Restricted representations


business owners holding up red cards for reprimand

The TGA has handed down more than $23K in fines relating to unlawful advertising of medicinal cannabis to treat cancer, and of homeopathy for COVID-19

The Therapeutic Goods Administration made a statement this week about four infringement notices it handed to a person for alleged unlawful advertising of cannabidiol oil.

The four infringement notices, totalling $10,656 to a Sydney-based individual.

The TGA says that it raised concerns several times with the person, pointing out that they could not make reference to the substance Cannabidiol (CBD) in the advertising of CBD Oil or other medicinal cannabis products.

“This is because CBD (and goods containing CBD) is included in Schedule 3, 4 or 8 of the current Poisons Standard and cannot be advertised to the public unless the substance is also included in Appendix H of the Poisons Standard,” the TGA says.

While the TGA had made a final decision in December 2020 to downschedule certain cannabis products from Prescription Only to Pharmacist Only, coming into effect February 2021, no products have yet been released onto the pharmacy market. Aside from a very small number of prescription only products, medicinal cannabis products are not approved medicines in Australia.

The TGA noted that the Therapeutic goods Act prohibits consumer advertising of substances included in Schedule 3 (pharmacist only medicine) of the Poisons Standard unless the substance is also listed in Appendix H.

“Substances included in Schedule 4 (prescription only medicine) or Schedule 8 (controlled drug) of the Poisons Standard cannot be advertised to consumers,” it points out.

“It is also alleged that the CBD oil that was advertised was not entered, at the time of advertising, in the Australian Register of Therapeutic Goods.

“The Act prohibits consumer advertising of therapeutic goods that are not entered into the ARTG, unless a specific exemption, approval or authority applies (which had not occurred).”

The TGA alleges that the person in question had referred to the CBD oil in the advertisement as a treatment for “cancerous tumours”.

It notes that this is a prohibited representation, as was other alleged advertising on the same person’s website relating to Alzheimer’s Disease.

“Under the Act, the use of prohibited or restricted representations in advertising of therapeutic goods is unlawful without prior authorisation from the TGA. No relevant authorisations had been granted in relation to this matter.

“The TGA has informed the individual that the alleged unlawful website and social media advertising must be removed immediately.”

Meanwhile in Canberra, the TGA gave another person an infringement notice for $2,664 for alleged unlawful advertising of a homeopathic medicine in relation to COVID-19.

“The individual allegedly promoted, on their website, a homoeopathic immunisation product that contained a representation that the product provided ‘a more competent immune response to the Covid-2 virus, and also to those who [are] presenting with post Covid symptoms’.

“The advertisement further stated that the product was made from ‘the SARS Covid-2’.”

The TGA points out that the alleged advertising was unlawful because it made representations about COVID-19 – a restricted representation.

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