Complaints Register

COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2008-07-018 Clearskincare products

Meeting held 2 October 2008

1.      The complaint concerned internet advertisements published at the website www.clearskincare.com.au.

2.      The advertisements included claims such as “corrective skincare”, “for pigmentation”, “sunblock”, “a fully registered TGA sunscreen”, “we must wear sunscreen everyday, rain or shine, 365 days per year”, “assist the human body’s natural function to convert these new fine (vellus) hairs into normal (terminal) hairs”, “improves microcirculation of blood to the hair follicle”, “enhances the scalp improving scalp health”, and “good for treating sunburn, solar keratoses”.

3.      An excerpt of the advertisements can be viewed in the relevant Appendix to this determination.

4.      The advertisements promoted Clear Skin 2%, Clearskincare Sunscreen, Clearskincare CP Hair Tonic, and Clearskincare Vitamin C Serum.

5.      The advertiser was Clearskincare.

6.      The complainant was anonymous.

7.      The complaint related both to the internet advertisements and to an advertisement published in 9 to 5 magazine. However, the Panel was of the view that the magazine advertisement related to services only, and not to therapeutic goods, and therefore did not consider that aspect of the complaint.

8.      The complainant expressed the following concerns about the internet advertisements:

a)      That “none of the products advertised appear to be included on the ARTG and so cannot be advertised or supplied in ”, which the Panel took to be an allegation of a breach of section 42DL(1)(g) of the Act;

b)      That they included endorsement by a healthcare professional, which the Panel took to be an allegation of a breach of section 4(6)(b) of the Code;

c)      That they referred to the advertised products as “safe”, which the Panel took to be an allegation of a breach of section 4(2)(i) of the Code;

d)      That they contained “superlative claims of the products being the best, which is unbalanced”, which the Panel took to be an allegation of a breach of sections 4(1)(b) and 4(2)(c) of the Code;

e)      That they described a sunscreen product as a “sunblock”, which the Panel took to be an allegation of a breach of section 4(2)(c) of the Code;

f)        That they claim “that the SPF30+ sunscreen is approved and fully registered by the TGA... [and products] are not evaluated and approved as such”, which the Panel took to be an allegation of a breach of both section 4(6)(b) of the Code and section 42DL(1)(g) of the Act;

g)      That the sunscreen product was described as “the best sun protection” but should only be described as “very high protection”, which the Panel took to be an allegation of a breach of section 4(5) of the Code;

h)      That it is ‘incorrect and misleading to tell consumers that they “must wear sunscreen every day” [because] it is correct that people must protect themselves from the sun every day, but this does not mean it has to be through daily use of a sunscreen, as other protective and avoidance measures can be effective”, which the Panel took to be an allegation of a breach of sections 4(2)(f), 4(1)(b), and 4(2)(c) of the Code.

9.      The complainant also specifically noted sections 3(3), 4(1)(a), 4(6)(b), 4(2)(i), 4(5), 4(1)(b), and 4(6)(a) as having been breached by the advertisements.

10.  The complainant also made some notes throughout the printed copies of the advertisements.

11.  The advertiser argued that the print advertisement “does not mention any Clearskincare products”.

12.  The advertiser stated that Clearskin 2% “is a Schedule 2 cosmetic cream” and that “Clearskincare is licensed by NSW Health to supply Schedule 2 substances”, and that they had “been advised by various TGA officers and [their] Regulatory Affairs Advisor that a Schedule 2 cosmetic cream does not require listing or registration with TGA, provided no therapeutic claims are made in relation to the product”, and “Clearskincare does not make any therapeutic claims in relation to Clearskin 2%”.

13.  In relation to the sunscreen product, the advertiser stated that it is in fact Listed on the Register and provided an Aust L number in relation to it.

14.  In relation to the Hair Tonic and Vitamin C Serum products, the advertiser stated only that they were cosmetic products.

15.  In relation to the allegation of endorsement by a healthcare professional, the advertiser stated that “there is no product endorsement by myself in either the print advertisement or the website.”

16.  The advertiser stated that the claim that the Hair Tonic product is “safe”, and that the sunscreen product is the “best” would be removed from future advertising, that the word “sunblock” would be replaced with “sunscreen”, and that any references to TGA registration would be removed.

17.  In relation to the recommendation that sunscreen “must” be worn every day, the advertiser stated, “As a doctor, I recommend my patients wear Sunscreen everyday [sic], the website will be amended to reflect this recommendation”, and, “I do not agree with the complainant’s viewpoint on this issue.”

18.  As noted above, the Panel agreed with the advertiser that the print advertisement did not promote therapeutic goods, and did not consider that aspect of the complaint.

19.  Section 42DL(1)(g) of the Act prohibits the publication of advertisements for therapeutic goods that are not included in the Register. Therapeutic goods are defined in the Act to include goods that are represented in any way to be for therapeutic use. Therapeutic use is defined to include use in or in connection with influencing, inhibiting, or modifying a physiological process in persons.

20.  The advertiser argued that the Clearskin 2%, CP Hair Tonic, and Vitamin C Serum products were cosmetic products, and in relation to the Clearskin 2% product, stated that “no therapeutic claims” were made for it. The Panel was satisfied that the internet advertisements did in fact promote these products as being for therapeutic use. In particular, the Panel noted that:

a)      The Clearskin 2% product was described as being able to “treat the face and neck”, and as being “for patients with significant hyperpigmentation”;

b)      The CP Hair Tonic product was described as having “active ingredients” (namely “2nd generation copper peptides and soothing aloe vera”), and as “assist[ing] the human body’s natural function to convert... new fine (vellus) hairs into normal (terminal) hairs”, “improv[ing] microcirculation of blood to the hair follicle”, “enhanc[ing] the scalp improving scalp health”, and “improve[ing] scalp health damaged by hair treatments”;

c)      The Vitamin C Serum product was described as being “good for treating sunburn [and] solar keratoses”, and having “other benefits includ[ing] stimulation of dermal collagen production, significant antioxidant activity... and reduction of melanin production.”

21.  For these reasons, the publication on the website of the advertisements promoting these products constituted breaches of section 42DL(1)(g) of the Act. This aspect of the complaint was therefore justified.

22.  The Panel accepted that the sunscreen product did appear to be included on the Register, and that advertising it therefore did not breach section 42DL(1)(g) of the Act.

23.  Section 4(6)(b) of the Code prohibits representations that therapeutic goods are endorsed by healthcare professionals. The website included a number of references to Dr Philippa McCaffery, describing her as the “founder and creator of Clearskincare”. The Panel considered the references to Dr McCaffery to be clear representations that the products advertised are endorsed by a healthcare professional. This aspect of the complaint was therefore justified.

24.  Section 4(6)(b) of the Code also prohibits representations that therapeutic goods are endorsed by government agencies. While in one sense words such as “a fully registered TGA sunscreen” may constitute an attempt to indicate compliance with the Act, they are likely to convey an implication that the goods so listed are approved by an Australian government agency to a degree that is not factually correct, particularly regarding the efficacy of the product. This aspect of the complaint was therefore justified. However, for the advertiser's benefit, the Panel noted that s.42DL(1)(e)(i) of the Act, whilst prohibiting “a reference to the Act”, does permit a statement to the effect that “Product X is listed in the ARTG, AUST L 123”. The Panel also noted that such a statement makes no direct reference to any government agency.

25.  Section 4(2)(i) of the Code prohibits representations that therapeutic goods advertised are completely safe, harmless, or free of side-effects. The website advertisements included words such as “safe, effective, and affordable product” in relation to the advertised goods. This aspect of the complaint was therefore justified.

26.  Section 4(1)(b) of the Code requires that advertisements for therapeutic goods “contain correct and balanced statements only and claims which the sponsor has already verified.” Section 4(2)(c) of the Code prohibits representations that “mislead directly or by implication or through emphasis, comparisons, contrasts or omissions”.

27.  In the absence of any relevant response from the advertiser, the Panel concluded that the superlative claims for the advertised products (such as “know that you are doing the best possible thing for your skin”), breached sections 4(1)(b) and 4(2)(c) of the Code. Further, the claim that the sunscreen product was a “sunblock” was misleading and breached section 4(2)(c) of the Code. These aspects of the complaint were therefore justified.

28.  Section 4(5) of the Code requires comparisons in advertisements to be balanced, not to be misleading or likely to be misleading and should not “imply that the therapeutic goods, or classes of therapeutic goods, with which comparison is made, are harmful or ineffectual.” On the basis of the material before it, the Panel considered claims such as “SPF30+ sunscreens are usually very greasy and not at all suitable to use as a moisturiser” and “the best sunprotection” (sic) to be comparisons that breached section 4(5) of the Code. This aspect of the complaint was therefore justified.

29.  Section 4(2)(f) of the Code prohibits representations that “encourage inappropriate or excessive use” of therapeutic goods. The complainant expressed a view that the words “in Australia we are exposed to sun every day, even just walking around... so we must wear Sunscreen every day, rain or shine, 365 days per year” were misleading and incorrect, since “other protective and avoidance measures can be effective.” On the basis of the material before it, the Panel agreed with the complainant that these words were misleading, since there are in fact appropriate and sensible approaches to sun protection that do not involve wearing sunscreen every day. The advertisement therefore breached sections 4(1)(b), 4(2)(c), and 4(2)(f) of the Code, and this aspect of the complaint was justified.

30.  The complainant also made reference to sections 3(3), 4(1)(a), and 4(6)(a­) of the Code, without specifically stating which aspects of the advertisements might breach these sections. The Panel was unable to find possible breaches of sections 3(3) or 4(6)(a) of the Code in the website advertisements.

31.  Section 4(1)(a) of the Code requires advertisements for therapeutic goods to comply with the statute and common law of the Commonwealth, States and Territories. Any breach of the Code or Act, such as those noted above, also constitutes a breach of section 4(1)(a) of the Code. This aspect of the complaint was therefore justified.

32.  The Panel requests Clearskincare, in accordance with subregulation 42ZCAI(1) of the Therapeutic Goods Regulations 1990:

a)      to withdraw the advertisements from further publication;

b)      to withdraw any representations that the advertised sunscreen is the best possible sun protection, must be used every day, is a “sunblock”, is safe, or is endorsed by a healthcare professional or government agency,  together with any representations that the Clearskin 2%, CP Hair Tonic, and Vitamin C Serum products are for therapeutic uses such as those noted above;

c)      not to use the representations in (b) above in any other advertisement unless Clearskincare satisfies the Panel that the use of the representation would not result in a contravention of the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 or the Therapeutic Goods Advertising Code;

d)      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 representation(s) should be withdrawn; and,

e)      within 14 days of being notified of this request, to provide evidence to the Panel of its compliance, such as copies of instructions to advertising agents or publishers, or correspondence with retailers and other third party advertisers.

33.  The advertiser’s attention is drawn to the provisions of sub-regulations 42ZCAI(3) and (4) which permit the Panel to make recommendations to the Secretary in the event of non-compliance with this request, including a recommendation that the inclusion of the goods on the Register be cancelled.

Dated 22 October 2008

For the Panel

Jason Korke

Chairman

In this determination, unless otherwise specified:

a)      “the Act” means the Therapeutic Goods Act 1989;

b)      “the Regulations” means the Therapeutic Goods Regulations 1990;

c)      “the Code” means the Therapeutic Goods Advertising Code;

d)      “the Register” means the Australian Register of Therapeutic Goods;

e)      “any other advertisement” appearing in sub-regulation 42ZCA1(1)(d) is not confined to advertisements in specified or broadcast media (in relation to which complaints may be made to the Panel under Regulation 42ZCAB).