The purpose of this guidance is to help health practitioners, consumers, importers and other sponsors, wholesalers and manufacturers to understand the minimum safety and quality requirements that apply to unregistered products under the Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021. It also explains our role in regulating vaping devices.
Contents
- About this guidance
- What this guidance does not cover
- Advertising nicotine vaping products
- The TGO 110 product standard
- Commencement
- Objectives of TGO 110
- Nicotine vaping products captured by TGO 110
- Overview of TGO 110 requirements
- Application of TGO 110 requirements
- Personal Importation Scheme
- Record-keeping obligations for Australian sponsors
- Who is an Australian sponsor
- Types of records that must be kept
- Updates and record retention
- 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
- Child-resistant packaging (CRP)
- Ingredients in nicotine vaping products
- Active ingredients
- Nicotine is the only permitted active ingredient
- Actual vs labelled nicotine concentration/content
- Limits on nicotine concentration
- Excipient ingredients and flavours
- Prohibited ingredients
- Flavoured nicotine vaping products
- Active ingredients
- Contaminants and product quality
- Default standards
- Microbiological standards
- Contaminants
- Report side effects and problems
- Vaping devices
- Devices not regulated by the TGA
- Devices regulated by the TGA
- Appendix A: References
Supporting documents
Topics