Potential reforms to the regulation of nicotine vaping products - consultation paper

Consumer information, labelling (TBT); Prevention of deceptive practices and consumer protection (TBT); Protection of human health or safety (TBT); Quality requirements (TBT)

Nicotine-containing products intended to be used in vaping devices such as e-cigarettes, e-cigars and other electronic nicotine delivery systems (ENDs).One of the possible reform options would also affect the importation of vaping devices that do not contain nicotine (ENNDs). TOBACCO AND MANUFACTURED TOBACCO SUBSTITUTES (HS 24); PHARMACEUTICAL PRODUCTS (HS 30)

Link to ePing

24 - TOBACCO AND MANUFACTURED TOBACCO SUBSTITUTES; 30 - PHARMACEUTICAL PRODUCTS; 24 - TOBACCO AND MANUFACTURED TOBACCO SUBSTITUTES; 30 - PHARMACEUTICAL PRODUCTS

65.160 - Tobacco, tobacco products and related equipment; 65.160 - Tobacco, tobacco products and related equipment

Human health; Human health

Proposed reforms to the regulation of Electronic Nicotine Delivery systems (ENDs) and Electronic Non-Nicotine Delivery systems (ENNDs) notified in G/TBT/N/AUS/151 and G/TBT/N/AUS/151.add1 are being implemented in 2024. Adopted reforms include implementing changes to Australia’s borders to restrict the importation of vapes. From 1 January 2024, the importation of all single use disposable vapes is prohibited, subject to very limited exceptions.Additionally, from 1 March 2024: importation of all vapes without an import licence and permit from the Office of Drug Control is prohibited, subject to limited exceptions. to obtain an import permit, importers are required to notify the Therapeutic Goods Administration (TGA) that a vape is:only for smoking cessation or the management of nicotine dependence, and that the vape complies with relevant product standards (Australian manufacturers must also make a notification to that effect before first releasing vapes for supply); ora vaping device that is only for use with medicinal cannabis, and the device complies with the essential principles in the Therapeutic Goods (Medical Devices) Regulations 2002 (the pre-existing requirement to obtain an import permit for vaping substances containing cannabis has not changed).the standard that previously only applied to nicotine vapes applies to all therapeutic vapes for smoking cessation and the management of nicotine dependence, irrespective of nicotine content. New flavour restrictions have also been added to this standard.vaping devices that are not exclusively for the administration of a medicine are no longer excluded from the therapeutic goods regulatory framework. A new medical device standard applies to these devices as an alternative to essential principles that ordinarily apply to medical devices. individuals are no longer able to access the personal importation scheme to import therapeutic vapes for personal use, apart from a limited exemption for travellers to Australia under which modest quantities are permitted. The updated minimum quality and safety standard, which applies to both ENDS and ENNDS for smoking cessation or the management of nicotine dependence, includes requirements for: product labelling (including an over sticker or in an information sheet provided with the product)child resistant packagingrequirement for the product label to list all active ingredients and state the nicotine concentration of the vapeprohibited ingredientslimited flavours permitted (mint, menthol and tobacco only)quality management system requirements for vaping devices and vaping device accessories that do not comply with the essential principles that ordinarily apply to medical devicesdocumentation that needs to be kept by the Australian sponsor of the product demonstrating compliance with the requirements of the minimum quality and safety standards. The new medical device standard provides minimum certification requirements for therapeutic vaping devices and therapeutic vaping device accessories that were excluded goods as 1 January 2024. Other proposed measures that have been previously notified in G/TBT/N/AUS/151 and G/TBT/N/AUS/151.add1 are also being pursued. On 21 March 2024, the Australian Government introduced the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 into the Parliament of Australia. The Bill proposes strict domestic controls on all vaping goods. It proposes prohibiting the importation, domestic manufacture, supply, commercial possession, and advertisement of single use disposable vapes and non-therapeutic vaping goods. Therapeutic vaping goods will continue to be available and subject to regulation under the Therapeutic Goods Act 1989, in line with other medicines and therapeutic goods.Further details about the reforms is available at: Vaping hub | Therapeutic Goods Administration (TGA)

1:File here 2:File here 3:File here 4:File here 5:File here 6:File here 7:File here 8:File here 9:File here 10:File here 11:File here 12:File here 13:File here 14:File here 15:File here 16:File here 17:File here 18:File here 19:File here 20:File here

EN:File here

FR:File here

ES:File here

Active Inactive