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), possibly in 2021.
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 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.
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.
KEY HIGHLIGHTS:
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
Cassandra Hunt, Managing Director of FreshLeaf
