Australians will be able to access some CBD products from pharmacists without a prescription after authorities announced re-written drug standards. But some critics are calling the rules too restrictive.
The changes will see the Therapeutic Goods Administration (TGA) amend its Poison Standard by downscheduling CBD from a Schedule 4 prescription drug to Schedule 3 “pharmacist only” medicine – meaning some low-content CBD products will not be available off-the-shelf but may be obtained from pharmacists who can consult on usage.
CBD products must be approved by the TGA and must earn listings in the Australian Register of Therapeutic Goods (ARTG).
‘Right direction; do more’
“While the scheduling changes announced by the TGA are a step in the right direction, there is much more they can do to allow easy and affordable access of CBD to the community,” Tim Schmidt, President of the Australian Hemp Council, told HempToday. “This product should be available in supermarkets and corner stores, at the same time creating a lucrative cropping option for Australian farmers,” said Schmidt, whose organization has representatives from each state and territory in Australia representing growers and processors.
Critics have said the requirement to meet ARTG and other standards means CBD products will face many of the same hurdles and regulations that govern approval of prescription pharmaceuticals in Australia. The current registration pathway for Schedule 3 drugs requires efficacy data, which could be difficult to produce from CBD with low doses, some have warned.
What’s not allowed
The TGA rules disallow smokable hemp, vape products and topical applications, three of the most dynamic CBD sub-sectors, also to the dissatisfaction of industry players.
Both natural, plant-derived CBD as well as synthetic variations in a range of oral forms are to be allowed under the revised TGA regulations. Dosage is capped at 150 mg of CBD per day. Product stocks are to be kept behind pharmacist counters, and sales are restricted to those 18 or older.
Only products that contain 98% CBD qualify under the rules, with other cannabinoid content limited to 2%. CBD must come in child-resistant packaging, and customers may purchase a maximum 30-day supply. Advertising of CBD is not allowed.
Products on market in 2022
Strict standards under ARTG require that the product’s final formulation be manufactured with “minimal batch-to-batch variability,” and that non-active ingredients are proven to be safe from adverse effects when administered at much higher than recommended doses. Products must be tested in rigorous double-blind, randomized, controlled clinical trials that show statistically significant results supporting any therapeutic claims. Synthetic products will be required to follow more rigid protocols.
Companies can apply now for inclusion of Schedule 3 CBD preparations on the ARTG, but with significant submission requirements under TGA’s review timeline, products aren’t likely to hit the market soon. Melbourne-based CBD maker Entoura has said it will apply for ARTG registration for three of its products. But Clare Barker, the company’s general manager, said the TGA process would indicate Schedule 3 CBD products won’t be available to Australian consumers until 2022.
“We may see CBD to be further descheduled over time as TGA becomes comfortable with the safety of CBD. It’s a step-by-step process designed to protect consumers,” said Alex Keach, Founder of hemp food company ECS Botanics, Sydney, which is listed on the Australian Securities Exchange.
“With the European Union’s highest court ruling in November that CBD isn’t a narcotic drug, this has to be looked at closely over the next couple of years by other countries including Australia. If Europe doesn’t have any problems over the next couple of years, you would expect us to follow suit,” Keach told HempToday. The European Commission earlier this month reversed its preliminary assessment on CBD, and said the compound is not a narcotic.
TGA revised the daily dosing proposal from its original interim rule from 60mg to 150mg after further study and comments received during a public comment period. “That’s a 2.5 times increase on their initial guidance, and a huge vote for the safety of CBD,” Keach said.
With reporting by Andi Lucas