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Purpose
Tampons are therapeutic goods that are exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG).However, they must comply with the Therapeutic Goods (Standards for Tampons) (TGO 103) Order 2019 before they can be legally supplied in Australia.
Under TGO 103, the applicable standard is “AS 2869:2022 Tampons – Menstrual” which sets out requirements for the manufacture and labelling of tampons to help minimise health risks. The standard addresses several aspects including:
- Packaging and labelling
- performance requirements
- absorptive capacity
- microbial content
- withdrawal cord strength
- water repellence.
A copy of the standard can be obtained from SAI Global.
If you experience a problem with a tampon, please report it using the Report a medical device adverse event (medical device user) form.
Tampons must meet AS 2869:2022 Tampons – Menstrual.
It is an offence under the Therapeutic Goods Act 1989 to import or supply tampons that do not comply with an applicable standard (see sections 14 and 14A of the Act).
Legislation and regulatory requirements
In addition to complying with AS 2869:2022 and TGO 103, tampons must also meet the requirements of the:
• Therapeutic Goods Act 1989
• Therapeutic Goods Regulations 1990
• Therapeutic Goods Advertising Code 2015
• Therapeutic Goods (Single Therapeutic Goods) Order No.1 of 1991
Regulatory requirements
Tampons must meet the manufacturing, design, labelling and testing requirements specified in AS 2869:2022. Key regulatory requirements are summarised below:
Materials
Tampons must be made from materials that do not pose a hazard. Certain materials are prohibited, such as polyester foam and carboxymethylcellulose (CMC). The standard also includes requirements for freedom from toxic or irritant effects and freedom from impurities.
Design requirements
Withdrawal cord
Tampons must include a withdrawal cord at least 80mm in length and meeting minimum water repellence and strength requirements.
Applicators
Applicators (if included) must be smooth and designed to minimise trauma.
Packaging
Each tampon (and applicator, where provided) must be individually wrapped in a sealed unit pack. The unit packs must be supplied in a protective tamper-evident primary pack.
The packaging must be marked with the following information:
- Batch or lot number
- Description of the contents
- Absorbency range
- List of tampon components
- The following warning in words with a height not less than one millimetre:
| IMPORTANT: Tampon use has been associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and keep the enclosed information. |
Information leaflet
An information leaflet must contain the following information:
- Instructions for use including hygiene warnings.
- Information on Toxic Shock Syndrome.
- A note that tampons are not supplied sterile and may contain small amounts of airborne bacteria, but not the bacteria that causes TSS.
Manufacturer's details
The name or trademark of the manufacturer or supplier must be included on the packaging or on the information leaflet.
Testing
Testing must confirm compliance with:
- Absorptive capacity: Number tested, high/low results, absorbency range
- Cord strength: Dry and wet
- Microbial load: Aerobic microbial count per gram of each tampon/applicator
Page history
Updated out of date content.
Title changed from 'Regulation of tampons in Australia' to 'Manufacturing or supplying tampons' as part of migration to new 'Guidance' content type:
- Consistent ‘Purpose’ heading.
- ‘Legislation’ section to clearly show which laws the Guidance relates to.
- ‘Page history’ section replaces document version history.
- New page navigation features.
- Updated page summaries.
- Complex images include long descriptions.
- New ‘Save as PDF’ feature.
New template.
Therapeutic Goods order for Tampons renewed.
Updated to reflect the exemption of tampons from the regulatory requirement to include them on the ARTG.
Original publication.
Updated out of date content.
Title changed from 'Regulation of tampons in Australia' to 'Manufacturing or supplying tampons' as part of migration to new 'Guidance' content type:
- Consistent ‘Purpose’ heading.
- ‘Legislation’ section to clearly show which laws the Guidance relates to.
- ‘Page history’ section replaces document version history.
- New page navigation features.
- Updated page summaries.
- Complex images include long descriptions.
- New ‘Save as PDF’ feature.
New template.
Therapeutic Goods order for Tampons renewed.
Updated to reflect the exemption of tampons from the regulatory requirement to include them on the ARTG.
Original publication.