TGA Under Fire for Health Claim List that Critics say Endorses Pseudoscience
Hundreds of bizarre health claims such as “tonifies kidney essence” and “opens body orifices” will be approved by the Therapeutic Goods Administration and appear on complementary medicine labels under new laws being pushed by the federal government, horrifying doctors.
In July last year, the TGA began developing a list of “permitted indications” that would restrict vitamin and herbal medicine companies to make only government-approved health claims on their products once the Therapeutic Goods Amendment bill passes.
Health groups were expecting a list of about 100 clinical indications, each backed with scientific evidence.
Instead, it has ballooned to more than 1000 claims, most of which they say are misleading, potentially harmful and based on pseudoscience.
“The TGA held industry consultations and just lost the plot; it gave them a licence to deceive,” said Allan Asher, a regulatory expert and former deputy chair of the Australian Competition and Consumer Commission.
“Everybody thought things would get better, but it’s made things worse because the indications will be government-approved and government-required, and under product liability laws, if something is required by a government, it can’t be found to be a hazardous product.”
If the bill passes, complementary medicine companies will only be able to draw from the list of permitted indications (that is, claimed purpose or health benefit) when registering, and later labelling, their products.
The list will be a legislative instrument.
The latest draft list contains innocuous items such as “relieves itchy eyes” and reassuringly shows the TGA has struck off dubious claims such as “helps increase hand to eye coordination”, noting “remove – not plausible”.
But critics claim 86 per cent of the 1019 indications are not supported by scientific evidence, including “softens hardness”, “replenishes gate of vitality” and “moistens dryness in the triple burner”.
“There’s this yawning loophole where if you can’t say that it’s scientific, you can say there’s evidence it’s traditionally been used,” said Mr Asher, chair of the TGA Complaints Resolution Panel, which will be scrapped under the bill.
“I’m worried consumers will think these traditional claims have some form of government imprimatur and are thus likely to be effective, when there is no such guarantee.”
Two years ago, the National Health and Medical Research Council reviewed 225 research papers on homeopathy and concluded there was no good quality evidence to support the claim that homeopathy works better than a placebo.
Complementary medicines include vitamins, mineral and nutritional supplements, homeopathic, aromatherapy products and herbal medicines.
Seven out of 10 Australians take some form of vitamin or supplement.
Dr Bastian Seidel, president of the Royal Australian College of General Practitioners (RACGP), said some of the indications were a dangerous mixture of “fiction and hope” and, at worst, could interact with pharmaceuticals and be harmful.
“The TGA needs to have a good look at its role as a regulator and realise it should not endorse wannabe indications that are not based on science, logic or common sense,” he said.
“Its role is to protect the public from made-up claims and protect them from spending significant amounts of money on voodoo medicines that only benefit the company selling them.”
The RACGP, along with consumer group Choice, are calling for mandatory disclaimers on all traditional complementary medicines, as seen in the United States, that say the claims are “not accepted by most modern medical experts” and “there is no good scientific evidence that this product works”.
Katinka Day from Choice said they were seriously concerned that the changes would fail to protect consumers from ineffective drugs.
“From supplements which claim to suppress your hunger to tablets which say they’ll increase your libido, consumers will have no way of finding out whether these products actually work,” she said.
“We’ve already seen vitamins company Swisse evade a TGA ban on its Ultiboost Appetite Suppressant by changing the label to claim its traditional use.”
The bill was recently amended in the senate after consumer groups expressed concerns about the immediate removal of the pre-approval process of advertisements for complementary medicines. This has been extended by two years.
The bill is scheduled to be debated on Monday, and if passed, will return to the lower house.
‘It’s not Voodoo’
A TGA spokeswoman said the list was previously unlimited but it had gone through a careful process of limiting the indications to “very low” level statements suitable for self-selected medicines.
She said “traditional use” complementary medicines will be required to carry mandatory statements such as “traditionally used in Chinese medicine”.
“Equating traditional Chinese medicines to voodoo and pseudoscience ignores the very long history of continuous use of these medicines and the recognition they have worldwide,” she said.
“Australia has endorsed the WHO position on the role of complementary medicines [and] this position acknowledges that traditional medicines have a valid function in modern medicinal frameworks.”
Carl Gibson, chief executive officer of peak body Complementary Medicines Australia, said traditional evidence claims have been upheld in Australian and international law.
The complementary medicines industry in Australia is enjoying rapid growth, with annual sales of sports nutrition, vitamin, weight loss and herbal products tripling to $4.9 billion in 2017 over the past 15 years, according to Euromonitor figures.
“Products that make a traditional use claim are already the most heavily regulated in Australia versus elsewhere around the world,” Mr Gibson said.
“In Australia, complementary medicines based on a tradition of use are already required to state this on the product label and in advertisements.”
Room for Improvement
In relation to the permitted indications, Opposition health spokesman Tony Zappia said much of the detail contained in the TGA reforms were going to be in regulations that they will closely scrutinise.
Mr Asher said regardless of the bill, the TGA had sufficient power to address the concerns and apply a stricter criteria.
The Consumer Health Forum of Australia said while it supported a list of permitted indications, the current list had far too many permitted indications and the all-inclusive approach adopted by the TGA was diminishing the benefits of having one.
“Some of the indications on this list may not be understood by many consumers,” its spokeswoman said.
“It may give some misplaced confidence in the evidence behind the list.”