Product Standards
Regulatory alignment
CHOSEN vapouriser liquids and LULA devices and pod systems align with the revised TGO 110 and MDSO requirements to support lawful supply.
These products are intended for smoking cessation and the management of nicotine dependence, in accordance with applicable regulatory frameworks.
Ensuring conformance
Applicable product standards, including the Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) and the Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order (MDSO), set requirements relating to:
- Device safety
- Materials and construction
- Battery function and performance
- Nicotine content and formulation
- Contaminant and ingredient limits
- Packaging, labelling and product information
Bay Pharma therapeutic nicotine vaping products are not included on the Australian Register of Therapeutic Goods (ARTG) and are not approved smoking cessation aids in Australia. As unapproved therapeutic goods, they may be considered for patients who are seeking to quit smoking and have discussed available options with a healthcare practitioner. Use should occur within an evidence-informed, shared decision-making process.