You are here

NitWits - SI&D (Aust) Pty Ltd - Complaint No. 2012-11-013

8 December 2014

Regulation 48 review update

8 December 2014

Following an initial decision made by a delegate of the Secretary of the Department of Health on 17 June 2014, SI&D (Aust) Pty Ltd sought a review of that decision under regulation 48 of the Therapeutic Goods Regulations 1990.

On 7 November 2014, a delegate of the Minister for Health revoked the initial decision and substituted it with the following order:

  1. withdraw any representations, including implied representations that the advertised NitWits Anti-Lice & Detangling Spray and Head-Lice Comb products are for therapeutic use, including the prevention of head lice infestation in children
  2. not use the representations referred to in paragraph (1) above in any advertisement unless the Advertiser satisfies the Secretary that the use of the representations would not result in contravention of the Therapeutic Goods Act 1989 (the Act), the Regulations, or the Therapeutic Goods Advertising Code 2007 (the Code)
  3. 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published or is intended to be published by such parties, to advise those parties that the representation(s) should be withdrawn.

In a letter dated 21 November 2014, SI&D (Aust) Pty Ltd advised that it will abide by the orders set out in the delegate's decision on 7 November 2014.

Regulation 48 review update

17 September 2014

The Minister for Health has received from SI&D (Aust) Pty Ltd, by letter received on 9 September 2014, a request for review under regulation 48 of the Therapeutic Goods Regulations 1990 in relation to the 'initial decision' by the Delegate.

NitWits - SI&D (Aust) Pty Ltd - Complaint No. 2012-11-013

On 7 November 2014, a delegate of the Minister for Health revoked this decision and substituted it with a new order. Details of this can be found above in the update published on 8 December 2014.

4 July 2014

Decision under regulation 9 of the Therapeutic Goods Regulations 1990

SI&D (Aust) Pty Ltd has been ordered to undertake a number of actions regarding advertisements for its NitWits Natural Anti-Lice & Detangling Spray, NitWits Head-Lice Combing Solution and NitWits Absolute Head Lice Solution, 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 20 November 2012 (complaint no. 2012-11-013).

On 12 September 2013, 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 12 November 2013, as a result of SI&D (Aust) 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 17 June 2014.

The decision

The Delegate found that the advertisements:

  1. were for products for which therapeutic claims were made that were not included in the Australian Register of Therapeutic Goods and were therefore in breach of section 42DL(1)(g) 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 in respect of NitWits Absolute Head Lice Solution 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 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 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
  7. included misleading testimonial content and was therefore in breach of section 4(7) of the Code
  8. did not include a list of active ingredients or the statements 'Use only as directed' and '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 SI&D (Aust) Pty Ltd to:

  1. withdraw any representations, including implied representations:
    1. that the advertised NitWits Natural Anti-Lice & Detangling Spray and Head-Lice Combing Solution products are for therapeutic use, including use in the prevention of head lice infestation in children, the eradication of head lice, or the eradication of head lice eggs
    2. that the advertised Absolute Head Lice Solution is free of chemical pesticides or contains "no chemical pesticides"
    3. that the advertised product NitWits Absolute Head Lice Solution is an "absolute solution" for head lice, including representations conveyed by the words "absolute head lice solution";
    4. that the advertised product NitWits Natural Anti-Lice & Detangling Spray is free from pesticides, or that other head lice products contain substances that may be harmful or are "potentially harmful";
  2. not use the representations referred to in paragraph (1) above in any other advertisement unless the advertiser satisfies the Secretary that the use of the representations would not result in a contravention of the Therapeutic Goods Act 1989 (the Act), the Regulations or the Therapeutic Goods Advertising Code 2007 (the Code)
  3. 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
  4. to arrange for publication of a retraction on the website, www.nitwits.com.au> 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, SI&D (Aust) Pty Ltd will provide evidence of compliance with this order
  2. within 10 working days of being notified of this order, SI&D (Aust) Pty Ltd will provide a written response indicating that SI&D (Aust) 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 a range of NitWits head lice products, which we published on this website, should not have been published.

In the advertisement, we unlawfully made claims that the NitWits Absolute Head Lice Solution product was "free of chemical pesticides" and that NitWits head lice products were likely to work when all or many other head lice products have failed.

A complaint about the advertisement was recently upheld by the Complaints Resolution Panel. We provided insufficient evidence to support the claims we made, and the Panel found that the claims were unlawful, misleading and breached the Therapeutic Goods Advertising Code. The Panel requested that we publish a retraction. We did not do so and the Panel recommended to the Secretary of the Department of Health that an order be made requiring us to publish a retraction.

The Secretary's delegate considered all the information before her and while satisfied that there was evidence in relation to the 'Absolute' head lice solution showing results in 20 minutes (killing by asphyxiation), found the same breaches of the therapeutic goods legislation were evident as identified above. The delegate therefore ordered that we publish this retraction.

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

A summary of the Secretary's delegate order can be found at: Decisions in relation to complaints about advertisements.