EXCLUSIVE: Three medicinal cannabis products publicly named by the Therapeutic Goods Administration as having failed to comply with required standards have been exonerated by third party analysis in a development that will increase pressure to produce standardised lab testing across Australia.
The disparity in test results will also concern the TGA which in September stated that five products were found to be stronger or weaker than permitted under Therapeutic Goods Order 93 (TGO93) regulations.
A report published by the TGA had named two Althea products, and one each from Little Green Pharma, Spectrum Therapeutics and Bedrocan as those which “failed” its analysis.
But following third party testing, it now says the Althea and Spectrum products were within required limits with the other two only fractionally out.
The disparity of the findings – and exoneration of some products – led to fresh calls for a standardised approach to lab testing.
It also led to renewed criticism that the TGA had been too quick to publish its original findings and to name the products and suppliers before they had a chance to properly respond.
The original lab analysis focused on whether the potency of the products matched that stated by the manufacturer on their TGO93 declaration.
TGO93 sets maximum upper and lower limits for cannabis product potency which vary slightly depending on the product type. For example, if a manufacturer declares that their oil product contains 100mg/ml of CBD, it must contain no less than 90mg/ml and no more than 110mg/ml.
Of the five samples found to breach the requirements, three failed to meet the lower limit while two exceeded the TGO93 declaration.
The trio found to be too weak were Bedrocan Dried Cannabis Flos for inhalation, imported from the Netherlands by Novachem, Spectrum Blue Cannabis Oil, imported from Canada by Anspec and Little Green Pharma’s LGP Classic 20:5 cannabis oil. Bedrocan and Spectrum had lower-than-declared THC levels while LGP did not have sufficient CBD.
The samples found with higher CBD content than the TGO93 declaration – Jasper and Capilano cannabis oils – were both supplied by Althea and imported from Canada.
In its newly-published update, the TGA stated that further analysis of the Spectrum sample “by an accredited third party laboratory” returned a result of 90.7% of the stated content.
The requirement for oil finished products are 90% to 110% of the stated content.
The original test returned a result of 87.3%.
Of the two Althea products, the TGA said further analysis showed the samples were, in fact, within range.
“Subsequent analysis by a third party laboratory returned results for total CBD that were below the upper limit of 110% for the stated content, meeting the requirement of TGO93,” it said.
A re-examination of the remaining two products also showed disparities with the first round of testing.
The Bedrocan sample initially returned a “low result” of 74.9%, but that increased markedly after the supplier told the TGA that its content was “declared in terms of an anhydrous basis”.
“When the moisture content of the product was taken into account the TGA result against this value would be 79.9% on an anhydrous basis,” the report said.
The new reading put the Bedrocan sample within 0.1% of the lower level required for plant material finished products of 80%.
Meanwhile, third party testing of the Little Green Pharma oil product returned a result of 89.1%, against the earlier reading of 88.3%.
The TGA acknowledged the varying results, admitting that “inconsistencies in testing results from different laboratories were observed during the survey”.
In the report, the TGA said it “utilised a solid state certified reference standard of CBD as the primary reference and used response factors calculated from validation studies to calculate the content of other cannabinoids (eg THC)”.
Althea welcomed the new results.
“We’re pleased that the TGA have updated their testing report to reflect the fact that all Althea products meet the relevant standards,” a spokesperson said.
“In the absence of a clear, published methodology, the medicinal cannabis industry will continue to receive inconsistent testing results. Althea joins other stakeholders in calling for the publication of a TGA-approved standardised testing method in order to remove the ambiguity seen in testing results.”
Novachem, which distributes Bedrocan products in Australia, said it was “disappointed” with the TGA and said it is seeking a “more harmonised approach”.
“We feel disappointed that the TGA published that information it had to hand when there was still ongoing discussion regarding the testing results and the basis for those,” it said. “However we are confident that the product we provide does now and always has met the TGA’s strict requirements on imported medicinal cannabis products, including potency.
“Quality of medicinal cannabis products must be at all times and in all ways paramount and ensuring patient wellbeing is the number one consideration. We remain 100% committed to providing this to Australian patients.”
Little Green Pharma said the disparity “demonstrates the need for improved national alignment and standardisation of the methodologies and reference standards used across all TGA GMP-licensed laboratories”.
“This is especially the case for (a) low-volume active ingredients, where tiny error margins or procedural differences have compounding effects; and (b) cannabis reference standards, with different laboratories and different jurisdictions expressing preferences for either solid or liquid standards, despite the apparent potential to produce inconsistent results.”
“As previously noted, LGP’s contracted GMP-licensed laboratory is working with the TGA to align their procedures, standards and outcomes. However, since the original finding LGP has engaged the above accredited laboratory for all its physical/chemical GMP testing requirements to ensure TGA laboratory conformity, and will do so until it is satisfied these laboratories are fully aligned.
“We would gladly welcome any TGA initiatives in this space, and indeed believe it essential to consolidating prescriber and patient trust in the rapidly growing medicinal cannabis industry.”
Canopy Growth (owner of Spectrum Therapeutics) regional managing director APAC Ben Quirin said: “We’ve stood by the reliability and quality of our products so it is great to see the TGA reflect the third party test results they commissioned.
“Part of growing and developing the medical cannabis sector in Australia is aligning on testing and we look forward to the TGA releasing the test method they use so the industry understands the parameters they are working with.
“As we continue to work through this process we remain focused on advancing our medical education programs and serving patients with high quality medical cannabis products and the medically approved devices they require.”