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Azelaic acid is a popular skincare ingredient used to treat a variety of skin concerns, including acne, dull skin, and uneven texture. However, its availability and accessibility in Australia have been a topic of discussion and debate among consumers and regulatory bodies. In November 2020, the Therapeutic Goods Administration (TGA) in Australia made an interim decision to retain the scheduling of azelaic acid in the current Poisons Standard, which means that azelaic acid is considered a pharmacy-only drug and cannot be purchased as a general sales product. This decision has sparked conversations among skincare enthusiasts, with some expressing disappointment over the limited availability of certain azelaic acid products, such as Paula's Choice 10% Azelaic Acid and The Ordinary's 10% Azelaic Acid Suspension. While the TGA's decision aims to prioritize public health and safety, it has also led to a search for alternative products and highlighted the need for more accessible options in the Australian market.
| Characteristics | Values |
|---|---|
| Status in Australia | Azelaic acid is classed as a pharmacy-only drug and can be sold only in over-the-counter creams from the chemist or prescription products. |
| Scheduling | The Poisons Standard states that azelaic acid is a Schedule 2 product, available in Australia at concentrations of 15% and 20%. |
| International availability | Azelaic acid is widely used in the UK, US, and EU in cosmetic and cosmeceuticals. |
| Hazards | The European Chemicals Agency requires a hazard/warning label for products containing azelaic acid. |
| Safety evidence | The Australian Industrial Chemical Induction Scheme (AICIS) is currently assessing azelaic acid to provide safety evidence. |
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What You'll Learn
Azelaic acid is classed as a pharmacy-only drug
Azelaic acid is a substance that is currently classified as a Schedule 2 product in Australia, meaning it is categorised as a 'Pharmacy Medicine'. This classification restricts the substance to over-the-counter sales in pharmacies and prescription products.
The classification of azelaic acid has been reviewed by the Therapeutic Goods Administration (TGA), which received 129 public submissions regarding the scheduling of the substance. The TGA's Advisory Committee on Medicines and Chemicals Scheduling recommended that the current scheduling of azelaic acid remains appropriate. This decision was based on considerations of the risks and benefits of the substance, its intended purpose and extent of use, its toxicity, and other factors deemed necessary to protect public health.
The TGA's interim decision was influenced by the lack of sufficient evidence to support a 10% cut-off to exempt azelaic acid from scheduling. This means that at concentrations of 10% or lower, azelaic acid cannot be supplied at the general sales level without access to health professional advice.
The TGA also considered the availability of superior products widely used in other countries, such as the UK, US, and EU, where azelaic acid is more accessible in cosmetic and cosmeceutical products. However, the TGA prioritised the potential risks associated with the substance, as reflected in its scheduling decision.
It is important to note that the Australian Industrial Chemical Induction Scheme (AICIS) is currently assessing azelaic acid, which may lead to a re-evaluation of its scheduling status in the future as more safety evidence becomes available.
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Azelaic acid is not approved for general sales
Azelaic acid is a substance that is currently classified as a Schedule 2 product in Australia, meaning it is a 'Pharmacy Medicine'. It is available in Australia in concentrations of 15% and 20%. In November 2020, an application was submitted to amend the classification of azelaic acid to allow for its general sale in topical preparations containing azelaic acid at a concentration of 10% or less.
The Therapeutic Goods Administration (TGA) made an interim decision to retain the current scheduling of azelaic acid. The TGA found that there was insufficient evidence to support a 10% cut-off to exempt azelaic acid from scheduling. The TGA was not satisfied that at this concentration, azelaic acid could be supplied at the general sales level with reasonable safety without access to health professional advice. The TGA considered the risks and benefits of the substance, its intended purpose and extent of use, and its toxicity when making this decision.
The TGA also considered the applicant's statement that down-scheduling azelaic acid would increase the availability of superior cosmetic and cosmeceutical products, as is the case in the UK, US, and EU. However, the TGA noted that any future applications to exempt topical azelaic acid at low concentrations should include evidence to support the cut-off concentrations. The Australian Industrial Chemical Induction Scheme (AICIS) is currently assessing azelaic acid, which may provide useful safety evidence for future consideration.
As a result of the TGA's decision, products such as Paula's Choice 10% Azelaic Acid and The Ordinary 10% Azelaic Acid Suspension are no longer sold in Australia.
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Azelaic acid is toxic
The specific risks associated with azelaic acid are not detailed, but the decision to classify it as a poison was made by the Advisory Committee on Medicines and Chemicals Scheduling, which considers the risks and benefits of substances, their intended use, and their toxicity when making scheduling recommendations.
Azelaic acid is available in Australia as a 'Pharmacy Only' medicine for dermal use. It is currently only approved for use in "dermal preparations," meaning it can be sold over the counter in creams from a chemist or with a prescription.
International brands market azelaic acid cosmeceuticals to Australians online without these restrictions, and these overseas products also promote therapeutic claims. The concentration of azelaic acid in a product is important, with higher concentrations requiring greater restrictions.
There have been applications to amend the scheduling of azelaic acid to increase its availability, but these have been denied due to insufficient evidence to support a safe cut-off concentration. The Committee recommended that the current scheduling of azelaic acid remains appropriate to protect public health.
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Overseas products market azelaic acid without restrictions
Azelaic acid is a substance that is currently approved by the Therapeutic Goods Administration (TGA) in Australia for use only in 'dermal preparations'. This means that it is classed as a pharmacy-only drug and can only be sold in over-the-counter creams from the chemist or prescription products.
International brands market azelaic acid cosmeceuticals to Australians without the restrictions imposed by the TGA. These overseas products also promote therapeutic claims of these cosmetics. The TGA has considered an application to amend the current Poisons Standard with respect to azelaic acid, but has decided to retain the scheduling of azelaic acid in the current Poisons Standard. The TGA found that there was insufficient evidence to support a 10% cut-off to exempt azelaic acid from scheduling, and that at this concentration, azelaic acid cannot be supplied at the general sales level with reasonable safety and without access to health professional advice.
Some examples of overseas products that market azelaic acid without restrictions to Australians include Paula's Choice 10% Azelaic Acid and The Ordinary Azelaic Acid Suspension 10%. These products are no longer being sold in Australia, likely due to the TGA's decision to retain the scheduling of azelaic acid.
In addition to these specific products, there are also alternative skincare products available in Australia that can help to improve skin radiance and clarity, such as the Pixi Clarity Concentrate and the serum from Australian brand asap. These products contain a combination of AHAs and BHAs that are deemed safe for use in Australia.
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The Ordinary's Azelaic Acid Suspension 10% is not available in Australia
Azelaic acid is a substance that is currently approved by the Therapeutic Goods Administration (TGA) in Australia for use only in 'dermal preparations'. This means that azelaic acid is classed as a pharmacy-only drug and can be sold only in over-the-counter creams from the chemist or prescription products.
The Ordinary's Azelaic Acid Suspension 10% is a powerful serum designed to treat hyperpigmentation and banish dull skin. It contains a 10% concentration of azelaic acid, which is a natural and effective antioxidant found in grains. While this product is available in other countries, it is not currently available in Australia due to TGA regulations.
The TGA has made an interim decision to retain the scheduling of azelaic acid in the current Poisons Standard. This means that topical preparations containing azelaic acid at a concentration of 10% or less are not available for general sales and must be scheduled. The TGA has stated that there is insufficient evidence to support a 10% cut-off to exempt azelaic acid from scheduling and that they are not satisfied that at this concentration, azelaic acid can be supplied at the general sales level with reasonable safety.
The Ordinary's Azelaic Acid Suspension 10% is therefore not available for purchase in Australia through regular retail channels. However, consumers can still obtain azelaic acid products from pharmacies or through prescription, albeit at different concentrations and textures. It is important to note that the availability of azelaic acid products may vary over time as regulations and product offerings change.
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Frequently asked questions
Azelaic acid is not banned in Australia. However, it is a pharmacy-only drug and can be sold only in over-the-counter creams from the chemist or prescription products. The Australian Health Ministers' Advisory Council's Scheduling Policy Framework and the Scheduling Handbook recommend that the current scheduling of azelaic acid remains appropriate.
Paula's Choice 10% Azelaic Acid and The Ordinary Azelaic Acid Suspension 10% are two examples of azelaic acid products that are not sold in Australia.
Yes, there are alternative skincare products available in Australia that can help improve skin radiance and clarity. For example, the Pixi Clarity Concentrate serum is deemed safe for use in Australia and helps to gently exfoliate dead skin cells, leaving the complexion looking brighter and more even.
