23 June 2020
The Therapeutic Goods Administration (TGA) has commenced a review of complaints received alleging non-compliant advertising of medicinal cannabis products to the public.
The TGA has written to a number of entities in relation to non-compliance with the law with instruction to cease unlawful behaviour.
The majority of respondents have brought themselves into compliance. For those that have not, the TGA is considering appropriate action.
The TGA’s compliance focus is three-fold.
First, some medicinal cannabis products being offered for supply may not meet the same standards of quality and safety as products that have the appropriate approvals under the Narcotic Drugs Act 1967 and the Therapeutic Goods Act 1989 (“TG Act“) and Customs (Prohibited Imports) Regulations 1956.
The TGA are therefore prioritising complaints where consumers may be at risk because the medicinal cannabis products offered for sale have not been through regulatory checks.
Second, the status of cannabis and its derivatives as substances in Schedule 4 or 8 of the Poisons Standard means that they cannot be advertised to the public.
This means when entities publish information about medicinal cannabis, care needs to be taken to ensure the information does not promote its use or supply.
Finally, references to serious form of a disease, condition, ailment or defect are either restricted or prohibited representations that require the prior approval of the TGA before being used in an advertisement for a therapeutic good. Use of these representations without approval may also lead to a breach of the TG Act.
Reflecting the significance for public health, criminal offences and civil penalties apply to breaches of the TG Act. Criminal offences may also apply under State and Territory laws relating to the unlawful supply of “prescription only medicines” and “controlled drugs”.
More information on access to medicinal cannabis products in Australia is available on the TGA website and from the Office of Drug Control. The TGA website also has specific advertising guidance material for businesses involved with medicinal cannabis products.
Text by: Australian Government Department of Health Therapeutic Goods Administration