Banned synthetic cannabis blends are unlikely to be back on shelves, because attempting to prove they are safe could cost millions of dollars.
A Ministry of Health discussion document obtained by The New Zealand Herald shows manufacturers would probably face a costly process to have products approved.
"By the time you actually launch a product, it's going to cost you over a million dollars to get out there," an industry source said.
The document reveals all ingredients would need to be produced in a facility with "good manufacturing practice" (GMP) certification.
This is to ensure dosage did not vary dramatically from batch to batch, which had been recorded in BZP party pills and reported by some users of synthetic cannabis.
"To have something like that, it's going to cost millions ...
"There are not many places in New Zealand which are GMP to start with," the source said.
"And then you have to go through a clinical trial, which can take up to two years."
Kronic and other products were pulled off shelves last year after the Government urgently passed the Misuse of Drugs Amendment Act.
The bans are a stop-gap measure while the Government drafts a law putting the onus on manufacturers to prove their products were safe before they could be sold.
If products passed pre-clinical toxicology and good manufacturing requirements, human clinical trials would be likely.
Potential harm to physical and mental health would be recorded, as well as products' potential to cause dependence and withdrawal effects.
A government-appointed regulatory body would then make a final risk assessment of the drugs.
As well as data from the pre-clinical and human trials, societal implications of approval would be assessed.
These would include things like users' impairment while driving.
Finally, if a product was deemed safe for sale, it would likely face advertising and sale restrictions similar to those on tobacco and alcohol.
Associate Minister of Health Peter Dunne said this week the new regime was "on track" to be introduced this year.
Tough test
The proposed approval process for synthetic cannabis blends will require.-
• Pre-clinical toxicology data, including animal studies.
• Manufacturing quality requirements.
• Data from human clinical trials.
• A final risk assessment of the product.
