CBD supplements in Australia: Elixinol plots route to market via regulator’s special access scheme
The company first announced the plan to sell its hemp-derived CBD products in Australia via an exclusive deal with PharmaCann – a licensed medicinal cannabis and CBD products wholesaler in Australia and New Zealand – on July 27.
As CBD oral supplements are not legally allowed for sale in Australia, medicinal cannabis (including CBD supplements) are only permitted into the country when it is used in a clinical trial, or via the Therapeutic Goods Administration’s (TGA) Authorised Prescriber scheme or the Special Access Scheme.
For Elixinol, its CBD products will be available in Australia via the Special Access Scheme.
Under the scheme, consumers can have access to unapproved therapeutic goods through their health practitioners – who will then notify or apply to the TGA to supply the products via prescription to their patients.
This is not the first time that oral CBD products are available in Australia via the scheme.
Last year, MGC Pharma was granted the permission to import its CBD supplements MXP100 and MXC1:1 – both in oral oil form, into Australia via the scheme and for use in clinical trials.
MXP100 is mainly used for neurological conditions while MXC1:1 is for relief from certain types of inflammatory pain.
In response to queries from NutraIngredients-Asia, Elixinol CEO Oliver Horn said the company was aiming to sell a range of CBD ingestibles and oral supplements in Australia in the second half of this year.
“We believe that the first (set of) products will be available for sale no later than October,” he said.
He added that the company was still working through the selection of the specific products for sale.
The decision to sell CBD products in Australia was made as the company has been receiving queries on its products.
According to the company’s website, its CBD oral supplements include capsules containing CBD and other ingredients such as melatonin, Boswellia, ashwagandha, curcumin, DHA, and MCT coconut oil. They are targeted at relieving stress and supporting sleep, antioxidant activities etc.
Cannabis currently falls under two schedules of the Poisons Standard in Australia: as a prescription-only medicine under schedule 4, and as a controlled substance under schedule 8.
In April, the TGA announced a public consultation to consider the down-scheduling of CBD to a schedule 3 substance. This means CBD could be sold as a medicine available upon pharmacist’s advice.
The result of the public consultation is pending.
Japan
On the other hand, Elixinol has officially embarked on a licensing model for its business in Japan.
This was a plan hatched after the firm sold away its shares in Elixinol Japan to a Japanese investor.
Now, under the licensing model, Elixinol Japan will be able to manufacture and distribute locally made, Elixinol-branded CBD nutraceuticals in Japan.
As part of the arrangements, Elixinol Global will receive royalties of 3% in the first year and a 5% royalty in the subsequent years.
The company said this would allow it to continue to benefit from the brand equity that it has created in the Japanese market over the years.
The company reported to have achieved a revenue of JPY$170m (US$1.6m), out of a total market estimated at JPY$2bn (US$18.8m) last year.
Back home, the company will no longer sell its subsidiary Hemp Foods Australia, as the business has made significant improvement in recent months.
In the first half of FY2020, the business reported revenues of AUD$2m (US$ 1.4m), which was slightly higher than AUD$1.6m (US$1.1m) in FY2019.
EBITDA losses was reduced to a loss of AUD$300k (US$213k) from a loss of AUD$1.8m (US$1.28m) last year.
