Complaints Resolution Panel
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  Thursday 2 October 2014
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Complaint Submission Form

Please fill out the requested information to submit your complaint. Items marked with (*) are required.

Publication: *
Date/Edition: *
Product: *
Please identify the therapeutic goods that are promoted in the advertisement. If possible, identify the party responsible for publishing the advertisement.
Details of the Complaint: *
State clearly the nature of your complaint. It is not sufficient to highlight or quote words from the advertisement - explain what aspects of the advertisement are of concern to you and why. If possible, identify sections of the Therapeutic Goods Code, Act, or Regulations you believe may have been breached in the advertisement.
I have also contacted the advertiser directly: No Yes (Please provide details below)
This matter is also the subject of legal action: No Yes (Please provide details below)
Privacy Information
  • For general privacy information go to http://www.tga.gov.au/privacy
  • The Complaints Resolution Panel (CRP) is collecting personal information in this form in order to manage complaints made about therapeutic goods advertisements that are directed to the public.
  • The CRP may refer this complaint, including the personal information contained within the complaint, to other entities including:
    Government departments and bodies in Australia and overseas who have roles in regulating health,food, therapeutic goods or consumer protection law.
    The office administering the National Industrial Chemicals Notification and Assessment Scheme(NICNAS)
    Law enforcement agencies for administering the complaint.
  • For more information, please go the http://www.tga.gov.au/industry/adverstising-complaint.htm
Do you consent to your personal details being provided to the advertiser? No Yes
Do you consent to your personal details being released in the published CRP determination? No Yes
Complainant Information
Although Complaints may be made anonymously or with a pseudonym, you are encouraged to provide your contact details so that further information about your complaint can be obtained(if required) and you can be advised of the outcome of your complaint. Your personal details will not be provided to the advertiser or published in the CRP determination. if you have not given your consent to do so
Please keep my personal details confidential: No Yes
Name:
Postal Address:
Postal code:
Telephone:
Fax:
Email Address:
I am associated with the Therapeutic Goods Industry: No Yes
Supporting Documentation
Attach document supporting your complaint.
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Additional information for complainants
Your complaint is more likely to be effective if you observe the following advice.
Foods
The Panel has no jurisdiction over advertisements for foods, even where food advertisements make therapeutic claims.
Complaints by persons associated with the therapeutic goods industry
 
Complaints by persons associated with the therapeutic goods (other than as consumers) are subject to additional requirements, whether or not the complainant is associated with a commercial competitor of the advertiser. The additional requirements include:
-          The section of the Therapeutic Goods Act 1989 (Act), Therapeutic Goods Regulations 1990 (Regs) and/or Therapeutic Goods Advertising Code (refer www.tgacc.com.au ) (Code) alleged to have been breached
-          A rationale for each aspect of the complaint, including supporting data that is linked to the claims at issue
Where a claim is alleged to be unsubstantiated, it is not sufficient simply to state that the claim is not supported; evidence must be provided.
The Panel may request further information from the complainant in cases where it has not been provided.
Corrections/
Amendments
Once a complaint has been received, the Panel will not accept amendments, additional material, or corrections to complaints, although it may make additional enquiries if it finds it necessary to do so. Therefore, you should ensure that your complaint is complete before sending it to the Panel.
Product labels
The Panel does not have jurisdiction over product labels or packaging, except where they are reproduced in advertisements.
Price/Availability advertisements
The Code does not apply to advertisements that include only the name of a product, a product image, or information about its availability and price. Where additional information is included in the advertisement, the Code may apply. Please note that “additional information” may be inherent in the name of a product or in its image, if these convey information such as a therapeutic claim.
Sections of the Code and Act
Consumer complainants are not required to specify which sections of the Code, Regulations, or Act are alleged to have been breached. It is however helpful to do so, both by citing specific sections (see below), and by relating those sections to words or implications in the advertisement.
Frequently noted sections of the Act
The following summary is a guide only; complainants should also refer to the complete Therapeutic Goods Act 1989. The sections listed are often the subject of complaints. Note that exceptions apply to some of these requirements; refer to the Act for further information.
Section
Says that advertisements…
22(5)
must not refer to therapeutic uses not included on the Australian Register of Therapeutic Goods (ARTG) for the advertised goods (for medical devices, section 41FN applies).
42C(1)
must be approved (an exception applies for internet advertising and advertisements for medical devices) if published or broadcast (for valuable consideration) in specified media.
42C(2)
must not differ from the approved version of the ad.
42C(4)
must display a valid approval number (an exception applies for internet advertising and advertisements for medical devices).
42C(6)
must comply with all conditions for advertising approval.
42DL(1)(a)
must not contain a prohibited representation (see also Code section 5(1) below).
42DL(1)(c)
must not contain a restricted representation without prior approval (see also Code section 5(2) below).
42DL(1)(f)
must not refer to scheduled poisons.
42DL(1)(g)
must not promote therapeutic goods that are not included in the ARTG for sale in Australia.
42DM(1)
must comply with the Code (section 42DP applies to generic information.)
Frequently noted sections of the Code
The following summary is a guide only; complainants should also refer to the complete Therapeutic Goods Advertising Code. The sections listed are often the subject of complaints. Note that exceptions apply to some of these requirements; refer to the Code for further information.
Section
Says that advertisements…
4(1)(a)
must comply with Australian law.
4(1)(b)
must contain only correct and balanced statements which the product sponsor has verified.
4(2)(a)
must not arouse unrealistic or unwarranted expectations of product effectiveness.
4(2)(b)
must not be likely to lead to self-diagnosis or inappropriate self-treatment of potentially serious diseases.
4(2)(c)
must not mislead or be likely to mislead.
4(2)(d)
must not exploit the lack of knowledge of consumers or abuse their trust.
must not use language that causes fear or distress.
4(2)(e)
must not cause people to believe that they have a serious ailment.
must not case people to believe that harm will result from not using the advertised product.
4(2)(f)
must not encourage excessive or inappropriate use of the advertised product.
4(2)(g)
must not claim that the advertised product is magical or infallible.
4(2)(h)
must not claim that the advertised product is invariably effective.
4(2)(i)
must not claim that goods are completely safe, harmless, or free of side-effects.
4(2)(j)
must not be directed to minors (subject to exceptions.)
4(4)
must identify the researcher when research results are published.
must use appropriate and understandable language when providing scientific information.
4(5)
if making comparisons, must make only balanced and accurate comparisons.
must not imply that the therapeutic products being compared are ineffective or harmful.
4(6)(b)
must not claim that the product advertised is endorsed by a government body, including the TGA.
if referring to sponsorship of a healthcare facility or government body, must not imply that the sponsorship is also an endorsement.
if containing an endorsement by a healthcare professional or healthcare body, must include the name of the endorser and acknowledge any payment or other valuable consideration.
4(7)
where testimonials are included, must contain only typical and genuine testimonials and must not be misleading.
4(8)
must not offer samples of therapeutic goods.
5
must not refer to serious conditions such as cancer, sexually transmitted diseases, or mental illness (subject to exceptions).
must not refer to serious forms of conditions such as cardiovascular disease, dental disease, bone disease, liver, endocrine, gastrointestinal, haematological, infectious, immunological, metabolic, renal, or respiratory diseases, substance dependence, without prior approval by the TGA.
6(3)(a)
must contain the trade name of the goods advertised.
6(3)(b)
must contain a reference to the ARTG indications for the advertised product.
6(3)(c)
must include the words “Always read the label” or a full list of the active ingredients.
6(3)(d)
must include the words “Use only as directed” and “If symptoms persist see your doctor/healthcare professional.”
6(4)
must include a valid approval number, prominently displayed in the bottom right-hand corner of the advertisement (subject to exceptions.)
7(3)
if advertising weight loss, size loss, weight control, or similar effects, must have an appropriate balance between the claim and references to healthy lifestyle and diet.
 
I have read and understood the information and requirements set out in this form