Complaints to the TGA by Monash SPHPM Summer Vacation Scholarship students

Lucy Romanoff investigated the illegal promotion and supply of body-building supplements in Australia. This problem was highlighted by the ABC earlier this year, but no action has been taken by the TGA about the products mentioned.

One ingredient mentioned by the ABC was cardarine, recently placed into Schedule 10 of the Poisons Standard. This means that it is of such danger to health as to warrant total prohibition of sale, supply and use.

Yet Lucy found this ingredient (and other Scheduled drugs) in a body-building supplement, “The King Kong Stack”, advertised and supplied in Australia by Evolution Supplements. The complaint she worked up (and I submitted) is another example of the failure of the TGA to protect consumers from illegally supplied, dangerous products. Our complaint noted there are many other Australian body-building web sites supplying similar illegal drugs. This complaint was allocated reference number AL-IP17Y7E6/2018 and accorded “high”, not “critical” priority. The priority given is difficult to understand.

Darci Bucheli investigated the illegal promotion and supply of whole-body cryotherapy machines within Australia. Their alleged benefits include weight loss, relieving pain instantly, slowing down the ageing process, and improving acne, psoriasis, eczema and autoimmune diseases.

The U.S. FDA has warned consumers about these devices, but not the TGA.

Darci worked up a complaint for the TGA which I submitted. It was allocated reference no AC-SK500GAY/2018 and a “medium” priority. It provides yet another example of deficiencies in medical device regulation, recently highlighted by the International Consortium of Investigative Journalists.

Conclusion: The critique by Commissioner Haynes on the regulators of the financial services industry is equally applicable to the TGA. A failure to enforce the law undermines the authority of the regulator whose fundamental responsibility is to do just that. It also encourages others to break the law, leading to a race to the bottom.

Postscript (18 December 2018): Whacko! The TGA has taken its first company court action in almost a decade after alleging a prescription ‘peptides’ seller breached the regulator’s advertising code. The TGA action against Peptides Clinics Australia is the first civil penalty proceedings against a company since 2009, a health department spokesperson said.

It is also the first legal action the regulator has conducted since it won new compliance powers in the change up to the advertising complaints model. “[The action] is the first set of proceedings using the new compliance and enforcement regime included in the [TGA Act] from 6 March 2018,” the spokesperson said.

Hopefully, this is the first of many similar actions by the TGA against  numerous Australian companies promoting and supplying illegal, dangerous, scheduled poisons.

See also: Australian drug regulator takes action over claims products can treat disease
and: Health watchdog takes online supplier of bodybuilding supplements to court.

Postscript (26/01/2017): TGA Direction about advertisements: Evolution Supplements. It is reported that the company CEO Cumhur Keskin told the regulator he “did not wish to provide any written submissions in response to the warning letter, and that [he] would not take down the advertisements referred to in that letter”.

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About Dr Ken Harvey

Public Health Physician, Medical activitist
This entry was posted in Complementary medicine, Medical Devices, Pharmaceutical Promotion, Uncategorized, Weight loss and tagged , , , , , , , , , , , . Bookmark the permalink.

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