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Some questions for federal authorities on weight loss products

Ever since news broke about a US recall of weight loss products called Hydroxycut, the one-man industry watchdog Dr Ken Harvey has been on a campaign to get some action in Australia.

The Food and Drug Administration says the supplements have been associated with serious side effects, including liver toxicity.  In Canada, a class action law suit has been filed.

Harvey, Adjunct Senior Research Fellow School of Public Health, La Trobe University, says the key issue is why do the company &/or the TGA believe that Australian products are safe when some of those withdrawn in the US appear to be the same as those available in Australia; see here.

He says: “To-date, the TGA has only warned consumers not to purchase US productsvia the Internet! The assumption is that the Australian products have a different formulation and that makes them safe. No evidence has yet been provided to support this assumption.”

Here is Harvey’s letter with some questions for the Federal Government:

6 May 2009

Senator Jan McLucas
Parliamentary Secretary to the
Minister for Health and Ageing
Parliament House
Canberra ACT 2600

Dear Senator McLucas,

Re: TGA warning issued on complementary medicines weight loss products  (Hydroxycut)

Adam Cresswell reported today that “AUSTRALIA’S drug watchdog has warned consumers to stop using a range of weight-loss products bought on the internet from the US, after 23 reports of serious liver problems, including one death” .

“A TGA spokeswoman said last night it had been informed by the Australian sponsor, Export Corporation (Australia) Pty Ltd, that the four Hydroxycut products approved for sale in Australia had a different formulation to the products sold in the US, as some of the US ingredients were not permitted here”.

I am unclear why the TGA warning is restricted to US products bought on the Internet and why the TGA has accepted the sponsor’s advice that the Australian listed products differ from those removed in the US and Canada.

I have appended the names of Hydroxycut products (and their ingredients) listed on the ARTG as sponsored by Export Corporation (Australia) Pty Ltd.

I have attached printouts of three current Australian advertisements for Hydroxycut products from:
http://www.mrsupplement.com.au/

One advertisement promotes Hydroxycut (ARTG No: 154243) as “America’s #1 selling weight-loss supplement. The ingredients in this product appear to be the same as those in product removed from sale in the US and Canada. In particular, they include Garcinia quaesita (cambogia) . The latter ingredient has been associated with hepatoxity .

I have also attached the detailed US Health Hazard Evaluation Board Report concerning Hydroxycut, “Liver toxicity following consumption of dietary supplement”.

I have the following questions:
1.     In what way does the formulation of Hydroxycut product (ARTG No: 154243) differ from those removed from sale in the US and Canada?
2.    Why has the TGA not withdrawn this product from the Australian market as has occurred in the USA and Canada?
3.    Does the TGA agree that the claims made for these products in the attached advertisements breach the Therapeutic Goods Advertising Code? If so, what action will be taken?

Yours sincerely,

Dr. Ken Harvey
Adjunct Senior Research Fellow
School of Public Health, La Trobe University

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