A company has promised to follow the rules after a $63k penalty for alleged unlawful medicines advertising relating to COVID-19… but others face court action
Chemforce has voluntarily entered into an undertaking to provide the TGA with assurance of its ongoing compliance related to medicines advertising.
In June last year, the company was issued five infringement notices totalling $63,000 for alleged unlawful advertising in relation to COVID-19.
Its advertising for a product called RibaMin included claims to the effect that it was “a specific combination of known, tested FDA approved drugs that provides a unique SET of properties with sufficient potency to attack the virus, protect the necessary cells and systems in the body and provide symptomatic relief”.
The advertisement further claimed that the product was an “effective treatment for COVID-19 virus” and that it is “safe”.
As the product was not included in the Australian Register of Therapeutic Goods (ARTG), it cannot be lawfully advertised to the general public in Australia. Additionally, under the Therapeutic Goods Act 1989, any claims or references to treating COVID-19 and related terms are restricted representations.
Chemforce said its intention in advertising the product was to assist it in finding an investor to perform a clinical trial.
However it removed the advertisement on its website after being alerted by the TGA that it was unlawful.
Chemforce has now voluntarily entered into an undertaking to provide the TGA with assurance as to its ongoing compliance with the Act.
The company has undertaken not to, advertise therapeutic goods in Australia, import therapeutic goods into Australia, or supply therapeutic goods in Australia, that are not entered in the ARTG.
It may at any time apply to the Secretary for consent to vary this undertaking.
Chemforce must provide any documents or information requested in relation to its advertising, importation or supply of therapeutic goods to persons in Australia within 14 days after receiving a request from the TGA.
The TGA can choose to negotiate enforceable undertakings instead of pursuing court action, in circumstances where a company has breached an offence or civil penalty provision in the Act.
In a different case last year, another company was similarly fined in March last year but subsequently faced court action.
Oxymed Australia was issued five infringement notices totalling $63,000 and ordered to remove advertising of a product that made claims related to COVID-19.
The advertising allegedly promoted devices for the treatment of serious diseases and medical conditions, including coronavirus (COVID-19), cancer, post-traumatic stress disorder and autism spectrum disorders.
However this company did not pay its notices and the alleged unlawful advertising remained up on the company website after the notices were issued.
The TGA therefore initiated court proceedings to obtain an injunction restraining the company from advertising the product.
It also sought orders that the company and sole director pay penalties for alleged contraventions of the Act.
References to COVID-19 are of particular concern to the TGA given the current pandemic, and the TGA has published a warning to advertisers and consumers about illegal advertising relating to COVID-19.