COMPLAINTS RESOLUTION PANEL DETERMINATION Complaint...

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COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2016-10-025 Sambucol

ARTG ID: 167304, 178380, 180535, 195687, 205245, 220022, 220283

Meeting held 16 February 2017

Complaint summary^

Complainant Requested anonymity

Advertisers Pharmacare Laboratories Pty Ltd (sponsor)

Subject matter of complaint Internet advertisements

Type of determination Final

Sections of the Code,

Regulations or Act found to

have been breached*

Act section 42DM(1)

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

Sections of the Code,

Regulations or Act found

not to have been breached*

Code sections 4(2)(b), 4(2)(d), 4(2)(h)

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 internet advertisements published at the website pages at

www.sambucolaustralia.com (and the Sambucol product entries for Cold & Flu Liquid, Cold &

Flu capsules, Throat Lozenges, Cold & Flu Forte, Cold & Flu Kids Liquid, Immuno Forte, Kids

Immunity Gummies, Cold & Flu Kids Cough Liquid), and www.sambucolaustralia.com/the-

sambucol-story.html which were viewed by the complainant in September 2016.

2. The complaint also included:

1) material from overseas-based websites that were not within the Panel’s jurisdiction; and

2) a reference to an advertisement on the website www.chemistwarehouse.com.au for which no

advertising copy had been provided.

The Panel, therefore, was unable to consider these aspects of the complaint and advised the

product sponsor/advertiser accordingly.

3. The advertisement on www.sambucolaustralia.com displayed the Sambucol range of products

under the heading “Sambucol BLACK ELDERBERRY”. The representation “Clinically trialled

to shorten your cold by 3 days!” was superimposed over the product display. A panel on the

right hand side of the display included the wording “Discover more about Sambucol® and the

power of its natural key ingredient – extract of black elderberry. Sambucol is a supplement

developed over 20 years ago by a world renowned scientist to unlock the health-giving

properties of the plant.” Beneath the wording was an image of elderberries and the heading

“Learn about black elderberry here” and a link to the www.sambucolaustralia.com/the-

sambucol-story.html page.

4. The website page at www.sambucolaustralia.com/the-sambucol-story.html comprised a heading

“What is Sambucol? – Natural Cold + Flu Fighter”, beneath which was another image of

elderberries adjacent to the wording “Sambucol Cold & Flu liquid can help cut the duration of

influenza symptoms. It can also help reduce the severity of cold and flu symptoms,

including congestion, cough, aches and pains and fever.” and “Sambucol is made from black

elderberries and has the equivalent of up to 1000 black elderberries in every 120ml bottle. The

black elderberries in Sambucol have twice the natural antioxidant capacity of blueberries and

more than 50% the overall antioxidant capability of cranberries.” and other representations.

5. Representations included on the numerous Sambucol product entries included: “Clinically

proven” and “Clinically trialled” on pack shots, “Get better faster!”, “clinically proven to help

fight cold and flu symptoms and speed up recovery”, “cut the duration of flu symptoms”,

“Sambucol reduces the severity of cold and flu symptoms and shortens the duration of a cold”,

“Clinically proven to improve the quality of life while sick”, “Sambucol helps reduce the

severity of cold & flu symptoms including runny nose, congestion, cough, sneezing, sore throat,

fatigue”, “help soothe the throat, support the immune system and general health and wellbeing”,

“relieve cold and flu symptoms including fever, aches and pains and coughs”, “Sambucol’s kids

cold and flu liquid can help relieve sore throat, fever, cough & congestion, aches & pains”,

“Immuno FORTE provides immune boosting support”, “can help strengthen the body’s immune

system” and other claims.

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

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The product(s)

7. The advertisement promoted the Sambucol range of products (AUST L 167304, 178380,

180535, 195687, 205245, 220022 and 220283).

The advertiser(s)

8. The advertiser was the sponsor of the products, Pharmacare Laboratories Pty Ltd.

The complaint^

9. The complainant requested anonymity.

10. The complainant referred to previous complaints and subsequent actions taken by the sponsor

for this product as a result and then listed claims currently being made, alleged them as

breaching the regulations and commented on them, as follows:

- “cut the duration of flu symptoms”

This implies that symptoms such as runny nose, congestion, fever and fatigue are relieved

faster than using no medication at all.

- “reduce the severity of cold and flu symptoms”

This indicates that the product is able to treat the whole range of cold and flu viruses,

including Influenza A, B, rhinovirus and coronavirus.

- “get better from a cold 3 days faster”

This suggests that Sambucol has based this on previous research. It implies efficacy of

Sambucol in relation to any cold.

- “boost the immune system”

This indicates that it can help provide protection against pathogens by preparing or

strengthening the immune system. Booster vaccines exist, which can boost the immune

system by priming lymphocytes. When Sambucol claims they can “boost the immune

system” this may imply that the two have a similar positive effect.

- “clinically proven” and on some websites such as [……] “clinically trialled”

Originally Sambucol stated that their product was “clinically proven” and after their

retractions, on the majority of websites, the wording has been changed to “clinically

trialled.” Both wordings sound similar and the adapted version may sound like there is

evidence supporting the efficacy of the product. What is clearly missing is the results which

likely do not substantiate or prove that it is efficacious in proposed ways.

- “Contain an antiviral agent, ‘Antivirin’” [Note: as this claim was included only in

overseas advertisement so the Panel was unable to consider it]

Indicates that Sambucol is effective against all viral infections.

Furthermore, Sambucol also markets products for children specifically, and the general

range can also be given to children over 2 years of age. This implies that there is evidence

that Sambucol is as effective in children as it is in adults, and should be supported by

evidence.

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11. The complainant provided “A summary of the key scientific evidence for &/or against with

articles attached.” As part of the complaint, the complainant also provided screenshots of

packshots and claims on the product pages for Sambucol Cold & Flu Liquid (“clinically proven”

on the pack), Sambucol Cold & Flu capsules (“clinically trialled” on the pack) and “helps cut

the duration of flu symptoms”, Sambucol Throat Lozenges “support the immune system”,

Sambucol Cod & Flu Forte “relieves cold & flu symptoms including aches and pains and

coughs” and “support your natural immune system”, Sambucol for Kids “can help relieve: Sore

throat, Fever, Cough & congestion, Aches & pains”, Sambucol Immunity “provides immune

boosting support”, Samucol Immunity Kids Gummies “Boost the Immune System”, Sambucol

Cold & Flu Kids Cough Liquid “Soothes and relieves coughs, Thin and loosen mucus,

Clear chest congestion for easier breathing, Boost the immune system” and many other claims.

12. In addition, the www.sambucolaustralia.com/the-sambucol-story.html page included the claims

highlighted by the complainant “Sambucol Black Elderberry Cold & Flu can help cut the

duration of influenza symptoms”, “Reduce the severity of flu symptoms including: congestion,

cough, aches and pain, and fever”, and “The black elderberries in Sambucol have twice the

natural antioxidant capacity of blueberries and more than 50% the overall antioxidant capability

of cranberries”.

13. The following reference material was provided to the Panel:

1) Zakay-Rones Z, Thom E, Wollan T, Wadstein J. Randomized Study of the Efficacy and

Safety of Oral Elderberry Extract in the Treatment of Influenza A and B Virus Infections.

Journal of International Medical Research. 2004;32(2):132-140.

2) Zakay-Rones Z, Varsano N, Zlotnik M, Manor O, Regev L, Schlesinger M et al. Inhibition

of Several Strains of Influenza Virus in Vitro and Reduction of Symptoms by an Elderberry

Extract (Sambucus nigra L.) during an Outbreak of Influenza B Panama. The Journal of

Alternative and Complementary Medicine. 1995;1(4):361-369.

3) Barak V, Halperin T, Kalickman I. The effect of Sambucol, a black elderberry-based,

natural product, on the production of human cytokines: I. Inflammatory cytokines. European

Cytokine Network. 2001;12(2):290-6.

4) Vlachojannis J, Cameron M, Chrubasik S. A systematic review on the sambuci fructus effect

and efficacy profiles. Phytother Res. 2010;24(1):1-8.

14. The complainant gave a detailed explanation of their view of each of the papers above, finding

some evidence of value but problems of small study sizes, limitations according to target

population and specific viruses, a lack of evidence to support extrapolation to children, elderly

or high risk patients, reliance on self recordings of overall well being after treatment, unknown

bioavailability as it was an in vitro study which, therefore, cannot be generalised to oral

dosages. The complainant stated “The claims Sambucol contains the antiviral agent, Antivirin,

and had immonumodulatory (sic) effects are justified in the literature. It is also reasonable to

say the Sambucol is effective in shortening the duration and severity of influenza A and B flu

symptoms, however, quantifying it to the extent of a “30%” reduction is not justified. In saying

that, while the evidence supports these claims, the data in these studies are (sic) not strong

enough to be generalised, and require (sic) further research.”

15. In summary, the following allegations of breaches of the Code were specified by the

complainant in relation to the website advertisements identified above that were within the

Panel’s jurisdiction and for which advertising copy had been provided:

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1) sections 4(1)(b), 4(2)(a), 4(2)(c) and 4(2)(d) in relation to the claims “clinically trialled”,

“clinically trialled to shorten your cold by 3 days” and “clinically proven” as the “evidence

is moderate in terms of recuing symptoms and illness duration and so misleads consumers

about the efficacy of the product”;

2) sections 4(2)(c), 4(2)(d) and 4(2)(h) in relation to using Sambucol Cold & Flu Liquid and

Sambucol Immuno Forte for children because “Sambucol markets the same benefits for

children as it does for adults. However studies examined had very little evidence

concerning the effects on children.”; and

3) sections 4(2)(b), 4(2)(c) and 4(2)(h) because “Studies analysed did not look into the benefits

of Sambucol for cold or other strains of flu viruses, such as rhinovirus and coronavirus.”

16. The complainant also alleged breaches of section 42DM(1) of the Act and section 3(1)(a) of the

Code because “Advertisements for therapeutic goods directed to consumers must comply with

the Code”.

Additional matter raised by the Panel

17. 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 an

additional matter of a possible breach of section 5(2) of the Code because of the reference to

“influenza”.

The advertiser’s response to the complaint^

18. The advertiser was PharmaCare Laboratories Pty Ltd (“PharmaCare”).

19. PharmaCare responded to the complaint about the use of the claims “Clinically trialled to

shorten your cold by 3 days”, “clinically trialled” and “clinically proven” by stating in relation

to the Sambucol Cold & Flu liquid product (AUST L 167304) as advertised on the

www.sambucolaustralia.com/ [and www.chemistwarehouse.com.au websites] by referring to the

TGA “Evidence Guidelines: Guidelines on the evidence required to support indications for

listed complimentary (sic) medicines” version 2.1, July 2014. The response referred to the

guidelines’ wording on the use of the terms “clinically proven” and similar wording, and the

need for unequivocal support by robustly designed, published, peer-reviewed clinical trial(s)

conducted on the actual medicine being advertised, or an identical formulation and dose (as a

minimum).

20. In refuting the alleged breaches, PharmaCare asserted that “the claims “clinically proven” and

“clinically trialled” are justified” for the product Sambucol Cold & Flu Liquid product.

PharmaCare provided a copy of a recent, unpublished clinical trial that had been conducted on

the product and stated that, in accordance with the TGA evidence requirements for a ‘clinical’

claim, this study has been robustly designed, conducted on the actual medicine being advertised,

is statistically significant, and was unpublished double peer reviewed in two stages.

21. PharmaCare also noted that the use of the representation “clinically trialled” in a TVC had been

approved by the ASMI and provided the Panel with a copy of the approval.

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22. In addition PharmaCare provided a range of other supporting evidence in substantiation of

Sambucol Cold and Flu Liquid clinical claims and noted that the product Sambucol Cold and

Flu 178280 has been specially formulated to provide the same amount of Elderberry active as

that which was clinically trialled recently and, therefore, “the product attracts the ‘lesser’ claim

of ‘Clinically Trialled’.

23. In response to the complaint about the claims on the www.sambucolaustralia.com/the-

sambucol-story.html page of the website, i.e. “Sambucol Black Elderberry Cold & Flu can help

cut the duration of influenza symptoms”, “Reduce the severity of flu symptoms including:

congestion, cough, aches and pain, and fever”, and “The black elderberries in Sambuol have

twice the natural antioxidant capacity of blueberries and more than 50% the overall antioxidant

capability of cranberries”, PharmaCare provided the Panel with amended versions of the first

three claims, stated that the last claim had been removed and said “We are therefore of the view

that we are not in breach of any of the above aspects of the Code.”

24. PharmaCare refuted the allegations made by the complainant in relation to the product pages for

Sambucol Cold & Flu Liquid (“clinically proven” on the pack) and “Clinically proven to help

fight cold and flu symptoms and speed up recovery.”, “Sambucol reduces the severity of cold

and flu symptoms and shortens the duration of a cold.”, “Clinically proven to improve the

quality of life while sick”, “Helps reduce the severity of cold and flu symptoms including:

Runny nose, Congestion, Cough, Sneezing, Sore Throat, Fatigue, Get better from your cold 3

days faster, Relieve symptom severity by 30%.”, Sambucol Cold & Flu capsules (“clinically

trialled” on the pack) and “helps cut the duration of flu symptoms”, “Helps reduce the severity

of cold and flu symptoms including: Runny nose, Congestion, Cough, Sneezing, Sore Throat,

Fatigue, Get better from your cold 3 days faster, Relieve symptom severity by 30%.”, Sambucol

Throat Lozenges “help soothe the throat”, “support the immune system and general health and

wellbeing”, Antioxidant support, Sambucol Cold & Flu Forte “relieves cold & flu symptoms

including aches and pains and coughs” and “support your natural immune system”, Sambucol

for Kids “can help relieve: Sore throat, Fever, Cough & congestion, Aches & pains”, Sambucol

Immunity “provides immune boosting support”, Sambucol Immunity Kids Gummies “Boost the

Immune System”, Sambucol Cold & Flu Kids Cough Liquid “Soothes and relieve coughs, Thin

and loosen mucus, Clear chest congestion for easier breathing, Boost the immune system” and

many other claims. PharmaCare held that they “are of the view that we hold the evidence from

the claims listed on the packaging and ARTG entries for the goods, above.” and “We are

therefore of the view that we are not in breach of any aspect of the Code.”

25. In responding to the matter raised by the complainant in relation to a previous complaint about

Sambucol, PharmaCare noted that they had complied with the sanction and retractions requested

in relation to that complaint; and that the recent, unpublished, clinical trial “builds on the

existing body of evidence on Sambucol’s efficacy, as reviewed by the Complainant.”

26. In relation to the claims “Cut the duration of flu symptoms” and “reduce the severity of cold and

flu symptoms”, PharmaCare stated that:

1) the Cold and Flu Liquid website has been amended to: “can help cut the duration of cold and

flu symptoms & help reduce the severity of cold and flu symptoms”; and

2) the Sambucol range page has been amended to “clinically proven to help fight cold and flu

symptoms”/ “reduces severity of cold and flu symptoms.”,

27. In relation to the Sambucol Cold and Flu capsules, PharmaCare stated that the website

www.sambucolaustralia.com/the-sambucol-story.html has been amended to “can help cut the

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duration of cold and flu symptoms” & “help reduce the severity of cold and flu symptoms.” and

the website www.sambucolaustralia.com/the-sambucol-range-24646 website to “cut the

duration of cold and flu symptoms”/ “helps reduce the severity of cold and flu symptoms”.

PharmaCare then held “we are therefore of the view that we are not in breach of Sections

4(2)(b), 4(2)(c) or 4(2)(h) of the Code”.

28. In response to the complaint about the claims “get better from a cold 3 days faster”, “Clinically

proven”, “Clinically trialled”, PharmaCare again relied on the TGA “Evidence Guidelines”

document, the recent clinical trial on the product to substantiate the claims of clinically proven

for the Cold and Flu Liquid, and the special formulation of the Cold and Flu capsules to the

same amount of Elderberry active as in that of the recent, unpublished, clinical trial to support

the “clinically trialled” claim. PharmaCare then held “we are therefore of the view that we are

not in breach of Sections 4(2)(b), 4(2)(c) or 4(2)(h) of the Code”.

29. In response to the complaint about the “Boost your immune system” claims, PharmaCare was

“of the view that we hold the evidence for this claim” and cited “attachment J”.

30. With respect to the complainant’s concern about the safety and efficacy dosage rationale for the

use of Sambucol Cold and Flu Liquid in children, PharmaCare relied on Young’s rule

calculation when calculated as a proportion of the full clinical adult dose (per the recent,

unpublished, clinical trial).

31. In response to the additional possible breach of section 5(2) because of the reference to

“influenza”, PharmaCare dismissed the complaint as irrelevant to the subject matter as they

were on an international website, gave an explanation as to the overlap in aetiology and

symptomatology of common cold and flu symptoms, stated that they are clearly represented in

the WURSS instrument, were clearly assessed in the recent, unpublished clinical trial report,

restated the amended claims for Sambucol Cold and Flu Liquid and Sambucol Cold and Flu

capsules and concluded by saying “PharmaCare are (sic) therefore of the view that we are not in

breach of section 5(2) of the Code.”

32. As well as a copy of the recent, unpublished clinical trial report and associated papers,

PharmaCare provided a range of papers.

Findings of the Panel

Preliminary matter – the evidence provided

33. The Panel considered all of the material provided by the complainant and the advertiser.

the recent, unpublished, clinical trial

34. Noting PharmaCare’s reliance on the findings of the report of the recently conducted,

unpublished clinical trial and the two peer-reviews (and re-reviews) of the trial, the Panel

expressed the following concerns:

1) The trial report indicated that the material provided focussed on a common cold subgroup

within a larger clinical trial, which appeared to also include at least one other subgroup, a flu

subgroup. The data from the flu subgroup and from the overarching study was missing from

the material presented to the Panel. No explanation was provided as to why this was so.

2) It appeared to the Panel that there was a lack of clarity as to the way in which the trial had

been conducted, including what was involved in earlier iterations of the paper and the

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decision- making process around the inclusion of additional participants to the final version

of the trial paper and the avoidance of bias in this unusual change. A statement was included

in PharmaCare’s response from the lead researcher indicating that “A report was provided to

Pharmacare in February 2016 based on the data from the above clinical trial cold sub-study

conducted in 2015. The Flu study continued during in [sic] 2016 and when this data was

reviewed prior to un-blinding, 5 additional participants were determined as having a cold.

This data was added to the original data and then re-analysed by an independent statistician,

and included in the final report V5.” It appeared that the paper had been finalised and peer-

reviewed firstly as version 3 in early 2016 (one of the peer reviews referred to versions 3

and 5 (Final) – it is not clear what happened to version 4). As a result, Version 5 of the

paper (provided to the Panel) presented different statistical results to the earlier version as

described in the peer review reports by the same reviewers in early 2017. The Panel was of

the view, therefore, that the study could not reasonably be described as ‘robustly designed’.

3) The Panel noted the requirements set out in the TGA “Evidence Guidelines: Guidelines on

the evidence required to support indications for listed complementary medicines” version

2.1, July 2014, as described by PharmaCare in their response, i.e. “Unpublished studies can

contribute to your evidence base for a scientific indication if they are relevant and have been

reviewed by at least two independent reviewers. To facilitate an accurate interpretation of

methodological quality, any original research must be appropriately documented [Schulz

et.al. (2010).” The Panel noted that both of the reviewers had connections with PharmaCare

Laboratories Pty Ltd or the paper’s authors, one as an independent ad hoc paid consultant

and the other as having published at least one academic paper together with the lead author

of the unpublished paper. One of the reviewers provided two reasonably robust reports,

noting a possible conflict of interest, but the other reviewer’s reports were relatively sparse

on detail concerning that reviewer’s views of the research paper, and, notably, one of that

reviewer’s reviews did not clearly advise which paper version was being reviewed

(presumably version 3 or 4). No discussion was provided by the paper authors or by

Pharmacare concerning the choice of peer reviewers and the noted potential conflicts of

interest (although the authors themselves declared the potential conflicts of interest in their

reports).

4) The Panel did not accept that the results from this trial could be extrapolated to children as

the dose level required in an adult population is well defined. However, an appropriate

children’s dose or efficacy in children was not demonstrated. Sufficient evidence that the

proposed reliance on Young’s Rule was not provided. As no children participated in this

trial, without there having been a clinical trial specifically conducted on children, claims of

efficacy of the low-dose product in children should not be made.

other evidence provided

35. Relevant papers such as the two Zakay-Rones studies from 1995 and 2004 (copies provided by

both the complainant and the advertiser), looked at influenza viruses, but the Panel considered

that rapid adaptation of these viruses since then was likely to diminish the value of the studies,

as well as the fact that the sample sizes were small and included only limited numbers of

children.

36. It was not clear to the Panel, from the materials provided, on which specific “cold and flu”

virus(es) the product was intended to work. Rather, it was implied that the product was

clinically trialled or proven to be effective on the myriad of different evolving pathogens that

cause cold and flu symptoms.

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sections of the Code alleged to have been breached

37. 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.”

38. Section 4(2)(a) of the Code prohibits representations that are “likely to arouse unwarranted and

unrealistic expectations of product effectiveness”.

39. Section 4(2)(b) of the Code prohibits advertisements that are “likely to lead to consumers self-

diagnosing or inappropriately treating potentially serious diseases”.

40. Section 4(2)(c) of the Code prohibits representations that “mislead directly or by implication or

through emphasis, comparisons, contrasts or omissions”.

41. Section 4(2)(d) of the Code prohibits advertisements which “abuse the trust or exploit the lack

of knowledge of consumers or contain language which could bring about fear or distress.”

42. Section 4(2)(h) of the Code prohibits advertisements for therapeutic goods that “contain any

claim, statement or implication that it is effective in all cases of a condition”.

43. 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.

44. Section 42DM(1) of the Act and section 3(1)(a) of the Code state that it is an offence to publish

or broadcast an advertisement about therapeutic goods that does not comply with the

Therapeutic Goods Advertising Code.

the claims: clinically proven, clinically trialled, clinically trialled to shorten your cold by 3 days

45. The Panel was of the view that the claims “clinically proven” and “clinically trialled” are very

powerful statements for consumers, and particularly so when combined with the “shorten your

cold by 3 days” claim. The Panel’s view on the level of evidence required to substantiate such

strong claims is that they must be unequivocally supported by robustly designed, published,

peer-reviewed and replicated clinical trials. While the advertiser does hold a growing body of

evidence regarding Sambucol, the particular claim regarding the shortening of colds by 3 days

was not supported by other evidence held by the advertiser. While more modest claims might be

made about this sort of evidence, the Panel was not satisfied that strong qualifiers such as

“clinically trialled” or “clinically proven” could be reasonably used together with strong claims

such as “shorten your cold by 3 days”, particularly in the apparent absence of statistical power

or sufficient explanation to address the range of different cold and flu causing pathogens or

replication of results in other clinical trials.

46. The Panel noted that the reviews of the clinical trial would be more robust were there no link

between the reviewers and the paper. The Panel has a long-held, well-publicised view, to which

it continues to subscribe, that the take-out by any “reasonable consumer” is that terms such as

“clinically trialled to…”, “scientifically researched to…” etc. are understood by consumers to

convey proof of efficacy. The Panel noted that there is some evidence that Sambucol can have a

modest, positive effect in relation to “colds and flu” in the general sense of mild upper

respiratory tract infections in adults. However, given the Panel’s view of the problems

associated with the recent, unpublished, clinical trial and other relevant studies, it was satisfied

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that it has not been clearly demonstrated that the study results can be generalised to the general

public as the product having been “clinically proven”, “clinically trialled” or “clinically trialled

to shorten your cold by 3 days”.

47. The Panel was satisfied that these claims were not correct or balanced, had not been verified,

were likely to arouse unwarranted and unrealistic expectations of the products’ effectiveness

and were misleading in breach of sections 4(1)(b), 4(2)(a) and 4(2)(c) of the Code.

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

49. The complainant had also alleged breaches of sections 4(2)(d) and 4(2)(h) of the Code in

relation to these claims. However, the Panel did not agree with the complainant and was

satisfied the language used in the advertisements did not go so far as to abuse the trust of, or

bring about fear or distress in consumers. Nor, in the Panel’s view, did it contain any claims,

statement or implication that the Sambucol products are effective in all cases of a condition.

50. The Panel found, therefore, that these aspects of the complaint were not justified.

51. In their response, PharmaCare noted that the use of the representation “clinically trialled” in a

TVC had been approved by the ASMI and provided the Panel with a copy of the approval. The

Panel notes that the process of pre-approval of advertising does not involve any substantiation

of advertising claims where the claims are consistent with the product indications on the

Register that have been entered by the sponsor.

immune system claims

52. The complainant had raised a concern about the claim “Boost the Immune System” by stating

“This indicates that it can help provide protection against pathogens by preparing or

strengthening the immune system. Booster vaccines exist, which can boost the immune system

by priming lymphocytes. When Sambucol claims they can “boost the immune system” this may

imply that the two have a similar positive effect.” The complainant subsequently identified a

number of other claims relating to the “immune system” for the following products: Sambucol

Throat Lozenges “support the immune system and general health and wellbeing” Sambucol

Cold & Flu Forte “support your natural immune system”, Sambucol Immunity “provides

immune boosting support”, Sambucol Immunity Kids Gummies “Boost the Immune System”,

and Sambucol Cold & Flu Kids Cough Liquid “Boost the immune system”.

53. PharmaCare refuted the complaint by stating that the evidence provided to the Panel was

sufficient to support the “Boost the immune system” claim.

54. Having considered the evidence to which PharmaCare referred, the Panel formed the view that

the unqualified “Boost the immune system” claim was a strong claim of a kind that ought to

have been supported by a robust and extensive body of evidence conducted on the target

populations, in this case both adults and children, before being made in an advertisement

directed to consumers. The Panel was satisfied that the advertisement breached sections

4(1)(b), 4(2)(a) and 4(2)(c) in relation to boosting the immune system claims.

55. The Panel found, therefore, that this aspects of the complaint were justified.

cold and flu, flu, and influenza claims

56. The Panel raised as an additional matter a possible breach of section 5(2) of the Code because of

the reference to “influenza”.

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57. The Panel is satisfied that instances of the word “flu” in an advertisement do not necessarily

refer to serious forms of flu where, taken in context, they refer to symptomatic treatment of

“cold and flu”. An ordinary and reasonable consumer could properly attend to symptoms of

“cold and flu” with a medicine such as the advertised product, when accompanied by warnings

such as “if symptoms persist consult your healthcare professional” and in a context where the

emphasis is wholly on symptomatic relief. However, when used as a stand-alone claim, “flu” is

generally used as an abbreviation for “influenza”, which, without any qualification, is a

reference to a serious disease that is generally accepted not to be diagnosed and/or treated

without consulting a suitably qualified healthcare profession; and to be beyond the ability of the

average consumer to evaluate accurately, and to treat safely, without supervision by a qualified

healthcare professional. Such a reference is a restricted representation for which prior approval

is required from the Secretary of the Department of Health.

58. The Panel was satisfied that the reference to “influenza” in the claim “Sambucol Black

Elderberry Cold & Flu can help cut the duration of influenza symptoms”, on the

www.sambucolaustralia.com/the-sambucol-story.html website page, constituted a reference to a

restricted representation in breach of section 5(2) of the Code.

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

60. The complainant also raised a possible breach of section 4(2)(b) of the Code in relation to

“generalisation of medication for all colds and flu’s”.

61. The Panel was satisfied that in the context of the generally understood and accepted meaning of

the combination wording of “colds and flu”, rather than either stand-alone “flu” or “influenza”,

consumers would not be likely to self-diagnose or inappropriately treat potentially serious

disease.

62. The Panel found, therefore, that this aspect of the complaint was not justified.

63. The complainant had highlighted the claims in the advertisement “Sambucol Black Elderberry

Cold & Flu can help cut the duration of influenza symptoms”, “Reduce the severity of flu

symptoms including: congestion, cough, aches and pain, and fever”, and “The black elderberries

in Sambucol have twice the natural antioxidant capacity of blueberries and more than 50% the

overall antioxidant capability of cranberries”.

64. The advertiser addressed these concerns by stating that the Cold and Flu Liquid website has

been amended to: “can help cut the duration of cold and flu symptoms & help reduce the

severity of cold and flu symptoms”; and the Sambucol range page amended to “clinically

trialled to help fight cold and flu symptoms”/ “reduces severity of cold and flu symptoms.” The

advertiser also amended the third statement above to state: “The black elderberries in Sambucol

have the natural antioxidant capacity of blueberries” and removed the claim “50% the overall

antioxidant capability of cranberries”.

65. The Panel noted that by amending the claims as set out above, the advertiser appeared to

concede the possible breach of section 5(2) of the Code in relation to influenza; and, by

amending the claims and providing no specific substantiating material to support the statement

“The black elderberries in Sambucol have twice the natural antioxidant capacity of blueberries

and more than 50% the overall antioxidant capability of cranberries” claim, appeared to concede

the possible breach of section 4(1)(b) of the Code.


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using Sambucol Cold & Flu Liquid and Sambucol Immuno Forte for children

67. The complainant alleged a breach of section 4(2)(c) of the Code, saying that “Sambucol also

markets products for children specifically, and the general range can also be given to children

over 2 years of age. This implies that there is evidence that Sambucol is as effective in children

as it is in adults, and should be supported by evidence.” and “However studies examined had

very little evidence concerning the effects on children.”

68. As well as referring to the use of Young’s rule to extrapolate dosage in children, the advertiser

stated “Sambucol Immune Forte is formulated to support the immune system of the whole

family including both adults and children. Unlike Sambucol Cold & Flu liquid, Sambucol

Immuno Forte does not make the claim of helping to relieve Cold & flu symptoms nor relieving

the duration of a cold. Instead the product is formulated to provide strengthening of the immune

system during the cold and flu season and therefore includes additional ingredients, Zinc and

Vitamin C, to support this claim. Please cite supportive evidence summary for this product

(Attachment I).”

69. The Panel was of the view that the website appears to relate specifically to the use of the adult

formulae in children: i.e. Sambucol Cold & Flu (AUST L 178380) and Sambucol Immuno Forte

(AUST L 220022); and that it is misleading if “Sambucol” elderberry is not the active

ingredient on a website that promotes the efficacy of sambucol elderberry. The Panel was

satisfied that there was very little evidence for the use of this product ingredient in children and

that the bold statements Sambucol Kids Cold & Flu Liquid and Sambucol Immuno Forte family

pack were very strong, unqualified and misleading when it appears that, rather than being based

on Sambucol elderberry, the efficacy appears to be based on the use of other substances in the

medicine, such as zinc and vitamin C.

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

71. The complainant had also alleged breaches of sections 4(2)(d) and 4(2)(h) of the Code in

relation to these claims. However, the Panel did not agree with the complainant and was

satisfied the language used in the advertisements did not go so far as to abuse the trust of, or

bring about fear or distress in consumers. Nor, in the Panel’s view, did it contain any claims,

statement or implication that the Sambucol products are effective in all cases of a condition.

72. The Panel found, therefore, that these aspects of the complaint were not justified.

compliance with the Code

73. The complainant raised possible breaches of section 42DM(1) of the Act and section 3(1)(a) of

the Code which require advertisements for therapeutic goods directed to consumers to comply

with the Therapeutic Goods Advertising Code.

74. Given the findings made above, the Panel was satisfied that the advertisement did not comply

with the Code.


Sanctions

76. The Panel requests Pharmacare Laboratories Pty Ltd, in accordance with subregulation

42ZCAI(1) of the Therapeutic Goods Regulations 1990:

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a) to withdraw the advertisement from further publication;

b) to withdraw any representations found above to breach the Act or the Code, including those

that convey, expressly or by implication, that the advertised product is clinically proven or

clinically trialled to shorten your cold by 3 days, any references to influenza, or to flu

without the reference being in association with colds, and claims that Sambucol Immune

Forte is formulated to support the immune system of the whole family, including both adults

and children;

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.

77. 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 30 May 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

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