Unregistered Cannabis Products Fail to Meet TGA Requirements
22nd September, 2020
The TGA’s recent Laboratories Testing Report on routine surveillance of unregistered products supplied to the Australian market via the SAS scheme has revealed that almost one quarter of samples received for testing failed to meet TG093 requirements relating to declarations made to the TGA regarding content of active ingredients.
The TGA requires that plant material finished products contain 80-120% of the stated content, while requirements for oil finished products, tablet or capsule products not included on the ARTG, and other dosage forms are 90-110% of the stated content. The affected products – oil and plant material – returned results up to 5% outside of upper or lower limits.
The top 25 supplied medicinal cannabis products by volume in the market were targeted. Of these 25:
- 3 were not supplied due to no longer being available
- 3 were found to have less than the stated content of active ingredient
- 2 were found to have more than the stated content of active ingredient
- 17 met stated content of active ingredient
The TGA only tested the stated content of active ingredients and did not test other TGO93 requirements including presence of heavy metals, pesticides and various toxins.
Prominent Australian medicinal cannabis companies were included in the group of products failing to meet obligations and while stability for plant-based medicines is a known challenge in the industry, the inconsistencies in label claims and declared stated content are concerning.
FreshLeaf understands that suppliers of products failing to meet requirements have been notified of the testing results and reminded of the requirements of the TG093 and the provisions of penalties if they fail to meet them. Some suppliers are said to have responded with evidence to demonstrate that products had met requirements at the time of manufacture and it’s reported that suppliers have given assurances that any remaining stock would not be supplied under the current TG093 declaration until the matter has been resolved to the satisfaction of the TGA.
While some results were only marginally above or below, as an industry we can ill-afford the negative attention stemming from failing to meet TGA requirements, particularly when these results are coming from some of the industry’s leaders. Moving medicinal cannabis into the registered medicine channel with S3, S4 or S8 products manufactured under TGA certified GMP will help improve quality and should reduce the incidence of non-compliance.
The TGA states “it is a criminal offence under section 14 and a contravention of section 14A of the Therapeutic Goods Act 1989 (the Act) for a person to import and supply therapeutic goods that do not conform with a standard applicable to the goods, without the written consent of the Secretary”. One can only hope that these test results serve as a wake-up call for all players in the industry, with companies putting necessary checks in place to ensure industry-wide compliance with TG093 requirements.
Cassandra Hunt, Managing Director of FreshLeaf commented: “It is encouraging that the TGA is starting to test the quality of the unregistered medicinal cannabis products being supplied in Australia. More widespread testing of products will hopefully lead to higher product quality and an industry in Australia that leads the world in terms of medicinal cannabis standards.”
Tony Whittaker, Regulatory Specialist FreshLeaf commented: “Products supplied under SAS are not subject to the same level of quality, safety and efficacy controls as TGA-registered products. These results reinforce the need to move towards products that are evaluated and registered by the TGA and manufactured under GMP-licensed conditions.”
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FreshLeaf Analytics, part of the Southern Cannabis Holdings group, is Australia’s leading source of data and information about the medicinal cannabis industry. FreshLeaf provides strategic consulting services to industry and government clients. For more information: [email protected] or [email protected] (+61) 2 8203 8741 @FreshLeafA
About Southern Cannabis Holdings: SCH specializes in building and operating cannabis businesses in markets where cannabis is regulated as a pharmaceutical product. SCH companies include CA Clinics, Applied Cannabis Research and FreshLeafAnalytics. To find out more about SCH, please visit www.southerncannabisholdings.com.au [email protected]