Exemptions for the sale or supply of lawfully prescribed nicotine
Exemptions for the sale or supply of nicotine-containing e-cigarettes
On 1 October 2021, the Tobacco and E-Cigarette Products (E-Cigarette Liquid) Variation Regulations 2021 were made. The new Regulations clarify that an e-cigarette liquid is an e-cigarette product.
According to the new Regulations, the following products are included as a prescribed ‘e-cigarette product’ under section 4(1) of the Act:
The effects of this clarification are that:
The Regulations also include the definition of an ‘e-cigarette liquid’, which is ‘a liquid of a kind designed or intended for use in an e-cigarette’.
No, this is a clarification to the definition of ‘e-cigarette product’ to make it clearer that e-cigarette liquids are regulated by the e-cigarette laws too.
The definition of
‘e-cigarette product’ in the Act already included ‘a cartridge, capsule or
other container designed to contain a liquid, aerosol, gas, vapour or other
substance for use in an e-cigarette’. The
Tobacco and E-Cigarette Products (E-Cigarette Liquid) Variation Regulations
2021 clarify the inclusion of liquids, and liquid constituents, in the definition.
These changes do not affect the current regulation of liquid nicotine, which is regulated under the South Australian Controlled Substances Act 1984. Nicotine for use in e-cigarette products cannot be lawfully sold by tobacco or e-cigarette
retailers in South Australia. It is also an offence to be in possession of a
Schedule 4 Prescription Only Medicine, including nicotine, unless it has been
lawfully prescribed and supplied to that person.
From 1 October 2021, changes by the Therapeutic Goods Administration (TGA) to the national classification of nicotine in the Poisons Standard clarify the regulation of nicotine as a Schedule 4 Prescription Only Medicine.
The effect of the national changes will be that consumers who wish to legally access nicotine-containing e-cigarettes and nicotine vaping products in Australia will require a prescription from an Australian medical practitioner, including for accessing products that are imported into Australia. There are currently no nicotine vaping products approved by the TGA and registered in the Australian Register of Therapeutic Goods (ARTG). Medicines that are not in the ARTG are known as ‘unapproved’ medicines.
The TGA has information available for consumers, health professionals, sponsors, wholesalers and manufacturers, including links to resources and factsheets about access to nicotine vaping products at https://www.tga.gov.au/nicotine-vaping-products. For further information, you can contact the TGA on 1800 020 653.
The South Australian Government has also issued a Proclamation under the Tobacco and E-Cigarette Products Act 1997 so that pharmacists and medical practitioners, who may sell nicotine lawfully prescribed as a Schedule 4 Prescription Only Medicine, are exempt from certain offences in the Act to allow the lawful sale or supply of nicotine e-cigarettes in accordance with the TGA’s national scheme.
These exemptions apply from 1 October 2021 and support the lawful sale or supply of nicotine as Schedule 4 Prescription Only Medicine for smoking cessation.
For more information about the Proclamation.