New Zealand’s Medsafe retains classification of low-dose CBD

The Medicines and Medical Devices Safety Authority (Medsafe) has recommended New Zealand keep its current regulatory classification of low dose cannabidiol (CBD), setting the country up to diverge from the position of its neighbor Australia.
At its latest meeting, Medsafe’s Medicines Classification Committee looked at the regulatory status of CBD, following the down-scheduling of CBD doses below 150 mg to pharmacy-only status by Australia’s Therapeutic Goods Administration (TGA). TGA agreed to allow 150 mg doses of CBD to be sold over the counter two years ago after finding a lack of serious adverse events at low doses.
In its review, Medsafe’s committee considered TGA’s rationale and the evidence behind the decision. The review also looked at regulatory advice from Medsafe and the Medicinal Cannabis Agency and five comments it received after announcing the topic was to be discussed at the meeting. Based on the evidence, the Medsafe committee saw too much uncertainty to recommend allowing over-the-counter sales of low-dose CBD in New Zealand.
“The committee noted that CBD medicines did not have an established long-term safety profile, when used as medicines, which would usually be expected to support down-scheduling of a substance. They also noted that there are currently no approved products in New Zealand that have a daily dose of [less than] 150 mg, it was not clear what indications this dose would cover, and therefore there was no clear access issue for these specific medicines,” Medsafe wrote in its summary of the discussion.
At the time of TGA’s down-scheduling of low-dose CBD, Australia was also yet to approve a product that met the criteria for sale over the counter.


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