Why The Interim CBD Decision Actually Means Nothing (For Now)

Cannabis to be over the counter in Australia! Cannabis soon to be legal. The media continues to blow the potential down scheduling of CBD oil out of proportion. Unfortunately, this interim by the ACMS means nothing for patients and the industry overall in its current form. Here’s why…

Key Points
  1. Low dose CBD will likely become a s3 substance in 2021.
  2. CBD for sale over the counter in pharmacies will need to be listed on the ARTG.
  3. With current regulations, it’s likely that manufacturers won’t be able to meet the listing requirements and therefore CBD will not be available to consumers for a very long time

In this video Rhys Cohen explains the AMCS’s interim decision on the down scheduling of CBD in Australia and why it has little meaning in its current form.

A background on down scheduling CBD oil

At the start of 2020, the Department of Health (DOH) proposed that low dose CBD products be made available over the counter at pharmacies in Australia. That recommendation was made to the Advisory Committee on Medicine Scheduling (ACMS).

Since the recommendation, the committee took public submission and reviewed those submissions and other recommendations about making CBD oil more accessible. The regulators also made their own recommendations to be taken into account. 

The ACMS has come back with their first decision, their interim decision, which broadly agreed with the government’s original proposal.

Overview of the decision

The ACMS has made the following recommendations:

  1. Access: 18+ through a pharmacist
  2. Product types: oral products only – no inhalants or vape products
  3. Product contents: Cannabidiol (CBD) any cannabinoids, other than cannabidiol, must comprise 2 per cent or less of the total cannabinoid content.
  4. Manufacturing: no compounded products, Australian Register of Therapeutic Goods (ARTG) listed products only. 
  5. Dosages: 60mg per day, 30 day packs
  6. Patient info: No advertising allowed – same laws as current medical cannabis

The reasons the decision is almost useless for patients and industry are covered by points 4 and 6 above.

What this means for industry and patients

Listing on the ARTG

To explain why this decision doesn’t do much for Australians we’ll briefly explain ARTG listing. 

Before anyone can access CBD over the counter or without a prescription, these CBD products must be listed on the ARTG. To list, CBD manufacturers need to prove that their product is both safe and effective for treating a specific symptom or indication. This evidence is typically gathered during clinical trials which can often take years to complete. 

Clinical trials have five phases in total and listing a product on the ARTG usually happens after the third phase of trials.

While this is the interim decision and there is a possibility that the burden of proof will change, in its current form, proving that CBD is effective at these doses will be almost impossible.

Advertising restrictions

For anyone who’s tried to understand the journey one must take to get medical cannabis in Australia or looked for information about medical cannabis products, you’ll know it’s almost impossible to find. 

The TGA’s current advertising guidelines treat cannabis like any other pharmaceutical when, in fact, there are so many reasons that it’s not. Under the plan for down-scheduling CBD, the current advertising restrictions will remain in place. As a consumer – it will continue to be almost impossible to find information about cannabis or CBD.

What’s next? What can I do to help?

This was the interim decision. There’s now another round of public consultation. You can submit your comments to the TGA here until the end of October.

The final decision will be made in November, and any decision made in November will be implemented in law in June 2021.

Info to help with your submission of comments

Here are just a few important facts that were made public about the proposals and submissions which you may want to use in any further submission:

  • The last open submission had 5409 public submissions received.
  • The majority of these submissions (approx. 52%) supported an alternative proposal set out in the campaign while and just under half (46%) agreed with the private submission (government’s proposal).

What we find interesting is that if 52% supported an alternative framework and only 46% supported the government’s proposal – why did we get a decision that’s simply a replica of the private submission?


The positive is that the decision by the AMCS is a small step toward the recognition of cannabis as a health and wellness supplement. Unfortunately, that’s about it.

It will be interesting to see what this new submission and review period will bring. We hope to see the final decision, in November, reflect the following statement put out by the World Health Organisation, “CBD is a promising treatment for a number of medical conditions, is well tolerated, has a good safety profile, and doesn’t appear to be a risk for abuse, dependence, or other public-health related problems.” 


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Rhys Cohen

Rhys is a drug policy and politics nerd with a social science background. He’s a passionate advocate for evidence-based drug policy and medical cannabis access.

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Tom Brown

Tom is a co-founder of honahlee, startup junkie, a cannabis enthusiast and a digital marketer. His interest in cannabis began as a teenager growing up in New York. Tom loves to trawl through cannabis research, documenting cannabis truths and myths. He started honahlee to help reduce the stigma around cannabis in Australia by educating people about the many uses of the plant.


The team at honahlee are not doctors and are not providing medical advice. Neither Rhys Cohen nor the honahlee team are recommending the use of marijuana (cannabis) for medical or adult use purposes. Cannabis does not work for everyone and may have negative side effects. In Australia, medical marijuana (cannabis) is regulated by the TGA. If you think cannabis is right for you, please consult with your doctor or specialist.