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Direction about advertisements: Cat Media Pty Ltd

Direction under Section 42DV

24 December 2019

THERAPEUTIC GOODS ACT 1989


DIRECTION UNDER SECTION 42DV

ISSUED TO: Cat Media Pty Ltd

ON: 20 November 2019

ABOUT: FatBlaster Clinical (ARTG 295575)

BY: Nicole McLay
Assistant Secretary
Regulatory Education and Compliance
Therapeutic Goods Administration (Delegate of the Secretary of the Australian Department of Health)


Therapeutic Goods Administration
PO Box 100
Woden ACT 2606

Contact Officer Name:
[REDACTED]

Contact Officer Telephone:
[REDACTED]

Contact Officer Email:
[REDACTED]


DIRECTION ABOUT AN ADVERTISMENT

Made Under Section 42DV of the Therapeutic Goods Act 1989

TO: Cat Media Pty Ltd
[REDACTED]

Email: [REDACTED]

I, Nicole McLay, delegate of the Secretary of the Australian Department of Health in the Therapeutic Goods Administration (TGA) being satisfied, for the reasons set out in Attachment 1, that there has been a contravention of the Therapeutic Goods Act 1989 (the TG Act) including because there has been a contravention of the Therapeutic Goods Advertising Code (No.2) 2018 (the Code) in relation to the advertising for FatBlaster Clinical (ARTG 295575) (the Medicine),

DIRECT you, as the person apparently responsible for that advertising of the therapeutic goods, to:

  1. Cease making claims or representations in connection with the Medicine that imply that it can assist with weight loss; and
  2. Cease using, in any advertising of FatBlaster Clinical, the image of the slim female torso that currently appears on the label.

CONDITIONS

under subsection 42DV(3) of the TG Act

  1. This Direction is subject to the following conditions that you must:
    1. complete each action you are directed to carry out including as required by these conditions within 7 days of the date of this Direction;
    2. cease, permanently, publishing claims or representations listed above in paragraph 1-3, for example, by not including those claims or representations in any other advertising for which Cat Media Pty Ltd appears responsible or to have caused; and
    3. email evidence of your compliance with this Direction to the email address listed on the first page of this Direction within 28 days of the date of this Direction.

OTHER INFORMATION

  1. Important information about the reasons for making this Direction and its effect is set out in Attachment 1.
  2. The possible consequences of failing to comply with this Direction are explained in Attachment 2.
  3. The sections of the TG Act relevant to the making of this Direction are set out in Attachment 3.
  4. This is an 'initial decision' and is reviewable. Your review rights are set out in Attachment 4.
  5. Please Note, as required under subsection 42DV(6) of the TG Act, the TGA will publish this Direction on its website. Publication is planned in the week commencing 25 November 2019.

DATED: 20 November 2019

Nicole McLay
Assistant Secretary
Regulatory Education and Compliance
Therapeutic Goods Administration
Delegate of the Secretary
Australian Government Department of Health

Statement of reasons for making this direction

Relevant legislation

  1. The advertising of therapeutic goods to the public in Australia must comply with the requirements specified in the TG Act, including compliance with the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code).
  2. The definition of "advertise" in subsection 3(1) of the TG Act is:

    advertise, in relation to therapeutic goods, includes make any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design:

    1. is on the label of the goods; or
    2. is on the package in which the goods are contained; or
    3. is on any material included with the package in which the goods are contained.
  3. Section 9 of the Code relevantly provides:

    Advertising for therapeutic goods must satisfy the following:

    1. any claims made in the advertising are valid and accurate, and all information presented has been substantiated before the advertising occurs; and
    2. it is truthful, balanced and not misleading or likely to mislead, including in its claims, presentations, representations and comparisons; and...
  4. Paragraph 10(a)(ii) of the Code provides:

    Advertising for therapeutic goods must:

    1. support the safe and proper use of therapeutic goods by:

      ...

      1. not exaggerating product efficacy or performance...
  5. Section 42DV of the TG Act relevantly provides:
    1. If, in relation to the advertising of therapeutic goods, the Secretary is satisfied that there has been a contravention of this Act or the regulations, the Secretary may, in writing, direct a person apparently responsible for advertising the therapeutic goods, or for causing the advertising of the therapeutic goods, to do one or more of the following:

      ...

      1. cease making a particular claim or representation made by the advertisement
  6. Section 42DMA of the TG Act provides for civil penalties where a person advertises, by any means, therapeutic goods, (or causes such advertising, by any means) and the advertisement does not comply with the Code.

Background

  1. FatBlaster Clinical is included in the Australian Register of Therapeutic Goods (Register) with the following indications:
    1. Antioxidant/Reduce free radicals formed in the body
    2. Helps reduce/decrease free radical damage to body cells
    3. Maintain/support vitality
    4. Helps enhance/promote general health and wellbeing
    5. Maintain/support general health and wellbeing
    6. Anti-inflammatory/relieve inflammation
    7. Helps decrease/reduce body weight
    8. Helps in the maintenance of a healthy body weight
    9. Helps maintain/support healthy Body Mass Index (BMI)
    10. Helps enhance/promote/increase weight loss
  2. On 29 May 2019, I wrote to you proposing to issue a direction under section 42DV of the Act concerning the advertising of the Medicine.
  3. You provided a response to the proposal on 27 June 2019.

Advertising contraventions of the Act

  1. You have contended that the evidence submitted in support of the weight loss claims is supportive of those claims, and therefore sections 9 and 10 of the Code have been complied with.
  2. For the reasons set out in Attachment A, I am not satisfied that the evidence you have provided is sufficient to substantiate the weight loss claims for the Medicine, and as such, I consider that those claims are not accurate and are likely to mislead, in breach of section 9 of the Code.
  3. Notwithstanding the amendments that have been made to the advertisement for the Medicine on the website at [REDACTED WEB ADDRESS], the advertisement on that website and label of the Medicine still imply clinically proven weight loss due to the name of the Medicine and the image of the slim torso.
  4. I am satisfied that the image of the slim torso with the tape measure exaggerates the efficacy of the Medicine, as it implies significant weight loss and reduction in body measurements. Even if the tape measure is removed, the image still exaggerates the efficacy of the Medicine by implying significant weight loss, in breach of section 10 of the Code.
  5. You have contended that section 26 of the Code does not preclude an image of the type that is featured on the label and packaging for the Medicine. You contended that the inclusion of the words 'those individuals' in subsection 26(3) contemplates that the images the subject of that provision are images of persons who have used the goods and that it is addressed to persons providing testimonials by inclusion of their image.
  6. In my view, the interpretation of subsection 26(3) you have proposed is unduly narrow. Having regard to the context, it appears that the purpose of section 26 is to impose special requirements for the advertising of therapeutic goods for weight loss and weight management, due to the particular susceptibility of consumers wanting to lose weight to marketing that promises such results. Therefore, I consider that subsection 26(3) prohibits the use of any image of a person unless the results that are implied by the image would be expected to be achieved on average by users of the good. The image of the very slim torso in question implies that the individual portrayed by the image has used the goods and has achieved significant weight loss and a significant reduction in waist circumference, neither of which are supported by the evidence.
  7. I am satisfied that even if the tape measure was removed, the image of the slim torso would remain in breach of subsection 26(3) of the Code because it is an image of an individual that implies significant weight loss. Therefore, I am not satisfied that removal of the tape measure from the image is sufficient to resolve this matter.
  8. I note that you have amended the advertising of the Medicine on your website subsequent to my proposal to direct in May 2019. However, I am satisfied that the advertisements continue to breach the Code to the extent that they imply that the Medicine is clinically proven to assist with weight loss. Specifically, the use of the image of the slim woman on the label of the Medicine (with or without the tape measure), together with the manner in which the Medicine is presented (as detailed in Attachment A), create the impression that it is clinically proven to assist with weight loss. As the evidence does not substantiate this, the advertisements remain in breach of the Code notwithstanding the steps you have taken to resolve this matter.

Conclusion

  1. For the reasons set out above, I am satisfied that advertisements for the Medicine that you have published breach sections 9, 10 and 26 of the Code, thereby breaching section 42DMA of the Code. Accordingly, I make the Direction set out in paragraphs 1 and 2 of this letter together with the associated conditions.

EFFECT OF NOT COMPLYING WITH THESE DIRECTIONS

If you contravene a direction or a condition of a direction made under subsections 42DV(1) or (2) of the TG Act, you may breach criminal offence provisions under section 42DW or contravene a civil penalty provision under section 42DX which could lead to court action against you.

The TGA could also issue you an infringement notice as an alternative to these actions.

In conjunction with pursuing civil or criminal sanctions, the TGA may also seek an injunction from a Federal Court to immediately cease your advertising.

The TGA can also alert the public to its concerns about particular therapeutic goods advertising through the use of public warning notices (section 42DY).

Please Note:

Subsection 42DV(6) states

As soon as practicable after giving a direction under subsection (1) or (2), the Secretary must cause the direction to be published on the Department's website.

Therapeutic Goods Act 1989

Part 5-1 - Advertising and generic information

Division 6 - Directions about advertisements or generic information

42DV Directions about advertisements or generic information

Advertisements
  1. If, in relation to the advertising of therapeutic goods, the Secretary is satisfied that there has been a contravention of this Act or the regulations, the Secretary may, in writing, direct a person apparently responsible for advertising the therapeutic goods, or for causing the advertising of the therapeutic goods, to do one or more of the following:
    1. cease the advertisement;
    2. make a retraction;
    3. make a correction;
    4. recover any advertisement that is still in circulation;
    5. destroy the advertisement;
    6. cease making a particular claim or representation made by the advertisement.
Generic information
  1. If, in relation to the dissemination of generic information about therapeutic goods to the public or a section of the public, the Secretary is satisfied that there has been a contravention of this Act or the regulations, the Secretary may, in writing, direct a person apparently responsible for the dissemination, or for causing the dissemination, to do one or more of the following:
    1. withdraw the generic information;
    2. make a retraction;
    3. make a correction;
    4. recover any generic information that is still in circulation;
    5. destroy the generic information;
    6. cease making a particular claim or representation made by the generic information.
Conditions
  1. A direction under subsection (1) or (2) may be subject to conditions specified in the direction.
  2. Without limiting subsection (3), the conditions may relate to one or more of the following:
    1. the period for doing a thing the subject of the direction;
    2. in relation to the making of a retraction or correction, either or both of the following:
      1. the form and manner of the retraction or correction;
      2. the period for which the retraction or correction must be made publicly available;
    3. the reporting to the Secretary of compliance with the direction.
Direction not a legislative instrument
  1. A direction under subsection (1) or (2) is not a legislative instrument.
Publication
  1. As soon as practicable after giving a direction under subsection (1) or (2), the Secretary must cause the direction to be published on the Department's website.
42DW Offences - contravening direction under section 42DV
  1. A person commits an offence if:
    1. the Secretary has given a direction to the person under subsection 42DV(1) or (2) in relation to therapeutic goods; and
    2. the person does an act or omits to do an act; and
    3. the act or omission contravenes the direction or a condition of the direction; and
    4. either:
      1. the use of the goods has resulted in, will result in, or is likely to result in, harm or injury to any person; or
      2. the use of the goods, if the goods were used, would result in, or would be likely to result in, harm or injury to any person; and
    5. the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because of the contravention.
    Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
  2. A person commits an offence if:
    1. the Secretary has given a direction to the person under subsection 42DV(1) or (2); and
    2. the person does an act or omits to do an act; and
    3. the act or omission contravenes the direction or a condition of the direction.
    Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
  3. A person commits an offence if:
    1. the Secretary has given a direction to the person under subsection 42DV(1) or (2); and
    2. the person does an act or omits to do an act; and
    3. the act or omission contravenes the direction or a condition of the direction.
    Penalty: 100 penalty units.
  4. An offence against subsection (3) is an offence of strict liability.
42DX Civil penalty for contravening direction under section 42DV

A person contravenes this section if:

  1. the Secretary has given a direction to the person under subsection 42DV(1) or (2); and
  2. the person does an act or omits to do an act; and
  3. the act or omission contravenes the direction or a condition of the direction.

Maximum civil penalty:

  1. for an individual - 5,000 penalty units; and
  2. for a body corporate - 50,000 penalty units.

Request for reconsideration of an initial decision

This decision is a reviewable initial decision under section 60 of the TG Act. Under section 60, a person whose interests are affected by a 'reviewable' initial decision, can seek reconsideration of the initial decision.

As this document constitutes written notice of the making of an initial decision being given by the Secretary, a request for reconsideration of this initial decision must be given to the Minister within 90 days and be accompanied by any information that you wish to have considered. A request for reconsideration given to the Minister outside the statutory 90 day reconsideration period cannot be accepted.

The Minister may either personally undertake a request for reconsideration of an initial decision or delegate to an officer of the Department with the appropriate delegation.

Under section 60(3A) of the TG Act, the Minister (or the Minister's delegate) is not able to consider any information provided after the notification is made of a request for reconsideration of an initial decision unless the information is provided in response to a request from the Minister (or the Minister's delegate), or it is information that indicates that the quality, safety or efficacy of the relevant therapeutic goods is unacceptable.

Guidelines for requesting reconsideration of an initial decision

A request for reconsideration should be made in writing, signed and dated by the person requesting reconsideration, should be titled "<insert person/company name> - Request for Reconsideration Under Section 60 of the Therapeutic Goods Act 1989" and should include the following:

  • a copy of the initial decision notification letter (or other evidence of notification);
  • identify, and describe with as much specificity as possible, which component(s) of the initial decision should be reconsidered and set out the reasons why reconsideration is requested;
  • any information/documentation in support of the request, clearly labelled to correspond with (any or each of) the reasons why reconsideration is requested; and
  • an email address nominated for the purposes of receiving correspondence in relation to the request for reconsideration.

ll requests for reconsideration should be given to the Minister by email:

Email: 'minister.hunt.DLO@health.gov.au' and copied to 'decision.review@health.gov.au'

Requests for reconsideration that include dossiers (or similar bulk material) that cannot easily be attached to the request given first by email, may then be submitted on a USB drive or CD sent by express post or registered mail to:

Mail:

Minister for Health
Suite M1 40
c/- Parliament House
CANBERRA ACT 2600

If upon reconsideration by the Minister (or the Minister's delegate), you are dissatisfied with that decision, you can apply to the Administrative Appeals Tribunal (AAT) for a review of that decision (see the Administrative Appeals Tribunal Act 1975 (AAT Act)).

NOTE: This initial decision remains in effect unless and until it is revoked or revoked and substituted by the Minister (or the Minister's delegate) as a result of a request for reconsideration under section 60 of the TG Act OR is set aside, varied or remitted by the AAT or is otherwise overturned or stayed.