Direction about advertisements: 13 Vape Pty Ltd

THERAPEUTIC GOODS ACT 1989

DIRECTION UNDER SECTION 42DV

ISSUED TO: 13 Vape Pty Ltd ACN 652 404 263 as trustee for 13 Vape Discretionary Trust and [REDACTED]

ON: 1 JULY 2022

ABOUT: Advertising nicotine vaping products for use and supply to Australian consumers

BY:
Delegate of the Secretary of the Australian Government Department of Health and Aged Care

Therapeutic Goods Administration
PO Box 100
Woden ACT 2606

Contact officer details:
[REDACTED]

DIRECTION ABOUT AN ADVERTISMENT

Made Under Section 42DV of the Therapeutic Goods Act 1989

TO: 13 Vape Pty Ltd
ABN 82 744 583 729
C/- [REDACTED]
Indooroopilly QLD 4068

AND

[REDACTED]

By express post and email:[REDACTED]

I, delegate of the Secretary of the Australian Department of Health and Aged Care (the Delegate) in the Therapeutic Goods Administration (TGA), being satisfied, for the reasons set out in Attachment A, that there has been a contravention of the Therapeutic Goods Act 1989 (the Act) in relation to the advertising of therapeutic goods; namely, nicotine vaping products (the Goods)

DIRECT you, as the persons apparently responsible for the advertising or for causing the advertising of the Goods, to:

1. Cease all advertising of the Goods to Australians, including but not limited to the advertising on your websites at the following Uniform Resource Locators (URLs): [REDACTED] (the Websites)

   This includes ceasing representing material on the website in such a way that is promoting the use and supply of nicotine vaping products, as a class of therapeutic goods. As such you are directed to:

   1. cease using references in the URL of the Website or any related or future URL to ‘vape’ or any variation of the word such as ‘vaping’, in conjunction with words ‘prescription’, ‘medical’, ‘pharmacy’, or any variation of these words such as script.
   2. cease using references in the trading name of 13 Vape Pty Ltd as trustee for 13 Vape Discretionary Trust ABN and [REDACTED] or any related or future trading name or business venture to ‘vape’ or any variation of the word such as ‘vaping’, in conjunction with words ‘prescription’, ‘medical’, ‘pharmacy’, or any variation of these words such as script.
   3. Cease providing unbalanced information about nicotine vaping as a smoking cessation treatment option, including on the following URLs::
      1. [REDACTED]
      2. [REDACTED];
      3. [REDACTED]

CONDITIONS

under subsection 42DV(3) of the Act

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, by 5pm on 29 July 2022; and
2. cease, for the period of 3 years, all advertising referred to at paragraph 1 above; and
3. email evidence of your compliance with this Direction to the email address listed on the first page of this Direction by 5pm on 29 July 2022.

OTHER INFORMATION

Important information about the reasons for making this Direction and its effect is set out in Attachment A (see PDF). The possible consequences of failing to comply with this Direction are explained in Attachment B (see PDF).

The sections of the Act relevant to the making of this Direction are set out in Attachment C (see PDF).

This is an initial decision and is reviewable. Your review rights are set out in Attachment D (see PDF).

Examples of the alleged unlawful advertising is reproduced at Attachment E (see PDF).

Please note, under subsection 42DV(6) of the Act, the TGA will publish this Direction on its website. Publication is planned to occur on or before 2 business days from date of notice.

DATED: 22 June 2022

Nicole McLay

Delegate of the Secretary
Therapeutic Goods Administration
Australian Department of Health and Aged Care