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THERAPEUTIC GOODS ACT 1989
DIRECTION UNDER SECTION 42DV
ISSUED TO: [REDACTED]
ON: 24 January 2023
ABOUT: Promoting the use and supply of nicotine vaping products to Australian consumers
BY: [REDACTED]
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 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:
[REDACTED]
By express post and by 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 (see PDF), that there have been contraventions of the Therapeutic Goods Act 1989 (the TG Act) in relation to the advertising of nicotine vaping products, including those goods set out at Attachment E (the Goods) (see PDF).
DIRECT you, as the person apparently responsible for that advertising or for causing the advertising of the Goods, to:
- Cease all advertising of nicotine vaping products, including but not limited to the advertising on the websites at the Uniform Resource Locators (URLs):
- [REDACTED]; and
- [REDACTED] (collectively, the Websites)
CONDITIONS
under subsection 42DV(3) of the TG Act
This Direction is subject to the following conditions that you must:
- complete each action you are directed to carry out, including as required by these conditions, by 5pm on 5 business days from date of this notice;
- cease, for the period of 3 years, all advertising referred to at paragraph 1 above; and
- email evidence of your compliance with this Direction to the email address listed on the first page of this Direction by 5 business days from date of notice.
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 TG Act relevant to the making of this Direction and The Therapeutic Goods (Restricted and Prohibited Representations - Nicotine) Permission (No. 2) 2021 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 TG 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: 24 January 2023
Delegate of the Secretary
Therapeutic Goods Administration
Australian Government Department of Health and Aged Care