Can the TGA ever win? Regulator in hot debate over ear candles
It’s probably not going to shake the foundations of healthcare, but last month the TGA issued a statement on its website declaring it would no longer bother regulating the sale and use of ‘thermal auricular therapies’ — a fancy term for what we know as ear candles.
Ear candles have been a big seller in the world of alternative medicine for some years and you can still find them on pharmacy shelves promoted as a treatment for the build-up of ear wax and numerous other ailments from vertigo to deafness.
And along with their popularity has come the documented cases of burns, otitis externa and perforated eardrums — the consequences of DIY therapy gone wrong.
The reason the TGA says that ear candles are no longer part of its remit is because the claims made for these products are “consistent with cosmetic or personal hygiene”.
Therefore the products are “more appropriately considered as consumer goods”.
The watchdog has applied a similar argument to deodorants — which in theory it has also been tasked with regulating.
It admits its oversight has contributed little and it suggests — using slightly more words — that it has better things to do than perform a review of the efficacy of Lynx Africa.
However, not everyone is happy.
Criticism has come from the TGA’s familiar foe Dr Ken Harvey, a spokesman for Friends of Science in Medicines, who is accusing the watchdog of “abdicating its responsibility”.
The issue is not just about ear candles.
The TGA, as part of an ongoing review, has also been looking at other products such as homoeopathic remedies.
It is yet to make a decision, saying it needs to conduct yet more consultation with stakeholders.
But it could apply the same logic it applied to ear candles and kick the other products outside its jurisdiction even though they are marketed to patients as therapeutic goods.
At this point you could feel a little sympathy for the TGA.
For years it has been widely condemned for officially listing 'quack' treatments like homoeopathy and ear candles as therapeutic goods.
It takes a decision to remove some of them and it still gets a bashing.
But Dr Harvey warns that without the TGA, responsibility for monitoring these non-therapeutic therapeutic goods will lie with the ACCC.
“Given the wide-ranging brief and enormous workload of the ACCC, this would effectively mean no regulation at all as the ACCC only has the resources to act on the most egregious cases,” he says.
*This article first appeared in Australian Doctor