Australia's Over-the-Counter CBD Isn't Strong Enough

Co-author of a newly published research paper is calling for stronger dose CBD to replace the government's plan for low-dosage products.

Following the recent rescheduling of registered low-dosage CBD products by the Therapeutic Goods Administration (TGA) co-author Professor Iain McGregor, academic director of Sydney University's Lambert Initiative for Cannabinoid Therapeutics, has shot down the decision, suggesting it is unlikely to benefit patients.

"There is no good-quality evidence that 60mg does anything useful," said Professor McGregor, calling for much higher doses to elicit the required relief to patients suffering from chronic pain, insomnia, anxiety and epilepsy.

Comparing the availability of CBD products and the associated legislative and regulatory background in nine selected countries, McGregor shows the TGA, along with many other legal authorities, have severely underestimated the required dosage for CBD products.

Reviewing the USA, Canada, Germany, Ireland, United Kingdom, Switzerland, Japan, Australia, and New Zealand as of May 2020, the minimum daily dosage was "substantially lower" than those found to have "therapeutic effects". Legal foundations were largely blamed for being "unclear" coupled with a disparity of product availability between the USA and European countries.

In considering the benefits of CBD, researchers classified a low dose of CBD as 150mg per day, based upon clinical dosing of around 12-23 mg/kg per day. While doses between 300-1500 mg are reported to have therapeutic effects, the paper's introduction alludes to "various therapeutical actions of CBD reported in clinical trials," with doses of up to 6000mg being "reasonably well-tolerated." Referencing Epidiolex – an oil containing 100mg/ml of CBD – the typical dose for a 40kg child suffering from pediatric epilepsy is 800mg total (20mg/kg). The highest recommended daily dose available for an orally-administered CBD product was between 100-240 mg.

The daily recommended doses with orally administered non-prescription products were typically well below 150 mg and substantially lower than the doses reported to have therapeutic effects in published clinical trials (e.g., 300-1500 mg).I.S. McGregor, et al. International Journal of Drug Policy

Out of the non-prescription products reviewed, all but one provided a recommended daily dosage below 150mg (3.75mg/kg). In spite of increased international access to low-dose CBD products, high-quality evidence supporting their therapeutic benefits is "scarce at best." In New Zealand, for example, a general practitioner recommended a dose of 40-300mg, resulting in "improved quality of life and no major adverse effects."

Asking fellow scientists to "backfill the evidence" on the low-dose CBD phenomenon, future research beyond this paper will either "validate" consumers, or "illustrate the magnificent folly of the entire enterprise." Unfortunately, with Australian CBD products expected to be sold over the counter, Greens Senator Rachel Siewert is worried "ineffective doses" that are supplied to consumers, "will diminish confidence in the product".

While this move by the TGA has been welcomed by many in the cannabis industry and abroad, marijuana businesses are also concerned about the "efficacy of low does CBD". Describing it as having "a good safety profile," Managing Director of FreshLeaf Analytics, Cassandra Hunt noted the increased availability will lead to further clinical research.

"We certainly see this as a step in the right direction although the government is rightly being cautious. Calls to down-schedule CBD even further have so far been ruled out as pharmacist consultation allows the government to maintain some level of control, helping ensure patients consume these products safely and with an awareness of issues such as potential drug interactions."

MGC Pharma, on the other hand, has mentioned that the requirements for eligible CBD products under Schedule 3 may be difficult for a number of operators to meet. Regardless, Roby Zomer, Co-founder and Managing Director of MGC Pharma, is "very pleased to see the proposed down-scheduling changes from the TGA."

With research continuing at the Lambert Initiative for Cannabinoid Therapeutics and the Mind and Brain Centre thanks to a $1.7 million funding award, "the relationship between changes in pain and brain structure and function associated with CBD" may soon be determined. A discovery that could lead to higher-dose CBD with clinically demonstrated benefits reaching those who need it most.

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Elliot Nash
Elliot Nash

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