In Australia, the line between cosmetics and therapeutic goods can be surprisingly thin. The distinction, however, holds significant weight. It determines the regulatory requirements a product must meet. The Therapeutic Goods Administration (TGA) recently released a guidance document to address this very issue. This document aims to bring clarity to the classification process, ensuring both consumer safety and a fair playing field for businesses.

What are Cosmetics?
Cosmetics are products applied to the outside of the body or inside the mouth. They aim to enhance appearance, promote hygiene and health, or protect the body. Generally considered low-risk, cosmetics are subject to fewer regulations than therapeutic goods. Examples of cosmetics may include bath salts, some face creams, body lotions and hand creams, some deodorants and antiperspirants, etc.

What are Therapeutic Goods?
Therapeutic goods are products that are intended to treat or prevent diseases or to affect the structure or function of the human body. This category includes a wide range of products such as biologicals, prescription medications, over-the-counter medications, medical devices, and complementary medicines. Therapeutic goods are considered to be higher-risk products and are subject to more stringent regulations than cosmetics.

How to Determine if a Product is a Cosmetic or a Therapeutic Good?
The classification of a product as a cosmetic or a therapeutic good is based on a number of factors, including:

• The claims made about the product
• The ingredients of the product
• How the product is used
• Whether the product is an Excluded Good or the product is declared not to be a Therapeutic Good

This TGA guidance document provides a framework for manufacturers and suppliers to determine the classification of their products. This is important as it ensures that products are subject to the appropriate level of regulation.

The TGA also has an online tool to help businesses better determine if their product is a therapeutic good.

The Importance of Correct Classification
Correctly classifying a product as a cosmetic or a therapeutic good is very importance since most therapeutic goods in Australia need to be listed on the ARTG. This listing is mandatory unless there's a specific exemption or approval. Products not on the ARTG cannot be advertised, imported, exported, manufactured, or sold in Australia. Businesses that do not properly follow the regulations will be subjected to penalties by the TGA. 

Additional Information
For more information on the regulation of cosmetics and therapeutic goods in Australia, please refer to the following resources:

• Therapeutic Goods Administration (TGA) website
• The TGA guidance document on the classification of cosmetics and therapeutic goods
• Therapeutic Goods online tool

 

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