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Macular Health with Saffron - Orielton Laboratories Pty Ltd - Complaint No. 2012-05-008

14 February 2014

Decision under regulation 9 of the Therapeutic Goods Regulations 1990

Orielton Laboratories Pty Ltd has been ordered to undertake a number of actions regarding an internet advertisement for the product Macular Health with Saffron, including but not limited to withdrawing the advertisement from future publication and publishing a retraction on its website.

This order was made because the internet advertisement was found to breach sections of the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Advertising Code 2007 (the Code).

The internet advertisement was the subject of a complaint made to the Complaints Resolution Panel (the Panel) on 3 May 2012 (complaint no. 2012-05-008).

On 30 January 2013, the Panel issued a written determination that section 22(5) of the Act and sections 4(2)(a), 4(2)(b), 4(2)(c), 4(2)(d), 4(4), 5(2) and 6 of the Code were breached in relation to the internet advertisement (see paragraphs 13-23 of the Panel's determination).

On 6 March 2013, as a result of Orielton Laboratories 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 20 January 2014.

The decision

The Delegate found that the indications listed on the ARTG entry at the time did not match the representations in the advertisement, therefore the advertisement was in breach of section 22(5) of the Act.

In relation to the Code, the Delegate found that the internet advertisement:

  1. was likely to arouse unwarranted and unrealistic expectations of product effectiveness and was therefore in breach of section 4(2)(a) of the Code
  2. 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
  3. was misleading or likely to be misleading and was therefore in breach of section 4(2)(c) of the Code
  4. contained unverified and misleading representations regarding a serious disease and as such abused the trust and exploited the lack of knowledge of consumers, as well as containing language that could bring about distress in the minds of some consumers, and was therefore in breach of section 4(2)(d) of the Code
  5. referred to 'research' without identifying the researcher nor identifying the financial sponsor of the research, therefore breaching of section 4(4) of the Code
  6. referred to a serious disease specified in Part 2 of Appendix 6 of the Code for which it is generally accepted that it should not be diagnosed or treated without consulting a suitably qualified health professional and/or is 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
  7. did not include the statements 'Always read the label' as well as the inclusion of 'Use only as directed' and, for symptomatic relief 'If symptoms persist, see your doctor/healthcare professional', breaching section 6(3)(c)(i) of the Code.

The order

The Delegate ordered Orielton Laboratories Pty Ltd to:

  1. withdraw from future publication the website advertisement about the product 'Macular Health with Saffron' on the website (www.naturesgoodness.com.au)
  2. withdraw any representations, including implied representations, that:
    • the product 'may help protect the macular region of the retina from free radical damage'
    • the product 'is a saffron supplement to assist sufferers of macular degeneration'
    • the product is based on recipes that are thousands of years old
    • 'the latest research shows that Saffron supplementation can improve retinal function in macular degeneration sufferers as well as improving their visual acuity (sharpness)'
    • 'NEW Nature's Goodness Macular Health is a saffron supplement to assist sufferers of macular degeneration'
  3. not use the representations in (b) above in any other advertisement
  4. where the representation has 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
  5. To arrange for publication on the website www.naturesgoodness.com.au of a retraction.

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, Orielton Laboratories Pty Ltd will provide evidence to me of compliance with this order
  2. within 10 working days of being notified of this order Orielton Laboratories Pty Ltd will provide to me a written response indicating that Orielton Laboratories Pty Ltd will continue to abide by this order.

Retraction notice

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

RETRACTION

An advertisement for the product Macular Health with Saffron, 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 assist sufferers of macular degeneration and could improve retinal function in macular degeneration sufferers as well as improving their visual acuity (sharpness).

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 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 Orielton Laboratories 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