The SensaSlim “dieter’s dream” oral spray has been ordered off the market. Effective from December 1, the Therapeutic Goods Administration (TGA) order prohibits “the importing into, exporting from, Australia and the manufacturing or supply of the product in Australia, or the advertising of the product.”
The TGA directive cancelling SensaSlim Solution’s listing from the Australian Register of Therapeutic Goods follows the March complaints of false advertising lodged against SensaSlim by Dr Ken Harvey, an adjunct lecturer in public health at La Trobe University. In a letter to Dr Harvey, the TGA cites “a failure to comply with requirements of the [Therapeutic Goods] Act relating to the advertising of the product”.
Dr Harvey said that a big part of the problem was the “crazy regulatory system” for so-called complementary medicines. “It is essentially a system based on trust; the [product] sponsors tick boxes in electronic listings of the TGA’s computer system saying they hold evidence to support the claim that’s being made; they tick a box that the product only contains relatively safe ingredients; they tick another box saying that they’ve been manufactured under good manufacturing processes, they pay their money – which is relatively limited, $600 or so – and the system spits out at automatic ARTG [Australian Register of Therapeutic Goods] label and away you can go and market your product without any human hand or human brain looking at what you’ve got. It leads to a flood of shonky products and really no effective sanctions,” Dr Harvey said.
A TGA spokeswoman said that the agency was not a pre-sale testing unit for complementary medicines, and it was in the public’s interest to know that. She said the three conditions for registration under the complementary medicine class of products are that the item contains no prohibited substances; that it is manufactured safely, and that no false claims are made about it. Audits and checks are made after registration, complaints are encouraged, and action taken – as has been the case with SensaSlim – but consumers should understand that the market for such items is basically buyer beware. The spokeswoman also said that there was no accusation of SensaSlim being dangerous – it just did not work.
The Australian Competition and Consumer Commission has undertaken proceedings against SensaSlim for a range of alleged offences, including the claim that an international clinical trial had been held.
It was false claims that brought down SensaSlim Australia. In his official complaints – lodged with a variety of agencies in March – Dr Harvey had said that he could find no evidence to support SensaSlim Australia’s claims that the spray’s weight-loss properties had been scientifically established through international clinical trials. He was correct. After giving an interview about the spray to a pharmacists publication early this year, SensaSlim Australia hit him with an $800,000 defamation lawsuit in the NSW Supreme Court. When that was dismissed, the company hit Dr Harvey with a $1 million-plus lawsuit in Queensland. Defending himself against these cases has run up more than $40,000 in legal fees, much of which was donated after calls for assistance went out from the Australian Skeptics.
SensaSlim was given credulous coverage by the Seven network’s “current affairs and community interest” program, Today Tonight, which introduced it as an “TGA approved”. The product enjoyed a veneer of medical endorsement due to promotional statements by Dr Matthew S Capehorn, the Clinical Director of the National Obesity Forum (NOF) – which offers a one day Diploma in Obesity.
Dr Capehorn appeared in promotional videos as SensaSlim’s Research Director, but has since distanced himself from the company, saying that he was mislead by the company about its claims of clinical testing. Conman Peter Foster who has international experience peddling ‘weight loss’ or ‘cholesterol lowering’ teas, is allegedly associated with SensaSlim. Foster is behind bars in Queensland on charges of contempt of a previous court order barring him from the weight-loss supplement trade.