Lexi Webster
Australia has strict laws regarding the importation, sale, and use of sports supplements, therapeutic goods, and medicines. The government maintains a list of prohibited substances in sports, and athletes who test positive for these substances face lengthy bans from their respective sports. In Australia, some sports supplements are regulated as therapeutic goods or medicines to ensure they meet quality and safety standards under the Therapeutic Goods Act 1989. The Therapeutic Goods Administration (TGA) routinely reviews and tests sports supplement advertising and products to ensure they do not contain scheduled poisons or prohibited substances listed by the World Anti-Doping Agency (WADA). This raises the question of whether synephrine, also known as oxedrine, is banned in Australia.
| Characteristics | Values |
|---|---|
| Other names | Oxedrine |
| Side effects | Raised heart rate, increased blood pressure, stroke, heart attack |
| Prescription | Schedule 4 (prescription only) medicine for internal use except in preparations labelled with a recommended daily dose of 30mg or less |
| Legality | It is illegal for supplements labelled with a recommended daily dose of more than 30mg to be sold by retail supplement stores |
| Natural sources | Mandarin, orange, lemon, teff grass hay, herbal and nutritional supplements, bitter orange (peel extract), and Seville orange |
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What You'll Learn
- Synephrine, also known as oxedrine, is a prescription-only medicine in Australia
- It is illegal to sell supplements with a daily dose of synephrine/oxedrine greater than 30mg
- The Therapeutic Goods Administration regulates therapeutic goods in Australia
- The Australian sponsor must enter therapeutic goods in the Australian Register of Therapeutic Goods (ARTG)
- Sports Integrity Australia outlines banned substances in sports
Synephrine, also known as oxedrine, is a prescription-only medicine in Australia
The TGA ensures that therapeutic goods, including sports supplements, meet strict quality and safety standards as outlined in the Therapeutic Goods Act 1989. Any product that influences, inhibits, or modifies physiological processes in the body is considered a therapeutic good and falls under the regulation of the TGA. This includes sports supplements, which are often imported from international markets into Australia and must comply with specific labelling requirements.
To be imported, advertised, or supplied in Australia, therapeutic goods must be entered in the Australian Register of Therapeutic Goods (ARTG). The Australian sponsor is responsible for ensuring compliance with the relevant regulations and standards. The TGA undertakes laboratory testing of sports supplement products sampled from the Australian market to detect any prohibited ingredients, including those scheduled in the Poisons Standard and the World Anti-Doping Agency (WADA) list of prohibited substances for athletes.
In addition to synephrine, other substances that are banned or prescription-only in Australia include stenabolic, ibutamoren, SARMs, cardarine, and tadalafil. These substances are regulated due to their potential health risks, including increased risks of cancer, heart attack, and stroke, and other serious side effects. It is important to note that the regulations regarding therapeutic goods and sports supplements in Australia are subject to updates and changes, and it is the responsibility of the Australian sponsor to stay informed about the latest requirements.
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It is illegal to sell supplements with a daily dose of synephrine/oxedrine greater than 30mg
In Australia, synephrine, also known as oxedrine, is a Schedule 4 (prescription-only) medicine for internal use. It is illegal to sell supplements with a daily dose of synephrine/oxedrine greater than 30 mg. This is because, when taken in combination with caffeine and other stimulants, synephrine/oxedrine can have serious effects on the heart and blood vessels, including raised heart rate, increased blood pressure, stroke, and heart attack.
Synephrine/oxedrine can be found in herbal and nutritional supplements and in the peel extract of bitter orange (also known as Seville orange), which is used as a flavouring agent. It has also been detected in Teff grass hay in some countries.
To prevent positive findings of synephrine/oxedrine, it is recommended to use reputable suppliers of hay, feed, and supplements, check the environment for plants containing synephrine/oxedrine, and ensure that any personnel taking supplements or products containing synephrine/oxedrine wash their hands thoroughly after coming into contact with the substance.
In Australia, some sports supplements are regulated as therapeutic goods (medicines) under the Therapeutic Goods Act 1989 to ensure strict quality and safety standards. The Therapeutic Goods Administration (TGA) is responsible for regulating these products. An Australian sponsor must enter therapeutic goods in the Australian Register of Therapeutic Goods (ARTG) before they can be imported, manufactured, supplied, or advertised in Australia.
Other substances that are banned in sports supplements in Australia include stenabolic, ibutamoren, cardarine, and selective androgen receptor modulators (SARMs). These substances may be marketed as performance enhancers, anti-aging treatments, or fat-reducing products, but they have not been proven safe and may increase the risk of serious health issues.
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The Therapeutic Goods Administration regulates therapeutic goods in Australia
The Therapeutic Goods Administration (TGA) is a division of the Commonwealth Department of Health and Ageing in Australia. The TGA is responsible for evaluating, assessing, and monitoring therapeutic goods, including medicines, medical devices, and biologicals, to ensure the health and safety of Australians.
The TGA plays a crucial role in regulating therapeutic goods through the implementation of the Therapeutic Goods Act. This legislation provides a uniform national system of controls, ensuring consistency across the country. The TGA's regulatory scope includes complementary and alternative medicines, such as herbal remedies, nutritional supplements, and homeopathic medicines.
In addition to its regulatory functions, the TGA also provides resources and information to the public. For example, individuals can search the Australian Register of Therapeutic Goods (ARTG) to access Consumer Medicine Information (CMI) and Product Information (PI). The TGA also issues recalls and safety warnings for certain therapeutic goods, such as defective medical devices or medicines with potential contaminants.
Furthermore, the TGA is involved in the evaluation and approval of therapeutic goods. This includes assessing the safety and efficacy of medicines and medical devices before they can be marketed and sold in Australia. The TGA also provides guidance and regulations for prescribing unapproved therapeutic goods in specific circumstances.
The TGA works closely with other organizations, such as the Medicine and Medical Devices Safety Authority in New Zealand, to ensure the consistent and effective regulation of therapeutic goods. This collaboration resulted in the establishment of a single, bi-national agency in 2006 to regulate therapeutic products in both countries.
The TGA's role in regulating therapeutic goods helps maintain high standards for the safety and efficacy of medicines, medical devices, and related products in Australia. By doing so, the TGA plays a vital role in protecting public health and providing Australians with access to safe and effective therapeutic options.
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The Australian sponsor must enter therapeutic goods in the Australian Register of Therapeutic Goods (ARTG)
Synephrine, also known as oxedrine, is a substance that can have serious effects on the heart and blood vessels when taken in combination with caffeine and other stimulants. It is a prescription-only medicine for internal use unless the preparation is labelled with a recommended daily dose of 30mg or less.
In Australia, therapeutic goods must be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied, imported, or exported, unless they are exempt from being entered or are otherwise authorised by the Therapeutic Goods Administration (TGA). The ARTG is a public database of therapeutic goods that can be legally supplied in Australia. It includes information such as the product name, formulation details, active ingredients, classification, sponsor, and manufacturer details.
The process of applying for a therapeutic good to be included in the ARTG is known as market authorisation. If a product is not in the ARTG, or if a sponsor wishes to import it directly from the manufacturer and be the first point of supply, they must apply to the TGA for market authorisation. Sponsors are responsible for applying for and maintaining the ARTG entry. This involves registering their details with the TGA and obtaining a client identification number (Client ID).
The TGA assesses higher-risk therapeutic goods to ensure they meet the requirements for quality, safety, and efficacy and/or performance. They also validate lower-risk medicine, biological, or medical device applications. The ARTG is not intended to provide guidance, advice, or recommendations on therapeutic goods, but rather serves as a record of their contents and classification details.
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Sports Integrity Australia outlines banned substances in sports
Sport Integrity Australia was established in July 2020 to keep Australian sports safe and fair for all participants. The body offers a safe platform for individuals to seek guidance or report any concerns about the behaviour they have witnessed or experienced in sports.
Sport Integrity Australia's Chief Science Officer, Dr Naomi Speers, explains how a substance is added to the Prohibited List. Athletes competing in sports governed by a World Anti-Doping Code compliant anti-doping policy need to be aware of prohibited substances and methods banned. The World Anti-Doping Agency (WADA) updates and publishes the Prohibited List annually. This list outlines the substances and methods prohibited in and out of competition, as well as the sports in which they are prohibited.
The Prohibited List includes specific substances such as testosterone and its various forms, metabolites of dehydrochloromethyltestosterone, and exogenous testosterone. Additionally, certain methods are banned, such as intravenous infusions or injections exceeding 100 mL per 12-hour period unless administered in a hospital or clinical setting. The use of genome-altering technologies for performance enhancement is also prohibited.
It is important to note that overseas products with identical names and logos may contain prohibited substances. For example, Ventolin CFC-free Inhaler has a conditional status due to its active ingredient, salbutamol, which is permitted via inhalation below a specific threshold.
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Frequently asked questions
Also known as oxedrine, synephrine is a prescription-only medicine in Australia. It is illegal for supplements labelled with a recommended daily dose of more than 30 mg to be sold by retail supplement stores.
Synephrine is commonly found in the peel extract of bitter oranges and is used as a flavouring agent. It can also be found as an ingredient in herbal and nutritional supplements.
When taken in combination with caffeine and other stimulants, synephrine can have potentially serious effects on the heart and blood vessels, such as raised heart rate, increased blood pressure, stroke, and heart attack.
Other banned substances in Australia include stenabolic, ibutamoren, cardarine, and tadalafil. These substances are regulated by the Therapeutic Goods Administration (TGA) and are prohibited due to safety concerns and potential health risks.
