The Therapeutic Goods Administration (TGA) regulates therapeutic goods and the Australian Register of Therapeutic Goods (ARTG). Cosmetics do not need to be registered on the ARTG. However, there is often an interface between therapeutic goods and cosmetic products where someone makes a claim about the impact of the product on the human body. Products may not make therapeutic claims unless included on the ARTG. This article will explain:
- how to know if your product is a therapeutic good or cosmetic good;
- what cosmetic claims are; and
- the regulation of cosmetics.
1. Is Your Product a Therapeutic Good or Cosmetic Good?
Therapeutic Goods
Therapeutic goods are generally defined in Australia as goods that can treat an illness or ailment or those goods that are represented in any way to be or that are likely to be taken for therapeutic use. Further, for a product to be a therapeutic good, its intention should be to:
- modify a physiological process; or
- treat or prevent disease.
Cosmetic Goods
Generally, cosmetic products are a substance or preparation intended for placement in contact with any external part of the human body, with a view to:
- alter the odours of the body;
- change its appearance;
- cleanse it;
- maintain it in good condition;
- perfume it; or
- protect it.
Product Composition and Proposed Use
Generally, products are either cosmetics or therapeutic goods depending on the composition of the product and its proposed use in the context of marketing. The composition of the product refers to the ingredient or the concentration of a particular ingredient. Certain ingredients will make a product unsuitable as classification as a cosmetic and will require TGA approval for use.
The analysis of the proposed use takes into consideration the method of administration of the product and the claims made:
- on the package;
- in advertisements; and
- on product labels.
2. What Are Cosmetic Claims?
A cosmetic claim can be a word, sentence, paragraph or an implication about the use of a product that should present the product explicitly for cosmetic purposes only. However, it cannot make reference or suggest that someone can use the product for or in connection with a disease, ailment or defect. Otherwise, it may be seen as a therapeutic good.
The line between acceptable and unacceptable cosmetic claims can be unclear and often depends on the context and any relevant qualifications. The following example (as provided by the TGA) in relation to the word ‘relieves’ highlights the interface between cosmetic claims and therapeutic claims:
- ‘relieves skin dried by wind’ has a cosmetic implication and is therefore purely a cosmetic claim;
- ‘relieves itching’ is unclear and requires further qualification to clarify its strictly cosmetic use; and
- ‘relieves inflamed and irritated skin’ is unacceptable wording for a cosmetic product.
3. How Are Cosmetics Regulated?
The regulation of certain cosmetics will depend on what is in the particular cosmetic. The Industrial Chemicals Act 2019 sets out the requirements concerning permitted ingredients in cosmetics. The Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991 sets out the requirements concerning ingredient labelling information.
Additionally, the National Drugs and Poisons Schedule Committee (which is part of the TGA) oversees cosmetic products that contain a substance within the Standard for the Uniform Scheduling of Medicines and Poisons.
Importantly, cosmetic products will need to comply with the Australian Consumer Law. In particular:
- any claims made about the product cannot be misleading or deceptive;
- all products need to be safe and of acceptable quality; and
- all products must comply with the consumer guarantees.
The Australian Competition and Consumer Commission (ACCC) is responsible for enforcing cosmetic ingredient labelling requirements, as well as general advertising claims.
Key Takeaways
If you have a cosmetic good, you should carefully consider whether it could be a therapeutic good or if you are making any claims that could suggest or indicate that the product has therapeutic use. In general, the label or advertising of cosmetic products should not make reference to treating or preventing disease and should not be misleading or deceptive in any way. If you think your product is a therapeutic good, you must seek approval from the TGA before supplying, selling or marketing the product in Australia. For advice about advertising your cosmetic goods or making claims, contact LegalVision’s business lawyers on 1300 544 755 or fill out the form on this page.
Frequently Asked Questions
They are generally defined as a substance or preparation intended for placement in contact with any external part of the human body, with a view to alter the odours of the body, change its appearance, cleanse it, maintain it in good condition, perfume it or protect it.
Whether a product is cosmetic will largely depend on the composition of the product and proposed use and claims made about the product.
It can be a word, sentence, paragraph or an implication about the use of a product. Additionally, it should present the product explicitly for cosmetic purposes only and cannot make reference or suggest that the product can be used for or in connection with a disease, ailment or defect.
We appreciate your feedback – your submission has been successfully received.
