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Smokefree Clinic

Prescribed Nicotine Vaping

The use of prescribed Nicotine Vaping Products (NVPs) or e-cigarettes that are medically prescribed to assist with smoking cessation is known as Inhaled Nicotine Replacement Therapy (INRT).NVPs offer a novel way of delivering nicotine that closely mimics the hand-to-mouth experience and sensory aspects of smoking which some patients find helpful, without the harmful chemicals found in tobacco combustion.This may help you if you have previously tried traditional quit-smoking methods but have not yet been successful.As a relatively new technology, no nicotine vaping product has been assessed by the TGA and there are currently no TGA approved nicotine e-cigarettes in the Australian Register of Therapeutic Goods (ARTG). Nicotine vaping products are considered unapproved therapeutic goods in Australia, as such, they are only legally available to patients with a prescription from a suitably qualified doctor to assist with smoking cessation.

What are prescribed nicotine vaping products?

Prescribed nicotine vaping products are small battery-operated devices that heat a liquid to produce an aerosol (commonly known as vapour), which is then inhaled – mimicking the act of smoking.They are very different to cigarettes in this manner, as they do not generate any “smoke” by burning organic materials, like tobacco and paper. E-cigarettes typically heat a liquid that contains nicotine and are used as a replacement for smoking.The act of using a prescribed nicotine vaping product is commonly known as ‘vaping’, and they are designed to be used in a very similar manner to traditional cigarettes, helping to support the social and habitual aspects many smokers are accustomed to.Prescribed nicotine vaping products come in many different shapes, formats and sizes.Some larger devices require you to customise a range of settings to your personal preferences and are manually filled/re-refilled by the user. These devices are typically for experienced vapers and at high power settings can produce very large clouds of vapour.Alternatively, some smaller devices are pre-filled with nicotine e-liquid, have fixed settings and are ready to use straight from the box. These are known as ‘closed system’ devices. Closed system devices operate at a low, pre-set power setting and typically use a nicotine salt which provides a more effective nicotine delivery while generally producing comparatively smaller amounts of vapour.

How do they work?

Prescribed nicotine vaping products use a battery to heat a coil element. Inside the coil is a cotton wick that is saturated with nicotine e-liquid. The coil heats the e-liquid to create an aerosol, more commonly known as vapour. This can then be inhaled, in most cases, to deliver nicotine to the body.Unlike cigarettes, there is no burning (combustion) involved, and therefore no smoke is created. Combustion is the process that creates many of the toxins found in burning tobacco. Inhaling the smoke created by the combustion of tobacco is considered to be the primary cause of smoking-related disease.When using a prescribed nicotine vaping product, caution must always be taken to ensure that the reservoir containing the e-liquid does not run out. If the wick is heated when dry it may burn, creating by-products that are potentially harmful, as well as providing a very unpleasant vaping experience.There are many different types of prescribed nicotine vaping products with many different features and manufacturing qualities. High-quality products use microelectronics to control the temperature of the coil and prevent overheating or heating when there is no e-liquid present.Always check to ensure the product you’re using includes these safeguards.

What is e-liquid?

The liquid in a prescribed nicotine vaping product (the e-liquid) contains:
  • Nicotine (as freebase nicotine or as a nicotine salt);
  • propylene glycol;
  • vegetable glycerin; and
  • flavourings.
Nicotine is the addictive compound most commonly found in tobacco products and has been used safely for many decades in nicotine replacement therapies (NRTs) such as patches, gums and lozenges. Nicotine is not the primary cause of smoking-related disease. 1Propylene glycol is a common ingredient in many packaged food items, in a variety of medications and in many of the over-the-counter NRT products found in your local pharmacy.Vegetable glycerin is widely used in the food, cosmetics and pharmaceutical industries and is a common ingredient in pharmaceutical drugs, including heart medication, cough remedies and anaesthetics.Flavourings are present in most e-liquids, with only a few exceptions. Most flavourings for e-liquids are approved food additives, certain of which are labelled ‘generally recognised as safe’ (GRAS) by regulatory authorities. Products labelled as GRAS have been designated as safe for ingestion (eating), however, many GRAS flavours have never been toxicologically assessed at all, having been grandfathered into food safety regulations in the 1950s. 2Even more importantly, the GRAS designation does not involve testing for safety by inhalation. The inhalation route of exposure is completely different from ingestion to the extent that it directly exposes the lungs to compounds that could be hazardous to lung tissue specifically.High-quality e-liquids are typically made using pharmaceutical grade ingredients and have undergone an independent inhalation toxicological risk assessment (TRA), which looks at the impact of inhaling the flavourings as opposed to ingesting them like food flavourings.The TRA process provides doctors with the relevant information to assess the safety of the e-liquid when vapourised and inhaled.Always check to ensure that the e-liquid you’re using is made to acceptable standards and has undertaken adequate testing for your health and safety.

Why do I need a prescription?

On 1 October 2021, the Australian Government will implement new laws for nicotine vaping products. These laws will deem the importation, sale and possession of nicotine-containing products unlawful, except in accordance with a doctor’s prescription for the purposes of smoking cessation.The Government’s decision to regulate these resulted from extensive consultation with key medical and public health bodies. While these bodies agreed that adult smokers could benefit from access to prescribed nicotine vaping products to support smoking cessation, there was concern about the uptake of vaping by youth if there was easy access to these products via general retail.The new regulations do not mean that existing vapers and smokers seeking to quit are not allowed access to nicotine vaping products. When prescribed by a medical professional as a smoking cessation therapy, Australian residents are allowed to purchase and use nicotine vaping products for smoking cessation purposes.
1National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General. Atlanta (GA): Centers for Disease Control and Prevention (US); 2014.
2FDA’s Approach to the GRAS Provision: A History of Processes. US Food and Drug Administration. 4 January 2018.