Australian government proposes CBD be made available for retail sale
Today the Therapeutic Goods Administration released the Department of Health-initiated proposal to make low-dose CBD oil available for sale in pharmacies as a Schedule 3 drug.
The proposed changes would allow the sale of pure CBD oil (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.
This is the outcome of the previously announced Department of Health review of the literature regarding the safety of CBD at certain doses. That now-completed review (available here) found that CBD is safe for adults to use without doctor supervision in doses up to 1mg/kg/day.
The review concluded that up to 60mg/day was an appropriate dose for behind-the-counter CBD oil and noted that even at these low doses CBD ‘has possible utility in the management of chronic and generalised pain…and in anxiety and insomnia’
When will these changes be implemented?
The TGA is now accepting submissions from the public about these proposed changes. The Advisory Committee on Medicines Scheduling (ACMS) will receive submission up to May 22nd, in preparation for their late-June meeting. Interim decisions will then be published on September 9th. This will be followed by a second round of public consultations on the interim decisions before a final decision is published on November 25th.
Should the ACMS decide to reschedule CBD as per the proposed amendments, the SUSMP could be amended as early as February 1st, 2021.
There is no guarantee the ACMS will approve the proposed amendments in their current form, or at all. The AMCS is an independent decision-making body.
Will everyone be able to sell their CBD products from February 2021?
No. Only products that have been registered on the ARTG as Schedule 3 medicines (and that meet all requisite product specifications etc) will be available for sale.
This means CBD companies will not only have to demonstrate their products are manufactured to all appropriate quality standards, but also prove that they are safe and effective for treating a specific indication.
How big is the market for Schedule 3 CBD products in Australia?
The potential market is likely significant. A Gallup poll from September 2019 found that one in seven (14%) American adults had used a CBD product, mostly for pain, anxiety and sleep.
There are about 17 million Australians aged 18+. 14% of that population equates to roughly 2.4 million potential consumers. And that’s just domestic demand. Getting a Schedule 3 CBD product registered in Australia could potentially open up a global marketplace of hundreds of millions of consumers.
What can people do to support these changes?
The ACMS is now accepting submissions from the general public. If you feel strongly about these proposed changes, we encourage you to make a submission. You can do so via email, just make sure you complete and attach the appropriate cover sheet.
FreshLeaf Analytics, a division of Southern Cannabis Holdings, is the leading supplier of data about the medicinal cannabis industry in Australia. We have access to medicinal cannabis product, pricing and clinical data sets from some of Australia’s leading healthcare companies and organizations including healthcare clinics, pharmacies, product suppliers and the TGA. The FreshLeaf Analytics team provides custom research, analysis and consulting services in the Medicinal Cannabis market in Australia. The FreshLeaf Analytics team can be contacted on +61 2 8203 8741 or firstname.lastname@example.org