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Hippocrates Natural Vitamin D3 - Hippocrates Health Centre of Australia Pty Ltd - Complaint No. 2013-05-022

21 May 2014

Decision under regulation 9 of the Therapeutic Goods Regulations 1990

Hippocrates Health Centre of Australia Pty Ltd has been ordered to undertake a number of actions regarding an internet advertisement for Hippocrates Natural Vitamin D3, including but not limited to withdrawing the advertisements and publishing a retraction.

The advertisement, which appeared on Hippocrates Health Centre of Australia Pty Ltd's website, was the subject of a complaint made to the Complaints Resolution Panel (the Panel) on 31 May 2013 (complaint no. 2013-05-022).

On 4 February 2014, the Panel issued a written determination that the internet advertisement breached sections of the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Advertising Code 2007 (the Code).

On 13 March 2014, as a result of Hippocrates Health Centre of 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 8 May 2014.

The decision

The Delegate found that the internet advertisement:

  1. contained claims regarding indications that did not match the approved indications listed in the products Australian Register of Therapeutic Goods (ARTG) entry and therefore breached section 22(5) of the Act
  2. contained prohibited representations about serious diseases and therefore breached section 42DL(1)(a) of the Act and section 5(1) of the Code
  3. contained restricted representations about serious diseases that had not been given prior approval and therefore breached 42DL(1)(c) of the Act and section 5(2) of the Code
  4. contained numerous breaches of the Code and therefore breached section 42DM(1) of the Act
  5. did not comply with the statute law of the Commonwealth and therefore breached section 4(1)(a) of the Code
  6. contained claims that were incorrect, unbalanced and not previously verified by the sponsor, and was misleading and likely to arouse unwarranted and unrealistic expectations of product effectiveness, and therefore breached sections 4(1)(b), 4(2)(a) and 4(2)(c) of the Code
  7. was likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases and therefore breached section 4(2)(b) of the Code
  8. abused the trust of, exploited the lack of knowledge of, could bring about distress in consumers and therefore breached section 4(2)(d) of the Code
  9. contained scientific information that was presented in a manner that was inaccurate, unbalanced and misleading, and for which the researchers and financial sponsors were not identified, and therefore breached 4(4) of the Code
  10. contained comparisons to competing products that were misleading or likely to be misleading, without providing scientific evidence to support these statements, as well as claims that implied competing products could be harmful or ineffectual, and therefore breached 4(5) of the Code
  11. contained representations that implied the advertised product, or its ingredient, were endorsed by a healthcare professional (or someone who a reasonable person would believe to be a healthcare professional) and therefore breached section 4(6)(b) of the Code
  12. contained claims made in testimonials that were misleading and could not be regarded as illustrating typical results and was therefore in breach of section 4(7) of the Code
  13. did not include a list of active ingredients, mandatory warning statements for vitamins or the statements 'use only as directed' and 'if symptoms persist see your doctor/healthcare professional' and therefore breached sections 6(3)(c) and 6(3)(d) of the Code.

The order

The Delegate ordered Hippocrates Health Centre of Australia Pty Ltd to:

  1. withdraw the internet advertisement from further publication
  2. withdraw any representations, including implied representations, that:
    1. the advertised product can protect against, or treat, cancer, stroke, high blood pressure, diabetes, autoimmune disease, depression, chronic pain, arthritis, osteoporosis, muscle weakness/wasting, gum disease, birth defects, cataracts, swine flu, Parkinson's disease, Alzheimer's disease, asthma, heart disease or autism
    2. the advertised product can offer benefits in relation to athletic performance
    3. other products, including those that contain vitamin D2, could be harmful, ineffectual or inferior to the advertised product
    4. other products may contain additives that inhibit absorption of the active ingredient or may not contain the stated amount of ingredients
    5. imply endorsement by Dr John Cannell.
  3. not use any representations referred to in (b) in any other advertisement unless the advertiser satisfies the Secretary that the use of the representations would not result in a contravention of the Act, the Regulations or the Code
  4. where 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, advise them that the representations should be withdrawn
  5. arrange for the publication of a retraction on its website in the form noted below.

Conditions imposed on the order

Additionally, the Delegate imposed the following conditions under regulation 9(2) in relation to the order:

  1. within 10 working days of being notified of this order, Hippocrates Health Centre of Australia Pty Ltd will provide evidence of compliance with this order
  2. within 10 working days of being notified of this order, Hippocrates Health Centre of Australia Pty Ltd will provide a written response indicating that it will continue to abide by this order.

Retraction notice

The below retraction notice is to appear on the advertiser's website for no less than 90 days.

RETRACTION

An advertisement for Hippocrates Natural Vitamin D3, which we published on this website, should not have been published.

In the advertisement we unlawfully made claims that the product could have benefits in relation to cancer, diabetes, autism, stroke, muscle wasting, birth defects, cataracts, swine flu, Parkinson's disease, Alzheimer's disease, and many other serious health concerns. The advertisement also implied that competing products were likely to be inferior, ineffective, or contain incorrect amounts of ingredients.

A complaint about the advertisements was upheld by the Complaints Resolution Panel. We did not provide evidence that supported the use of the claims we made, and the Panel found that the claims were unlawful, misleading, and unverified and breached the Therapeutic Goods Advertising Code 2007.

Following receipt of the Panel's recommendation, the delegate of the Secretary of the Department of Health considered the information before her and decided to order Hippocrates Health Centre of Australia Pty Ltd to publish this retraction.

The full text of the Panel's determination can be found at: Complaints Register.

A summary of the Delegate's decision can be found on the TGA website at: Decisions in relation to complaints about advertisements.