1. Advisory Committee on Medicines Scheduling (ACMS #24)
Delegate's final decision
The delegate's final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990 (the Regulations) is not to amend the current Poisons Standard in relation to cannabidiol and tetrahydrocannabinoids.
Reasons:
The delegate has confirmed that the reasons for the final decision align with the reasons for the interim decision. Additional reasons for the final decision are the following:
- Cannabinoids may have benefits in a range of indications. While cannabidiol is not psychoactive, THC and selected other cannabinoids are, and this underlies the differing scheduling status of cannabidiol (Schedule 4) and tetrahydrocannabinols (Schedule 8).
- The Poisons Standard is a record of decisions on the scheduling of substances, not products. No adequate evidence has been provided to show that THC concentrations up to 1% are safe and have no psychotropic effects. No additional information was provided on the risks and benefits of tetrahydrocannabinol (THC) or other non-cannabidiol cannabinoids to justify their down-scheduling.
- THC is considered to be an 'impurity' of cannabidiol for the purposes of the cannabidiol schedule entry, and the amounts of this impurity must be specified in relation to amount of the active substance, in accordance with TGA-adopted ICH guidelines.[2]
Public submissions on the interim decision
One (1) public submission was received before the second closing date in response to an invitation published on 10 September 2018 under regulation 42ZCZP of the Regulations. The submission was in support of the interim decision.
The main points provided in support of the interim decision were:
- No changes should be made as the safety of a product is better determined by the total amount of active pharmaceutical ingredient consumed rather than the concentration across the final dose form.
- 1% THC across the whole product may allow some companies to circumvent the system.
The main points provided against:
One (1) public submission was received after the second closing date, and was opposed to the interim decision. The submission raised three additional points on the psychotropic threshold of THC in oral formulations.
- A study was provided[3] containing details of the limits required for THC psychotropic effects in individuals. From this study it was claimed that:
- Oral formulations only have a bioavailability of 10-20%; and
- The minimum amount of THC for psychotropic effects per individual is 10-20mg. This is well above the recommended maximum dose of 2 mL (2 mg THC) three times per day.
- The two applicants who 'opposed' the proposal appeared to not understand it as they made no mention of THC. Their comments were only about CBD and appeared to be neutral.
- The current (proposed) wording is flawed and should be changed as it does not give a true indication of THC content within cannabinoid products. Having a relative percentage as opposed to an absolute one is problematic as illustrated by the example below where a product with 10 times the amount of THC and potentially psychotropic is Schedule 4.
- Product A (XXXXXXXXX) 1 mg THC 20 mg CBD per ml = 4.7% of the total cannabinoid content (only 0.1% w/v) -Schedule 8 in the current Poisons Standard.
- Product B, 1 mg THC 50 mg CBD per mL = 1.9% of the total cannabinoid content (0.1% w/v) -Schedule 4 in the current Poisons Standard.
- Product C, 10 mg THC 500 mg CBD per mL = 1.9% of the total cannabinoid content (1% w/v) -Schedule 4 in the current Poisons Standard.
- The submission claims that the above three points are clearly in line with the ACMS advice that CBD is indeed the dominant ingredient and THC is not psychoactive in this formulation.
Interim decision
The interim decision was published on the TGA website on 10 September 2018 at Scheduling delegates' interim decisions and invitation for further comment: ACMS, September 2018 – 1.5 Cannabidiol and tetrahydrocannabinols (THCs).
Scheduling proposal
The pre-meeting scheduling proposal for cannabidiol and tetrahydrocannabinoids was published on the TGA website on 10 April 2018 at Consultation: Proposed amendments to the Poisons Standard being referred to the June 2018 meetings of the ACCS, ACMS and Joint ACCS/ACMS.
Footnotes
| [3] | Grotenhermen F. (2001). Harm reduction associated with inhalation and oral administration of cannabis and THC. Journal of Cannabis Therapeutics 1(3/4):133-152. |
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