Australia: TGA Issues Final Ruling On Over-The-Counter CBD And Increases Daily Dosage Limit

This article by Hugo Gray was originally published on The Green Fund, and appears here with permission.

Australian pot stocks now have a clear path towards CBD product registration, unlocking a market worth more than $200 million.

Earlier today the Therapeutic Goods Administration (TGA) handed down a final decision in favour of down-scheduling low dose cannabidiol (CBD) preparations from Schedule 4 to Schedule 3, which means they will soon be available for purchase from pharmacies over the counter.

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—while the implementation date has been brought forward to February 2021.

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.FreshLeaf Analytics Managing Director, Cassandra Hunt

The final decision was made—following an earlier TGA safety review and extensive public consultation—by a senior medical officer acting as a Delegate of the Secretary of the Department of Health.

The decision increase to maximum daily dose has generated particularly excitement in the cannabis industry, and was made in response to safety information, public submissions, and the advice of the Joint Committee of the Advisory Committees for Medicines Scheduling and Chemicals Scheduling.

As a result, Australian pot stocks now have a clear path towards CBD product registration—which means cannabis companies will be racing to get the compound to market as cheaply and quickly as possible—although it is unlikely to be available for sale until late 2021 or 2022.

"This could potentially result in more Australians benefiting from the therapeutic properties of cannabis. However, the effects of low-dose CBD may be negligible for many chronically ill patients," CA Clinics Medical Director Dr Mark Hardy said.   

"Pharmacists would also still need to consult with consumers to ensure they're aware of potential drug-drug interactions, as CBD can affect the way certain other medications are metabolised. Bottomline, consumers should consult their GP before taking OTC products."

According to FreshLeaf Analytics—which operates as a division of Southern Cannabis Holdings—the ruling will only cover CBD products that utilise oral, oral mucosal and sublingual formulations delivery mechanisms, which means that vapes and topical cream will be excluded.

There was an additional requirement that products be packaged securely, while companies must also demonstrate to the TGA that their products are high quality, safe, and efficacious before they can even get them on the shelves.

 "I am excited that TGA has now provided a pathway to approval of over-the-counter CBD products," FreshLeaf Analytics Regulatory Specialist Tony Whittaker said.

"This gives a great opportunity for industry to develop products that consumers can access directly after consultation with their pharmacist.  However, TGA has exacting standards, which will present a significant challenge to this young industry." 

"We look forward to working with TGA to clarify the requirements for OTC CBD products and navigating the path to approval and commercialisation."

Read the original Article on The Green Fund.

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