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Nicotine vaping products and vaping devices

Draft guidance for Therapeutic Goods Order 110 (TGO 110) and related matters
19 May 2021
Download Nicotine vaping products and vaping devices

Description

The purpose of this draft guidance is to help health practitioners, consumers, importers and other sponsors and manufacturers to understand the TGA's requirements for nicotine vaping products. In particular, the minimum Australian safety and quality requirements for unregistered products described in Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order. It also explains our role in regulating vaping devices.

This guidance is expected to be finalised in mid 2021.

  • About this guidance
    • Advertising nicotine vaping products
  • The TGO 110 product standard
    • Commencement
    • Objectives of TGO 110
    • Nicotine vaping products captured by TGO 110
      • Personal Importation Scheme
  • Record-keeping obligations for Australian sponsors
    • Who is affected
    • Types of records that must be kept
  • Labelling of nicotine vaping products
    • Ingredient list
    • Nicotine concentration
    • Warnings statements
  • Product packaging and closures
    • Child-resistant packaging (CRP)
      • Child-resistant packaging requirements in TGO 95
    • No other mandatory container requirements
      • Tamper-evident packaging
    • Container volumes
  • Ingredients in nicotine vaping products
    • Active ingredients
      • Actual vs labelled nicotine concentration/content
      • Limits on nicotine concentration
    • Excipient ingredients and flavours
      • Prohibited ingredients
      • Flavoured nicotine vaping products
  • Contaminants and product quality
    • Default standards
    • Microbiological standards
    • Contaminants
  • Vaping devices
    • Devices not regulated by the TGA
    • Devices regulated by the TGA
  • Appendix A: References

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