Many heralded the TGA’s proposal to downschedule low-dose cannabidiol (CBD) to S3 as groundbreaking, however, as I’ve covered in a previous blog, there are additional complications that need to be addressed. The TGA’s initial safety review made recommendations for the dose of S3 CBD to be limited to 60mg/day, which received a fair amount of industry backlash as many felt it would be challenging, if not impossible, for clinical trials to prove efficacy at such a low dose.
The TGA seems to have agreed; when they made their final decision, the maximum dose of CBD was bumped up from 60mg/day to 150 mg/day. While this is all well and good, I think the regulators have accidentally created a grey area that warrants some prodding.
We know three things for sure:
- Pure CBD is considered S4.
- A 150mg/day dose of CBD is considered S3.
- The TGA concluded in their safety review that known adverse events of CBD at low doses were not serious and that they considered 60mg a safe daily dose.
For me, the underlying message is “different concentrations of CBD can be regulated differently.” It also seems that some of the groundwork has already been done via the TGA’s safety review which could inadvertently be used as evidence to allow any CBD dose lower than 150mg to be classed differently, i.e. in the complementary medicines category or even cosmetics.
There are also international precedents for treating CBD differently. For example:
- Recently the EU updated their cosmetics guidelines to add CBD as an approved ingredient.
- South African legislation allows CBD as a supplement when in pack sizes containing 600mg or less of CBD and limited to maximum dose of 20mg/day. Otherwise it is considered a prescription only medication (Schedule 4).
Currently there are some legislative blocks that do not allow CBD into cosmetics or complementary medicines in Australia. This is due to where CBD is listed the Poisons Schedule (S4 and S3). If we want to see more freedoms in Australia similar to those enjoyed in other parts of the world (and to drastically open up the market) there are at a minimum, 3 pieces of legislation that need to be changed:
- The Poisons Standard (SUSMP) – e.g. to exclude 60mg CBD from being listed, or to be listed under S5 or S6.
- Therapeutics Goods (Excluded Goods Determination 2018) – e.g. to allow the 60mg/day dose as an allowable ingredient in cosmetics.
- Therapeutic Goods (Permissible Ingredients) Determination 2020 – e.g. to allow 60mg/day dose as an allowable ingredient in listed complementary medicines/supplements.
Whilst I use the 60mg maximum dose as an example, technically a 150mg/day dose of CBD is considered S3 and it could reasonably be argued that any dose below 150mg/day could be unscheduled!
If you want to read more on similar topics, the following blogs may also be of interest:
- New ODC guidelines align industrial hemp and medicinal cannabis industries
- ODC updates from the Australian Medicinal Cannabis Conference 2020
- Low-dose CBD has been down-scheduled, but what does it mean?