Low-dose CBD products can go on sale over the counter in Australia from next year – but no smoking, vaping, topicals.
The Therapeutic Goods Administration (TGA) announced its decision on Tuesday 9 September, to make registered low-dose CBD products available for sale in Australian pharmacies from next year, as a Schedule 3 drug.
The decision had no major changes from the initial proposal made in April 2020 and opens the door for companies to apply for registration of their applicable products to be available over the counter in late 2021-2022.
The new regulations will allow the sale of registered pure CBD products (with 2% or less other cannabinoids) to adults in packets containing up to 1,800mg of CBD. This is 30 days supply of the recommended maximum daily dose of 60mg.
The announcement limited the products available to oral, oral mucosal and sublingual formulations only, ruling out vaping or topical cream products.
There was also an additional requirement that products be packaged securely and advertising to the general public will not be allowed.
Australian medical cannabis market experts, FreshLeaf Analytics, welcomed the decision, managing director, Cassandra Hunt, commented: “This will be the biggest thing to happen in the industry since legalisation of medicinal cannabis. We expect it will result in more Australians benefiting from the healing properties of cannabis and will reduce the number of people seeking products through unregulated illicit channels. The next challenge will be getting products in the market as quickly and cost effectively as possible.”
There are currently 17 low-dose CBD products available via the SAS-B and Authorised Prescriber pathways in Australia, with CBD products currently making up about 40 percent of all medicinal cannabis prescriptions.
FreshLeaf expects the over-the-counter CBD market to grow rapidly and exceed $200 million of revenue.
“We believe low dose CBD will become the largest market in Australia for cannabis products, quickly generating revenue in the hundreds of millions of dollars. There is a significant opportunity here for product companies to supply high quality, low cost medicine to pharmacies,” said Tim Drury, director of Southern Cannabis Holdings.
Pharmacists will still need to consult with consumers to ensure they are aware of potential drug-drug interactions as CBD can affect the way certain other medications are metabolised.
Dr Melissa Benson, advisory board member of Applied Cannabis Research said: “This is a win for supporting further clinical research in the area of low dose CBD medicines. It could also promote greater safety for patients if it leads to less use of illicit CBD products, which can expose patients to potential harms associated with unregulated products including contamination with heavy metals, pesticides and the like.”
However, Dr Mark Hardy, addiction specialist and CA Clinics medical advisory board member added: “This is a welcome move but it’s important to note that the effects of low-dose CBD may be negligible for many patients.
“Patients seeking treatment for chronic conditions that may benefit from medicinal cannabis may require higher dosages or other cannabinoids such as THC and should therefore consult their GP before taking these products, even in small amounts.”
The proposed implementation date has moved to 1 June 2021.
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