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.