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Megahydrate - Vitality Plus Australia Pty Ltd - Complaint No. 2012-05-012 and 2012-06-026
Decision under regulation 9 of the Therapeutic Goods Regulations 1990
Vitality Plus Australia Pty Ltd has been ordered to undertake a number of actions regarding an internet advertisement for the product Megahydrate, including but not limited to withdrawing certain representations made in the advertisement and publishing a retraction on its website.
On 29 January 2013, the Panel issued a written determination that the internet advertisement breached a section of the Therapeutic Goods Act 1989 (the Act) and sections of the Therapeutic Goods Advertising Code 2007 (the Code).
On 6 March 2013, as a result of Vitality Plus Australia Pty Ltd not fully complying with the Panel's determination, the Panel recommended the TGA delegate of the Secretary of the Department of Health (the Delegate) review the matter.
Following investigation, the Delegate's decision was made on 25 November 2013.
The Delegate found that the internet advertisement:
- was for a therapeutic good that should have been included in the Australian Register of Therapeutic Goods but was not, and was therefore in breach of section 42DL(1)(g) of the Act
- was incorrect and unbalanced and was therefore in breach of section 4(1)(b) of the Code
- was likely to arouse unwarranted and unrealistic expectations of product effectiveness and was therefore in breach of section 4(2)(a) of the Code
- was misleading or likely to be misleading and was therefore in breach of section 4(2)(c) of the Code
- included misleading scientific information and was therefore in breach of section 4(4) of the Code
- inappropriately implied endorsement by healthcare professionals and was therefore in breach of section 4(6)(b) of the Code
- included misleading testimonial content and was therefore in breach of section 4(7) of the Code
- inappropriately implied that Megahydrate could be used to treat cancer and was therefore in breach of section 5(1) of the Code
- did not include statements required to be included in advertisements for therapeutic goods and therefore breached section 6(3) of the Code.
The Delegate ordered Vitality Plus Australia Pty Ltd to:
- withdraw any representations, including implied representations, that Megahydrate:
- is endorsed by a doctor or any other healthcare professional
- can affect the 'zeta potential' of blood cells, cause blood cells to be less 'clustered together' and therefore less prone to 'trap waste elements between them', or otherwise affect blood cells
- may act as an alternative to eating fruit and vegetables, or is equivalent to 10,000 organic oranges
- is 'life water'
- aids longevity or heart health
- can cause 'good health and longevity' and 'healthy active lives past the age of 100 years'
- the product's benefits or 'glacial milk' are supported by an authoritative body of scientific or medical evidence
- is for any therapeutic use
- has any association with preventing or treating cancer.
- not use the representations in (a) above in any other advertisement
- 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 representations should be withdrawn
- to arrange for the publication of a retraction in the form noted below on the main page of the advertiser's website.
Conditions imposed on the order
Additionally, the Delegate imposed the following conditions under regulation 9(2) in relation to the order:
- within 10 working days of being notified of this order, Vitality Plus Australia Pty Ltd will provide evidence of compliance with this order
- within 10 working days of being notified of this order, Vitality Plus Australia Pty Ltd will provide a written response indicating that it will continue to abide by this order.
The below retraction notice is to appear on the advertiser's website for a demonstrable period of no less than 120 days.
An advertisement for the product Megahydrate, which we published on this website, was misleading and abused the trust of consumers. We should not have published it.
In the advertisement we unlawfully made claims that the product could affect blood cells, reduce waste "trapped" between blood cells, act as "life water", aid longevity and heart health, cause 'healthy active lives past the age of 100 years, 'alkalise the human body, and treat cancer. We also unlawfully claimed that Megahydrate includes negative hydrogen ions within so-called 'micro-clusters' and that these ions have a positive influence on human health. We implied that claims about the Megahydrate were supported by scientific research.
A complaint about the advertisement was upheld by the Complaints Resolution Panel. We provided no evidence to support the claims we made, and the Panel found that the claims were unlawful, misleading, and unverified and breached the Therapeutic Goods Advertising Code.
Following receipt of the Panel's recommendation, the delegate of the Secretary for Health considered the information before her and decided to order that Vitality Plus Australia Pty Ltd to publish this retraction.
The full text of the Panel's determination can be found at: Complaints Register.