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Prohibition on importing e-cigarettes containing vaporiser nicotine
26 June 2020
The implementation timeframe for the proposed prohibition on the importation of e-cigarettes containing vaporiser nicotine has been extended by six months to 1 January 2021.
The Australian Government has announced that they intend to ask the Governor-General in Council to amend the Customs (Prohibited Import) Regulations from 1 January 2021 prohibiting the importation of e-cigarettes containing vaporiser nicotine (nicotine in solution or in salt or base form) and nicotine-containing refills unless on prescription from a doctor.
If the Governor-General agrees to make the regulations, the following questions and answers provide further information for individuals, health professionals and importers who may be affected by the prohibition.
Questions and answers
Purpose of the regulation
The sale of e-cigarettes containing vaporiser nicotine (nicotine in a solution or in salt or base form) is already prohibited by law by each state and territory, because of public health concerns. This measure further strengthens Australia's precautionary approach to e-cigarettes, by prohibiting the importation of nicotine for use in e-cigarettes unless exempt under specific circumstances.
Evidence suggests that the use of e-cigarettes by non-smoking youths predicts future take up of smoking. In the USA, there was a 78% increase in the number of high school children who are vaping over the most recent 12-month period surveyed. Without action, Australian youth will also be at risk.
The Victorian Poisons Information Centre reported 41 cases of liquid nicotine poisonings in 2019, up from 21 in 2018. In July 2018, a Victorian toddler died from e-cigarette liquid nicotine consumption.
Information for individuals
If both you and your doctor believe that the use of nicotine e-cigarettes can help you to stop smoking then you can still access the products with appropriate medical supervision.
You will need a prescription from your doctor for an e-cigarette containing vaporiser nicotine, and it will need to be obtained on your behalf by a medical supplier or from a pharmacist who dispenses it for your use as the named patient. The company or the pharmacist will need to be given a copy of your prescription.
You are no longer permitted to import nicotine for use in e-cigarettes directly from an overseas supplier without a valid import permit.
If you have been using non-nicotine containing e-cigarettes, you can locally purchase (where legal in your state or territory); or alternatively you can import e-cigarettes which do not contain vaporiser nicotine.
Other nicotine replacement therapies including sprays, patches, lozenges and chews will remain available.
An Australian pharmacist may dispense or compound vaporiser nicotine for use in an e-cigarette by a named patient holding a valid Australian prescription.
The Australian Border Force (ABF) is obliged by law to seize e-cigarettes containing vaporiser nicotine which arrive in Australia on or after 1 January 2021.
The ABF is also obliged to send you a seizure letter giving you an opportunity to object to the seizure of the e-cigarettes. For example, a valid objection may be because they do not contain vaporiser nicotine. The government, through the TGA laboratories, may also test products that are suspected of containing nicotine.
No. If your product is prohibited under the new regulations, then you will not be entitled to a refund if it's seized by the ABF from 1 January 2021 onwards.
You may not bring e-cigarettes containing vaporiser nicotine into Australia by international surface or airmail services. A doctor may apply for permission to import and, if successful, may use courier services (e.g. Federal Express or UPS), or a commercial organisation that handles prescription e-cigarettes may apply for a permit and import the products through these routes. Supply to you would be in accordance with the doctor's prescription.
If you travel to Australia by aircraft or ship you may bring in e-cigarettes containing vaporiser nicotine if it is for your medical treatment and its use and supply is under doctor's prescription. You will need to have a copy of the prescription with you.
There are harsh penalties for importing, attempting to import and possessing a prohibited import under the Customs Act 1901. These offences are punishable by penalty of up to 1,000 penalty units (from 1 January 2021, $222,000).
To comply with the law, if you believe e-cigarettes may assist you with smoking cessation please discuss with your doctor and follow the correct procedure.
Information for health professionals
The published evidence on whether nicotine-containing e-cigarettes are effective in assisting smoking cessation is mixed and public health experts hold a wide range of views on the subject.
The RACGP's Supporting smoking cessation - A guide for health professionals stipulates that nicotine-containing e-cigarettes are not first-line treatments for smoking cessation and the strongest evidence base for efficacy and safety is for currently approved pharmacological therapies combined with behavioural support.
The guidelines also state nicotine containing e-cigarettes may be a reasonable intervention for individuals who have failed to achieve smoking cessation with approved pharmacotherapies, but remain motivated to quit smoking and have raised e-cigarette usage with their healthcare practitioner.
However, practitioners should exercise caution in deciding whether it is in the patient's best interest to prescribe nicotine for inhalation as a smoking cessation aide.
If, in consultation with your patient, you believe that e-cigarettes may assist your patient to stop smoking the steps to follow are:
- apply online to the Therapeutic Goods Administration (TGA) for an approval to supply the goods under Special Access Scheme B or authorisation as an authorised prescriber. The TGA has a dedicated web page including step-by-step instructions to making an application;
- prescribe e-cigarettes containing vaporiser nicotine;
- You can either:
- apply online to the Office of Drug Control (ODC) for an import permit; the ODC will have a dedicated webpage including step-by-step instructions on making an application for a permit including the application form and instructions to attach a copy of the TGA SAS B approval or authorised prescriber authority; OR
- arrange their importation through a pharmacy or one of a number of companies which import products for this purpose - in this case the pharmacy or the medical supply business would apply for an import permit; OR
- an Australian pharmacist may dispense or extemporaneously compound vaporiser nicotine for use in an e-cigarette by a named patient on submission of a prescription.
The Government has foreshadowed establishing a streamlined process for patients obtaining prescriptions through their GP.
Information for import businesses
You can apply online to the Office of Drug Control (ODC) for an import permit; the ODC will have a dedicated webpage including step-by-step instructions on making an application for a permit including attesting that your business complies with the conditions specified in the Therapeutic Goods Regulations for lawful importation of an unregistered medicine.
You can then sell to doctors (or pharmacists on their behalf) the e-cigarettes containing vaporiser nicotine on evidence of a TGA Special Access Scheme B approval or Authorised Prescriber Authority for supply to a named patient (along with the supporting prescription).
TGA rescheduling proposal
The TGA is currently undertaking a consultation and decision-making process for a proposed clarification to the treatment of nicotine in the Poisons Standard.
The rescheduling process, if agreed to, would clarify that nicotine products for human use require a valid prescription (except for tobacco cigarettes or registered smoking cessation products such as gums, sprays and patches).
Nicotine replacement therapies like sprays, patches, lozenges and chews will still be available without a prescription.
The inclusion of nicotine as a prohibited import is in place for 12 months to allow the rescheduling process to run its course.