Australian Therapeutic Goods Administration Responds to 2Firsts: Monitoring E-Cigarette Ads with Penalties Up to AUD 20M

Previously, the Australian Therapeutic Goods Administration (TGA) conducted an investigation into the Chinese freight forwarding company Huawell Trade Export Shipping. The company was accused of promoting and transporting e-cigarettes to Australia on social media, potentially violating local regulations (Chinese freight forwarding company suspected of illegally transporting e-cigarettes, Australian drug administration agency intervenes in investigation).

In response, 2Firsts immediately contacted the TGA to obtain more information.

In response to questions about 2Firsts, the TGA did not disclose details of the follow-up investigation into Huawell Trade Export Shipping, but emphasized that they are strengthening monitoring of e-cigarette advertising and have established clear penalty standards.

The following is the translated response from the TGA: Thank you for your inquiry. We appreciate your interest in our services. Our team is currently reviewing your request and will get back to you as soon as possible with further information. Thank you for your patience.

Advertising of e-cigarette products is prohibited unless expressly permitted by the authorization of therapeutic products (2024 e-cigarette product advertising).

Advertising of e-cigarette products to the public is prohibited. Only in very limited circumstances are advertisements allowed for notified therapeutic e-cigarette products.

The Therapeutic Goods Administration (TGA) is monitoring advertisements for e-cigarettes and will take action against any illegal promotion of e-cigarette products.

The Therapeutic Goods Administration's enforcement actions against illegal advertising may result in significant fines or the initiation of criminal prosecution or civil penalty proceedings, with the amount of penalties depending on the misconduct.

The maximum civil penalties for each violation are proposed as follows: Individuals face a maximum fine of 7,000 penalty units (approximately 2.19 million Australian dollars), while companies face a maximum fine of 70,000 penalty units (approximately 21.91 million Australian dollars).

The following is the original email:

The TGA does not comment on individual matters including whether they may be subject to investigation or compliance and enforcement activities.

·       The advertising of vaping goods is banned, unless expressly permitted by the Therapeutic Goods (Vaping Goods – Advertising) Authorisation 2024.

o  The are no permissions to advertise vaping goods to the public.

o  An authorisation to advertise notified therapeutic vaping goods is only permitted in very limited circumstances.

·       Advertising of vapes is being monitored by the TGA and action will be taken against the unlawful promotion of vaping goods.

·       TGA enforcement action against unlawful advertising may result in the issue of significant fines or the commencement of criminal prosecution or civil penalty proceedings. The amount of the penalties depends on the conduct.

o  The maximum civil penalty per contravention is proposed to be 7,000 penalty units ($2.191 million) for an individual and 70,000 penalty units ($21.91 million) for a corporation.

 

Previously, in response to the investigation, 2Firsts communicated with Tang Shunliang, a partner at Tianyuan Law Firm who has many years of experience in the tobacco industry, regarding industry compliance and legal risk issues (Lawyer's interpretation | Chinese freight forwarder under investigation by Australia TGA, exporters may face dual domestic and foreign risks). As the investigation progresses, 2Firsts continues to monitor the developments of the event and provide the latest information in a timely manner.

Further reading: Compilation of 2Firsts connecting with global regulatory agencies

United States Food and Drug Administration (FDA)

FDA Interview: Over 50,000 Compliance Inspections of Tobacco Product Retailers in Past 8 Months, Over Half Reported Using ELFBAR

British Medicines and Healthcare products Regulatory Agency (MHRA)

Philip Morris International's e-cigarette has not been registered with the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The MHRA has responded that they will be conducting an investigation.

Australia's Therapeutic Goods Administration (TGA)

The Australian Therapeutic Goods Administration (TGA) has responded to two items listed as containing illegal ingredients on the HQD, IGET, and Gunnpod. Distributors may face lawsuits.

Spanish Ministry of Health

The Spanish Ministry of Health granted a exclusive interview to 2FIRSTS: The Comprehensive Anti-Tobacco Plan will be implemented in the first half of 2024, but there are no plans to restrict e-cigarette flavors in the near future.