Direction about advertisements: MDNE Enterprises Pty Ltd

THERAPEUTIC GOODS ACT 1989

DIRECTION UNDER SECTION 42DV

ISSUED TO: MDNE Enterprises Pty Ltd ACN 654 012 156 and [REDACTED] DOB

ON: 20 September 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: MDNE Enterprises Pty Ltd
ACN 654 012 156
[REDACTED]

AND

[REDACTED]

By post and by email:
[REDACTED]

I, a 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

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

1. Cease all advertising of nicotine vaping products to Australians, including but
   not limited to the advertising on your website at the following Uniform Resource
   Locators (URLs):
   1. [REDACTED] (the [REDACTED] Website)
   2. [REDACTED] (the [REDACTED] Website)
   3. [REDACTED] (the [REDACTED] Website)
   4. [REDACTED] and [REDACTED] (collectively, the [REDACTED] Instagram Accounts)

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 19 October 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 19 October 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 unlawful advertisements are set out in 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: 20 September 2022

Nicole McLay

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