertised AcuScen product range of medical devices have benefits in relation to treating or relieving pain, chronic disease, or other disorders; and
- not use claims or representations mentioned in (b) above in any other advertisement for the AcuScen product range of medical devices unless satisfying me, as the delegate of the Secretary of the Department of Health and Ageing, that the use of the claims or representations would not result in a contravention of the Act, the Regulations or the Code.
Conditions imposed on the order
Pursuant to subregulation 9(2) of the Regulations, the order is subject to the following conditions:
- within 10 working days of being issued with the order, Malouf Industries Pty Ltd T/A PainGoes is required to provide evidence to the delegate of the Secretary of compliance by Malouf Industries Pty Ltd T/A PainGoes 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 10 working days of being issued with the order, Malouf Industries Pty Ltd T/A PainGoes is required to provide to the delegate a response in writing indicating that Malouf Industries Pty Ltd T/A PainGoes will abide by the order.
On 14 September 2011 Malouf Industries Pty Ltd T/A PainGoes advised the delegate of the Secretary that it had complied with the order.