CBD frustration: Aussie supplement firms thwarted by rules while pharma advances march on
Complementary Medicines Australia (CMA) CEO Carl Gibson was speaking to NutraIngredients-Asia after biopharma firm MGC Pharmaceuticals announced a series of major business milestones, chief among them the Therapeutic Goods Administration (TGA) green-lighting its CBD-based Alzheimer's disease treatment for clinical trials.
The firm, known for its medical cannabis innovations, received formal approval from the Australian regulator to begin Phase IIb of its clinical trial on CogniCann, a pharmaceutical-grade, GMP-certified medicinal cannabis formulation.
The latest phase of the trial, to be conducted in collaboration with the University of Notre Dame in Western Australia, will test CogniCann's effects on mild dementia and Alzheimer’s symptoms in patients aged 65 and older. It has also been approved by the Human Research Ethics Committee (HREC).
Domestic and foreign approval
Outside of Australia, MGC has also received approvals in the EU, including a permit from the Slovenian Ministry of Health allowing it to develop phytocannabinoids at its extraction facility (one of the first EU facilities to develop its own natural phytocannabinoids).
Additionally, MGC is now the first Australian medicinal cannabis firm to have received SME qualification feom the European Medicines Agency (EMA), the TGA and FDA’s European counterpart.
This in turn enables MGC to apply for drug evaluation, official advice, and registration of its cannabidiol (CBD) products.
Approved trials versus permitted sales
When it comes to CBD health supplements, however, the rules are far stricter.
A TGA spokesman told NutraIngredients-Asia: "The TGA administers schemes to enable lawful access to 'unapproved' therapeutic goods in clinical trials, which are subject to the Clinical Trial Notification (CTN) scheme, whereby the TGA must be notified of a clinical trial before the trial sponsor can supply the 'unapproved' therapeutic goods in the trial, though the TGA does not review or evaluate any data at the time of notification."
He added that the CTN scheme was just one of the mandatory steps in conducting clinical trials in Australia — jurisdictional, site, and ethics committee approvals are also required.
All material relating to the proposed trial, including the trial protocol, must be submitted directly to the HREC by the researcher at the sponsor's request of the sponsor.
The HREC is then responsible for assessing the scientific validity of the trial design, the balance of risk versus harm of the therapeutic goods involved, and the trial's overall ethical acceptability.
While supplement firms in Australia are allowed to conduct such trials using CBD, they are not allowed to sell supplements containing CBD locally. The spokesman explained that this was because CBD fell under the Poisons standard as a schedule 4 prescription-only medicine in Australia.
Furthermore, the import of products containing CBD requires a licence and permit under the Office of Drug Control’s (ODC) Customs (Prohibited Imports) Regulations 1956.
"In Australia, products containing CBD are prescription-only medicines and cannot be used in products such as foods or cosmetics. As per the obligations under the international drug treaties, which Australia is signatory to, all products — excluding fibre and seed — derived from cannabis are considered drugs and may only be used for medical or scientific purposes.
"CBD products manufactured in Australia may only be supplied, imported or exported for medical or scientific purposes, as per the requirements of the international drug conventions," the spokesman added.
Hemp seed, hemp seed meal, hemp fibre and hemp seed oil are all permitted for use in nutraceuticals and dietary supplements, but CBD is only allowed in medicines, which are available solely via the Special Access Scheme. So far, only around 2,000 patients in Australia have been permitted to use medicines containing CBD.
The long wait
These rules are unlikely to change, meaning that companies such as Bod Australia and BioCeuticals, who have conducted clinical trials on the health benefits of CBD, will continue to be unable to produce or sell CBD supplements in their home countries.
Bod Australia's way around this has been to focus on selling its CBD products in European markets. The company then reformulates these products by swapping out the CBD extracts for hemp seed oil so they can still be sold in Australia.
Late last year, Blackmores' practitioner-only firm BioCeuticals announced a $500,000 investment in medical cannabis research, embarking on a Phase II RCT to investigate the effects of orally ingested medicinal cannabis on brain tumour patients.
BioCeuticals MD Eyal Wolstin told NutraIngredients-Asia that the regulatory hurdles surrounding CBD in supplements were responsible for a lack of industry knowledge in this regard.
Gibson said: "The rules won't be relaxed anytime soon, and that's the difficulty we have. I remember it took a long time to successfully argue for hemp to be deregulated to food status in Australia. It was already being used in cosmetics and pet food, but it took five years for it to be considered a food product.
"Australia is a little behind everywhere else in the world, especially when it comes to CBD. As far as the authorities are concerned, they don't have to give any reason as to why this is the case.
"It's going to take us many, many years to even get to a position similar to where the UK is. It's frustrating that CBD is currently regulated under the Poisons standard, which ties our hands."
Presently, while medicinal licences for CBD oil have not been granted in the UK, products containing CBD can still be sold as dietary supplements, as long as manufacturers do not make any medical claims on the product packaging or in their marketing.
Gibson said, "Unless there's a change of policy, supplement companies will be able to conduct clinical trials on the benefits of CBD for various health issues, but will not be able to develop or sell products containing CBD in Australia itself, and that's the frustrating part."