TGA Testing Cannabis Products: 5 Fail & The Meaning For Patients

Under Therapeutic Goods Order 93 (TGO93), the TGA tested 25 of the most prescribed medical cannabis products in Australia. Five of the products failed to meet the requirements. Is this a TGA issue or a product manufacturer issue? Find out below.

Key Points
  1. The TGA tested 25 medical cannabis products for cannabinoid content (potency).
  2. Five products failed (3 products too low, 2 products too high).
  3. Some of the products were previously tested by a TGA approved lab and met the criteria.
  4. Patients who have products from the failed batches can contact the manufacturer for more info.

In this video cannabis consultant Rhys Cohen discusses the TGA’s testing of 25 medical cannabis products, the outcomes and what it means for patients and industry.

In September 2020, the Therapeutic Goods Administration (TGA) released their first-ever results from Australian medical cannabis product testing. The TGA requested samples of the top 25 products sold under the Special Access Scheme (SAS) from 2019. Most of the products passed, but five did not.

In this article, you’ll learn the facts about the outcomes, and what they mean for patients and industry. Here are the topics covered:

Overview of TGA Testing Policies

Australian cannabis products are unlisted or unregistered. Unregistered means that doctors prescribe cannabis through the SAS. Any unregistered cannabis medicine that gets supplied in Australia needs to conform with a quality standard called Therapeutic Goods Order 93 or TGO93. TGO93 covers regulatory requirements for both local and imported products.

TGO93 covers a range of cannabis regulations. For the purposes of this article, the focus is on the requirement for all medical cannabis products to actually contain the stated content of each active ingredient from batch to batch (with slight variation).

Overview of cannabis products tested and results

The TGA tested products from a list of the most approved (SAS approval) products in 2019. They chose the top 25 products to make sure they were compliant with quality standards. The results were as follows:

  • 3 of the products were no longer on the shelf and therefore, weren’t tested.
  • 3 of the products failed with too low cannabinoid content.
  • 2 of the products failed with too high cannabinoid content.

Products that didn’t meet the requirements

Products fell into two categories:

  1. Under the required threshold for cannabinoid content (less potent)
  2. Over the necessary threshold for cannabinoid content (too potent)

IMPORTANT: These products are still safe as there weren’t any other harmful chemicals found in these products – they just missed their threshold requirements.

Products under required threshold

The products that contained low cannabinoid content are:

  1. Bedrocan Dried Cannabis Flos – THC too low
  2. Spectrum Blue Cannabis Oil – THC too low
  3. LGP Classic 20:5 Cannabis Oil – CBD too low

Products over the required threshold

The products that contained high cannabinoid content are:

  1. Althea Capilano Cannabis Oil – CBD too high
  2. Althea Jasper Cannabis Oil – CBD too high

What this means for suppliers

If products from these batches are still on the shelves, they are not allowed to be sent to patients until verified there are no more issues, and they meet compliance.

The batch numbers for these products are:

  • Bedrocan Dried Cannabis Flos – Batch: 19I30EY19K05
  • Spectrum Blue Cannabis Oil – Batch: 1900013049
  • Althea Capilano Cannabis Oil – Batch: 6985-8649
  • Althea Jasper Cannabis Oil – Batch: 6988-8650
  • LGP Classic 20:5 Oil – Batch: P1338

From a supplier or manufacturer lens, it’s also raised new questions about the extent to which the testing requirements that we have in Australia are working or can work. 

The challenge is that some of these products did undergo batch testing by a TGA accredited laboratory before sale. The TGA approved lab said that they conformed with the quality standard. And, when tested later, a TGA laboratory found different, non-compliant results.

What this means for patients

Again, it’s important to note that these products are not ‘unsafe’ as the only information the TGA gave us was low or high cannabinoid content. 

It’s also crucial for patients to know that so long as you’re getting a prescribed cannabis product, you’re almost always going to get what’s on the label. There are many checks and balances in place to make sure that continues to happen. 

We don’t know why these products failed. But, what we do know is that the testing methods used on the products tested before supply and then by the TGA were different.

With these new findings, the regulatory bodies and manufacturers will need to review policies and procedures to make sure our companies are compliant and that the testing is standardised.

What this means for the industry

To sum this up, we’ll use Rhys’s words:

 “It’s a bit of a wake-up call. It’s really sent a strong signal to the industry that you need to be very, very rigorous with ensuring your products meet the appropriate quality standards. And I think it’s also provided some insights into which laboratories are using the testing methods they’re using.

I think there’s an ongoing conversation that needs to be had between the TGA and their accredited laboratories to make sure that everyone’s using the same methods to achieve the same analysis.”

Conclusion: Industry, patients & the TGA

While on its face, these results are disappointing; it’s a good thing for the cannabis industry in the long term.

From an industry and TGA perspective, these findings should mean a review of regulations and the processes and procedures around compliance. While we have some of the highest regulatory standards in the world, perhaps this shows that the regulatory focus is in the wrong place. 

Suppose we had a uniform testing methodology, more TGA driven reviews and fewer rules that push our cultivators’ and manufacturers’ money toward security measures and operational oversight. Would we have the same problems?

For patients, it’s simple. Patients want better access, lower prices and consistent products. They also want to be able to trust the importers, manufacturers and regulatory bodies to be transparent. Patients pay a lot of money for products – so surely those supplying products can meet the requirements. And, maybe the regulatory bodies need to review the requirements so they are achievable and standardise testing? Can they do it in a way that makes products more reasonably priced?

Finally, here’s a note for patients arguing that it’s better to go to the green market than the legal route. In a majority of cases, going legal will provide you with a more consistent and safer product than going green.

There are variances in testing which regulators should fix. There are accepted margins of error. And, cannabinoids’ begin to degrade over time. The rate of degradation depends on factors such as light and temperature. 

These issues may occur with any products. So, yes, there has been a hiccup in the legal framework. But, do some googling about the labelling accuracy of CBD oil, and you’ll find that companies of all sizes, all over the world have had issues. 

When you go green market, you have less ability to confirm consistency and quality in your product. But, to be clear, we also believe in your right to choose. So, if you are happy with your product, then stay your course. Just know that the legal cannabis space is ever-expanding and one day we’ll see cannabis more broadly available in Australia.


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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.


Disclaimer: Currently, in Australia, cannabis is only legal with a prescription. 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.