In Australia, beauty products are legally classified into two distinct categories: cosmetics and therapeutic goods. The classification of a product as either "cosmetics" or "therapeutic goods" is typically determined by three key factors: 1) the primary purpose of the product, 2) the ingredients it contains, and 3) the claims made about the product. It is important to note that the regulations governing each category vary significantly.
Part 1 Regulatory Framework and Competent Authority
1.1 Existing Main Therapeutic Goods Regulations
Regulations | Functions | Effective Date of the Latest Version | Status |
Overarching regulation for therapeutic goods. | 2023-09-21 | In force | |
Enforcement rules of Therapeutic Goods Act 1989 | 2023-11-28 | In force | |
Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2023 | Collection of permissible ingredients | 2023-10-25 | In force |
Therapeutic Goods (Manufacturing Principles) Determination 2020 | Principles to be observed in the manufacture of therapeutic goods for use in humans | 2022-07-01 | In force |
Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 | Requirements for advertising | 2019-7-30 | In force |
Therapeutic Goods Order No. 92 - Standard for Labels of Non-prescription Medicines | Standard for labels of non-prescription medicines | 2023-04-30 | In force |
Regulation that excludes certain goods from the scope of the 1989 Act | 2022-10-01 | In force | |
Also known as the 'Standard for the Uniform Scheduling of Medicines and Poisons' (SUSMP), it regulates substances applicable to medicines, cosmetics, agricultural products, or household cleaners, as well as the related packaging and labeling requirements. | 2023-09-22 | In force | |
AS/NZS 2604:2021 Sunscreen Products – Evaluation and Classification | Standard for sunscreen products in Australia | 2021-06-25 | In force |
A public database of therapeutic goods lawfully supplied in Australia | - | In force |
1.2 Competent Authority
The Therapeutic Goods Administration (TGA), a division of the Australian Government Department of Health, holds the responsibility for overseeing therapeutic goods and associated manufacturing, labeling, and advertising requirements. Specifically in the cosmetic realm, the TGA focuses its assessments on cosmetics that assert therapeutic claims.
Part 2 Therapeutic Goods
2.1 Definition
As defined by the Therapeutic Goods Act 1989, "therapeutic goods" refer to products intended for human use to achieve various health effects, including:
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 in persons.
Testing for pregnancy in persons.
The replacement or modification of parts of the anatomy in persons.
2.2 Classification
They are broadly categorized into four main groups:
Medicines: Encompassing prescription, over-the-counter, and complementary medicines like paracetamol and echinacea.
Biologicals: Products made from or containing human cells or tissues, such as human stem cells or skin.
Medical Devices: Including instruments, apparatuses, and appliances like pacemakers and sterile bandages.
Other Therapeutic Goods (OTGs): Covering sterilants, disinfectants, tampons, menstrual cups, and more.
Distinguishing between therapeutic goods and cosmetics can be challenging. While a product may seem like a cosmetic, it is legally classified as a therapeutic good. Factors influencing this classification include primary use, ingredients, claims made, route of administration, overall presentation and context, etc.
For instance, a claim like "soothes dry skin" for a skin cream doesn't make it a therapeutic good. However, when coupled with visual representations of severe dry skin conditions, such as psoriasis, the perception of the product having therapeutic effect may be inadvertently conveyed.
The presence of specific ingredients can also lead to the classification of a cosmetic product as a therapeutic good. For example, moisturizers featuring a sun-screening agent as a secondary component with an SPF exceeding 15 fall into this category, subject to regulation as medicines. Similarly, products that produce a skin-whitening effect by coloring the skin may initially be classified as cosmetics. However, if the product contains hydroquinone, known for inhibiting the physiological process of melanin production, it is then considered a therapeutic good.
2.3 Approval Process
Unless a specific exemption, approval, or authority applies, any individual or company wishing to import and/or manufacture therapeutic goods for supply in Australia, referred to as a “sponsor” of therapeutic goods, must apply for market authorization with the TGA. This involves submitting relevant supporting data related to quality, safety, and efficacy to have their therapeutic good included on the Australian Register of Therapeutic Goods (ARTG).
The ARTG in Australia serves as a comprehensive database of therapeutic goods lawfully supplied in the country. It contains key information about the therapeutic good, including product name, active ingredients, classification (if it is a medical device), sponsor, and manufacturer details. In most cases, therapeutic goods must be listed on the ARTG before they can be legally supplied in Australia.
The sponsor, who bears financial and legal responsibility for the therapeutic good, must either be a resident of Australia or an incorporated body in Australia conducting business within the country where the representative of the company resides in Australia.
It's important to note that the steps, costs, and the level of information required during the application process vary based on the type and risk level of therapeutic goods. The table below provides a step-by-step guide to assist enterprises in making initial decisions about supplying a therapeutic good and how to commence the process.
Step 1: Check the Regulatory Status of the Product | Before proceeding, an enterprise should verify whether the product intended for supply qualify as therapeutic goods. This involves ensuring compliance with the Therapeutic Goods Act 1989 and checking for exclusion under the Therapeutic Goods (Excluded Goods) Determination 2018. If the product is indeed therapeutic goods, it's crucial to further check whether it falls under exempted goods in Schedule 5, 5A, or 7 of the Therapeutic Goods Regulations 1990. Additionally, the enterprise should confirm if he/she is exempted persons according to Schedule 8 of the Therapeutic Goods Regulation 1990. Alternatively, TGA's interactive decision tools can be referenced for clarification. |
Step 2: Find out Whether the Product is Already Authorized for Supply in Australia | Next, search the ARTG to determine the product's authorization status.
Applications for entry into the ARTG are submitted electronically through the TGA Business Services portal (TBS). The TGA employs a risk-based approach in assessing market authorization applications. Lower-risk products undergo a streamlined certification process, while higher-risk products undergo a meticulous assessment involving the active evaluation of information provided by sponsors. The TGA adds therapeutic goods to the ARTG under the following circumstances:
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Step 3: Identify the Type of Therapeutic Goods | Therapeutic goods encompass a range from prescription and over-the-counter medicines to complementary medicines and devices, varying in risk levels. The regulatory framework for medicines, including complementary medicines, operates on a two-tiered system:
The application processes and regulatory requirements differ based on the type of therapeutic good and its associated risk level. Sponsors are encouraged to thoroughly review relevant guideline documents before reaching out to the TGA for further inquiries. |
Step 4: Ensure Compliance with Legal Requirements for Approval | The TGA will only approve and authorize the supply of products if they fully comply with all relevant legal prerequisites. These encompass overarching legal requirements applicable to all therapeutic goods, including manufacturing standards, product and labeling standards, and substantiated evidence supporting any therapeutic claims made about the products. Furthermore, specific requirements tailored to each type of therapeutic product must also be met to ensure regulatory approval. |
Step 5: Be Aware of Sponsor's Legal Responsibilities | Once a product is approved and included in the ARTG, sponsors bear ongoing legal responsibilities. These post-market obligations encompass:
Failure to meet these obligations may result in civil and criminal penalties. |
STEP 6: Assess Associated Costs | Market authorization applications involve fees and charges, which can vary based on the therapeutic goods' type. Fees pertain to specific services, such as product evaluation/assessment, while charges represent a form of industry tax imposed annually from July 1 to June 30. Non-payment of the required annual charge may lead to the removal of the product from the ARTG. Further details are available on the TGA website. |
2.4 Ingredient Requirements
The inclusion of ingredients into the formulation of therapeutic goods is subject to specific requirements and restrictions. Currently, AICIS has established regulatory frameworks for therapeutic ingredients, including the Poisons Standard and the Therapeutic Goods (Permissible Ingredients) Determination.
Registered medicines, which commonly feature higher-risk ingredients, are governed by scheduling in the Poisons Standard. Listed medicines are confined to low-risk, pre-approved ingredients known as permissible ingredients, as outlined in the Therapeutic Goods (Permissible Ingredients) Determination. Ensuring compliance with these standards is essential for enterprises in the therapeutic goods sector.
2.5 Advertising and Claims
Advertising encompasses any form of communication, whether statements, imagery, and design, aimed at promoting a product. This includes labels, packaging, point-of-sale materials, catalogues and inserts, leaflets, booklets, and more. As consumers rely on therapeutic goods for their health, advertising in this domain is held to a higher ethical standard.
Current regulations, the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (commonly known as “the Advertising Code”), govern advertising practices. The first two regulations outline some general requirements, forbidding practices like promoting therapeutic goods not on the ARTG when they should be, using "prohibited representations" such as references to cancer, and the authorized use of restricted representations, such as references to serious diseases and conditions.
The Advertising Code further refines these regulations, outlining specific criteria for public-facing advertising. For example, it stipulates the following principles for therapeutic foods advertisements:
Accuracy: Ensuring objective truthfulness, freedom from errors, and the inclusion of current and correct information.
Balance: Providing fair and unbiased claims and disclosing contra-indications or precautions when relevant.
Non-misleading: Avoiding false impressions, misinterpretation, omission of important information, and exaggerated or irrelevant claims.
Certain words or images used in advertising may indicate that a product is a therapeutic good, such as those related to preventing, diagnosing, curing, or alleviating diseases, influencing physiological processes, or modifying bodily functions. Below is a comparison between claims made for cosmetics and therapeutic products:
Cosmetics | Therapeutic products |
Soothes dry skin | Relieves rashes |
Covers pimples | Heals pimples |
Smooths wrinkles | Aids in repair of skin tissue |
2.6 Labelling
The TGA has implemented specific labelling requirements for medicines supplied in Australia, divided into two distinct labelling Orders:
TGO 91 - Standard for labels of prescription and related medicines (TGO91)
TGO 92 - Standard for labels of non-prescription medicines (TGO92)
This division aims to more effectively address the varying risk levels between prescription and non-prescription medicines, and enhance overall clarity and readability. For detailed labelling and packaging requirements, please refer to the link provided.
Part 3 Requirements for Specific Product Types
Below is the comparison of some types of products that can be either therapeutic goods or cosmetic.
3.1 Sunscreens
In Australia, sunscreens are divided into two categories: therapeutic sunscreens and cosmetic sunscreens.
Cosmetic sunscreens | Therapeutic Sunscreens | |
Regulator | AICIS | TGA |
Examples | Most secondary sunscreens, primarily serving purposes other than sunscreen but containing sunscreen agents, are classified as cosmetics. Examples include:
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Labeling Requirements | Labeling for cosmetic sunscreens should comply with Australian laws for labelling and product safety. | The label of therapeutic sunscreens shall include:
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Approval Requirements | For detailed information on supplying cosmetic sunscreens in Australia, consult the AICIS website. | Detailed instructions for supplying therapeutic sunscreens in Australia can be found in the Australian Regulatory Guidelines for Sunscreens and the Australian and New Zealand Sunscreen Standard AS/NZS 2604 Sunscreen Products - Evaluation and Classification. |
3.2 Anti-Dandruff & Anti-Acne Skin Care Products
Cosmetics | Therapeutic goods | |
Anti-dandruff Products | They control or prevent dandruff through actions like cleansing, moisturizing, exfoliating, or drying the scalp, including shampoos and conditioners. | Anti-dandruff and anti-acne skincare products fall under the category of “therapeutic goods” if they:
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Anti-acne Products | They control or prevent acne through actions like cleansing, moisturizing, exfoliating, or drying the skin. Examples include spot treatments, cleansers, face scrubs, masks, etc. |
3.3 Anti-bacterial Products
Cosmetic Anti-bacterial Products | Therapeutic Anti-bacterial Products |
Cosmetic anti-bacterial products, excluded from TGA regulation, must not contain substances listed in Schedules 2, 3, 4, or 8 to the Poisons Standard. Examples include cleansers, gels, face scrubs, masks, anti-bacterial hand lotions, sanitizers, and wipes.
They can only be advertised or presented for supply as being active against bacteria and must not be advertised as:
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