Australia’s Therapeutic Goods Administration (TGA) has delayed their final decision on over-the-counter CBD oil.
The TGA has been deliberating on a change in cannabis scheduling that would allow low dose CBD oil to be sold over-the-counter in pharmacies. The change would reschedule CBD products from a Schedule 4 drug to a Schedule 3 drug.
To be eligible for sale in pharmacies, products must contain at least 98% pure CBD oil. This would include roughly 40% of Australia’s cannabis medications.
Rescheduling CBD was first introduced in a proposal in April 2020. The TGA then tentatively approved the rescheduling in early September with a final decision to be released on November 25. According to a notice released that same day the decision has now been delayed until late December.
In a recent interview, Entoura’s managing director Claire Barker suggested that the TGA may be struggling to decide on CBD dosing.
Under the proposed changes, CBD oil doses would be limited to 1,800mg per bottle – or 60mg per day over 30 days. This dosage is significantly lower than the standard dosing range recommended to medical cannabis patients. There is also little clinical evidence such a low dosage will be effective.
Barker believes that the TGA is “trying to get it right” by patients and won’t move forward with the rescheduling until they are convinced it is the right decision. She was quoted as saying:
The last thing the industry wants is to make CBD more accessible to patients, but then patients take it and it doesn’t work – that’s doing nothing for the industry.
Others within the industry have speculated that the TGA is weighing up the feedback from medical cannabis companies, patients, doctors and the public. After the dosage limitations were revealed the TGA faced criticism from many cannabis companies, as clinical research and product trials will depend on the decision. Over 5,400 Australians also submitted testimonies weighing in on the decision.
The rescheduling of CBD oil is a huge step forward for the medical cannabis industry, as it will bring medical cannabis to more Australians. It will also contribute to the growth of Australia’s ASX-listed medical cannabis companies, listed here.