COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2010-10-017 Berocca Performance

Meeting held 17 February 2011

Complaint summary
Complainant Dr Ken Harvey
Advertiser Bayer Australia Pty Ltd
Subject matter of Website advertisements
complaint

Type of determination Final

Sections of the Code, Code sections 4(1)(b), 4(2)(a), 4(2)(c)
Regulations or Act found
to have been breached*

Sections of the Code, None

Regulations or Act found
not to have been
breached*

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

www.beroccatwist.com, and other retail websites.

2. The advertisements contained three relevant claims:

a) “Berocca Performance has been clinically trialled and demonstrated to improve

concentration and reduced tiredness”;

b) “it has been clinically proven to improve concentration and reduce tiredness and
stress”; and,

c) “Berocca Performance is scientifically proven to improve concentration. When taken

daily for 28 days, Berocca Performance will also reduce stress and mental tiredness”.

3. Excerpts of the advertisements can be viewed in the relevant Appendix to this

determination.

The product(s)

4. The advertisement promoted Berocca Performance.

The advertiser(s)

5. The advertiser was Bayer Australia Pty Ltd.

The complaint

6. The complainant was Dr Ken Harvey.

7. The complainant alleged that the advertisements breached sections 4(1)(b), 4(2)(a), and
4(2)(c) of the Code. The complainant argued that evidence material said to support the
advertising claims was inadequate to support the use of such words as “clinically
trialled”, “clinically proven”, and “scientifically proven”.

8. The complainant argued that even where results were statistically significant, they could
not necessarily be regarded as clinically significant.

The advertiser’s response to the complaint

9. The advertiser argued that the complaint could be simplified, in that it could be said to
relate to two paraphrased claims, namely:

a) “clinically proven to reduce tiredness”; and,

b) “clinically proven to improve concentration”.

10. The advertiser responded to the complaint on this basis.

11. In relation to each of the two claims, the advertiser summarised research material said to
support the claim. The advertiser also provided copies of research material.

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12. The advertiser argued that “in lieu of an agreed ‘clinically significant’ value for mental
fatigue, we must rely on statistical significance to prove the effect of treatment.”

13. The advertiser also stated that they “recognise[d] that a claim of ‘clinically proven’
cannot be made on one isolated piece of evidence or on clinical results which differ
markedly from the body of evidence”, and that they had therefore conducted a literature
search which identified three additional trials.

Findings of the Panel

14. . As a preliminary matter, the Panel considered whether the complaint could in fact be
simplified in the way suggested by the advertiser. The Panel did not agree that this was
entirely the case, noting that the complainant had also expressed concern about references
to the reduction of stress and that stress was not included among the two paraphrased
claims suggested by the advertiser. The Panel also noted that the complainant had cited
the words “clinically trialled and demonstrated”, while the advertiser had simplified this
using the words “clinically proven”. The Panel did agree with the advertiser in this
respect, and found that the words “clinically trialled and demonstrated” had essentially
the same meaning as “clinically proven”.

15. 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”.

16. The Panel reviewed the evidence material provided by the advertiser.

17. Not all of the evidence material provided by the advertiser appeared to the Panel to be
sufficiently relevant to the advertised product. For example, one study related to “a
probiotic multivitamin compound”, while the advertised product does not contain
probiotic ingredients. Another study involved a product containing herbal ingredients, and
a third involved a form of Berocca containing a different ingredients profile. While these
studies might not be wholly irrelevant to claims about the advertised product, they were
not sufficiently relevant to support claims of “clinical proof” or “scientific proof”.

18. Two studies, the Caroll et al. study and the Kennedy et al. study appeared to be most
relevant to the advertised product and to the claims made in the advertisement, and were
the primary studies relied upon by the advertiser. On reviewing this material, the Panel
observed that:

a) the Kennedy et al. study included results in relation to “mental tiredness” and not to
“tiredness” in a more general sense;

b) the Caroll et al. paper did include results related to a reduction in tiredness, but these
results were (as acknowledged by the advertiser) not statistically significant;

c) the Caroll et al. paper utilised subjective outcome measures, in the form of a
“questionnaire and self-report package” at days 1 and 28 of the study only;

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 d) both studies involved outcome measures made at least 28 days after the
commencement of intervention; and,

e) both studies were conducted only on male subjects.

19. The Panel was satisfied that the evidence provided by the advertiser constituted only
modest evidence – and certainly not clinical or scientific proof – that the advertised
product could have benefits in relation to concentration and mental tiredness when taken
for 28 days or more. The Panel noted that in some instances the advertisements were
likely to convey that any product benefits could be immediate or rapid, rather than
requiring use of the product for several weeks. Given the very modest nature of the
evidence provided by the advertiser, the Panel was of the view that even modest claims
regarding concentration and mental tiredness would be misleading unless qualified by
reference to the period of use required for any possible benefits to accrue.

20. The Panel also noted that “mental tiredness” was not the same as “tiredness” in a more
general sense.

21. The Panel was therefore satisfied that the claims that the advertised product was clinically
or scientifically proven to have benefits in relation to concentration, tiredness, or stress, or
that it could have immediate or rapid benefits in relation to concentration, tiredness, or
stress, were unverified, likely to arouse unwarranted expectations, and misleading.

22. The complaint was therefore justified.

23. The Panel resolved to remind the advertiser that where claims are made on the basis of
modest or limited evidence, they should be expressed in similarly modest or limited
terms.

Sanctions

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

a) to withdraw the advertisement from further publication;

b) to withdraw any representations that the advertised Berocca Performance product has
immediate or rapid benefits in relation to improving concentration, tiredness, or stress,
or that it is clinically or scientifically proven to have benefits in relation to improving
concentration, tiredness, or stress;

c) 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

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

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

Dated 14 March 2011

For the Panel

Jason Korke
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).

*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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