Therapeutic Goods Administration (TGA) boss John Skerritt has called on the industry to prove CBD can work safely and effectively at higher doses and help rework the current rules “which are not written in stone”.
In December 2020, the TGA announced its decision to down-schedule CBD at a maximum dose of 150mg/day, already an increase on the 60mg/day it signalled in its interim decision in September last year.
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Describing 150mg/day as ‘a compromise’, Skerritt told delegates at the MCIA’s virtual ACannabis EVOLVE conference today that the scheduling of cannabis products has been changed several times over recent years.
He said the maximum dosage for over-the-counter (OTC) CBD could go as high as 500mg/day if companies can prove safety and efficacy at that level.
“If a company did clinical trials and showed us that a product at 300mg or 400mg had an OTC-like side-effect profile, they could put in a rescheduling application at any time,” said Skerritt.
“In the future, 4-500mg of cannabidiol could be OTC, it’s just that there wasn’t the safety data to support that at this stage. But that doesn’t dissuade future research and future submissions.”
“I would encourage companies to do clinical trials at 150mg/day and maybe 300mg/day. Let’s say the 300mg works beautifully and 150mg’s not very good. The company could put in a rescheduling application for 300mg to become OTC, because presumably they have good safety data on that too.”
“Think a little outside the square because numbers specified in scheduling are not permanent.”