尼古丁袋（Nicotine Pouches）
我们注意到尼古丁袋在澳大利亚的知名度不断提高，尤其是将尼古丁袋作为戒烟或戒烟辅助工具进行宣传。
尼古丁袋受到严格监管，只能根据1989年《治疗商品法》以及各州和地区的药品和毒药法进口、供应和宣传。
在澳大利亚，我们尚未对任何尼古丁袋的质量、安全性或有效性进行评估。任何尼古丁袋均未列入《澳大利亚治疗用品登记册》（ARTG）。
尼古丁袋是一种小袋（或袋子），内含尼古丁，有时还含有甜味剂和香精等其他成分。尼古丁袋设计用于放置在嘴唇和牙龈之间，不含烟叶、烟尘或烟梗，通常被描述为含有 "合成尼古丁"。
目前还没有强有力的证据支持使用尼古丁袋戒烟或吸食电子烟。证据显示尼古丁可能有害，并可能对青少年的大脑发育产生不利影响。
我们鼓励包括青少年在内的任何需要戒烟或戒烟支持的人联系健康专业人士或拨打戒烟热线137848 (13QUIT)。
广告
由于ARTG上没有尼古丁烟嘴，因此为尼古丁烟嘴做广告是非法的，包括为戒烟或戒烟烟雾宣传这些产品。这包括在线广告。
此外，尼古丁袋不能公开宣传，因为为戒烟以外的目的供应尼古丁袋需要处方。处方药的广告是被禁止的。
我们正在对违反 1989 年《治疗用品法》的广告进行监督，并采取合规和执法行动。被指控在澳大利亚为尼古丁袋做广告的人可能会受到处罚。
供应
根据澳大利亚法律，尼古丁袋属于治疗商品。要在澳大利亚合法供应，尼古丁袋必须列入ARTG或获得1989年《治疗商品法》的授权或批准。
截至发稿时，尚无尼古丁袋被列入 ARTG 或获得授权或批准。这意味着尼古丁袋不能由澳大利亚零售商合法出售给消费者。
澳大利亚药品管理局批准或授权供应此类商品的条件是该产品在药店销售。
烟草商、便利店和其他零售商不能向消费者出售此类商品。
根据澳大利亚法律，任何未明确用于戒烟的尼古丁袋--包括声称用于娱乐的尼古丁袋--都属于处方药。这意味着，如果没有澳大利亚医生开具的有效处方，消费者在网上或零售店购买尼古丁袋均属违法行为。
烟草商和便利店等零售商出售处方药，甚至向持有处方的顾客出售处方药，均属违法行为。
根据 1989 年《治疗用品法》，对广告和供应违法行为的适用处罚包括最高 5 年监禁或最高 4,000 个处罚单位，或两者并罚（视情况而定），以及相应的民事处罚，个人最高 5,000 个处罚单位，公司最高 50,000 个处罚单位。根据各州和地区的药品和毒药法，还可能适用进一步的制裁措施。
进口
由于ARTG中不包括尼古丁袋，根据1989年《治疗商品法》，合法进口尼古丁袋必须获得我们的豁免、批准或授权。
消费者可根据个人进口计划，凭澳大利亚注册医生的有效处方进口尼古丁袋。任何使用个人进口计划的行为均须遵守该计划的其他条件。
如果进口不符合这些条件，且没有其他例外情况，产品可能会被扣押和销毁。
在所有情况下，尼古丁袋也需要符合州或地区的进口要求。
我们正与澳大利亚边境部队合作，继续监测尼古丁袋的非法进口和供应情况，并根据情况采取适当和必要的行动。
口嚼烟草
澳大利亚禁止用于口腔的咀嚼烟草和鼻烟。澳大利亚自 1991 年 6 月起禁止口服烟草产品。
报告违规行为
如果您怀疑治疗用品或其广告存在违规行为，可随时向我们举报。
原文如下：（https://www.tga.gov.au/products/unapproved-therapeutic-goods/vaping-hub/nicotine-pouches）
We are aware of the rising profile of nicotine pouches in Australia, particularly the promotion of nicotine pouches as an aid to support smoking or vaping cessation.
Nicotine pouches are subject to strict regulation and can only be imported, supplied and advertised in accordance with the Therapeutic Goods Act 1989 and state and territory medicines and poisons law.
No nicotine pouches have been evaluated by us for quality, safety or efficacy in Australia. No nicotine pouch is included in the Australian Register of Therapeutic Goods (ARTG).
Nicotine pouches are small pouches (or bags) containing nicotine and sometimes other ingredients such as sweeteners and flavours. Designed to be placed between the lip and gum, nicotine pouches do not contain tobacco leaf, dust, or stem, and are usually described as containing ‘synthetic nicotine’.
There is no strong evidence to support the use of nicotine pouches for smoking or vaping cessation. Evidence shows nicotine can be harmful and may have adverse impacts on adolescent brain development.
Anyone, including young people, requiring support to quit smoking or vaping are encouraged to reach out to a health professional or call the Quitline on 137848 (13QUIT).
Advertising
As there are no nicotine pouches on the ARTG, it is unlawful to advertise nicotine pouches, including when advertising these products for the purposes of smoking or vaping cessation. This includes online advertising.In addition, a nicotine pouch cannot be publicly advertised because the supply of a nicotine pouch for a purpose other than smoking cessation requires a prescription. The advertisement of prescription medicines is prohibited.
We are monitoring and taking compliance and enforcement action where advertisements breach the Therapeutic Goods Act 1989. Penalties may apply to those who are alleged to have advertised nicotine pouches in Australia.
Supply
Under Australian law, nicotine pouches are therapeutic goods. To be lawfully supplied in Australia, nicotine pouches must be included in the ARTG or have an authority or approval under the Therapeutic Goods Act 1989.At the time of publication, no nicotine pouch has been included in the ARTG or received an authority or approval. This means nicotine pouches cannot be lawfully sold to consumers by Australian retailers.
A TGA approval or authority to supply goods of this nature would be conditional on the product being sold in pharmacy settings.
Tobacconists, convenience stores and other retailers cannot sell these goods to consumers.
Any nicotine pouch that is not expressly intended for smoking cessation - including when represented to be for recreational use - is a prescription medicine under Australian law. This means that it is illegal for consumers to buy nicotine pouches online or from retail outlets without a valid prescription from an Australian doctor.
It is unlawful for retailers such as tobacconists and convenience stores, to sell prescription medicines, even to customers with a prescription.
Applicable penalties under the Therapeutic Goods Act 1989 for advertising and supply offences include imprisonment for up to 5 years or up to 4,000 penalty units or both, depending on the circumstances, and for corresponding civil penalties, up to 5,000 penalty units for an individual or 50,000 penalty units for a company. Further sanctions under state and territory medicines and poisons laws may also apply.
Importation
As no nicotine pouch is included in the ARTG, an exemption, approval or authority from us under the Therapeutic Goods Act 1989 is required for lawful importation.Consumers can import nicotine pouches under the Personal Importation Scheme with a valid prescription from an Australian-registered medical practitioner. Any use of the personal importation scheme is subject to the other conditions of scheme.
If an import does not meet these conditions, and no other exception applies, the products may be seized and destroyed.
In all instances, a nicotine pouch would also need to meet state or territory requirements to be imported.
We are working with the Australian Border Force and continuing to monitor and take action against unlawful importation and supply of nicotine pouches as appropriate and necessary in the circumstances.
Oral tobacco
There is a ban on chewing tobacco and snuffs intended for oral use. Oral tobacco products have been prohibited in Australia since June 1991.Reporting non-compliance
If you suspect non-compliance in relation to therapeutic goods or their advertising, you can report it to us at any time.Further information
More information on the rollout of reforms to vape regulation in Australia is available on the Vaping hub.
Contact for members of the media:
- Email: news@health.gov.au
- Phone: 02 6289 7400
