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TGA warns consumers about potential harm from unlawfully supplied medicinal cannabis

3 May 2021

The Therapeutic Goods Administration (TGA) is warning consumers about the risks of buying medicinal cannabis products online. Medicinal cannabis products bought online may be unsafe, of poor quality or contain a different dose to what the label claims.

Access to medicinal cannabis

In Australia, patients may legally access medicinal cannabis if a registered doctor gives them a prescription and the patient fills the prescription at a pharmacy.

With the exception of a very small number of prescription only products, medicinal cannabis products are not approved medicines in Australia, which means the TGA has not assessed them for safety, quality or effectiveness.

Since 1 February 2021 pharmacists have been able to supply certain TGA approved medical cannabis products containing a low dose of cannabidiol (CBD) over-the-counter. However, to date there are no approved products of this type. In practice, patients must still obtain a prescription to access any medicinal cannabis product in Australia.

Currently there is limited evidence about the effectiveness of medicinal cannabis for use for different medical conditions. There is also little known about the most suitable doses of individual cannabis products. The TGA has published medicinal cannabis guidance documents to assist doctors in considering medicinal cannabis for the treatment of certain conditions.

If a doctor determines that an unapproved medicinal cannabis product is suitable for a patient, the doctor can apply to the TGA for access to unapproved products via the Special Access Scheme (SAS) or the Authorised Prescriber Scheme.

The TGA has published information for consumers on how to access medicinal cannabis, including a printable infographic.

Beware of fake medicinal cannabis

Beware of buying medicines online. It may seem like a simple, affordable option, but products bought over the internet may be a serious risk to your health and a waste of money.

Products sold on the black market, especially from online sellers that do not request a doctor's prescription, are unlikely to achieve the desired results and can be very dangerous. Counterfeit (fake) products mimic authentic goods but may contain undeclared hazardous ingredients. A lack of manufacturing and testing standards may also result in contaminated products. Using fake products can put you at serious risk of unpredictable or severe adverse reactions.

Medicinal cannabis products generally contain CBD and/or tetrahydrocannabinol (THC), which is the psychoactive substance in cannabis. A study published in the Journal of Clinical Pharmacology found that it is common for CBD products to be labelled with inaccurate dosage and that CBD concentration varied across batches of the same product, purchased at different times. This study also highlighted that without independent testing from a laboratory experienced in analysing CBD content, it is impossible to confirm if the level of THC stated on the label is correct and that the product is not contaminated. These results serve as a warning against buying medicinal cannabis products online.

Seek advice before driving

If you are using medicinal cannabis, seek advice from your doctor before operating machinery or driving due to the risk of experiencing drowsiness. Although drowsiness is not a known side effect of CBD alone, it may occur if the CBD interacts with other medications you may be taking. You should not operate machinery or drive while being treated with medicinal products containing the psychoactive substance THC.

The states and territories are responsible for driving laws, including laws on driving with medicinal cannabis or prescription medicines in your system. Laws may differ between states and territories.

Medicinal cannabis bought online may not be accurately labelled, including the actual amount of THC. You could lose your driver's license and be fined if found to be driving under the influence of THC.

Advertising medicinal cannabis

Advertising medicinal cannabis products to consumers in Australia is illegal.

Advertising medicines that are not in the Australian Register of Therapeutic Goods (ARTG) is generally prohibited. Unless entered in the ARTG, a medicinal cannabis product has not been assessed by the TGA for safety, quality or effectiveness and therefore advertising it to consumers is inappropriate.

Many of the diseases and conditions that advertisers claim can be treated or relieved by medicinal cannabis products are either prohibited or restricted by therapeutic goods legislation. For example, any advertising that claims a medicinal cannabis product can treat cancer, mental illness, epilepsy or any other serious condition is likely to be breaking the law, even if the advertiser believes there is evidence to support the claim. These rules protect vulnerable consumers.

The TGA takes action against illegal activity

The regulatory scheme is critical to the safety of Australian consumers, and the TGA investigates suspected illegal activity in relation to therapeutic goods, including advertising. A range of compliance and enforcement tools are available and may include criminal or civil court proceedings, which can result in substantial fines and or imprisonment.

The TGA will review complaints of alleged non-compliant advertising of medicinal cannabis products to the public. In December 2020, a man was issued four infringement notices totalling $10,656 for alleged unlawful advertising of cannabidiol (CBD).

If you suspect non-compliance in relation to medicinal cannabis, you can report illegal or questionable practices online to the TGA. The TGA also encourages people to report suspected non-compliant advertising via its advertising reporting form.

If you have concerns about health practitioners, notify the Australian Health Practitioner Regulation Agency (AHPRA).

For more information about medicinal cannabis, the TGA has published a suite of medicinal cannabis resources, including resources for consumers, health professionals and businesses. If you have any other questions about medicinal cannabis, please talk to your doctor for advice.