Australia's 2024 vaping reforms: prescription model, pharmacy supply, import ban

What changed

The Therapeutic Goods Amendment (Vaping Reforms) Act 2024 fundamentally altered the regulatory framework for therapeutic vapes in Australia, encompassing both nicotine and non-nicotine products. Prior to these changes, therapeutic vapes were more widely available. The new legislation establishes a phased approach to restrict access and control supply.

The primary shift occurred from 1 July 2024, when the supply of all therapeutic vapes transitioned to a prescription-only model. This means that therapeutic vapes are now administered through pharmacies, requiring a prescription from a healthcare professional.

A further change took effect from 1 October 2024. Adults aged 18 and over can now access low-nicotine therapeutic vapes from a pharmacist without a prescription. This access is conditional upon safeguards being in place, including age verification, identity checks, and the provision of smoking-cessation guidance.

The personal-importation ban

The Personal Importation Scheme, previously allowing individuals to import limited quantities of medicines for personal use, has been removed for therapeutic vapes. This means individuals can no longer legally import vapes for personal use under this scheme.

The Australian Border Force has the authority to intercept and destroy any therapeutic vape products that do not comply with regulations at the border. This measure is designed to prevent non-compliant products from entering the country.

Businesses seeking to import therapeutic vapes must now obtain appropriate sponsorship, registration, and Therapeutic Goods Administration (TGA) approval. This ensures that only approved products are available within the Australian market.

Product standards

Therapeutic vapes must adhere to specific quality standards outlined in the Therapeutic Goods (Standard for Nicotine Vape Products) (TGO 110). This standard details requirements relating to ingredients, packaging, and labelling.

The TGO 110 also restricts certain product characteristics. This includes limitations on flavours and packaging designs. Examples of restricted elements include the use of cartoon characters and packaging that mimics confectionery-style names.

Products failing to meet the requirements of TGO 110 cannot be legally supplied as therapeutic vapes.

Penalties + enforcement

Criminal and civil penalties, as outlined in the Therapeutic Goods Act 1989, will be applied to those who engage in unlawful activities related to vapes. These activities include, but are not limited to, the supply, importation, advertising, and manufacture of vapes.

The most serious offences carry significant consequences, with maximum penalties including the possibility of imprisonment alongside substantial fines. The specific penalties will depend on the nature and severity of the offence.

Enforcement of the new regulations will be a joint effort. The Therapeutic Goods Administration, Australian Border Force, and state and territory police and health departments will work together to ensure compliance.