The TGA's down-scheduling of CBD comes into effect today.
The Therapeutic Goods Administration's (TGA) decision to move low-dose Cannabidiol (CBD) from a Schedule 4 to Schedule 3 comes into effect today, meaning that Australians may soon be able to access CBD products without a prescription, provided those products are approved by the TGA.
Companies will first need their products to be registered to be available over-the-counter in pharmacies and as an S3 medicine, and so Australian's will have to wait some time before products hit the shelves.
CBD is the non-psychoactive component of the cannabis plant, and many are opting to use it for medicinal or therapeutic purposes to get the benefits of cannabis without the high associated with it.
CBD is gaining popularity among those suffering from chronic or cancer-related pains, anxiety, insomnia, epilepsy, and many other conditions. With regard to chronic pain alone, there were over 3 million Australians living with chronic pain in 2020 – a number that is set to rise as the population grows older.
Under the ruling, individuals will be able to purchase a maximum of 150 mg per day—which is a significant increase on the previously proposed limit of 60mg.
Freshleaf Analytics predicts that the market for over-the-counter CBD in Australia is estimated to exceed $200 million per annum, with the lion's share of that market going to first-movers in the space.
At the time of the TGA's announcement, Freshleaf's Cassandra Hunt stated:
"History suggests that the first movers among product companies will be the winners, with the first movers in the medicinal cannabis industry in Australia still dominating the industry today. The race is now on to get products in the market as quickly and cost-effectively as possible, assuming companies are able to overcome the challenge of proving efficacy."
Creso Pharma (ASX:CPH) Is Well-Positioned to be a First Mover
Creso Pharma (ASX:CPH) is a global supplier of cannabis and hemp-derived products for both people and animals that has established a presence in almost every continent on the planet.
Since its origin, Creso has hit many milestones through a combination of innovation and acquisitions, which have allowed the company to further its global expansion and progress its four key focus areas; animal health, nutraceuticals, cosmetics, and therapeutics.
We spoke with Adam Blumenthal, a non-executive chairman at Creso, who said that the TGA's recent decision to down-schedule CBD "paves the way for more people to "safely access the benefits of CBD to address a wide range of indications."
There are an estimated 1.5 million Australians using cannabis to self-medicate.Adam Blumenthal, Non-Executive Chairman at Creso Pharma
And, when it comes to providing over-the-counter CBD to Australians, Blumenthal continued, Creso Pharma is well-positioned.
"Creso Pharma has a range of sophisticated products that can be introduced to meet those needs. Creso's product design approach is a key differentiating factor. For example, our flagship product, cannaQIX® 50 is in a lozenge format which enables CBD to be directly absorbed through the buccal (cheek) membranes."
"Other oral products will be absorbed through the intestines with the majority of CBD metabolised in the first pass by the liver before it has access to the rest of the body. Unlike unpalatable liquid and oil products, the cannaQIX® 50 lozenge delivers a consistent dose of CBD in an extremely patient- friendly format."
In December 2020, Creso's signed a heads of agreement with leading natural, sustainable health and lifestyle brand supplier Martin & Pleasance Pty Ltd to bring Creso's suite of cannabis-based products to the Australian market.
"Creso has partnered with leading Australian company, Martin & Pleasance to accelerate access to the Australian market. Martin & Pleasance has its own in-house regulatory team who will partner in managing the ARTG listing process."
"They also have a full in-house brand and sales team managing
sales into its distribution network of over 4,000 pharmacies as well as online channels, grocery and practitioner suppliers. The potential size for this market is very significant with estimates exceeding A$200m per annum," Blumenthal concluded.
Investors saw the benefits of the deal and Creso's new position within the Australian CBD space, and promptly after the agreement was announced, CPH shares climbed 29% higher.
Disclaimer: Past performance is not an indicator of future performance.
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