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:
- 00:25 | Overview of TGA testing policy.
- 01:00 | Overview of cannabis products tested and results.
- 01:43 | A list of products that didn’t meet the requirements.
- 02:22 | What this means for the suppliers.
- 03:16 | Takeaways for medical cannabis patients.
- 03:45 | Takeaways for the industry.
- Conclusion: Industry, patients & the TGA
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:
- Under the required threshold for cannabinoid content (less potent)
- 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:
- Bedrocan Dried Cannabis Flos – THC too low
- Spectrum Blue Cannabis Oil – THC too low
- LGP Classic 20:5 Cannabis Oil – CBD too low
Products over the required threshold
The products that contained high cannabinoid content are:
- Althea Capilano Cannabis Oil – CBD too high
- 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.