Not a day goes by when Hemple Co-Founder Georgia Branch doesn’t get a request (or a dozen) from an Australian consumer or health retailer asking how they can get hold of the company’s cannibidoil products.
Cannabidiol (abbreviated to CBD oil) is made from the flowering head the Cannabis Sativa plant and is currently being used to treat cancer, seizures and chronic pain. Outside Australia the laws vary considerably, but CBD oil is available over the counter in many countries, including the US and UK where it’s sold in forms ranging from tinctures to cosmetics and skincare.
The collective market for CBD sales in America is expected to surpass $20 billion by 2024 – compound annual growth rate of 49 per cent, according to recent research by leading cannabis researchers BDS Analytics and Arcview Market Research. In CBD cosmetics the global market is estimated to be valued at over $580 million (with North America leading the way) according to a recent Market Watch report and grow by 31 per cent to 2025, according to Adroit Market Research.
In Australia, CBD oil is only available with a prescription from an approved prescriber, or for approved medical research. It’s prohibited here for topical, cosmetic or nutritional purposes. This means company’s like Hemple aren’t allowed to manufacture, sell or export CBD products from Australia under the current Government regime.
According to leading therapeutic goods lawyer Dr Teresa Nicoletti, that’s not going to change anytime soon.
Dr Nicoletti explains cannibidoil products for medicinal purposes are classed as Schedule 8 products and are only available in Australia under the Special Access Scheme or Authorised Prescriber Scheme. If they’re for non-medicinal purposes, they’re classed as Schedule 9 substances, or poisons, and are prohibited altogether unless used for approved medical or scientific research.
“So at the moment a person will only be able to take CBD oil for medicinal purposes and, of courses, that’s subject to whether their doctor has been able to gain approval under one of the schemes. So if any person wants to take CBD oil for topical, cosmetic or nutritional purposes, they won’t be allowed to,” she said.
Hemp oil, CBD oil and ‘hemp CBD oil’ – what’s the difference?
Almost two years after it was legalised for consumption as food, it’s fair to say Australia is in the midst of hemp fever with this unique ingredient making appearances in everything from skincare, to gin, beer, bars and burgers to pantry staples like honey and hemp mylk.
Globally public interest is at an all-time high – and in Australia, so is confusion. According to Google Trends, Australia has the world’s highest per capita search for ‘CBD oil’. But with the local industry so new and a myriad of (often conflicting) information online it’s hard to separate the fact from fiction or wishful thinking.
Hemp and CBD oil are both produced from the same plant – Cannabis Sativa – and contain less than 0.3 per cent of tetrahydrocannabinol or THC (the psychoactive component). So while both don’t contain THC, different parts of the Cannabis Sativa contain different amounts of cannabidiol. So the difference between hemp and CBD oil is based on which part of the plant is used to create the oil.
The flowers, leaves and stalk contain the highest amount of CBD and are the parts used to make CBD oil for medicinal purposes. In Australia it’s currently prohibited to use the flower, leaves and stalk to make CBD Oil. Hemp oil or hemp seed oil comes from the hemp seed and contains very low or trace amounts of CBD. Hemp oil contains high amounts of Omega 3 and 6, protein, fibre and magnesium.
But there’s another variation in the terminology being marketed online in Australia called ‘hemp CBD oil’. According to Australian Primary Hemp this is adding to the confusion.
“As for Australian Hemp CBD Oil, we recommend doing your research to make sure it is the real deal! Because of the restrictions around producing CBD Oil, it is likely that Hemp CBD Oil sold in Australia may only contain incredibly small amounts of CBD that are found in the seed of the plant and therefore may not have the therapeutic effect intended,” the company explains on its website.
Benefits of CBD oil
Research shows that CBD may be effective in alleviating anxiety, chronic inflammation and pain, insomnia and some of the worst kinds of childhood epilepsy. A long-term study published in the Journal of Alzheimer’s Disease found CBD may help prevent cognitive decline. In addition, according to a review published in the Neurotherapeutics journal, CBD may also be effective in treating substance use disorder.
In the US baby-boomers are one of the largest demographics using hemp-derived CBD for chronic joint pain and sleep and this trend is expected to continue as they seek to replace prescription and OTC pharmaceuticals with hemp-derived products.
Is it harmful
While there are documented side effects, a report from the World Health Organization, “In humans, CBD exhibits no effects indicative of any abuse or dependence potential…. To date, there is no evidence of public health related problems associated with the use of pure CBD.”
Australian companies capitalise offshore
Hemple is one Australian company that has taken its CBD oil products overseas, selling in both the UK and US while Australia plays catch up. In July 2019 Hemple launched its premium CBD oil that uses nanotechnology to achieve a 90 per cent absorbtion rate.
“We launched the company two years ago with hemp foods, but our real passion is CBD oil,” she said.
“There’s a huge amount of public interest, but unfortunately as a business we’ve had to shift our focus away from Australia because it’s so restrictive here,” Ms Branch said.
“We have so much interest in CBD oil – everyday Australians are contacting via our website or Instagram asking us what’s happening in Australia with CBD and how can I access it. People are very confused. Some are buying it from overseas.”
“What’s disappointing is that there are a lot of Australian business doing well in other markets, it would be amazing if we could bring that success back into Australia. But in Australia we’re very complacent, there’s not a lot of push for change,” she said.
She said she agreed with the approach to make CBD in high does available by prescription, but she believes it should be available in lower doses as a wellness supplement for people looking to manage everyday stress and anxiety. “We think great starting point for Australia would be to have it as practitioner only product, behind the counter where you have to have a conversation with practitioner – education is key,” she said.
“The WHO has been very clear on the benefits and low risk – there are 50 different conditions where significant numbers of studies show its efficacy,” she said.
Dr Nicoletti said there will be ongoing pressure on Australian regulators to align with the rest of the world but the path to change was complicated.
The World Health Organisation is currently considering delisting CBD oil from the Single Convention on Narcotic Drugs with a decision expected by March 2020. Dr Nicoletti said if that happened, it would automatically mean it was delisted in Australia because of the way the Australian Narcotic Drugs Act was written.
“But that’s only a small part of where we need to get to because everything else requires proactive submission and proactive lobbying and proactive pressure on government to align with whatever changes the World Health Organisation makes and ensure the regulatory framework as a whole aligns with that,” she said.
“I think you could be looking at two years before we get a framework that can operate, but that presupposes the regulatory authorities will cooperate. Unless they have a view that WHO is making this decision so we will align and we will assist industry to implement these changes, then it’s just going to be an uphill battle to get all of the changes we want. It’s not say we won’t do that, but a lot of companies just don’t appreciate that there is limited flow from whatever WHO does,” she said.
“If changes were made you’d still have CBD as Schedule 4 and everything else is Schedule 8, and everything that’s not medicinal is Schedule 9. You can’t advertise, you can’t manufacture, you can’t supply, until that changes as well. Even if it was unscheduled by the WHO and then the [Australian] scheduling committee decided to unscheduled CBD containing products, and even if the TGA added CBD and hemp oil onto the permitted ingredients list, the ability to market these products as medicines is still limited – you can only market them for general wellbeing. If you want me make claims like dermatitis or epilepsy or other serious conditions, it still becomes a registered medicine whether the substance is registered or not.
“The therapeutic goods regime is not just about the scheduling stuff of the substance, it also about the indications and claims you want to make. The reality is so many people are savvy now and they know what these products do. If the regime opens up you could list a product for general health and wellbeing but people will know what else it’s beneficial for by the concentration of CBD oil.”