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Azelaic acid is an organic compound found in grains such as barley, wheat, and rye. It is well-regarded among dermatologists for its antibacterial, antioxidant, and anti-inflammatory properties. In addition to treating acne, rosacea, and pigmentation, azelaic acid is also used to address skin concerns such as melasma and post-inflammatory hyperpigmentation. While it is considered a gentle skincare ingredient, higher concentrations may cause mild irritation or sensitivity. In Australia, the Therapeutic Goods Administration (TGA) has made an interim decision to retain the scheduling of azelaic acid in the current Poisons Standard, specifically rejecting the proposal to down-schedule azelaic acid to the general sales level. This means that azelaic acid is classed as a pharmacy-only drug and can only be sold over-the-counter or with a prescription. As a result, certain products containing azelaic acid, such as Paula's Choice 10% Azelaic Acid and The Ordinary Azelaic Acid Suspension 10%, are no longer available for purchase in Australia.
| Characteristics | Values |
|---|---|
| Is azelaic acid banned in Australia? | No, but it is a pharmacy-only drug and can be sold only in over-the-counter creams from the chemist or prescription products. |
| Azelaic acid products available in Australia | Azclear, Finacea |
| Concentration of azelaic acid in over-the-counter products | 10% or lower |
| Concentration of azelaic acid recommended by dermatologists | 15% to 20% |
| Benefits of azelaic acid | Treats comedonal and inflammatory acne, rosacea, pigmentation, keratosis pilaris, and post-inflammatory hyperpigmentation |
| Side effects | Mild irritation or sensitivity, redness, dryness, or peeling of the skin |
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What You'll Learn
Azelaic acid is not banned in Australia
In Australia, azelaic acid is considered a pharmacy-only drug. This means that it can only be sold over the counter in pharmacies and requires a prescription for other forms. The concentration of azelaic acid in these products is also important. The Ordinary Azelaic Acid Suspension, for example, contains 10% azelaic acid and is approved by the Therapeutic Goods Administration (TGA) for use in dermal preparations.
The TGA has received applications to amend the Poisons Standard with respect to azelaic acid, particularly regarding the scheduling of the substance. The TGA's interim decision was to retain the current scheduling of azelaic acid, specifically rejecting the proposal to down-schedule the substance to a general sales level for topical preparations containing azelaic acid at a concentration of 10% or less. Instead, the TGA proposed to up-schedule therapeutic and cosmetic preparations with a concentration greater than 10% to Schedule 5, which would reduce consumer availability.
The TGA considered the risks and benefits of azelaic acid use, the purposes for which it is used, its toxicity, and other matters necessary to protect public health. They also noted that the Australian Industrial Chemical Induction Scheme (AICIS) is currently assessing azelaic acid, which may provide useful safety evidence for future consideration.
While azelaic acid is not banned in Australia, specific products containing azelaic acid may not be available in the country. For example, Paula's Choice 10% Azelaic Acid and The Ordinary Azelaic Acid Suspension 10% are no longer being sold in Australia, according to some sources. However, alternative products containing azelaic acid, such as Azclear, are still available in Australian pharmacies.
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It is classed as a pharmacy-only drug
Azelaic acid is an organic compound that can be found in barley, wheat, and rye. It is well-regarded among dermatologists for its antibacterial, antioxidant, and anti-inflammatory properties. It is effective in treating comedonal and inflammatory acne, rosacea, and pigmentation concerns, including melasma and post-inflammatory hyperpigmentation. It is also a gentle exfoliant that can be used by those with sensitive skin.
In Australia, azelaic acid is classed as a pharmacy-only drug. This means that it can only be sold in over-the-counter creams from a chemist or as prescription products. The Ordinary Azelaic Acid Suspension 10%, for example, contains a 10% concentration of azelaic acid in a lightweight gel/cream hybrid. However, it is not currently available in Australia due to this regulation.
The Australian Therapeutic Goods Administration (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 will remain scheduled and not be available for general sales. Preparations with a concentration greater than 10% will be up-scheduled to Schedule 5, further reducing their availability to consumers.
The TGA considered the applicant's statement that down-scheduling azelaic acid would increase the availability of superior products widely used in the UK, US, and EU. However, they found insufficient evidence to support a 10% cut-off to exempt azelaic acid from scheduling. The TGA is not satisfied that at this concentration, azelaic acid can be supplied at the general sales level with reasonable safety without access to health professional advice.
It is important to note 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.
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It is available in over-the-counter creams
Azelaic acid is not banned in Australia. It is available in over-the-counter creams from pharmacies without a prescription. However, it is classified as a pharmacy-only drug, and specific products and concentrations may not be available.
The Ordinary Azelaic Acid Suspension 10%, for example, is not available in Australia. This is because azelaic acid is approved by the Therapeutic Goods Administration (TGA) for use only in 'dermal preparations'. The TGA has made an interim decision to retain the scheduling of azelaic acid in the current Poisons Standard, specifically rejecting the proposal to down-schedule the acid to a general sales level. This means that azelaic acid will continue to be classified as a pharmacy medicine in Australia, and products containing the acid will be available only from pharmacies.
The TGA's decision was based on the risks and benefits of the substance, the purposes for which it is used, its toxicity, and other matters considered necessary to protect public health. The TGA found that there was insufficient evidence to support a 10% cut-off to exempt azelaic acid from scheduling.
Azelaic acid is an organic compound found in grains such as barley, wheat, and rye. It is well-regarded by dermatologists for its skincare benefits, particularly for treating acne, rosacea, and pigmentation concerns. It is considered safe even for those with sensitive skin or who are pregnant or breastfeeding. However, it can cause mild irritation or sensitivity, especially at higher concentrations, so it is important to do a patch test before use and choose a product with the appropriate concentration of azelaic acid.
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It is used to treat acne, pigmentation, and rosacea
Azelaic acid is a naturally occurring by-product of the metabolism of the yeast Malassezia furfur. It is predominantly used as a topical treatment for mild to moderate acne and may be combined with oral antibiotics or hormonal therapy. It is also useful for both comedonal and inflammatory acne vulgaris.
Azelaic acid is a tyrosine inhibitor, which helps to reduce pigmentation. This makes it particularly useful for darker-skinned patients whose acne spots leave persistent brown marks (post-inflammatory pigmentation) or who have melasma. It is also used to treat post-acne scarring. It is one of the few treatment options that can be used by children and people who are pregnant or breastfeeding.
Azelaic acid is also used to treat rosacea. People being treated for rosacea might need to use this medication for up to 12 weeks before their skin starts to get better. It may cause skin lightening (hypopigmentation) that is more apparent in darker skin tones.
In Australia, azelaic acid is a pharmacy-only drug and can be sold only in over-the-counter creams from the chemist or prescription products.
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It is considered safe for pregnant and breastfeeding people
Azelaic acid is a skincare ingredient that is well-regarded among dermatologists for its antibacterial, antioxidant, and anti-inflammatory properties. It is effective in treating comedonal and inflammatory acne, pigmentation, and rosacea. While it is generally a gentle skincare ingredient, it can cause mild irritation or sensitivity, especially at higher concentrations.
In Australia, azelaic acid is considered a pharmacy-only drug and can be sold only as an over-the-counter cream or prescription product. The Australian Therapeutic Goods Administration (TGA) has made an interim decision to retain the scheduling of azelaic acid in the current Poisons Standard. This means that azelaic acid will not be available for general sales and will remain a pharmacy-only medicine.
Despite being generally safe, azelaic acid, like any medication, should be used during pregnancy and breastfeeding only after consulting with a healthcare professional. According to Dr. Garshick, a board-certified dermatologist, azelaic acid is considered safe for use during pregnancy and breastfeeding. However, as a precaution, it is always advised to check with an OB-GYN or a healthcare provider before using any medication during these periods.
Azelaic acid has benefits for those dealing with rosacea and pigmentation issues, especially melasma and post-inflammatory hyperpigmentation (PIH), which are common during pregnancy. Its gentle exfoliating properties make it suitable for sensitive skin, and it can be safely used on the entire face, addressing both acne and discolouration. Its keratolytic effects also make it useful for treating keratosis pilaris, either alone or with other exfoliating acids.
While azelaic acid is considered safe for pregnant and breastfeeding individuals, it is important to be cautious and consult a healthcare professional before using any new medication or skincare product during these important periods.
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Frequently asked questions
No, 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.
Some products that contain azelaic acid include Paula's Choice 10% Azelaic Acid, The Ordinary Azelaic Acid Suspension 10%, and AzClear.
Azelaic acid is an effective treatment for acne, rosacea, and pigmentation concerns such as melasma and post-inflammatory hyperpigmentation. It is also a gentle exfoliant that can be suitable for those with sensitive skin.
While azelaic acid is generally considered a gentle skincare ingredient, it can cause mild irritation or sensitivity, especially at higher concentrations. Side effects may include redness, dryness, or peeling of the skin.
According to Dr. Garshick, azelaic acid is considered safe to use even during pregnancy or breastfeeding. However, it is always recommended to consult with your healthcare provider before starting any new medication or treatment.
