Australian health authorities expect to conclude their safety review of cannabidiol in low doses in March, the results of which could inform any decision to down-schedule the popular cannabinoid.
Any move to reschedule certain doses of CBD, making it available over the counter, could open the door to new market opportunities for businesses.
The Therapeutic Goods Administration, the regulatory body for therapeutic products in Australia, started the review in late 2019, a spokesperson for the Department of Health (DOH) told Marijuana Business Daily.
The review is expected to conclude in early March.
“The review will consider whether there is any new information that should be considered in terms of the scheduling of low-dose CBD products since CBD was last considered by the scheduling committee,” the DOH spokesperson said.
“Based on the outcome of this review, it is possible that relaxation of the scheduling status of low-dose CBD – e.g., to over the counter – could be considered during 2020.”
The normal rescheduling process involves requests for public submissions, followed by consideration by the Advisory Committees on Medicines and Chemical Scheduling.
“Following the Advisory Committees, a delegate of the Secretary of the Department of Health would consider the submissions and advice from the Advisory Committees and make an interim decision on the proposal,” the spokesperson said of the process required to reschedule low-dose CBD.
The proposal would go out for more public submissions before the delegate makes a final decision.
There is no need for new regulations as CBD products can be legally supplied already as prescription medicines, the DOH spokesperson said.
Currently, CBD is legally available in Australia only by prescription.
According to newly released Department of Health data, of all medical cannabis products available in Australia:
- A quarter are CBD-only.
- 7% are THC-only.
- 70% are a combination of THC and CBD.
Schedule 4 CBD medicines may contain 2% or less of other cannabinoids.