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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.
53. The Panel found, therefore, that these aspects of the
complaint were justified.
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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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64. The Panel found, therefore, that these aspects of the
complaint were justified.
“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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Page 13 of 15
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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Page 15 of 15
Appendix B: Excerpt of the Advertisement