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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 3

Pre-approval of Advertisements 3

Classification of Promotional Materials 4

3 This Discussion Paper..................................................................................................................................... 4

4 Proposed Definitions and Substantiation....................................................................................................... 1

5 Information Required to Make a Submission.........................................................................................................1

Australian Self Medication Industry Complementary Healthcare Council of Australia Page 2 of 24


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 full-day 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.



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



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.



4 Proposed Definitions and Substantiation



Type of Claim / Indication

Context Definition Substantiation Example

Clinically proven Scientifically proven

Proven

The use of words should be carefully considered

This is a strong claim and there is clear potential for it to mislead and confuse consumers

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.

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.

Product X is clinically proven to relieve arthritis pain for up to 8 hours

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





Clinically trialled

Scientifically tested

Scientifically trialled

Clinically tested

Reports and communicates to the consumer that the product or the ingredient has been subject to a clinical trial.

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.

Criteria to support this claim in reference to a product or ingredient:

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

A clinical trial found that a daily dose of Ingredient X helps reduce joint inflammation and provides temporary relief from pain associated with arthritis

Clinically trialled formula / ingredient

Scientifically tested formula / ingredient

Mechanism Claims:Scientifically tested to kill x% of bacteria”





Unique Formulation

Unique Product

Unique Combination

Unique Benefit (Therapeutic)

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.

In the context of Australian therapeutic goods, the ‘uniqueness’ should be applicable to Australia.

Sponsors must hold and provide evidence if asked by the regulator, Advertising Services Managers, Complaints Resolution Panel or by the ACCC.

Can be supported by any of the following;

ARTG search

Evidence of exclusivity agreement

Any relevant patents

Other market data or relevant evidence

Our antiperspirant is unique because it provides 48 hours of continual wetnessprotection

Shampoo X fights dandruff and has a unique shine enhancing ingredient





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.

TGAC does not define “trade name”

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 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.

Substantiation is required:

The ARTG number on the ARTG certificate and product label needs to match.

A copy of the product label and TGA eBS must be provided.

ARTG Name:Herbal Liniment Gel

Trade Name:Zen Herbal Gel (where Zen’ is the brand name)





Indications consistent with the ARTG

Claims within advertisements, do not need to be word for word with indications on the ARTG.

The meaning needs to be the same/consistent, but the wording does not need to be the same.

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.

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.

A claim may speak to the justification of a particular ingredient in the formulation, or the benefits (including emotional benefits) of a particular product.

No substantiation is required. A copy or link to current indications of use as entered in ARTG should be sufficient.

Indications and claims within advertisements need to have the intent and meaning of the indications listed on the ARTG.

They are not required to be identical with indications on the ARTG.

1. 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”





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.

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.

Happy Healthy Kids

Be on top of your game

Tired of being tired

Look good for your wedding

Marketing Claims – non-therapeutic and not based on ARTG Indications


Include statements & descriptions that are not necessary related to a therapeutic benefit, but are factual in relation to a product or ingredient.

These statements must be verifiable.

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)

High Strength Formula

Sustained Release

Insight Claims These do not need to be included on the ARTG.

These do not need to be linked to an indication on the ARTG.

Consumer insights are an intuitive understanding of a how a targeted demographic think or feel about a situation.

They do not need to be included on the ARTG.

No substantiation is required

Every woman wants to look good on their wedding day.





Puffery These do not need to be included on the ARTG.


Extract below from ACCC website “misleading and deceptive conduct” page.

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'.

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’.

No substantiation is required. Best food in town

Freshest taste ever

Feel good on Brand X





Marketing Tag lines or slogans



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).

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.

No substantiation is required.

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).

Best of Science & Best of Nature

Be your best

Medical Information / Background Information / Basic Physiology(Medical Claims)



Must be consistent within the therapeutic area the product is linked to.

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.

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

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





Structure / Function Claims



Must be consistent within the therapeutic area the product is linked to.

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.

This information does need to be substantiated by any relevant source e.g;

Textbooks, papers – published

Reputable peak bodies/guidelines/govt. sources etc


Co-Enzyme Q10 is responsible for cellular energy production

Glucosamine is naturally found in the joints





Business / Company Claims



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.

Regulation of business or company claims falls under consumer or competition law, not the TGAC.



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)

Company Certificates or appropriate company documentation (including justifications from raw material suppliers or manufacturers)


Source reference must be cited within the advertisement.

The number 1 children’s multivitamin

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)





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.

Official vitamin of X Team

“Reader’s Digest trusted vitamins”

“Choice recommended brand”





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).

Documentation signed by the person being represented is sufficient.

Words do not need to be word for word if they mean the same thing.

Product X worked for me, it helped get rid of the aches and pain in my joints

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).

‘Nature identical’ is not considered natural

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





Natural Source / Naturally Derived

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 goodHealth

Contains naturally derived herbal ingredients





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.

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.

Definition is used as filter/justification.

Note: the test here is that the "average consumer" would "probably" not be mislead, not "possibly".

# 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



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: [email protected]

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

mailto:[email protected]


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

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