From 1 October 2021, the Poisons Standard clarified the regulation of nicotine as a Schedule 4 medicine. This includes nicotine for use in e-cigarettes, e-juice, heat-not-burn tobacco products and other novel nicotine products, even if no therapeutic claim is made. This scheduling change aligns with state and territory laws, which prohibit the sale or possession (other than in South Australia) of nicotine vaping products.

Consumers will require a prescription from an Australian-registered medical practitioner to access nicotine vaping products for e-cigarettes including access from overseas. This has implications for practice, and represents an opportunity for GPs to discuss smoking cessation strategies with current smokers and nicotine vape users.

Considerations for your clinical practice

As there are currently no TGA-approved nicotine vaping products, regulatory changes may create the perception of an uncertain clinical practice environment. However, this change provides an opportunity for GPs to have new conversations with patients about potential risks and benefits of nicotine vaping products, and how to reduce the risks associated with nicotine use. GPs can fully assess a patient’s need for nicotine vaping products and determine their willingness to try alternative approaches to smoking cessation.

The scheduling decision is in keeping with the RACGP’s current guidelines on smoking cessation.  The guidelines state that nicotine vaping products are not recommended as first-line treatments for smoking cessation but are a reasonable intervention for those who have unsuccessfully attempted to stop smoking with approved pharmacotherapies and are still motivated to quit. The guidelines note the potential benefits of nicotine vaping products to assist in smoking cessation, which is consistent with recent evidence. 

Medical Indemnity

Before prescribing nicotine vaping products, prescribers should ensure the patient is aware that:

  • there are no approved vaping products available;
  • the long-term health effects of vaping are unknown;
  • access to nicotine vaping products without a prescription is illegal;
  • in order to maximise possible benefit and minimise risk of harms, only short-term use to support smoking cessation is recommended; and
  • dual (concurrent) use with tobacco smoking must be avoided.

We are Australian medical indemnity insurance providers and cover your practice with medical indemnity insurance, medical malpractice insurance, doctors indemnity insurance, gp medical indemnity insurance,, medical practice insurance, and more. If you are a health practitioner with Tego, we offer 24/7 medico-legal advice and support in regards to what you need to know about nicotine vaping products and the practice implications of the scheduling changes.

This publication is general in nature and is not comprehensive or constitutes legal or medical advice. You should seek legal, medical or other professional advice before relying on any content, and practice proper clinical decision making with regard to individual circumstances. Persons implementing any recommendations contained in this publication must exercise their own independent skill or judgment or seek appropriate professional advice relevant to their own particular practice. Compliance with any recommendations will not in any way guarantee discharge of the duty of care owed to patients and others coming into contact with the health professional or practice. Tego Insurance Pty Ltd is not responsible to you or anyone else for any loss suffered in connection with the use of this information. All content on this page has been written in a generic way, and has not been presented with any knowledge of your personal objectives or financial needs.