Almost a quarter of 22 medical cannabis products tested by the Therapeutic Goods Administration failed to comply with required standards, data has revealed.
Laboratory analysis found five products were either stronger or weaker than they should have been, with suppliers warned that another “failed batch” would be in breach of the Therapeutics Goods Act.
The TGA announced in March that it would undertake an audit of unregistered medical cannabis products supplied through the Special Access Scheme. The TGA said importers or suppliers of products that do not comply with standards “may be subject to a range of regulatory compliance actions, including civil and criminal penalties”.
The audit, which was carried out in July and August, requested samples of the top 25 products by volume supplied through the SAS. Three were no longer available, leaving the TGA to test 22.
The lab analysis focused on whether the potency of the products matched that stated by the manufacturer on their Therapeutic Goods Order 93 (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 “marginally” 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. Additionally, they had a declared stated content that was lower than the amount listed on the label.
“The inconsistencies in the label claim and declared state content were highlighted as a concern with the supplier,” the TGA said in its report.
The remaining 17 products examined by the TGA fell within the permitted range.
Of the 22 products, 17 were an oral oil, three were dried flower, one was a capsule, and one was a spray. Ten were schedule 4 CBD products with less than 2% of other cannabinoids.
The full list of samples and test results can be found here.
The TGA said responses from the suppliers included “evidence to demonstrate the products had met the requirements at the time of manufacture”.
For products with “unacceptably low levels of active ingredients”, assurances had also been given “that any remaining stock would not be supplied under the current TGO93 declaration until the matter has been resolved to the satisfaction of the TGA.”
A spokesperson for the TGA told Cannabiz: “We have requested that any remaining stock is quarantined and also advised the affected suppliers that any further supply of a failed batch would be in breach of section 14 of the Therapeutic Goods Act 1989 as the goods do not conform to the applicable standard.
“The TGA is currently planning another round of testing of medicinal cannabis for compliance with TGO93 in 2020-21. The next testing will include both imported and domestically manufactured products.”
Batches of the two products with higher potency had already reached the end of their shelf life and were therefore not quarantined, the TGA added.
While the audit found the vast majority of samples complied with the ingredient requirements, there will be concern that nearly one in four of the most-approved products were either weaker or stronger than they should have been, according to the TGA laboratories.
Some of the products of concern were manufactured in Australia and underwent local batch testing by a TGA-approved laboratory. But when tested by the TGA themselves these products were found to be non-compliant.
The results highlight the scientific and technical challenges of product consistency and analytical accuracy.
LGP chief executive Fleta Solomon told Cannabiz it took all the necessary measures to abide by TGA regulations.
“Prior to releasing the LGP Classic 20:5 medicine to market and in accordance with TGA requirements, LGP engaged an Australian Government-owned, NATA-accredited and TGA-regulated and licensed GMP laboratory to conduct testing of the relevant medicines,” she said. “We received test results that confirmed the medicine’s active ingredients were well within the tolerance for medicinal cannabis labelling.
“LGP welcomes the opportunity to work with the TGA and testing laboratories to improve standardization and ensure alignment between testing practices and chemical standards.
“LGP remains totally committed to patient safety and medicine quality in a new and evolving industry. Patients and prescribers can be assured that the product batch in question is no longer available to be dispensed in Australia and that the safety of the medicine has not been questioned.”
Canopy Growth managing director APAC Ben Quirin, owner of Spectrum Therapeutics, said the company acted as soon as it was notified of the Spectrum Blue results by the TGA.
“This batch of Spectrum Blue Oil was approved within specification by third-party testing prior to being shipped from Canada, and subsequently passed additional third-party testing in Canada as well as the third-party testing requested by the TGA.
“As soon as we were initially notified by the TGA of the results of their in-house testing and out of an abundance of caution we pulled this batch from the market and we are engaging with them to better understand the variance between their in-house test and the three other successful third-party tests completed on the product.”
Althea chief executive Josh Fegan said the products named in the report “underwent extensive testing” prior to release, including pre-importation testing in Canada using independent laboratories and post-importation analysis in Australia using NATA ISO/IEC accredited labs.
“With respect to the products listed in the TGA report, prior to release Althea received results confirming the CBD content was within the tolerance of the required standard,” he said. “These test results were further confirmed post release as part of Althea’s routine rotational testing protocol.
“In the light of this, Althea is currently in dialogue with the TGA regarding findings published in this report. We appreciate the fact that in the absence of a nationally accepted pharmacopeial standard for medicinal cannabis, interlaboratory variances will occur, and we look forward to clarifying the results with the TGA.
“We otherwise note that the TGA did not require Althea to take any action with respect to the products.”
On the apparent discrepancies between the declaration and labelling, Fegan said: “To date, with products imported from Canada, in addition to information submitted to the TGA, batch-specific concentrations are printed on the product label. The TGA is aware of this practice and has no issue with it.”
Novachem, which distributes Bedrocan in Australia, said it was in dialogue with the TGA.
Business development manager Andrew Heath said: “The company is having ongoing discussions with the TGA about its findings and until those discussions are concluded it is inappropriate for me to comment further.”