Low-dose CBD products all but cleared for sale in Australian pharmacies
Cannabidiol (CBD) products may be cleared for over-the-counter purchase under a proposed Therapeutic Goods Administration reclassification, opening up a potential $200 million market segment.
The proposed amendment represents an interim ruling to downgrade CBD against the Poisons Standard from Schedule 4 to Schedule 3, which would clear the way for Australians to purchase products containing the substance without a prescription, over the counter at pharmacies.
The recommendation applies to registered pure CBD products (with 2 per cent or less other cannabinoids) sold to adults in packets containing up to 1800 mg (equivalent to 90 days supply) and with the counsel of pharmacists, like other OTC medicines.
Smoking, vaping, and topical use of CBD would remain banned under the proposed reclassification.
Recommendations by the TGA are typically adopted by the government and this one is the result of a long, two-part review process.
“We applaud the TGA’s interim decision in this matter and see it as one of the biggest developments in our industry to date,” said medicinal cannabis firm Althea’s CEO Josh Fegan.
“The interim decision reflects the significant shift in community and government attitudes towards medicinal cannabis since it was legalised in Australia in late 2016, which has seen it move from a fringe alternative towards an accepted mainstream option.
“As a strong advocate for patient access, Althea has closely monitored the proposed amendment since it began and has participated in the consultation process. We are excited by the TGA’s interim decision to down schedule CBD products and see this development as a big step forward for prescription cannabis products already available in Australia.”
However, critics of the interim decision have expressed concerns that products containing limited doses of CBD may be too weak to have any demonstrable clinical effect.
“This is a welcome move but it’s important to note that the effects of low-dose CBD may be negligible for many patients,” said CA Clinics medical advisory board member and addiction specialist Dr Mark Hardy.
“Patients seeking treatment for chronic conditions that may benefit from medicinal cannabis may require higher dosages or other cannabinoids such as THC and should therefore consult their GP before taking these products, even in small amounts.”
“We believe low-dose CBD will become the largest market in Australia for cannabis products, quickly generating revenue in the hundreds of millions of dollars,” added Southern Cannabis Holdings director Tim Drury. “There is a significant opportunity here for product companies to supply high quality, low cost medicine to pharmacies.”