COMPLAINTS RESOLUTION PANEL DETERMINATION ......bioavailability and efficacy through improved absorption”, “better absorbed”, “receive a much more potent benefit”, “delivers

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COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2016-10-017 Nutra-Life BioActive Curcumin

ARTG ID: AUST L 217653

Meeting held 19 January 2017

Complaint summary^

Complainant Requested anonymity

Advertisers Vitaco Health Australia Pty Ltd

Subject matter of complaint Internet advertisements

Type of determination Final

Sections of the Code,

Regulations or Act found to

have been breached*

Code sections 4(1)(b), 4(2)(a), 4(2)(c), 4(4), 4(5), 5(2), 6(3)(d)

Sections of the Code,

Regulations or Act found not

to have been breached*

None

Sanctions

Withdrawal of representations

Withdrawal of advertisement

* only sections of the Code, Act, or Regulations that were part of the complaint or were raised by

the Panel are listed.

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The advertisement(s)^

1. The complaint concerned an internet advertisement published at the website www.nutralife.com.au, viewed by the complainant in August 2016. The complaint also

included advertisements from other retailer websites www.sportyshealth.com.au,

www.naturalhealthorganics.com.au and www.healyourself.com.au for which advertising

copy was provided, and listed numerous other websites for which advertising copy was not

provided.

2. The advertisement at www.nutralife.com.au comprised a pack shot of the product BioActive Curcumin adjacent to the wording “Nutra-Life BioActive curcumin contains a clinically

trialled and patented form of Curcumin which delivers increased bioavailability and efficacy

through improved absorption”. Under the heading “Features and Benefits”, the advertisement

included representations such as “This means it is much better absorbed than standard

Turmeric or Curcumin extracts, meaning you take much less to receive a much more potent

benefit”, “Used for a number of inflammatory conditions, Turmeric is found to be especially

beneficial in reducing inflammation associated with digestive and joint symptoms, however

needs to be taken in large doses to be efficacious” and “Recommended for: temporary relief

of arthritis and relief of symptoms associated with medically diagnosed Irritable Bowel

Syndrome”.

3. The ingredients were listed as “Each capsule provides: MERIVA® Curcumin phospholipid complex 550mg – Equiv. Curcumin 99mg” and the dosage “Take 2 capsules daily, with food,

or as directed by your healthcare professional”.

4. The advertisement at www.sportyshealth.com.au included the representations “Nutra-Life BioActive Curcumin is a potent anti-inflammatory supplement that delivers 29x greater

bioavailability and absorption than regular, standard Curcumin extract (standardised to

contain Curcuminoids – Curcumin, Demethoxycurcumin and Bismethoxycurcumin)”,

“BioActive curcumin utilises the addition of a phytosome complex to improve absorption by

allowing entry of the curcumin molecule into the cell, via its phospholipid membrane,

increasing the efficacy of Nutra-Life BioActive Curcumin”, “Use of the Curcumin-

Phosphatidylcholine phytosome complex means the anti-inflammaorty (sic) effects are

achieved at a much smaller dosage. The multi-facteted (sic) anti-inflammatory action of

Curcumin allows for its use in the reduction of symptoms related to medically diagnosed

irritable Bower (sic) Syndrome (IBS). BioActive Curcumin may also relief (sic) other

inflammatory disorders such as arthritis.

5. The advertisements on the websites www.naturalhealthorganics.com.au, and www.healyourself.com.au included similar representations.

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

The product(s)

7. The advertisements promoted the product Nutra-Life BioActive Curcumin (AUST L 217653).

The advertiser(s)

8. The advertiser was Vitaco Health Australia Pty Ltd.

http://www.nutralife.com.au/http://www.sportyshealth.com.au/http://www.naturalhealthorganics.com.au/http://www.healyourself.com.au/http://www.nutralife.com.au/

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The complaint^

9. The complainant requested anonymity.

10. In support of the complaint, the complainant provided summaries (apparently prepared by the complainant) relating to a number of studies of apparent relevance to the advertised product.

The complainant also described a strategy by means of which they searched for relevant

studies.

11. The complainant alleged that the advertisement breached the Code because of the claims:

a) “Nutri-life Bioactive curcumin ... contains a clinically trialled form of Curcumin”

b) “Potent anti-inflammatory supplement .... for arthritis and irritable bowel syndrome (IBS)”

c) “Provides 29 x greater bioavailability and absorption and improved efficacy… compared to regular curcumin and turmeric extracts”

d) “Has been shown in clinical trials to decrease pain and inflammation and assist in the management and symptomatic relief of osteoarthritis”

e) “Supports gastrointestinal health”

12. The complainant argued that the advertisements breached sections 4(2)(a), 4(2)(c), 4(4) and 6(3)(d) of the Code. The Panel also interpreted the complainant as alleging a breach of

section 4(1)(b) of the Code in relation to the complainant’s analysis of evidence.

13. The complainant also stated that:

a) “All these claims imply that many clinical studies have investigated the effects of Meriva®, overstating the available supporting evidence, giving rise to false expectations

on the product’s reliability”;

b) “scarce data was available regarding GI health improvements, which may misinform the public on the actual results found and limits the products credibility”;

c) “claims about bioavailability have extrapolated data from rat experiments to humans, which may be inaccurate and misleading the public about the effectiveness of the

product”; and,

d) “the claims do not specify the populations used in the clinical studies. Therefore it omits information for the effects of Meriva® in people with cardiovascular disease, diabetes,

obesity, gastroduodenal pathology ... etc., that might consider using this product”.

14. The complainant “ask[ed] that further clinical studies are produced to validate these claims or that these exaggerated claims are revised to realistically describe the supporting studies and

effectiveness of the product.”

15. The complainant also referred to indications included in the public ARTG summary document relating to the advertised product. This material did not appear to the Panel to fall

within its jurisdiction, and the Panel, therefore, was unable to consider these aspects of the

complaint.

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Additional matters raised by the Panel

16. Under sub-regulation 42ZCAH(1), the Panel is empowered to raise matters other than those specified in the complaint, where the Panel is satisfied that the advertisement to which the

complaint relates contains matter that is not mentioned in the complaint, which may

contravene the Act, Regulations, or the Code in other ways. The Panel was so satisfied and

raised as additional matters possible breaches of:

a) Sections 4(1)(b), 4(2)(a), 4(2)(c) and 4(5) of the Code in relation to the claims about greater/increased bioavailability, efficacy and absorption, such as “increased

bioavailability and efficacy through improved absorption”, “better absorbed”, “receive a

much more potent benefit”, “delivers 29x greater bioavailability and absorption” and

“BioActive Curcumin utilises the addition of a phytosome complex to improve

absorption by allowing entry of the curcumin molecule into the cell, via its phospholipid

membrane, increasing the efficacy of Nutra-Life BioActive Curcumin”; and,

b) Section 5(2) of the Code in relation to the references to unqualified arthritis.

The advertiser’s response to the complaint^

17. The advertiser included with the response a letter which raised certain issues under the section 44 of the CRP Procedures document and part 42ZB of the Therapeutic Goods

Regulations relating to conflict of interest obligations. Further, the advertiser raised concerns

about confidentiality of material submitted in the complaints process and sought that a named

Panel member be excluded from the review process.

18. The advertiser provided copies of studies in support of the claims that were the subject of the complaint.

19. The advertiser stated:

a) in relation to the claim “Nutra-life Bioactive curcumin… contains a clinically trialled form of curcumin”, that a 2010 study by Belcaro et al supported the claim, noting that the

complainant had referred to the same study but had interpreted it differently;

b) in relation to the claim “Provides 29 x greater bioavailability and absorption and improved efficacy .... compared to regular curcumin and turmeric extracts”, that a 2010

study by Cuomo et al supported the claim;

c) in relation to claims relating to irritable bowel syndrome, that these claims were supported by a 2004 study by Bundy et al, but that on review the advertiser had decided,

on the basis of a statistical analysis of the study, to withdraw all reference to irritable

bowel syndrome from the advertisements;

d) in relation to the claim “supports gastrointestinal health”, that the claim was supported by evidence. The advertiser provided evidence said to support “this non-specific indication”

(but it should be noted that this claim did not appear in the advertisement material

provided by the complainant, and was not considered by the Panel);

e) in relation to the possible breach of section 5(2) of the Code, that it had “amended all claims relating to arthritis so as to clearly qualify them as mild osteoarthritis.”

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20. The advertiser also appeared to take responsibility for the representations made in all the advertisements, including those on the retailer websites, and stated “Please see the attached

website updates for the four website advertisements in question i.e. Nutralife.com.au;

sportyshealth.com.au; naturalhealthorganics.com.au and healyourself.com.au. All of the

above mentioned changes have been implemented.”

Findings of the Panel

preliminary issues raised by the advertiser

21. The advertiser included with the response a letter which raised certain issues under the section 44 of the CRP Procedures document and part 42ZB of the Therapeutic Goods

Regulations relating to conflict of interest obligations. Further, the advertiser raised concerns

about confidentiality of material submitted in the complaints process and sought that a named

Panel member be excluded from the review process.

22. The Panel considered the advertiser’s request concerning conflict of interest and confidentiality in the context of the Therapeutic Goods Regulations 1990 and the Panel’s

Procedures and was satisfied that the matter could be discussed at this meeting. It notes the

following for the benefit of the advertiser and the readers of this determination:

Regulations applying to the Panel

The Complaints Resolution Panel (and its members) are bound by the Therapeutic Goods

Regulations and the CRP Procedures document (a copy of which is provided to parties to any

complaint), to ensure the highest level of probity in the discharge of its functions. This

includes meticulous attention to issues of conflict of interest obligations of Panel members

and confidentiality.

Composition of the Panel

The Complaints Resolution Panel is an example of a partnership between government and

non-government stakeholders to exercise controls. The membership of the Panel consists of

representatives from industry, consumers, healthcare professionals and government. It is

chaired by a person nominated by the Therapeutic Goods Advertising Code Council.

The Panel is part of a system of advertising arrangements for therapeutic goods designed to

ensure public health and safety while allowing a dynamic and fair environment for the

manufacturing of products. These arrangements control promotional messages and general

information about products to the public and are in place to ensure that all communications

are truthful, valid and not misleading, such as by making unverified representations, arousing

unwarranted expectations or downplaying possible risks.

The long-term strength of the Panel derives from the strong commitment from government,

industry and non-government stakeholders to providing skilled and dedicated representatives.

A diversity of views, skills and experiences amongst Panel members contributes to well-

rounded decisions. Panel members engage in respectful debate on the merits of complaints

against the provisions of the relevant laws, regulations and procedures.

Conflict of interest obligations

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In relation to conflict of interest obligations, the regulations and procedures refer to a

member who “has a direct or indirect material personal interest (whether pecuniary or not) in

a matter being considered or about to be considered at a meeting” The Panel is of the view

that to preclude a member from participation in a decision, the conflict must relate to the

matter to be determined.

At the beginning of each Panel meeting members are called on to make disclosures and

where the Panel determines, is excluded from all discussion of the matter in question. It

should be noted that an actual conflict of interest is just one of three possible areas of

concern. Apparent and Potential Conflicts of Interest are also matters which need to be

considered.

Confidentiality

The Procedure for Complaints about Advertisements (and/or Generic Information) for

Therapeutic Goods that are directed to Consumers in Specified Media, published 3 December

2015 (the Procedure), includes strong confidentiality provisions at paragraphs 41 and 42.

The Procedure requires Panel members (and others) to observe complete confidentiality in

relation to all information concerning the deliberations of the Panel.

It should be noted that after the Panel’s final written determination has been communicated

to the known parties to a complaint and made available to the public, Panel members,

observers and the Panel secretariat may educate and inform the public about the general

principles arising from the determination and may participate in public discussion of the

procedures of the Panel.

As well, it should be noted that the regulations allow for a representative organisation of the

Panel to nominate an alternative person to attend any Panel meeting in the absence of the

nominee.

background

23. The advertised product contained an active ingredient called “Meriva”, which was said to be a “curcumin phospholipid complex”.

24. Both the complainant and the advertiser provided copies of studies said to be relevant to the subject matter of the complaint. In some instances both the complainant and the advertiser

provided copies of the same studies. The complainant and advertiser differed in their

interpretation of the studies and the claims that could properly be supported by them.

the evidence material generally

25. The Panel reviewed all of the evidence material provided by the parties.

26. The most prominent evidence was as follows:

a) A 2006 study by Marczylo et al related to oral bioavailability of the Meriva ingredient and involved a comparison of levels of curcumin and curcumin metabolites in rats that

had been given either the Meriva ingredient or an unformulated form of curcumin.

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b) A 2010 study by Cuomo et al which related to the oral bioavailability of the Meriva ingredient in humans.

c) A 2010 study by Belcaro et al related to osteoarthritis and compared treatment with “the best available treatment” and treatment with “the best available treatment” plus the

Meriva ingredient.

d) A second 2010 study by Belcaro et al, also relating to osteoarthritis, but involving a larger subject group and a longer treatment period.

e) A 2004 study by Bundy et al relating to the treatment of irritable bowel syndrome with a turmeric extract.

f) A range of monograph material relating to turmeric.

27. The two Belcaro studies and the Marczylo study were relied upon by both the advertiser and the complainant. The Bundy study, the Cuomo study, and the monograph material were

relied upon and provided to the Panel by the advertiser but not the complainant.

evidence about bioavailability

28. The Panel was satisfied that, taken together, the Cuomo study and the Marczylo study supported a proposition that the Meriva ingredient had higher oral bioavailability than an

unformulated form of curcumin. The Panel noted that (on the basis of the evidence material)

the degree to which particular curcuminoids were more bioavailable from the Meriva

ingredient varied – that is, when comparing the absorption of unformulated curcumin with

the absorption of Meriva, the levels of some curcuminoid components were more elevated

than others. Depending on which components were considered, or whether the curcumin as a

whole was considered, the relative absorption recorded in the Cuomo study ranged from

17.5:1 up to 68.3:1. The relative absorption was also different depending on the dose of

Meriva that was used.

29. Therefore, while the Panel accepted that the evidence appeared to support at least a preliminary and very qualified view that the Meriva ingredient was potentially a more

bioavailable form of curcumin than an unformulated form of curcumin, it also found that:

a) there was no reasonable basis for a specific quantification of comparative bioavailability such as “29 times”;

b) it was not clear that the levels of curcuminoids or metabolites measured in the study could be regarded as indicative of increased bioavailability of free curcumin, nor that the

overall profile of absorption of any components of curcumin was similar to that of

unmodified or unprocessed curcumin or a “standard Turmeric or Curcumin extract”;

c) there was no apparent basis for concluding that any higher rate of absorption, if there were in fact a higher rate of absorption, would have any effect on therapeutic efficacy or

would result in increased therapeutic efficacy, and the studies themselves did not support

any claims for efficacy; and,

d) it was unclear whether the unformulated form (or forms) of curcumin used in the studies were typical of those described in the advertisement as “standard Turmeric or Curcumin

extracts”.

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evidence about osteoarthritis

30. The Panel had some concerns about the two Belcaro studies. Both involved two authors who appeared to be employees of the manufacturer of the Meriva ingredient. In both cases,

subjects received the “best available treatment”, either together with the Meriva ingredient or

without it. It was unclear what treatment subjects were receiving, and it appeared that the

treatment could have been different for each subject. It was unclear whether there was any

blinding either of subjects or researchers, or indeed of the practitioners prescribing the “best

available treatment” for each subject. Neither study involved a comparison between the use

of the Meriva ingredient alone as against the use of an established osteoarthritis treatment.

31. Nevertheless, the Panel noted that the second, larger study, in particular, was reasonably substantial and was satisfied that, taken together, the studies appeared to amount to modest

and preliminary evidence that would warrant further investigation of possible benefits from

the Meriva ingredient in relation to osteoarthritis symptoms, such as pain and inflammation.

evidence about irritable bowel syndrome

32. The advertiser referred the Panel to the Bundy study but stated that, on review, it had decided to withdraw claims relating to irritable bowel syndrome as it did not consider the Bundy

study to provide sufficiently robust support.

33. The Panel therefore did not review the Bundy study in further detail.

evidence about gastrointestinal health

34. The advertiser provided copies of some monograph material in relation to the claim “supports gastrointestinal health”. It did not appear to the Panel that the material provided by

the advertiser provided any consistent or clearly defined support for any claims about the

support of gastrointestinal health. At best, it could be regarded as providing some preliminary

basis for investigating possible benefits in relation to particular gastrointestinal symptoms

such as flatulence or dyspepsia, but even in those cases, the material was extremely limited

and could not, in the Panel’s view, properly support claims made in advertisements directed

to consumers. However, the claim “supports gastrointestinal health” did not appear in the

advertisement material provided by the complainant, and was not considered by the Panel.

the content of the advertisements

35. The advertisements for which the complainant provided full copies were not identical, but had similar content. The complainant also provided web addresses (but not full copies) of

other advertisements; the Panel did not consider these advertisements as it did not have

copies of them that were contemporaneous with the complaint, but noted that the advertiser

appeared to be prepared to arrange for any necessary amendment of them arising from the

complaint.

36. Section 1(3) of the Code states that the Code should be interpreted with an emphasis on the object and the principles of the Code, and the total presentation and context of the

advertisement. Section 3(2) of the Code states that the conformity of an advertisement with

this Code should be assessed in terms of its probable impact upon the reasonable person to

whom the advertisement is directed. In assessing the advertisement, the Panel was mindful

not only of the particular words cited by the complainant, but of the entire context of the

advertisement and its likely impact on a reasonable consumer.

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37. The Panel noted that the advertisement at www.nutralife.com.au referred to the advertised product as containing “a clinically trialled and patented form of Curcumin”, as did several of

the other advertisements to which the complainant referred.

38. The Panel was satisfied that, in the context of claims that the product contained a “clinically trialled” ingredient (for those advertisements which included the “clinically trialled”

representation), claims of product efficacy would be taken by an ordinary and reasonable

consumer to be supported by a robust and persuasive body of clinical evidence.

39. The Panel was also satisfied that the advertisements conveyed that the advertised product could offer therapeutic benefits in relation to:

a) inflammation or “a number of inflammatory conditions”;

b) arthritis pain and inflammation;

c) arthritis generally;

d) symptoms of irritable bowel syndrome;

e) digestive symptoms;

f) joint symptoms;

and that they conveyed that the curcumin extract in the advertised product was more

bioavailable than other curcumin extracts and offered improved absorption by comparison

with other curcumin extracts.

the Panel’s findings in relation to bioavailability

40. 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)(a) of the Code prohibits representations that are “likely to arouse unwarranted

and unrealistic expectations of product effectiveness”. Section 4(2)(c) of the Code prohibits

representations that “mislead directly or by implication or through emphasis, comparisons,

contrasts or omissions”. Section 4(5) of the Code requires that comparisons made in

advertisements must be balanced and must not be misleading or likely to be misleading, and

prohibits the inclusion in advertisements of comparisons that “imply that the therapeutic

goods, or classes of therapeutic goods, with which comparison is made, are harmful or

ineffectual.”

41. The Panel raised with the advertiser possible breaches of these provisions because of claims about greater/increased bioavailability, efficacy and absorption, such as “increased

bioavailability and efficacy through improved absorption”, “better absorbed”, “receive a

much more potent benefit”, “delivers 29x greater bioavailability and absorption” and

“BioActive Curcumin utilises the addition of a phytosome complex to improve absorption by

allowing entry of the curcumin molecule into the cell, via its phospholipid membrane,

increasing the efficacy of Nutra-Life BioActive Curcumin”.

42. Section 4(4) of the Code requires scientific information to be “presented in a manner that is accurate, balanced and not misleading”, and requires that publication of scientific research

results should “identify the researcher and financial sponsor of the research.”

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43. The complainant alleged that the advertisements breached sections 4(2)(a), 4(2)(c) and 4(4) of the Code because of the claim “provides 29x greater bioavailability and absorption and

improved efficacy… compared to regular curcumin and turmeric extracts”.

44. The Panel was satisfied that the claims about bioavailability constituted comparisons with other therapeutic goods.

45. As noted above, the Panel was satisfied that there was some evidence supporting a view that the Meriva ingredient was more bioavailable than an unformulated form of curcumin.

46. However, the evidence provided by the advertiser did not, in the Panel’s view, support a reference to a specific quantification of greater bioavailability (such as “29x”). Nor was it

clear whether forms of curcumin extract commonly available in the Australian marketplace

were similar to the unformulated form of curcumin used in the studies provided by the

advertiser. In the absence of clear evidence supporting a comparison as to bioavailability

with products that were available to local consumers, the Panel did not regard the evidence as

sufficiently relevant to the Australian marketplace or capable of supporting advertising

claims directed at Australian consumers.

47. The Panel, therefore, was satisfied that the representations about greater/increased bioavailability, efficacy and absorption, such as “increased bioavailability and efficacy

through improved absorption”, “better absorbed”, “receive a much more potent benefit”,

“delivers 29x greater bioavailability and absorption” and “BioActive Curcumin utilises the

addition of a phytosome complex to improve absorption by allowing entry of the curcumin

molecule into the cell, via its phospholipid membrane, increasing the efficacy of Nutra-Life

BioActive Curcumin” breached sections 4(1)(b), 4(2)(a), 4(2)(c) and 4(5) of the Code.

48. Moreover, the Panel noted that it did not necessarily follow from increased bioavailability that there would be a “much more potent benefit” or that the relative bioavailability would

“increase[e] the efficacy” of the advertised product. The Panel also noted that the material

before the Panel did not appear to substantiate the claim that the mechanism by which

bioavailability was increased (assuming it was increased) was “allowing the entry of the

curcumin molecule into the cell, via its phospholipid membrane”.

49. The Panel was also satisfied that the specific quantification of “29x” amounted to the publication of scientific research results falling within the scope of section 4(4) of the Code,

and that the claim was misleading for the reasons already noted.

50. The Panel found, therefore, that these aspects of the complaint were justified.

the Panel’s findings in relation to irritable bowel syndrome

51. The advertiser stated that, on review of the evidence material, it no longer regarded claims about irritable bowel syndrome to be adequately supported, and that it had therefore

withdrawn such claims from advertising.

52. On this basis the Panel found that the claims about irritable bowel syndrome were likely to arouse unwarranted expectations and were misleading, in breach of sections 4(2)(a) and

4(2)(c) of the Code.


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54. The Panel also was satisfied that, in the advertisements where there was reference to the ingredient being “clinically trialled”, and in the absence of any qualification as to the

preliminary and modest nature of the clinical trial evidence, the claims about irritable bowel

syndrome breached section 4(4) of the Code.

55. The Panel found, therefore, that this aspect of the complaint was justified.

the Panel’s findings in relation to arthritis

56. Section 5(2) of the Code prohibits advertisements that “refer, expressly or by implication, to serious forms of diseases, conditions, ailments or defects specified in Part 2 of Appendix 6,

unless prior approval is given under the Therapeutic Goods Act 1989.” The diseases and

conditions specified in Part 2 of Appendix 6 of the Code include “serious forms of” a wide

range of health concerns.

57. The Panel raised with the advertiser possible breaches of this provision because of references to arthritis.

58. The complainant alleged that claims about benefits in relation to arthritis breached sections 4(2)(a), 4(2)(c) and 4(4) of the Code.

59. The Panel noted that references to arthritis, without qualification as to severity or type, are likely to breach this provision by implicitly encompassing serious forms of arthritis such as

rheumatoid arthritis or osteoarthritis that is more severe than mild osteoarthritis.

60. The advertisements for which the complainant provided copies all referred to “arthritis” and were not specific as to osteoarthritis, nor as to the severity of any form of arthritis.

61. As already noted, the Panel was satisfied that there was some preliminary basis in the evidence material for modest claims about osteoarthritis. Such claims would, if they were not

to be misleading, need to be expressed in terms that clearly conveyed that the evidentiary

basis for them was modest and preliminary.

62. The Panel was satisfied that:

a) the claims related to arthritis were not qualified as to the type of arthritis – that is, osteoarthritis;

b) they were not qualified as to the severity of arthritis – that is, they were not expressly confined to mild osteoarthritis;

c) in some instances, they conveyed that the claims were supported by clinical trials (and the Panel noted that these references brought those advertisements within the scope of

section 4(4) of the Code), without any qualification as to the preliminary and modest

nature of the clinical trial evidence;

d) even where there was no reference to clinical trials, the claims about arthritis were likely to be taken by an ordinary and reasonable consumer to be based upon scientific evidence

to a degree that was not warranted by the modest and preliminary evidence available.

63. The Panel was satisfied that the claims about arthritis breached sections 4(2)(a), 4(2)(c), 4(4) and 5(2) of the Code.

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“clinically trialled”

65. The Panel also was satisfied that, in the advertisements where there was reference to the ingredient being “clinically trialled”, and in the absence of any qualification as to the

preliminary and modest nature of the clinical trial evidence, any other claims about the

effects of the advertised product breached section 4(4) of the Code.

mandatory statements

66. The advertisements did not appear to include the words “if symptoms persist see your doctor/healthcare professional”, and in some cases did not include “use only as directed”, as

required by section 6(3)(d) of the Code.

67. The Panel found, therefore, that this aspect of the complaint was justified.

Sanctions

68. The Panel requests Vitaco Health Australia Pty Ltd, in accordance with subregulation 42ZCAI(1) of the Therapeutic Goods Regulations 1990:

a) to withdraw the advertisements from further publication;

b) to withdraw all representations that were found above to breach the Code, including that:

i) the advertised product has clinically trialled, except where such claims are clearly qualified with express reference to the preliminary and modest nature of the evidence

material;

ii) the advertised product offers benefits in relation to irritable bowel syndrome;

iii) make reference to arthritis without clear qualification as to the type and severity of the arthritis, as for example through words such as “mild osteoarthritis”;

iv) the advertised product contains a form of curcumin or curcumin extract that is more bioavailable or more readily absorbed than other the curcumin extract(s) used in other

products in the Australian marketplace.

c) to give a written undertaking not to use the representations in (b) above in any other advertisement*;

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, including a response in writing that they will comply with the Panel’s

sanctions, and where appropriate, supporting material such as copies of instructions to

advertising agents or publishers, or correspondence with retailers and other third party

advertisers.

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69. 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.

Dated 21 June 2017

For the Panel

Allan Asher

Chairman

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Appendix A: Definitions and footnotes

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). It should be noted that HTML metatags

and other information which can be retrieved by internet search engines, whether or not it

is ordinarily viewed directly by consumers, constitutes advertisement material.

^Readers of the determination should note that the sections “complaint summary”, “the advertisement(s)”, “the

complaint”, and “[a party]’s response to the complaint”, are summaries that are intended to aid readers of this

document. In reaching its decision, the Panel considered all of the material before it, including material that may

not be mentioned specifically in the summaries. The summaries do not form part of the Panel’s reasoning.

*Under regulation 42ZCAI of the Regulations, the Panel may request that a representation not be used in any other

advertisement unless the advertiser 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. Under the Panel’s procedures, the Panel will not ordinarily give additional consideration

to such a matter unless significant new material that was not available at the time of the Panel’s determination has

become available, or until at least 12 months have passed since the Panel’s request was made.

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Appendix B: Excerpt of the Advertisement

Documents

COMPLAINTS RESOLUTION PANEL DETERMINATION ......bioavailability and efficacy through improved absorption”, “better absorbed”, “receive a much more potent benefit”, “delivers