01.TGA put on hold
A behind-the-scenes look at the activity leading up to the defamation lawsuit against long-time consumer health advocate Dr Ken Harvey reveals what appears to be a toothless Therapeutic Goods Administration (TGA) bowing to pressure from the makers of a non-pharmaceutical weight-loss product.
The product, SensaSlim Solution, comes in spray form and claims to “send a message to the brain that suppresses the appetite, without affecting the central nervous system”.
SensaSlim also promises that users can lose weight while they sleep, that “potent active ingredients enter the bloodstream and naturally suppress the appetite”, and that the product “is unquestionably the most effective slimming solution available in the world today”.
SensaSlim says it has conducted an effectiveness trial of 11,453 people from over 100 countries and reports that “the number one side effect was excess weight loss! Some people lost so much weight that the researchers had to drop them from the study”.
Consumers are recommended to use the product “three times a day, at your convenience, by two sprays onto the tongue, ten minutes before meals. The effect of the formulation is felt immediately and suppression of appetite is swift”.
TGA regulations fall short
CHOICE has launched an investigation into the events surrounding the $800,000 lawsuit SensaSlim has brought against Dr Harvey and found that, regardless of the outcome of the case, the product maker, SensaSlim, can continue to reap profits while the TGA is powerless to act.
The case came about when an article about Dr Harvey’s TGA complaint was reported by AusPharm, an online news service for pharmacists. SensaSlim threatened legal action against AusPharm and Dr Harvey, demanding that AusPharm withdraw the story and that Dr Harvey withdraw the complaint. AusPharm complied, but Dr Harvey is standing his ground at significant personal cost.
Therapeutic Goods Regulations 1990 42ZCAJ (2) stipulates that the TGA’s Complaints Resolution Panel (CRP) cannot pursue complaints if the subject of the complaint is involved in legal proceedings. These SLAPP (strategic litigation against public participation) writs are not uncommon in the complementary medicines industry and allow product makers to continue to profit while complainants face the expense, inconvenience and distress of defending themselves in court.
CHOICE has obtained documents in which SensaSlim employee Adam Adams says “this defamation action, which could be in the courts for a year or two or even longer, basically gives an iron clad protection that nobody can raise a complaint against SensaSlim to the CRP and hurt us.”
While the CRP’s hands are now tied by their own regulations, they had earlier adjudicated on a similar SensaSlim complaint, which determined that SensaSlim had to withdraw representations that the product suppresses the appetite, affects taste buds or taste sensitivity, improves weight management, leads to weight loss, or that it is effective or clinically proven to have such benefits. The determination also noted that SensaSlim contained ingredients similar to other weight-loss products that have no evidence of being effective.
CHOICE has also learned that SensaSlim successfully demanded that the CRP determination be withdrawn because of the pending court action with Dr Harvey. The CRP determination was posted for less than one hour before it was withdrawn, though CHOICE was able to obtain a copy of it.
The withdrawn determination suggests there is no evidence SensaSlim works as claimed, yet the product remains on the Australian Register of Therapeutic Goods for the purpose of weight loss.
CHOICE has also learned that a doctor featured prominently on SensaSlim’s marketing materials, Dr Matthew Capehorn, has since attempted to disassociate himself from the company, though he still appears on the website. According to documents obtained by CHOICE, Dr Capehorn entered a five-year agreement for $728,000 to represent the company but backed out when proof of the clinical trial results were not produced as promised.