The industry has broadly welcomed the Therapeutic Goods Administration’s decision to down schedule low-dose CBD – with some important caveats.
On Wednesday, the TGA announced a significant change in its final decision, with the maximum dose increased to 150mg/day, up from the 60mg/day it signalled in its interim decision in September.
The implementation date of the down scheduling was also brought forward from June 1 to February 1, 2021.
Medicinal Cannabis Industry Australia (MCIA) welcomed the change as providing the industry with the flexibility to develop products for the Schedule 3 registered pathway.
However, it said it would continue to work with the TGA with a view to lifting the dose to 300 mg/day as “this is the threshold at which higher quality evidence accumulates around CBD efficacy, in the absence of significant safety concerns”.
MCIA chair Peter Crock added: “Down-scheduling CBD will benefit patients by allowing them to move from the illicit market and providing easier and more affordable access to high-quality products.”
While noting products will require TGA approval and inclusion on the Australian Register of Therapeutic Goods (ARTG), along with a number of other restrictions, Crock said the decision will provide a pathway for the industry to develop products for this market.
“If fewer consumers seek out illicit CBD products, which have unknown content and quality, then this move ultimately promotes greater safety for patients, which has to be the priority,” he added.