The Therapeutic Goods Administration (TGA) within Australia’s Department of Health unveiled a proposal on Friday to reschedule cannabidiol (CBD), which would allow for low-dose CBD products to be sold over the counter. The Administration also opened a public comment window that will close next month.
Today, CBD preparations are placed in Schedule 4 and allowed for therapeutic use so long as 98 percent of the preparation’s cannabinoid content is CBD. One proposed change would add to that description “except when included in Schedule 3.”
Another proposed change would reserve Schedule 3 for CBD preparations that: are “either plant derived, or when synthetic only contains the (-) CBD enantiomer;” have a “maximum recommended daily dose” that “is 60 mg or less of cannabidiol;” and are “in packs containing not more than 30 days’ supply.” The 98 percent rule from Schedule 4 also applies. And these products can only be sold to those age 18 and older.
This proposal comes after the TGA conducted a “safety review” of CBD products. Schedule 3 was chosen over Schedule 2 because “pharmacist advice is necessary to mitigate safety risks” when it comes to drug interactions.
The TGA also points to comparatively lax CBD regulations around the world, including in the United States, where CBD is in such high demand and so freely available that the Food and Drug Administration is playing whack-a-mole with unscrupulous suppliers while crafting the regulatory framework for legal CBD products. (Read Cannabis Wire’s coverage of the FDA’s work with regard to CBD.)
Countries around the world are moving toward loosening restrictions around CBD. The World Health Organization (WHO) has recommended that CBD products with .2% THC or less should be descheduled, or, in other words, removed from international drug control. As Cannabis Wire reported, a vote was expected on this WHO recommendation during the United Nations Commission on Narcotic Drugs meeting in March, but the vote was postponed until the December meeting.
In recent months, Australia’s lawmakers and regulators have been actively working on medical cannabis. In March, as Cannabis Wire reported, Australia’s Senate Community Affairs References Committee published a report that examines “current barriers to patient access to medicinal cannabis in Australia.”