Pharma company fined and forced to change name of listed medicine after claiming it could be used to prevent and treat symptoms of COVID-19
Tianda Pharmaceuticals Australia has been issued two infringement notices totalling $26,640 for advertising its TGA-listed medicine, then called ‘Anti-Epidemic Formula 1’, on eBay for therapeutic uses in relation to COVID-19.
According to Tianda Pharmaceuticals’ website, the product is a traditional Chinese medicine that was initially posed as a formula “for improving people’s immune system, helping them to prevent influenza or COVID-19”.
The label and advertising for the medicine claimed uses for preventing, treating and relieving symptoms of COVID-19 and other infections, and strengthening a consumer’s ability to resist infection, a TGA compliance review found.
This advertising was allegedly in breach of the Therapeutic Goods Act, since claims of therapeutic use for COVID-19 are seen as “restricted representations”.
“These claims were not covered by the sponsor’s certification that they held evidence to substantiate them,” said the TGA.
While advertising for medicine claimed it could strengthen consumers’ ability to resist infection, the TGA warned consumers that it was not approved for this use and they should “be aware that the medicine may not work as expected in relation to these uses”.
In the eBay advertisement, Tianda Pharmaceuticals also allegedly claimed that the medicine was approved by the TGA.
“Advertisements for therapeutic goods must not make any statement that implies the goods have been recommended or approved by a government, except in very limited circumstances. This includes statements that therapeutic goods have been approved by the TGA or international regulators,” the regulator found.
While the medicine will continue to be permitted for supply following review, the sponsor was forced to update the label and advertising for the medicine to remove the claims related to serious forms of infectious diseases.
It also changed the name of the medicine to ‘Formula 1 Granules’ – removing the terms that implied the product could be used preventatively in an epidemic – and paid the financial penalty.
The sponsor withdrew stock from distributors for the purposes of re-packaging with a corrected label. Batches released after March 2021 must carry a corrected label.
Since early last year the TGA has been significantly cracking down on companies advertising medicines that purport to prevent or otherwise treat COVID-19.
“The references to COVID-19 and other infectious diseases have the potential to lead consumers with these conditions to delay access to timely medical advice or treatment when required, resulting in adverse outcomes,” it said of this latest medicine.
However it added that current data indicates that use of this specific medicine is unlikely to pose an “immediate” risk to consumer health and safety.
Public health physician, Dr Ken Harvey, who is the president of Friends of Science in Medicine (FSM), told the AJP that there is still more work to be done towards the regulation of complementary medicines in Australia.
The TGA conducts post-market compliance reviews of listed medicines, however Dr Harvey said FSM has been “suggesting for some time that the TGA should monitor new entries on the ARTG for suspect products”.
Due to its post-market monitoring approach, the ‘Anti-Epidemic Formula 1’ product – the label of which the TGA admits “carried an implied reference to COVID-19 through the name of the medicine” – was able to be sold under that name for nearly a year during the pandemic.
Once the TGA became aware of the restricted representations made in the eBay advertising, it notified the sponsor of its concerns and they were removed within a week. New labels with the new name were instituted a few months later.
Dr Harvey added: “While it’s good they have acted on the COVID-19 ‘Anti-Epidemic Formula 1’ there are plenty of others they could tackle if they had the will.”
This includes many complementary medicines often stocked on pharmacy shelves.
Permitted indications under the ARTG listing for the newly named Formula 1 Granules related to its use in traditional Chinese medicine, including to: “clear/dry/drain/eliminate/resolve dampness” and “increase/augment/generate/promote/strengthen qi”.
Dr Harvey said FSM and others have “long advocated” that an advisory be added to the pack and promotional material of all products such as traditional Chinese medicines which reads, for example: “This product is based on traditional beliefs and not modern scientific evidence”.
“But this has been resisted by industry, the TGA and government,” he added.
This week the TGA also issued seven infringement notices totalling $18,648 to an individual responsible for the Invigorate Labs website, for alleged breaches relating to the advertising of products containing cannabidiol (CBD).
The Invigorate Labs website allegedly advertised CBD vaping liquid and other CBD products that were not entered in the ARTG and were not exempt from being so.
Advertising on the Invigorate Labs website also allegedly claimed that a CBD cream product is an effective treatment for “palindromic rheumatoid arthritis”.
“As a serious form of a condition, this is a restricted representation that requires prior approval of the TGA before being used in advertising. In this case, no approval had been granted,” the TGA said.
The individual also allegedly made a prohibited representation on a related social media platform in relation to the use of CBD oil for the treatment of cancer.
The TGA notified the individual on multiple occasions to remove the relevant advertising, however on each occasion, the individual appeared to engage in a “phoenix” activity, where the website was removed and replaced.
Similar contraventions have resulted in steep penalties issued in court in recent months.
A different company, Evolution Supplements Australia, and its director were recently ordered by the Federal Court of Australia to pay a total of $12 million for the unlawful advertising of sports supplement products that had not been entered in the ARTG.
This article was edited at 2.15pm on 1/10/21 to add further comment from the TGA.