Healthy Skepticism Library item: 15416

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Cresswell A.
Ban urged on weight-loss medicine Mega Slim
The Australian 2009 Apr 8
http://www.theaustralian.news.com.au/story/0,25197,25306329-2702,00.html

Full text:

THE nation’s drug watchdog is being asked to ban the sale of a herbal weight-loss product on the grounds that it could harm or even kill people, amid claims an active ingredient has been linked to cases of heart complaints overseas.

The product, called Mega Slim, describes itself as a “thermogenic amplifier” and “premium fat burner” and claims to help reduce weight by increasing the body’s metabolism.

But in a complaint to the Therapeutic Goods Administration, which oversees the sale and supply of medicines in Australia, a drugs expert claims one of its three main herbal ingredients has been linked to 16 cases of serious heart conditions in reports to Canadian health authorities.

The complaint says individuals involved in the Canadian cases, reported between 1998 and 2004, experienced a rapid heartbeat, blackouts, collapse and heart attacks after consuming the ingredient, known as citrus aurantium, or bitter orange. Two patients died.

The maker of Mega Slim, the Victorian-based company Next Generation Supplements, has rejected any suggestion that its product poses a health risk, saying many other products also contain bitter orange.

Company co-owner Eddie Tannourji said the product had been cleared for sale by the TGA.

But the latest complaint has raised questions once again over Australia’s regulation of complementary medicines, with several expert bodies claiming the TGA’s proposals for tightening up the requirements are flawed and ineffectual.

Unlike registered pharmaceutical drugs, most herbal and complementary medicines are merely “listed” by the TGA, which means their makers pay a fee and are expected to hold evidence to back their claims. Listed products are not analysed by the TGA but are subject to random audits to ensure there is adequate evidence for their marketing claims.

The author of the new complaint, Ken Harvey, a health academic at La Trobe University, said Mega Slim’s maker recommended sedentary adults take 12,000 milligrams of citrus aurantium a day.

“Much smaller doses have been associated with serious side-effects,” his complaint to the TGA said.

Dr Harvey told The Australian the case reinforced the need for the TGA to “get their act together” on listed weight-loss products.

“Their laissez-faire attitude is putting consumers at risk and their current draft guidelines are a joke,” he said.

In February the TGA responded to criticism of the growing number of allegedly unproven weight-loss treatments by publishing new draft guidelines, which set out the evidence manufacturers needed to hold to substantiate their marketing claims.

However, some organisations have denounced the guidelines as ineffectual. In the latest example, a draft response to the TGA by the Royal Australasian College of Physicians said makers of herbal weight-loss treatments had “taken advantage of a lax regulatory system”.

A TGA spokeswoman said Dr Harvey’s complaint was being examined.