Cannabis currently falls under two schedules of the Poisons Standard in Australia: Schedule 4 as a prescription only medicine, and Schedule 8 as a controlled substance.
The country’s regulator Therapeutic Goods Administration (TGA) announced the proposal to down-schedule CBD to a schedule 3 substance late last month.
This move will not allow CBD in supplements but will allow it to be sold as a medicine available upon the pharmacist’s advice.
However, at the same time, The TGA has received a separate proposal from a private applicant who called for CBD products to be sold over the counter from any retailer or any health care professional.
TGA has opened a public consultation for both proposals which will end on May 22.
CMA said while it welcomed TGA’s move as “a good first step”, it also hoped to see greater consumer access to CBD products containing therapeutic doses of tetrahydrocannabinol (THC) in health foods stores.
Therefore, it is calling for a ‘pathway approach’ to make CBD an AUST-listed, unscheduled substance, backed by information from efficacy monographs in other nations.
Carl Gibson, CEO of CMA told NutraIngredients-Asia that an efficacy monograph would enable firms to develop more effective CBD products.
The World Health Organisation (WHO) has recommended that preparations containing CBD with no more than 0.2% THC should not be placed under international drug control.
“However, oddly enough, the low dose of 0.2% THC makes it difficult to make an efficacy claim to list it as an Australian complementary medicine.
“If we are able to get the TGA to agree on the monograph, where the products have to conform to certain dosages etc, then there will be no issue about the quality and safety, making it more widely available,” Gibson said.
The industry body plans to reference the existing CBD-related efficacy monographs from TGA’s comparable overseas regulators, such as those from Health Canada and the US Pharmacopoeia.
Politician and consumer driven
The re-assessment of the current CBD framework was driven by both politicians and consumers, CMA said.
Last November, the senate made an inquiry into the “Current barriers to patient access to medicinal cannabis” to the Senate Community Affairs References Committee.
One of the 20 recommendations that the committee had made, was thus for the TGA to relook the existing framework.
“The committee recommends that the Therapeutic Goods Administration, as a matter of priority, conduct broad public consultation on the future scheduling of cannabidiol and other non-psychoactive cannabinoids,” it said.
On the consumer front, Gibson said that parents with children suffering from epilepsy have been calling for wider access to CBD products.
“Quite a lot of parents have been calling in to the top radio shows to put pressure on access to CBD oil, medicinal cannabis to help with epilepsy, pain relief and a range of issues because CBD is tightly controlled.”
The wider availability of CBD products will also help bring down cost – which the inquiry committee had recognised as a key problem.
Less than 5% of CMA’s 152 members are involved in CBD business, Gibson said when asked.
Safety review
In its proposal, TGA said that the maximum recommended daily dose of CBD must not exceed 60mg.
The suggestion was made based on its document ‘Safety of low dose cannabidiol’, which stated that low doses of CBD at less than 60mg/day could have possible use for management of chronic and generalised pain.
“Cannabidiol in less than or equal to 1 mg/kg/day (up to ~60 mg/day) has possible utility in the management of chronic and generalised pain of broad aetiologies through both systemic and localised administration and in anxiety and insomnia,” TGA said in the document.
It added that plant-derived CBD is present only as the (-) CBD enantiomer. As such it has low affinity for CB1 and CB2 receptors and is thus not psychoactive.
However, there are some side effects reported with CBD use, including tiredness, diarrhoea, changes in appetite and weight, transaminase elevations, sedation, sleep disturbances, and infection.
Since there is limited evidence involving children, the TGA has proposed to restrict low dose CBD use to adults over 18 years old.
Domestic Vs International
There are seven medicines currently active on the Australian Register of Therapeutic Goods (ARTG) containing CBD as an active ingredient as of April 16.
A search on the ARTG shows that the products are mostly from Little Green Pharma and while one is from GD Pharma. All the seven products are for export only.