The TGA has issued seven infringement notices totalling A$18,648 to the individual responsible for the Invigorate Labs website for alleged breaches of the Therapeutic Goods Act 1989.
The alleged breaches related to the advertising of products containing CBD, including a CBD vaping liquid, that were not entered in the Australian Register of Therapeutic Goods (ARTG) and were not exempt from being so.
This means the TGA had not evaluated the products for quality, safety or efficacy and the manufacturer had not obtained relevant approvals.
Advertising on the Invigorate Labs website allegedly claimed that a CBD cream product was an effective treatment for “palindromic rheumatoid arthritis”. The TGA noted that this is a restricted representation that requires prior approval by the regulator before being used in advertising and that approval had not been granted.
In Australia, it is illegal to advertise therapeutic goods that have not been entered in the ARTG without an exemption or approval.
It is also alleged that the individual made a prohibited representation in relation to the use of CBD oil for the treatment of cancer on a related social media site.
On multiple occasions, the TGA notified the individual to remove the advertising, but on each occasion they appeared to engage in what the TGA described as a ‘phoenix activity’ — removing and replacing the website.
The TGA stated that it “is very concerned about advertisers engaging in deceptive conduct to evade the regulatory rules that are in place to protect the health of Australian consumers”.
The alleged breach comes after the use of duplicity by a business was recently criticised by the Federal Court of Australia when it ordered Evolution Supplements Australia and its director to pay a total of $12 million for the unlawful advertising of sports supplement products that had not been entered in the ARTG.
The court stated that “other traders should be sent a very strong message that such conduct should not occur” due to the seriousness of the contraventions and deceptive conduct.
The TGA has urged those with questions about medicinal cannabis for the possible treatment of health conditions to speak with their doctor.
The TGA website also includes a printable infographic about safe and legal access to medicinal cannabis products for suitable circumstances and encourages the reporting of suspected non-compliant advertising.