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If you are considering launching a skincare business, it is important to understand the difference between cosmetic and therapeutic products. Indeed, separate legislation and entities in Australia regulate cosmetic and therapeutic goods. Additionally, depending on whether you are selling comsetic or therapeutic goods, different registration and product safety requirements will apply. Therefore, this article will explore the differences between the two types of products and detail how to navigate the separate regulatory requirements. 

What is a Therapeutic Good?

Therapeutic goods are health-related products. Specifically, these goods include:

  • various types of medicines (prescription, over-the counter and complementary);
  • medical devices; and
  • other goods like disinfectants. 

As the name would suggest, the Therapeutic Goods Administration (TGA) regulates therapeutic goods.

For a product to be a therapeutic good, people must use it in connection with:

  • preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury;
  • influencing, inhibiting or modifying a physiological process;
  • testing the susceptibility of persons to a disease or ailment;
  • influencing, controlling or preventing conception; or
  • testing for pregnancy.

Generally, authorities will not consider cosmetics as a therapeutic good. However, its ultimate classificiation will depend on the product ingredients and claims you make about the product use through your marketing. For instance, certain ingredients will make a product unsuitable as classification as a cosmetic. In such cases, these products will then require TGA approval for use. For example, if the product contains a ‘scheduled poison’, the TGA will regulate it and and will likely require registration. Similarly, if you use the product to treat health conditions. it will require registration.

What is a Cosmetic Good?

According to the law in Australia, there are various requirements concerning permitted ingredients in cosmetics. Cosmetic products are goods that can you can apply to the external parts of the body, for the purpose of:

  • cleansing the body;
  • maintaining the body in good condition;
  • perfuming or protecting the body; or
  • changing the appearance or odour of the body.

What is the Difference Between a Therapeutic and Cosmetic Claim?

When assessing whether you are making a therapeutic or cosmetic claim, you will need to consider all the material and claims on:

  • the product label and packaging;
  • material and leaflets you include in the packaging; and
  • descriptions and material you have on your website about the product.

A therapeutic claim is one that would suggest the product can treat or alleviate a disease or injury. For example, ‘the cream will relieve and soothe irritated skin’ or ‘the cream can treat cuts and burns’.

Even if you have registered your product with the TGA, some types of claims that are still restricted under the Therapeutic Goods Advertising Code. For example, claims about treatment of serious diseases and health conditions including diabetes, arthritis and eczema. You can read more about these considerations here.

Contrastingly, the focus of a cosmetic claim will typically be for an effect on an external part of the body. For example, ‘helps relieve burns and cuts, and hydrates the skin’ will likely constitute a cosmetic claim. On the other hand, stating that the product ‘treats burns and cuts’ would likely constitute a therapeutic claim.

What are My Obligations if I Want to Sell Cosmetic Products?

If you want to sell cosmetic products, they must comply with the mandatory safety standard on cosmetic labelling. Beyond this, you will need to comply with advertising best practice, that your product claims are:

  • valid;
  • accurate; and
  • can be substantiated.

This article contains some additional details to consider when preparing your marketing material.

If you are involved in importing or manufacturing the cosmetic product, you may need to consider registering your business with the Australian Industrial Chemicals Introduction Scheme (‘AICIS’). You may also need to check whether the ingredients within your products are listed on the Australian Inventory of Chemical Substances. It is important to obtain legal guidance about your obligations in this respect. 

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Key Takeaways

In Australia, authorities regulate both therapeutic and cosmetic goods. Therapeutic goods and claims focus on health diagnoses and treatment. On the other hand, cosmetic goods are typically applied to the external parts of the body to change the appearance or for maintenance. If you have concerns or need advice on your product and the TGA, LegalVision’s regulatory lawyers can assist as part of our LegalVision membership. For a low monthly fee, you will have unlimited access to lawyers to answer your questions and draft and review your documents. Call us today on 1800 534 315 or visit our membership page.

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