An Australian company specialising in delta-8 THC products has responded to the Therapeutic Goods Administration’s firm stand on the cannabinoid, urging it to ‘foster not snuff out’ the medicine.
TGA boss Professor John Skerritt recently used the ACannabis conference to clarify the regulator’s position on delta-8.
And this week’s TGO93 reforms include a clause which appears to prevent delta-8 products from being prescribed in Australia.
Section 8(b) states: “The chemical structure of the active ingredient or other cannabinoid must not be modified or transformed in any way (including by chemical or other means).”
The small amounts of naturally occurring delta-8 THC in the cannabis plant mean chemicals are often used to produce it from cannabinoids such as CBD.
In a guidance note issued this week, the TGA said: “To comply with TGO93, medicinal cannabis products cannot contain… cannabinoids synthesised by chemical conversion, such as delta-8 THC derived from CBD.”
When asked for further clarification, a spokesperson told Cannabiz: “The recent changes to the wording of Section 8 in TGO93 make it clearer that the presence of any cannabinoid that is not extracted directly from the cannabis plant would result in non-compliant goods.
“The presence of naturally occurring trace levels of delta-8 THC in medicinal cannabis products would not result in a breach of section 8 of TGO93.
“However, the TGA is not aware of any commercial process to concentrate this cannabinoid to achieve therapeutically relevant levels.
“Goods claiming the presence of delta-8 THC as an active ingredient rely on chemical transformation of naturally occurring cannabidiol and consequently do not comply with section 8 of TGO93.”
Humacology manufactures delta-8 products at its GMP facility in the US, which it imports into Australia for GPs to prescribe through the Special Access Scheme.
Chief medical officer Dr Crosby Rechtin told Cannabiz: “The few adverse events in the US relating to delta-8 are the result of street-quality, non-GMP manufactured [products] that appear on the black and grey markets.
“It is unfair to make a false equivalence between this and our medicinal-grade, legal, GMP delta-8.
“Our therapies are not synthesised, synthetic, or made in haphazard ways. They are produced using accelerated isolation by our team of chemists per cGMP. Our Clinical Outcome Assessments, which are publicly available upon request, show no residual solvents or trace elements.”
Crosby said the firm chose delta-8 as the primary form of THC in its medicines because it has less psychoactivity “while appearing to retain a number of beneficial pharmacologic properties as an anti-emetic, anxiolytic, appetite stimulant, analgesic and neuroprotective agent”.
He insisted studies and patient feedback support the firm’s strategy and that it has had no known or reported adverse events from thousands of bottles prescribed to patients.
Crosby added: “Given the obvious potential for patients to receive benefit from delta-8 without the side-effect profile of delta-9 (and perhaps with less potential for abuse), surely it is worth the regulator fostering it, not snuffing it out.
“There are thousands of articles relating to adverse events and hospitalisations resulting from delta-9 use.
“Street-quality cannabis and its reportage should not be allowed to adversely impact delta-8 medicinal cannabis patients who are taking medicines manufactured in GMP facilities.”
Skerritt told ACannabis delegates products containing delta-8 which has been chemically transformed from CBD are not legal in Australia.
He said: “[Delta-8] is only found [naturally] in trace amounts, 0.1%, maybe 0.5% in some strains, but generally very, very low amounts, not commercially feasible to extract.”
“It has become popular because it can be chemically made… it’s generally converted by ‘cooking up’ CBD with acids, solvents and heat.”
“It is not legal in Australia, despite questions about it, because it is chemically manufactured.”
Cannabiz understands Humacology has requested a meeting with the TGA to discuss the issue, which will take place on April 7.