Therapeutic Goods Order No. 64A - Amendment to Therapeutic Goods Order No. 64 - Standard for Tampons - Menstrual (23/08/2001)

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, serves to regulate the provision of therapeutic goods to ensure their safety, efficacy, and quality. The Act establishes a comprehensive framework for the approval, manufacture, and distribution of therapeutic products, including medicines, medical devices, and other health-related items. One specific issue addressed by this legislation is the need for clear and accurate information regarding the safety and usage of menstrual products, particularly tampons, to prevent misinformation and protect public health. In response to this need, an amendment to the Therapeutic Goods Order No. 64, concerning the standard for tampons, was introduced to ensure consumers are provided with essential information about the sterility and safety of tampons, explicitly addressing concerns about the potential risk of Toxic Shock Syndrome. This legislative instrument was enacted to fill a gap in consumer education and to enhance public understanding of the safety profile of tampons.

Scope and Application

The Therapeutic Goods Order No. 64, "Standard for Tampons – Menstrual" applies to manufacturers, importers, and suppliers of tampons within the Australian jurisdiction. It pertains to the requirements for the safety, quality, and efficacy of tampons, ensuring that these products are safe for consumer use. The amendments to TGO 64, specifically concerning the information leaflet, apply to any entity involved in the production, distribution, or sale of tampons across Australia. This legislative instrument extends its jurisdictional reach throughout the Commonwealth, ensuring a uniform standard across all states and territories. The Order does not exclude any particular entities or types of tampons from its purview, but rather seeks to standardise the information provided to consumers to ensure they are adequately informed about the product's safety and characteristics. Any further specifications or detailed requirements may be outlined in subordinate instruments or additional guidelines issued under the authority of the Therapeutic Goods Act 1989.

Key Provisions

The key amendment to Therapeutic Goods Order No. 64 (TGO 64) under the Therapeutic Goods Act 1989 (section 10) is the addition of a new paragraph (11(c)) to Clause 11, which pertains to the Information Leaflet for tampons (paragraph 11). The new paragraph requires that an informational statement must be included, clarifying that tampons are not sterile and that their use does not inherently carry the bacteria responsible for Toxic Shock Syndrome (TSS) (section 11(c)). This amendment aims to ensure that consumers are properly informed about the nature of tampons and their microbial content. The obligation imposed by this amendment requires manufacturers, importers, and suppliers of tampons to include the specified statement on all informational leaflets accompanying the product. This statement must be prominently displayed and clearly written to inform consumers that tampons, although containing very small amounts of bacteria naturally present in the environment, have not been shown to carry the bacteria that cause Toxic Shock Syndrome. Additionally, the statement also emphasises that neither tampons nor the user's hands or vagina are sterile, providing a transparent disclosure about the product's characteristics and the inherent nature of its use. Breaches of this legislative requirement may lead to enforcement actions under the Therapeutic Goods Act 1989. Failure to comply with the amendment by not including the mandated statement on the information leaflet could result in regulatory penalties. The Act provides for both civil and criminal penalties for non-compliance. Civil penalties can include fines, while criminal penalties may involve imprisonment. The exact penalties depend on the severity and frequency of the breach, as outlined in the Act, but they are intended to ensure compliance and protect public health by ensuring accurate and necessary information is provided to consumers.