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Amber Necklace, Amber Bracelet, Wonder Balm and Bottom Balm - Nature's Child Pty Limited - Complaint No. 2011-09-020

13 March 2013

Therapeutic Goods Act 1989
Therapeutic Goods Regulations 1990

Decision under regulation 9 of the Therapeutic Goods Regulations 1990 in relation to an advertisement about the product "Amber Necklace, Amber Bracelet, Wonder Balm and Bottom Balm"
(Complaint No 2011-09-020)

Background

On 12 December 2012, the delegate of the Secretary to the Department of Health and Ageing (the Delegate) for the purposes of section 9(1) of the Therapeutic Goods Regulations 1990 (the Regulations) issued an order to Nature's Child Pty Ltd (Nature's Child) in relation to an internet advertisement at www.natureschild.com.au about the products "Amber Necklace, Amber Bracelet, Wonder Balm and Bottom Balm".

The decision to issue the order was made by the Delegate after a recommendation was made to the Secretary to the Department of Health and Ageing (the Secretary) by the Complaints Resolution Panel (the Panel) under section 42ZCAI(3) of the Regulations on 8 September 2011 in relation to the "Amber Necklace, Amber Bracelet, Wonder Balm and Bottom Balm" advertisements referred to above, the subject of Complaint No 2011-09-020. The recommendation was made as Nature's Child Pty Ltd had not fully complied with the Panel's determination issued on 30 November 2011.

The Panel's findings

The Panel found that "Nature's Child" internet advertisement breached sections 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(d) and 4(2)(g) of the Therapeutic Goods Advertising Code 2007 (the Code1) and section 42DL(1)(g) of the Therapeutic Goods Act 1989 (the Act). The discussion in relation to the Panel's findings may be found at paragraphs 18 - 30 of the Panel's determination which may be accessed from the Panel's Complaint Register at complaint No. 2011-09-020.

  1. Please refer to the webpage http://www.tga.gov.au/consumers/advertising-complaint-consumer-guide.htm for a summary of the advertising provisions that are commonly breached.

Code breaches

The Delegate was of the view that the "Wonder Balm, Bottom Balm and Amber Teething products" represented in the internet advertisement at www.natureschild.com.au at the time of the complaint breached sections 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(d) and 4(2)(g) of the Code and section 42DL(1)(g) of the Act.

Considerations

The Delegate reviewed the determination No 2011-09-020 and agreed with the Panel that the representations made for the "Amber Necklaces", "Bottom Balm" and "Wonder Balm" products were therapeutic claims either stated directly or implied through customer testimonials. Nature's Child did not provide any evidence in support of the representations in the advertisement and acknowledged that the claims they had made had not been scientifically validated.

The Delegate found that the advertisement as a whole conveyed unwarranted and unrealistic expectations of product effectiveness and was misleading through the unverified representations that the necklaces (and amber bracelets) could 'help relieve inflammation associated with teething', was a 'side-effect free remedy for the pain or complication of teething', could 'have an analgesic effect', or that 'recent scientific research had also proven its (amber) benefit's. Likewise, representations that the Wonder Balm and Bottom Balm had benefits in relation to inflammation, bites, burns, haemorrhoids and had 'healing properties' would foster unrealistic, unwarranted expectations of the products effectiveness and were likely to mislead consumers. The Delegate found therefore the advertisement at the time of the complaint to be in breach of sections 4(1)(b), 4(2)(a) and 4(2)(c) of the Code.

The Delegate also agreed with the Panel's determination finding that the language used in the advertisement would exploit the lack of knowledge of consumers, especially those parents seeking to alleviate the pain, suffering and distress associated with teething or with skin inflammations in their child. It was apparent to the Delegate that the use of words such as "...miracle results.." and "...any redness, inflammation, bite, rash is history when bottom balm is part of your daily nappy changing/ baby care routine..." were representations implying that the product was a certain or sure cure, and found the advertisement at the time of the complaint was in breach of sections 4(2)(d) and 4(2)(g) of the Code.

As the products were presented as therapeutic goods and are not included in the Australian Register of Therapeutic Goods (ARTG), as is required, the Delegate found that the advertisement at the time of the complaint breached section 42DL(1)(g) of the Act.

The Delegate also considered the publication of a retraction as requested by the Panel. In reaching her decision the Delegate examined all fourteen complaints about amber teething beads which had been determined by the Panel since November 2010 as well as the Australian Competition and Consumer Commission (ACCC) consumer protection notice issued to the public on 30 September 2011 that amber teething beads presented a choking hazard to children. The Delegate was of the view that there was no need to request the publication of a retraction in the form sought by the Panel as consumers could already obtain publicly available information about the hazards and possible unsupported claims made by suppliers of these products. The Delegate believed that the most important objective of a retraction is to protect public health and warn them of any public health risks arising from the supply of a particular product and that it was her view that these objectives had already been met.

Accordingly, the Delegate considered it necessary to issue the order, without a retraction, under regulation 9 of the Regulations to Nature's Child Pty Ltd requiring it to comply with all the actions set out in the order.

The order

The delegate of the Secretary ordered Nature's Child Pty Ltd to:

  1. withdraw the internet advertisement about the products "Amber Necklace, Amber Bracelet, Wonder Balm and Bottom Balm" found at the Nature's Child website (www.natureschild.com.au);
  2. withdraw any representations that the advertised products have benefits in relation to the management of nappy rash and other skin irritations, dry itching skin, bites, burns, skin grazes, cradle cap, haemorrhoids, dry skin, eczema-related soreness, bra rash, groin rash, thigh rubbing, childhood accidents, teething, acting as an anti-inflammatory, restoring calm to a tired and irritated baby, aiding sleep and skin irritations due to the positive effects on the immune system in babies, acting as a side effect free remedy for pain and complications of teething, acting as a natural pain reliever, having a positive effect on the blood stream, having healing properties, and having calmative, analgesic, antispasmodic, expectorant, and febrifuge or anti-fever effects, together with any representations that they are for any therapeutic use as defined in the Act, and any representation that availability of the amber necklaces and bracelets "in some European countries...in local pharmacies" means that amber products are supported by scientific evidence or are recognised by healthcare professionals as having therapeutic benefits;
  3. not use the representations in (b) above in any other advertisement; and
  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 representation has been published or is intended to be published by such parties, to advise those parties that the representations should be withdrawn.

Conditions imposed on the order

Pursuant to section 9(2) of the Regulations, the order was subject to the following conditions:

  • within 10 working days of being notified of the order, Nature's Child Pty Ltd will provide evidence to the Delegate of compliance with the order; and
  • within 10 working days of being notified of the order, Nature's Child Pty Ltd will provide to the Delegate a written response indicating that Nature's Child Pty Ltd will continue to abide by the order.

Outcome

The material found to be in breach by the Panel and specified in the regulation 9 order has been removed from the website and, on 12 March 2013, the TGA received advice from Nature's Child Pty Ltd in writing that they have complied with and will continue to comply with the regulation 9 order.