Consultation Document for
the Substantiation of Claims
in the Advertising of
Complementary Medicines &
Consumer Healthcare
Products
Draft 1, August
2012
Discussion Document Disclaimer
The Complementary Healthcare Council of Australia (CHC), in conjunction with the Australian Self
Medication Industry (ASMI) (the Associations), publish this discussion document as a service to
promote the awareness of industry issues to members and other stakeholders. The Associations
advise their stakeholders to carefully and independently consider each of the recommendations.
The Associations reserve the right to rescind or modify discussion statements and position
statements at any time.
This material may be found in third parties’ programs or materials. This does not imply an
endorsement or recommendation by either Association for such third parties’ organisations,
products or services, including these parties’ materials or information.
Consultation Document for the Substantiation of Claims in the Advertising of Complementary
Medicines & Consumer Healthcare Products
Table of Contents
1
Objective ..........................................................................................................................................................3
2
Background .......................................................................................................................................................3
The Legal Context
Pre-approval of Advertisements
Classification of Promotional Materials
3
This Discussion Paper ........................................................................................................................................4
4
Proposed Definitions and Substantiation ..........................................................................................................1
5
Information Required to Make a Submission ....................................................................................................1
Australian Self Medication Industry
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Consultation Document for the Substantiation of Claims in the Advertising of Complementary
Medicines & Consumer Healthcare Products
1 Objective
This document is a discussion paper to initiate discussion within the Complementary Medicine and
Consumer Healthcare Industry on specific issues relating to the substantiation of claims used in the
advertising of therapeutic goods.
It is important to note that no position has been adopted by either Association at this time.
The development of this discussion paper was initiated by a Joint Industry advertising meeting and two fullday meetings of a reference group of Complementary Medicine and Consumer Healthcare Industry
members. The Reference Group identified a range of issues and potential solutions, which are presented in
this paper.
The aim of this consultation is to produce a set of requirements reflective of the current views of industry
2 Background
The Legal Context
The Therapeutic Goods Administration (TGA) is the regulator of therapeutic goods for supply in Australia.
The advertising of devices and medicines (including prescription, over-the-counter and complementary) is
co-regulated by the TGA and industry to ensure that the marketing and advertising of therapeutic goods to
consumers is conducted in a manner that promotes the quality use of such goods, is socially responsible
and does not mislead or deceive the consumer.
For the purpose of regulating complementary medicines, the Therapeutic Goods Act 1989i (the Act) and the
Therapeutic Goods Regulations 1990ii (the Regulations) provide a definition of a complementary medicine
and designate the types of ingredients that may be used in such medicines.
The advertising of therapeutic goods in Australia is subject to the advertising requirements of the Act
(which adopts the Therapeutic Goods Advertising Code [TGAC] 2007), the supporting Regulations, the
Competition and Consumer Act 2010 and other relevant laws.
In addition, there is an industry code of practice for complementary healthcare products, the
Complementary Healthcare Council of Australia’s (CHC) Code of Practice for the Marketing of
Complementary Medicines and Healthfood Products – and a code of practice for non-prescription consumer
healthcare products, the ASMI Code of Practice.
Generally, advertisements for listed complementary medicines and consumer healthcare products may be
directed both to consumers and to healthcare professionals. The Regulations prohibit advertising to
consumers of certain goods, those classified as pharmacist only medicines, which are included in Schedule
3 of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).
Pre-approval of Advertisements
Under the Regulations, advertisements for therapeutic goods (unless exempt) require pre-approval before
publication, insertion or broadcast, for valuable consideration, in specified media. Advertisements
appearing in specified media (other than television and radio advertisements) must prominently display an
approval number in the bottom right hand corner of the advertisement, stand-alone.
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Consultation Document for the Substantiation of Claims in the Advertising of Complementary
Medicines & Consumer Healthcare Products
Classification of Promotional Materials
Advertisements to consumers can be classified as either above the line or below the line material:
 above the line material, is taken to be advertisements for designated therapeutic goods published
or inserted, or intended to be published or inserted, for valuable consideration, in specified media.
Such advertisements require approval under Part 2, Division 2 of the Regulations.
 below the line material, are brochures, leaflets, flyers, shelf talkers, newsletters, point of sale
material, videos, audio tapes and catalogues as well as any magazines or journals that are not
mainstream media. Such advertisements currently do not require pre-approval, however must still
comply with the Therapeutic Goods Advertising Code.
By law, all advertisements for therapeutic goods appearing in specified media (newspapers, magazines,
cinema, outdoor display, television and radio) must be approved prior to publication or broadcast. Outdoor
display includes displays about goods appearing in shopping malls (except inside individual shops), in or on
public transport and on billboards.
The regulations make provision for the Minister to delegate the approval function as follows:
 all broadcast advertising (television & radio) to the Australian Self-Medication Industry (ASMI).
 mainstream print, cinema and outdoor advertising of complementary healthcare products to the
Complementary Healthcare Council (CHC) of Australia.
Advertisements appearing on the internet or in below the line media, such as flyers or brochures, do not
require pre-approval, unless those materials are inserted into mainstream newspapers or magazines for
consumers, in which case they will also require pre-approval. Therefore, it is important to note that the
status of advertising material can change depending on where it appears.
3 This Discussion Paper
While the Associations support the general principles of the current regulatory approach for evidence
substantiation, it is acknowledged that both consumers and industry want accurate and adequate
information about complementary medicines and consumer healthcare products, whilst preventing
misleading claims and indications.
It is the co-regulated Industry’s aim to improve public health and wellbeing through education and
information on the use of complementary medicines, to support and enhance a robust, vital and
sustainable complementary healthcare products industry, and to support the ethical and responsible
promotion of complementary medicines and consumer healthcare products.
These definitions are intended to be used in conjunction with:

The Therapeutic Goods Advertising Code;

The Therapeutic Goods Act and Regulations;

CHC Code of Practice for the Marketing of Complementary Medicines and Health Food Products
(under review).

The ASMI Code of Practice
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Consultation Document for the Substantiation of Claims in the Advertising of Complementary
Medicines & Consumer Healthcare Products

The Guidelines for Levels and Kinds of Evidence to Support Claims and Indications for Therapeutic
Goods (under review).
These definitions are intended to be used to:

Clarify certain claims used in the marketing of complementary medicines and consumer healthcare
products;

Assist advertisers to provide consistent and adequate evidence to the Advertising Services
Managers to support marketing claims;
These definitions are not intended to be used to:

Provide an alternative – or guideline – to assist with provision of evidence in post-market review by
the regulator;
In developing the specific definitions, the following meanings were applied:

Claim: may speak to the justification of a particular ingredient in the formulation, or the benefits
(including emotional benefits) of a particular product. It is a description of the specific therapeutic
purpose of a product, is an advertising statement about a product and needs to be seen in the
broader advertising context. The link between an indication and a claim is through Section 22(5) of
the Therapeutic Goods Act 1989, which requires that sponsors may only make claims that are
consistent with the indications for the product recorded on the ARTG.

Indication: the therapeutic benefit that is achieved by the use of a therapeutic good. In the TGAC,
it is defined as the specific therapeutic uses of the goods.
The conformity of an advertisement with the TGAC should be assessed in terms of its probable impact upon
the reasonable person to whom the advertisement is directed.
Australian Self Medication Industry
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Consultation Document for the Substantiation of Claims in the Advertising of Complementary Medicines & Consumer Healthcare Products
4 Proposed Definitions and Substantiation
Type of Claim /
Indication
Context
Definition
Substantiation
Example
Clinically
proven
The use of words
should be carefully
considered
Claims that the product or the
ingredient has undergone rigorous
scientific investigation in a good
quality clinical trial demonstrating
significant results.
Criteria to support this claim in reference to a product or ingredient:
 A minimum of 1 randomised controlled trial(s) (RCT) is required
 The RCT should be product vs. placebo or gold standard#
 The RCT should be conducted on a formulation that contains the equivalent
active(s) and dose, e.g. same vitamin or mineral source/compound; if a herb,
same herbal plant part, species, etc.; If not identical, equivalence should be
justified.
 The RCT must show statistical significance and clinical significance
 If a RCT does not have a discussion on clinical significance, it is acceptable
provided the results align with the general body of evidence already accepted
on the actives/dose.
 The RCT should include an appropriate number of subjects. Ideally a power
calculation should be referred to in the publication.
 A RCT which does not align with the general body of evidence or is unique/new
requires an appropriate number of subjects derived from a power calculation.
 General “clinically proven” claims may need to be qualified, if all the indications
do not meet the criteria. E.g. “clinically proven for heart health*” on front of
pack of a multivitamin plus fish oil product, with an asterisk pointing to back of
pack blurb which qualifies the claim as “*Omega 3 fatty acids EPA and DHA
found in fish oil, have been clinically proven to support heart health”.
 The RCT should be peer reviewed by either being published or independently
reviewed by a credible expert. E.g. published in a journal, accepted as a poster
or abstract at a credible conference or independent expert opinion report.
Product X is
clinically proven
to relieve
arthritis pain for
up to 8 hours
Scientifically
proven
Proven
This is a strong claim
and there is clear
potential for it to
mislead and confuse
consumers
Product X is
clinically proven
to help enhance
mental and
physical
performance
Ingredient X is
clinically proven
to reduce the
symptoms of
colds and flus
NB: A statement in the CT concluding that more research is needed does NOT
indicate any weakness in the conclusions reached by the study and as such should
not be considered in acceptance or rejection of the study.
An expert opinion from a relevant, qualified expert who has reviewed the scientific
evidence can also act as supporting data.
Australian Self Medication Industry
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Consultation Document for the Substantiation of Claims in the Advertising of Complementary Medicines & Consumer Healthcare Products
Type of Claim /
Indication
Clinically
trialled
Scientifically
tested
Scientifically
trialled
Clinically
tested
Context
Definition
Substantiation
Example
Reports and communicates to the
consumer that the product or the
ingredient has been subject to a
clinical trial.
Criteria to support this claim in reference to a product or ingredient:
A clinical trial
found that a daily
dose of
Ingredient X
helps reduce
joint
inflammation and
provides
temporary relief
from pain
associated with
arthritis
If it only concerns specific
ingredients in the product, that has
to be clearly identified and
communicated. Furthermore the
clinical trial findings can be
communicated to the consumer, if
referenced.
a. “Clinically trialled” - A minimum of 1 clinical trial (CT) on formula or ingredient
Or
b. Scientifically tested/ trialled - valid scientific investigations for mechanism
claims (e.g in-vitro tests like dissolution and micro)
Or
c. Clinically-tested - In-vivo testing (e.g SPF and other dermatological tests)
 CT or investigation should be conducted on a formulation that contains the
same actives at same or equivalent dose but not necessarily the exact same
formulation i.e. excipients may vary.
 If using a CT, it should be peer reviewed by either being published or
independently reviewed by a credible expert. E.g. published in a journal,
accepted as a poster or abstract at a credible conference or independent expert
opinion report.
 CT or investigations must show statistical significance but may not need to
include any discussion of clinical significance
 “Scientifically demonstrated” can also include other valid scientific
investigations for mechanism claims etc.
An expert opinion from a relevant, qualified expert who has reviewed the scientific
evidence can also act as supporting data
Australian Self Medication Industry
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Clinically trialled
formula /
ingredient
Scientifically
tested formula /
ingredient
Mechanism
Claims:
Scientifically
tested to kill x%
of bacteria”
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Consultation Document for the Substantiation of Claims in the Advertising of Complementary Medicines & Consumer Healthcare Products
Type of Claim /
Indication
Context
Definition
Substantiation
Example
Unique
Formulation
All of these claims
are interpreted as
the same
Unique: existing as the only one or
as the sole example, having no like
or equal.
Sponsors must hold and provide evidence if asked by the regulator, Advertising
Services Managers, Complaints Resolution Panel or by the ACCC.
Our
antiperspirant is
unique because it
provides 48
hours of
continual
wetness
protection
Unique
Product
Unique
Combination
Can be supported by any of the following;
In the context of Australian
therapeutic goods, the ‘uniqueness’
should be applicable to Australia.
Unique
Benefit
(Therapeutic)
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ARTG search
Evidence of exclusivity agreement
Any relevant patents
Other market data or relevant evidence
Shampoo X fights
dandruff and has
a unique shine
enhancing
ingredient
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Consultation Document for the Substantiation of Claims in the Advertising of Complementary Medicines & Consumer Healthcare Products
Type of Claim /
Indication
Context
Definition
Substantiation
Example
Product Trade
Names vs.
ARTG Names
Consumers have to
be able to
adequately identify
a product in an
advertisement
TGAC requires the trade name of
the therapeutic goods to be
included in the advertisement.
Substantiation is required:
ARTG Name:
Herbal Liniment
Gel
TGAC does not define “trade name”
A copy of the product label and TGA eBS must be provided.
The Regs define a trade name as
“the commercial name given to
goods of that kind by the
manufacturer; and under which the
goods are supplied”
The ARTG number on the ARTG certificate and product label needs to match.
Trade Name:
Zen Herbal Gel
(where Zen’ is
the brand name)
The ARTG requires a product name
(this is not legally defined what a
product name needs to be).
The Act and Regs do not define
“product name”. Only TGO 69
defines what a product name is.
TGO 69
Product name means the
proprietary name of the goods, or if
there is no proprietary name, the
non-proprietary name of the goods
(TGO 69).
Proprietary name means the
registered trademark of the
therapeutic goods or the unique
name assigned to the goods by the
sponsor and appearing on the label
(TGO 69).
Therefore the ARTG does not need
to include the trade name.
Advertising should not be driving
what names are being entered into
Australian Self Medication Industry
the register as the TGA have strict
Complementary Healthcare Council of Australia
criteria around product naming
(duplication of names, umbrella
branding etc)
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Consultation Document for the Substantiation of Claims in the Advertising of Complementary Medicines & Consumer Healthcare Products
Type of Claim /
Indication
Context
Definition
Substantiation
Example
Indications
consistent
with the ARTG
Claims within
advertisements, do
not need to be word
for word with
indications on the
ARTG.
Indication: An indication for a
medicine is its purpose and /or
action in the treatment of a
condition -the specific therapeutic
uses of the goods.
No substantiation is required. A copy or link to current indications of use as entered
in ARTG should be sufficient.
1.
The meaning needs
to be the
same/consistent,
but the wording
does not need to be
the same.
Claim: A medicinal product claim
describes what a medicine is
intended for, what its actions are,
its therapeutic benefit or what can
be achieved by using the
therapeutic good.
They are not required to be identical with indications on the ARTG.
A claim may speak to the
justification of a particular
ingredient in the formulation, or the
benefits (including emotional
benefits) of a particular product.
Australian Self Medication Industry
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Indications and claims within advertisements need to have the intent and meaning
of the indications listed on the ARTG.
ARTG –
“Calcium is
important
for bone
health”
Advertisement –
“Calcium is a vital
mineral needed
for healthy
bones”
2.
ARTG –
“Helps
maintain
general
wellbeing”
Advertisement –
“…for supporting
good health and
wellbeing”
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Consultation Document for the Substantiation of Claims in the Advertising of Complementary Medicines & Consumer Healthcare Products
Type of Claim /
Indication
Context
Definition
Substantiation
Example
Marketing
Claims – based
on ARTG
Indications
These do not need
to be included on
the ARTG.
Include indications and claims that
have been reworded to be
consumer friendly.
They do not need to be included on the ARTG.
Happy Healthy
Kids
Provide justification on how the marketing claims link to the indication(s) on ARTG.
The exact same wording doesn’t need to be listed on the ARTG as long as
justifications and evidence are relevant and in line with regulation.
Be on top of your
game
Tired of being
tired
Look good for
your wedding
Marketing
Claims – nontherapeutic
and not based
on ARTG
Indications
Insight Claims
These do not need
to be included on
the ARTG.
These do not need
to be included on
the ARTG.
Include statements & descriptions
that are not necessary related to a
therapeutic benefit, but are factual
in relation to a product or
ingredient.
Consumer insights are an intuitive
understanding of a how a targeted
demographic think or feel about a
situation.
These statements must be verifiable.
High Strength
Formula
Substantiation can be via:

Market Research, e.g. product comparisons (across the market or within
one’s own range)

Company Certificates or appropriate company documentation (including
justifications from raw material suppliers or manufacturers)

valid scientific investigations (e.g in-vitro tests like dissolution and micro)
They do not need to be included on the ARTG.
No substantiation is required
Sustained
Release
Every woman
wants to look
good on their
wedding day.
These do not need
to be linked to an
indication on the
ARTG.
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Consultation Document for the Substantiation of Claims in the Advertising of Complementary Medicines & Consumer Healthcare Products
Type of Claim /
Indication
Context
Definition
Substantiation
Example
Puffery
These do not need
to be included on
the ARTG.
Extract below from ACCC website
“misleading and deceptive conduct”
page.
No substantiation is required.
Best food in town
These do not need
to be linked to an
indication on the
ARTG.
What is 'puffery'? Is 'puffery'
misleading?
Puffery is a term used to describe
wildly exaggerated, fanciful or
vague claims for a product or
service that nobody could possibly
treat seriously, and that nobody
could reasonably be misled by.
Examples of puffery include 'best
food in town' or 'freshest taste
ever'.
Freshest taste
ever
Feel good on
Brand X
Puffery in advertising is a practice
that is generally not prohibited by
the Australian Consumer Law.
This definition also appears in the
ACCC ‘Definition of Terms’.
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Consultation Document for the Substantiation of Claims in the Advertising of Complementary Medicines & Consumer Healthcare Products
Type of Claim /
Indication
Context
Definition
Substantiation
Example
Marketing Tag
lines or
slogans
These do not need
to be included on
the ARTG.
Slogans or taglines are memorable
phrases used to either summarise a
product or brand concept, or to
reinforce an audience's memory of
a product (or advertisement).
No substantiation is required.
Best of Science &
Best of Nature
These do not need
to be linked to an
indication on the
ARTG.
Medical
Information /
Background
Information /
Basic
Physiology
(Medical
Claims)
These do not need
to be included on
the ARTG.
These do not need
to be linked to an
indication on the
ARTG.
As such they should also be treated
in the same way as "puffery",
especially if they are accompanied
by mnemonic devices, such as
jingles, ditties, pictures or
animation.
These are additional information for
the consumer. They are not
therapeutic claims and do not need
to be linked to an indication. They
should be relevant to the product’s
therapeutic area.
If the tag line or slogan is an implied claim or refers to an indication then it needs to
be substantiated (see marketing claim substantiation above).
These claims do not need to be listed on the ARTG.
This information does need to be substantiated by any relevant source e.g;
Textbooks, papers – published
Reputable peak bodies/guidelines/govt. sources etc
An expert opinion from a relevant, qualified expert
Must be consistent
within the
therapeutic area the
product is linked to.
Australian Self Medication Industry
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Be your best
Vaginal thrush is
a common
infection caused
by a yeast-like
fungus
Osteoporosis
affects at least
600,000
Australians,
mostly women
and men of
middle age and
older
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Consultation Document for the Substantiation of Claims in the Advertising of Complementary Medicines & Consumer Healthcare Products
Type of Claim /
Indication
Context
Definition
Substantiation
Example
Structure /
Function
Claims
These do not need
to be included on
the ARTG.
Describes the normal factual effect
of a medicinal ingredient on a
structure or physiological function
in the human body
These claims do not need to be listed on the ARTG.
Co-Enzyme Q10
is responsible for
cellular energy
production
These do not need
to be linked to an
indication on the
ARTG.
This information does need to be substantiated by any relevant source e.g;
Textbooks, papers – published
Reputable peak bodies/guidelines/govt. sources etc
Glucosamine is
naturally found in
the joints
An expert opinion from a relevant, qualified expert
Must be consistent
within the
therapeutic area the
product is linked to.
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Type of Claim /
Indication
Context
Definition
Substantiation
Example
Business /
Company
Claims
These do not need
to be included on
the ARTG.
Business claims regarding
commercial success, or other
product attributes or comparisons
which are not therapeutic are not
included in the ARTG product
claims, and are not therapeutic
benefits.
These statements must be verifiable.
The number 1
children’s
multivitamin
Regulation of business or company
claims falls under consumer or
competition law, not the TGAC.
Company Certificates or appropriate company documentation (including
justifications from raw material suppliers or manufacturers)
These do not need
to be linked to an
indication on the
ARTG.
Substantiation can be via;
Sales data – AZTEC, IMS, Nielsen etc (dated within the last 12 months)
Market Research, Surveys (dated within the last 2 years)
An expert opinion from a relevant, qualified expert
These statements must be
verifiable.
Source reference must be cited within the advertisement.
The preferred
brand amongst
females
We grow, harvest
and process plants
on X thousand
acres of our
Organic farms.
We have more
than 100 scientists,
… microbiologists,
pharmacists, …
dedicated to
creating the best
supplements
possible.
We have more
than 70 years of
experience in
vitamins research
and production.
We produce …
vitamin and
mineral tablets
each year.
Premium quality
(ingredients or
product)
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Consultation Document for the Substantiation of Claims in the Advertising of Complementary Medicines & Consumer Healthcare Products
Type of Claim /
Indication
Context
Definition
Substantiation
Example
Endorsements
/ Sponsorship
The ad needs to
identify the type of
endorsement, the
name of body or
association, and if
consideration is
made for this
endorsement.
TGACC requirement;
Advertisements must not contain or
imply endorsement of the goods by
bodies or peak healthcare
professional associations that:
(i) represent the interests of health
consumers;
(ii) conduct or fund research into a
disease, condition disorder or
syndrome; or
(iii) represent healthcare
professionals;
unless:
(iv) the advertisement names the
body or association;
(v) the endorsement is
authenticated;
(vi) the nature of the endorsement
is clearly disclosed; and
(vii) the endorsement is based upon
an objective assessment of available
scientific data supporting the use of
that product. Where this is not the
case and where the body or
association has received valuable
consideration for the endorsement,
the advertisement must
acknowledge that consideration.
Contract or letter from the body or association declaring the intent of the
endorsement that is between them and the sponsor, and if this endorsement is only
relevant to particular products this also needs to be outlined. If based on objective
assessment by the body or association this needs to be outlined within the
letter/contract.
Approved by the
Heart
Foundation.
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Official vitamin of
X Team
“Reader’s Digest
trusted vitamins”
“Choice
recommended
brand”
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Consultation Document for the Substantiation of Claims in the Advertising of Complementary Medicines & Consumer Healthcare Products
Type of Claim /
Indication
Context
Definition
Substantiation
Example
Testimonials
TGAC 4(7):
Testimonials must
not breach the
Code. They must be
documented,
genuine, not
misleading and
illustrate typical
cases only.
A testimonial can be defined as:
1. A statement in support of a
particular truth, fact, or claim.
2. A written affirmation of another's
character or worth; a personal
recommendation.
3. Something given in appreciation
of a person's service or
achievement; a tribute.
A Legal statutory declaration is not required (there is no legal basis for this
requirement).
Product X
worked for me, it
helped get rid of
the aches and
pain in my joints
Documentation signed by the person being represented is sufficient.
Words do not need to be word for word if they mean the same thing.
After using the
product I saw
visible
improvements
within days
I use Product X to
help me sleep
Natural
An ingredient can be described as
“natural” if it is obtained from a
natural source material, is in a form
found in nature, and has undergone
only the most minimal processing
(e.g. drying, grinding, powdering,
chopping, encapsulating).
Substantiation is required by a relevant source e.g. Confirmation from raw material
supplier that it is natural
Product Y is 100%
natural
With natural
Vitamin E
‘Nature identical’ is not considered
natural
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Consultation Document for the Substantiation of Claims in the Advertising of Complementary Medicines & Consumer Healthcare Products
Type of Claim /
Indication
Natural Source
/ Naturally
Derived
Context
Definition
Substantiation
Example
An ingredient can be described as
“natural source” if it is obtained via
extraction, isolation and/or
processing of plant, algal, fungal,
bacterial, or animal material or
minerals. Processing can include
such steps as boiling and steaming.
The ingredient must have the same
chemical identity as that in the
source material. Ingredients found
in nature that undergo chemical
modification such as derivatives and
salts are considered synthetic and
not natural source.
Substantiation is required by a relevant source e.g. Confirmation from raw material
supplier that it is naturally sourced/naturally derived
Product Y
contains 60%
natural source
vitamin C for the
maintenance of
good
Health
Australian Self Medication Industry
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Contains
naturally derived
herbal
ingredients
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Consultation Document for the Substantiation of Claims in the Advertising of Complementary Medicines & Consumer Healthcare Products
Type of Claim /
Indication
Context
Definition
Substantiation
Average
Consumer
The context here is
to ensure that it is
probable that the
average consumer,
or target audience
of the
advertisement
would not be
mislead.
What an average Australian with a
secondary education would
understand.
Definition is used as filter/justification.
Example
Note: the test here is that the "average consumer" would "probably" not be
mislead, not "possibly".
The European Court of Justice
interprets the "average consumer"
as "reasonably well informed and
reasonably observant and
circumspect, taking into account
social cultural and linguistic
factors".
Note the average consumer
concept is one that should be
determined, at least in part, by the
market or demographic in which
the consumer of the particular good
belongs.
Average consumers do not have a
Scientific, Natural Health
background.
Consumers who are not naïve or an
expert.
# Gold Standard - Any standardised clinical assessment, method, procedure, intervention or measurement of known validity and reliability which is generally taken to be the best
available, against which new tests or results and protocols are compared
Australian Self Medication Industry
Complementary Healthcare Council of Australia
Page 14 of 21
Consultation Document for the Substantiation of Claims in the Advertising of Complementary
Medicines & Consumer Healthcare Products
5 Information Required to Make a Submission
CHC and ASMI invite you to make a submission on the Consultation Document: Substantiation of Claims in
the Advertising of Complementary Medicines & Consumer Healthcare Products. Note that the possible
solutions presented here do not constitute the Associations’ formal position on this topic. The
recommendations are provisional and may change after consultation. The development of this discussion
document is in accordance with the Associations’ procedures.
When commenting on the discussion document, you might also consider the following:

Have any terms been overlooked but appear to fall within the scope of the document?

Are there alternative definitions that the document has not addressed?

The practical value of the provisional draft definitions.
Documents for download
- Consultation Document: Substantiation of Claims in the Advertising of Complementary Medicines &
Consumer Healthcare Products;
- Submission Form and Template for comments.
How to make a submission
Download and complete the Submission Form and Template for comments, which include a request for
contact details. Submissions that do not include a completed form will be accepted, but there may be no
acknowledgement of receipt/inclusion. Electronic submission of comments is strongly encouraged. If this is
not possible, please make your submission in writing (preferably typed or word processed) and submit by
mail or fax.
Send your submissions to:
Complementary Healthcare Council
By email to: submissions@chc.org.au
By fax to:
+61 2 6260 4122
By mail to:
Submissions
Claims Consultation Document Submission
PO Box 450
Mawson, ACT 2607
Closing Date:
The closing date for submissions is 5pm AEST Friday, September 21, 2012.
Acknowledgement of submissions
You will receive an acknowledgement via email when your submission has been received and logged.
Australian Self Medication Industry
Complementary Healthcare Council of Australia
Consultation Document for the Substantiation of Claims in the Advertising of Complementary
Medicines & Consumer Healthcare Products
Submissions CHC is unable to accept:
Comments received after the consultation deadline.
What will happen to your submission?
All submissions will be considered by the Reference Group, CHC’s Regulatory Policy /Technical Committees
and the Association Secretariats at the end of the consultation period.
Comments received in the course of this member consultation may be published without identifiers (ie:
personal names and company details) in the interests of openness and transparency and to promote
understanding about how the joint Associations’ Position and recommendations were developed. The
comments are published as a record of submissions received and are not endorsed by either Associations’
Board, Secretariat or relevant Committees.
Note: CHC reserve the right to summarise and edit comments received during consultation, or not publish
them at all, where in the Associations’ reasonable opinion the comments are inappropriate, voluminous or
publication would be unlawful.
Anticipated publication date of the final draft of the Position Paper on Substantiation of Claims in the
Advertising of Complementary Medicines & Consumer Healthcare Products: November 2012
i
Definitions: Section 52F of the Therapeutic Goods Act.
ii
Designated Active Ingredients: Schedule 14 of the Therapeutic Goods Regulations.
Australian Self Medication Industry
Complementary Healthcare Council of Australia