FreshLeaf Analytics welcomes TGA interim decision on CBD down-scheduling
September 9th 2020
Therapeutic Goods Administration (TGA) sticks to their guns on initial proposal for over-the-Counter low-dose CBD but no smoking, vaping, topicals. Potential $200M market in Australia.
FreshLeaf Analytics has welcomed the interim decision today by the Therapeutic Goods Administration (TGA) to make registered low-dose CBD products available for sale in Australian pharmacies as a Schedule 3 drug. The interim decision, as expected, 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 (OTC) 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. Pharmacists would 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.
The proposed implementation date has moved to 1 June 2021. The traditional registration pathway for Schedule 3 requires efficacy data that may be challenging to produce at a 60mg dose. FreshLeaf are working with the TGA to better understand the data requirements for low-dose CBD submissions.
The announcement today limited the product delivery mechanism 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.
In the same announcement TGA made an interim decision not to accept a private scheduling application which would have made CBD a freely available unscheduled medicine. They also advised that advertising to the general public will not be allowed.
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% of all medicinal cannabis prescriptions. FreshLeaf Analytics expects the over-the-counter CBD market to grow rapidly and exceed $200M of revenue.
- FreshLeaf supports interim decision to make low dose S3/OTC CBD products available in Australia as a Schedule 3 medicine
- 60 mg per day, 30 day supply to be available over the counter, products expected in late 2021
- Oral, oral mucosal and sublingual formulations only – no vaping or topicals
- Potential for $200M market in Australia
- ARTG registration will be required – no SAS-B
- Final decision expected November 25, 2020
- Use of illicit CBD products may decrease
- Advertising to the general public will not be allowed
Cassandra Hunt, Managing Director of FreshLeaf 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.”
Dr Melissa Benson, Advisory Board member of Applied Cannabis Research added that: “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.”
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”.
Tim Drury, Director of Southern Cannabis Holdings: “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”.
FreshLeaf expects to release the next installment in its widely recognized Market Report series in Q3 2020.
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FreshLeaf Analytics, part of the Southern Cannabis Holdings group, is Australia’s leading source of data and information about the medicinal cannabis industry. FreshLeaf provides strategic consulting services to industry and government clients. For more information: [email protected] or [email protected] (+61) 2 8203 8741 @FreshLeafA
About Southern Cannabis Holdings: SCH specializes in building and operating cannabis businesses in markets where cannabis is regulated as a pharmaceutical product. SCH companies include CA Clinics, Applied Cannabis Research and FreshLeafAnalytics. To find out more about SCH, please visit www.southerncannabisholdings.com.au [email protected]