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What is TGA and how does it apply to Essential Oils?

Please note that this section applies to Oil Garden Aromatherapy oils only.

In Australia, medicinal products containing herbs, vitamins, minerals, and nutritional supplements, homoeopathic medicines and certain aromatherapy products are referred to as 'complementary medicines'. These are regulated as medicines under the Therapeutics Goods Act 1989# (the Act).

According to The Act, a 'therapeutic good' is broadly defined as a good which is represented in any way to be, or is likely to be taken to be, for therapeutic use (unless specifically excluded or included under Section 7 of the Therapeutic Goods Act 1989)*

Therapeutic use in connection with essential oils means preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury and influencing, inhibiting or modifying a physiological process*.

The TGA’s regulatory processes for control of the supply of therapeutic goods include three key elements in regards to quality, safety and efficacy*:

Auditing and assessment of the quality of their manufacture.
Australian manufactures must comply with the manufacturing principles of the Act in order to hold a license to produce products for human use.  Manufacturers must also comply with the Australian Code of Good Manufacturing Practice (GMP) for Medicinal Products*.
Pre-market assessment of the goods
The TGA has a strict risk-based pre-market assessment procedure. This assessment takes into consideration the toxicity of the ingredients, dosages, what the medicine is indicated for, side effects and interactions with other medicines and effects of prolonged use or inappropriate self-medication.  Listed and Registered medicines are identified on the product label by 'AUST L' or 'AUST R' respectively, followed by a unique number*.
Post market monitoring of compliance with standards once the goods are supplied on the market.
To ensure quality, safety and effectiveness of medicines supplied in Australia, products are subjected to post market monitoring to check compliance of standards.  This may include monitoring of adverse reactions, random surveillance in the market place, random laboratory testing of products and ingredients and control of advertising therapeutic goods*.

#Section 52F of the Act – Definitions
* The regulation of complementary medicines in Australia - an overview

For more information please visit the Department of Health and Aging Therapeutics Goods Administration website.