Lifelixer - Lifelixer Pty Ltd - Complaint No. 2012-03-026
Decision under regulation 9 of the Therapeutic Goods Regulations 1990
Lifelixer Pty Ltd has been ordered to undertake a number of actions regarding internet advertisements for the product Lifelixer, including but not limited to withdrawing the advertisements and publishing a retraction on its websites.
This order was made because the internet advertisements were found to breach sections of the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Advertising Code 2007 (the Code).
On 22 October 2012, the Panel found that sections 42DL(1)(a), 42DL(1)(g) and 42DM(1) of the Act and sections 4(1)(a), 4(1)(b), 4(2)(a), 4(2)(b), 4(2)(c), 4(2)(d), 4(2)(f), 4(2)(g), 4(2)(h), 4(2)(i), 4(4), 4(5), 4(6)(b), 4(7), 5(1), 5(2), 6(3)(c) and 6(3)(d) of the Code were breached in relation to the internet advertisements (see paragraphs 17-43 of the Panel's determination).
On 31 January 2013, as a result of Lifelixer Pty Ltd failing to fully comply with the Panel's determination, the Panel recommended the TGA delegate of the Secretary of the Department of Health (the Delegate) review the matter.
The Delegate's decision was made on 13 January 2014.
The Delegate found that the internet advertisements:
- contained prohibited representations about diseases and was therefore in breach of section 42DL(1)(a) of the Act
- were for a product for which therapeutic claims were made that was not included in the Australian Register of Therapeutic Goods and was therefore in breach of section 42DL(1)(g) of the Act
- contained numerous breaches of the Code and was therefore in breach of section 42DM(1) of the Act
- did not comply with the statute law of the Commonwealth and was therefore in breach of section 4(1)(a) of the Code
- contained incorrect and unbalanced statements 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 likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases and was therefore in breach of section 4(2)(b) of the Code
- was misleading or likely to be misleading and was therefore in breach of section 4(2)(c) of the Code
- contained unverified and misleading representations regarding a range of serious diseases and medical conditions and as such abused the trust and exploited the lack of knowledge of consumers, as well as contained heightened language that could bring about fear or distress in the minds of some consumers, and was therefore in breach of section 4(2)(d) of the Code
- encouraged inappropriate use, as Lifelixer Pty Ltd was not able to provide evidence to support its claims of efficacy, and was therefore in breach of section 4(2)(f) of the Code
- contained claims that the product had magical or miraculous qualities, and implied that these benefits were certain or guaranteed, and was therefore in breach of sections 4(2)(g) and 4(2)(h) of the Code
- contained claims that the product was safe and that there were no side effects associated with its use, and was therefore in breach of section 4(2)(i) of the Code
- included misleading scientific information and terminology that was inaccurate and unbalanced, and would not be readily understood by consumers, and was therefore in breach of section 4(4) of the Code
- included comparisons with other products that were unbalanced and implied that use of those products could be ineffectual or harmful, and was therefore in breach of section 4(5) of the Code
- implied endorsement by persons whom a consumer might reasonably believe to be health professionals and was therefore in breach of section 4(6)(b) of the Code
- included unqualified and misleading testimonial content and was therefore in breach of section 4(7) of the Code
- implied that the product could be used to treat or prevent diseases that are prohibited representations specified in Part 1 of Appendix 6 of the Code, and was therefore in breach of section 5(1) of the Code
- referred to serious diseases, conditions, ailments and defects specified in Part 2 of Appendix 6 of the Code, such as those for which it is generally accepted that they should not be diagnosed or treated without consulting a suitably qualified health professional and/or are beyond the ability of the average consumer to evaluate accurately or treat safely without regular supervision by a suitably qualified health professional, without prior authorisation under the Act, and was therefore in breach of section 5(2) of the Code.
The Delegate ordered Lifelixer Pty Ltd to:
- confirm in writing that the internet advertisement for the product found on www.lifelixer.com has been withdrawn
- withdraw any therapeutic claims about the product made in the internet advertisement on www.lifelixer.com.au
- withdraw any representations that the product is for any therapeutic use that offers benefits in relation to:
- longevity or lifespan
- ageing or the causes of ageing
- the immune system
- mental focus
- 'workload capacity'
- rejuvenating skin and muscle tissue
- sexual function
- athletic performance
- cardiovascular health
- skeletal strength
- energy levels
- cholesterol levels
- 'general depletion of nutrition, health and vitality'
- 'block[ing] free radicals that age [the] heart, brain and joints'
- strengthening the heart
- protecting 'vital blood vessels'
- 'digestive distress'
- mental clarity
- skin elasticity and firmness
- the prostate
- peripheral blood circulation
- blocking the production of DHT
- aiding in relation to hair loss or hair thinning
- breast cancer
- prostate cancer
- menopausal symptoms
- 'artery clogging plaque'
- heart attack
- mood swings
- obsessive-compulsive disorder
- panic disorder
- bipolar conditions
- thyroid function
- or other health concerns mentioned in the internet advertisements.
- They must also withdraw any representations that the product has been scientifically demonstrated to have any of the above benefits; is safe or free of side effects; is endorsed by any health professional; and that 'most natural based health and wellness products on the market today fail for the very reason that they are of such mild dosage quantity that there is not enough potency to be effective' or other comparisons to other products.
- not use the representations in (c) above in any other advertisements
- 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 are 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 all of the advertiser's websites.
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, Lifelixer Pty Ltd will provide evidence of compliance with this order
- within 10 working days of being notified of this order, Lifelixer 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 90 days.
An advertisement for Lifelixer, which we published on this website, should not have been published.
In the advertisement we unlawfully made claims that the product could have therapeutic benefits, including benefits connected with immune health, ageing, longevity, skin elasticity and firmness, stress, serious diseases such as depression and cancers and many other health concerns.
A complaint about the advertisement was recently upheld by the Complaint 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 we publish this retraction.
The full text of the Panel's determination can be found at: Complaints Register