FDA: Dieters should stop Hydroxycut use now

May 01, 2009 By RICARDO ALONSO-ZALDIVAR , Associated Press Writer

(AP) -- Government health officials warned dieters and body builders Friday to immediately stop using Hydroxycut, a widely sold supplement linked to cases of serious liver damage and at least one death.

The said the company that makes the dietary supplement has agreed to recall 14 Hydroxycut products. Available in grocery stores and pharmacies, Hydroxycut is advertised as made from natural ingredients. At least 9 million packages were sold last year, the FDA said.

Dr. Linda Katz of the FDA's food and nutrition division said the agency has received 23 reports of liver problems, including the death of a 19-year-old boy living in the Southwest. The teenager died in 2007, and the death was reported to the FDA this March.

Other patients experienced symptoms ranging from jaundice, or yellowing of the skin, to . One received a transplant and another was placed on a list to await a new liver. The patients were otherwise healthy and their symptoms began after they started using Hydroxycut.

Iovate Health Sciences, which makes the diet pills, said it agreed to the recall out of "an abundance of caution." The company is based in Canada and its U.S. distributor is headquartered near Buffalo, N.Y.

"While this is a small number of reports relative to the many millions of people who have used Hydroxycut products over the years, out of an abundance of caution and because consumer safety is our top priority, we are voluntarily recalling these Hydroxycut-branded products," the company said in a statement on its Web site. Consumers can get a refund by returning the pills to the store they purchased them from, the company said.

Dietary supplements aren't as tightly regulated by the government as medications. Manufacturers don't need to prove to the FDA that their products are safe and effective before they can sell them to consumers.

But regulators monitor aftermarket reports for signs of trouble, and in recent years companies have been put under stricter requirements to alert the FDA when they learn of problems. In 2004, the government banned ephedra, an ingredient in many supplements, linked to heart attacks and strokes.

Katz said it has taken so long to get a handle on the Hydroxycut problem because the cases of were rare and the FDA has no authority to review supplements before they're marketed. "Part of the problem is that the FDA looks at dietary supplements from a post-market perspective, and an isolated incident is often difficult to follow," she said.

The FDA relies on voluntary reports to detect such problems, and many cases are never reported, officials acknowledge.

Health officials said they have been unable to determine which Hydroxycut ingredients are potentially toxic, partially because the formulation has changed several times.

Public health researcher Ano Lobb, who has studied Hydroxycut and other dietary supplements for Consumer Reports, said the problem may be an ingredient called hydroxycitric acid. Derived from a tropical fruit, it's been linked to problems in at least one medical journal study. Lobb said it's likely that other supplements containing the same ingredient remain on the market.

"You really have to be careful about , especially weight-loss pills," said Lobb. "People believe that the FDA has verified that these products are at least safe and effective, and that's really not the case. When you see fantastic claims - that's generally what they are."

---

On the Net:

FDA press release: http://tinyurl.com/cfxjbe

©2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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gopher65
4.3 / 5 (3) May 01, 2009
Yet another case proving conclusively that all supplements and beauty products should be subject to the same safety regulations that their pharmaceutical cousins are.

It's a shame that the multi-billion dollar a year naturopathic and homeopathic industries have been allowed to derail efforts to regulate these products. These deaths and illnesses could have been prevented with minimal cost and effort.
physpuppy
5 / 5 (2) May 01, 2009
No Hydroxycut??? Oh dang, how am I going to lose weight now?

What do they expect people to do - eat less and exercise more???

Sheesh!

:-) :-) :-)

I think the latter is a bit more """natural""" than the former...

But then some other wise guy is going to tout their mixture of other combination of herbs and stuff together as "better and safer than Hydroycut!"
until people start popping off...
John_balls
4.5 / 5 (2) May 01, 2009
This is bullshit. How many people need a new liver due to alcohol. Has the FDA done anything to stop alcohol sales.

I would love to hear more about the specifics of each individual.
gopher65
4.3 / 5 (3) May 02, 2009
John balls: people know exactly what the risk of alcohol is, and they choose to take it anyway. That is free choice. With these supplements no one knows what is in them, or even if they work.

The few that have been tested have been found to contain large quantities of lead, mercury, and arsenic (yes, all three. In some folk medicine mercury is considered a "wonder-drug", so they purposefully put it in everything. Frightening, huh?). In the case of male enhancement "herbal" remedies, some were found to contain a bunch of random things to bulk them up, plus, guess what, ground up Viagra. Cause, like, that herbal and all, right;)? (But it works, since it is a tested drug, which is why they include it as an ingredient.)

The point is that even if some herbal remedies work, the general public has absolutely no way to know which are real and which are fraudulent, because the market is completely unregulated. This isn't like... I dunno... shoe sales or something, where people can tell the frauds from the quality brands by self-testing. If you self test with a herbal remedy you may well die.
Scire
4.3 / 5 (3) May 02, 2009
[quote="gopher65"]people know exactly what the risk of alcohol is, and they choose to take it anyway. That is free choice. With these supplements no one knows what is in them, or even if they work.[/quote]

It is a persons free choice to take these supplements also, and to be perfectly honest simply taking them without doing any research is careless at best and outright moronic at worst. Having said that it is difficult if no genuine research has been done and people have a tendency to mistake advertising for research.

Personally I feel that if anything should be regulated more it is the advertising these products have; not the products themselves. If the companies weren't allowed to make extraordinary claims without proper independent research to back it up people wouldn't want to buy these products in the first place.

tl;dr Better research, tighten advertising rules, let people poison themselves fully aware that they are poisoning themselves
John_balls
not rated yet May 02, 2009
John balls: people know exactly what the risk of alcohol is, and they choose to take it anyway. That is free choice. With these supplements no one knows what is in them, or even if they work.



The few that have been tested have been found to contain large quantities of lead, mercury, and arsenic (yes, all three. In some folk medicine mercury is considered a "wonder-drug", so they purposefully put it in everything. Frightening, huh?). In the case of male enhancement "herbal" remedies, some were found to contain a bunch of random things to bulk them up, plus, guess what, ground up Viagra. Cause, like, that herbal and all, right;)? (But it works, since it is a tested drug, which is why they include it as an ingredient.)



The point is that even if some herbal remedies work, the general public has absolutely no way to know which are real and which are fraudulent, because the market is completely unregulated. This isn't like... I dunno... shoe sales or something, where people can tell the frauds from the quality brands by self-testing. If you self test with a herbal remedy you may well die.


Point taken.
gopher65
5 / 5 (1) May 04, 2009
Scire: I don't disagree. The majority of the regulation that I want comes in the form of preventing untested advertising claims, and mandatory testing regiments for everything on the market. Plenty of things are poisonous, and I don't care if people take them (alcohol, coffee, and cola being good examples), but they should be able to find out *what* they are taking, if they desire to do so. Right now there is simply no information out there except for claims made by the advertising for these products.

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