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Once Off head lice lotion and Daily Control head lice spray - Hit Nitz 4 6 Pty Ltd - Complaint No. 2012-02-027

9 May 2014

Decision under regulation 9 of the Therapeutic Goods Regulations 1990

Hit Nitz 4 6 Pty Ltd has been ordered to undertake a number of actions regarding advertisements for the products Once Off head lice lotion and Daily Control head lice spray, including but not limited to withdrawing the advertisements from future publication and publishing a retraction on its website.

The advertisements were the subject of a complaint to the Complaints Resolution Panel (the Panel) on 29 February 2012 (complaint no. 2012-02-027).

On 13 August 2012, the Panel issued a written determination that the advertisements breached sections of the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Advertising Code 2007 (the Code)

On 3 October 2012, as a result of Hit Nitz 4 6 Pty Ltd not fully complying with the 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 7 March 2014.

The decision

The Delegate found that the advertisements:

  1. contained representations that did not match the indications for these products, as listed on the Australian Register of Therapeutic Goods, and were therefore in breach of section 22(5) of the Act
  2. contained claims that the advertiser could not demonstrate to be correct, verified and balanced and were therefore in breach of section 4(1)(b) of the Code
  3. were likely to arouse unwarranted and unrealistic expectations of product effectiveness and were therefore in breach of section 4(2)(a) of the Code
  4. were misleading or likely to be misleading and were therefore in breach of section 4(2)(c) of the Code
  5. contained language that abused the trust and exploited the lack of knowledge of consumers, as well as contained language that could bring about distress in the minds of some consumers, and were therefore in breach of section 4(2)(d) of the Code
  6. contained representations that were likely to encourage inappropriate or excessive use and were therefore in breach of section 4(2)(f) of the Code
  7. contained statements that the products were 100% effective and 'guaranteed' and were therefore in breach of sections 4(2)(g) and 4(2)(h) of the Code
  8. contained statements that the products had no potential to cause harm and were therefore in breach of section 4(2)(i) of the Code
  9. referred to 'research' that was insufficient to verify the claims made for the products, without identifying the researcher nor identifying the financial sponsor of the research, and were therefore in breach of section 4(4) of the Code
  10. contained comparative claims that were misleading and implied that other products could be harmful or ineffectual, and were therefore in breach of section 4(5) of the Code
  11. contained a testimonial that 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 were therefore in breach of section 4(7) of the Code
  12. referred to a serious form of disease, condition, ailment or defect specified in Part 2 of Appendix 6 of the Code, and were therefore in breach of section 5(2) of the Code
  13. 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', and were therefore in breach of sections 6(3)(c) and 6(3)(d) of the Code.

The order

The Delegate ordered Hit Nitz 4 6 Pty Ltd to:

  1. withdraw the advertisements from further publication
  2. to withdraw any representations that:
    • other head lice products 'all basically have the same ingredients'
    • head lice have become immune to the active ingredients in the majority of other head lice products
    • the active ingredient in the advertised products has never been used in head lice products before
    • there is no resistance in head lice to the advertised products or their active ingredient
    • the formulation of the advertised products is 'completely new'
    • the advertised products are 'the only product[s] on the market' that are '100% natural'
    • the advertised products do not contain any preservatives
    • the advertised products could enable users to be 'nit free forever'
    • the Once Off lotion product eradicates head lice, kills 100 percent of head lice, or has been tested to do so
    • other head lice products do not have a success rate comparable to that of the advertised products
    • most other head lice products contain toxic chemicals or poisons
    • the advertised products contain no chemicals or are 'chemical free' or 'poison free'
    • the advertised products are all natural and organic
    • the advertised products are safe
    • other head lice products contain ingredients such as preservatives and colours that are 'nasty' or may be harmful, or may 'fry' or otherwise harm the head of users
    • other head lice products, by comparison with the advertised products, contain chemicals or are 'the chemical stuff'
    • other head lice products leave a residue or are 'a poison that will stay in your child's hair for months and weeks'
    • other head lice products, by comparison with the advertised products, contain poisons or 'nasty highly dangerous poisons'
    • the Once Off lotion should be used 'upon suspicion of infestation' rather than in cases where infestation was confirmed
    • the advertised products can keep consumers head-lice free or 'nit free forever'
    • the advertised products were guaranteed not to disappoint
    • the advertised Once Off lotion has been 'tested to kill 100% of head lice'
    • the advertised products were clinically proven or clinically tested
    • the Daily Control product is 92% effective in keeping consumers free of head lice
    • that a head lice product available in Australia causes leukaemia in children, together with any references to leukaemia.
  3. not to use the representations in (b) above in any other advertisement;
  4. where the representations have 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 representation(s) should be withdrawn
  5. to arrange for publication on the www.headlicehq.com.au website of a correction in the form set out 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, Hit Nitz 4 6 Pty Ltd will provide evidence of compliance with this order
  2. within 10 working days of being notified of this order, Hit Nitz 4 6 Pty Ltd will provide a written response indicating that Hit Nitz 4 6 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

Advertisements for Hit Nitz 4 6 products, which we published on the website Hit Nitz 4 6 should not have been published.

In the advertisements we unlawfully made claims that the products were clinically proven, safe, guaranteed, new, all natural, chemical-free and that they would allow users to be nit-free or head lice free. The advertisements also unlawfully included claims that other head lice products were harmful, contained "poisons" or "chemicals", and were less effective than our products.

A complaint about the advertisements was upheld by the Complaints Resolution Panel. Upon being advised of the complaint, we withdrew the majority of the misleading claims. 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 Hit Nitz 4 6 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.