US Food & Drug Agency Advisory on Hydroxycut

[teamfatboy]

According to this article on 1 May 2009 the US FDA issued a Consumer Advisory on Hydroxycut products, and the manufacturer has decided to recall them. The FDA advisory also advises that customers cease using them.

The issue at the centre is "serious liver-related problems"

The following products are covered by this voluntary recall:

* Hydroxycut Regular Rapid Release Caplets

* Hydroxycut Caffeine-Free Rapid Release Caplets

* Hydroxycut Hardcore Liquid Capsules

* Hydroxycut Max Liquid Capsules

* Hydroxycut Regular Drink Packets

* Hydroxycut Caffeine-Free Drink Packets

* Hydroxycut Hardcore Drink Packets (Ignition Stix)

* Hydroxycut Max Drink Packets

* Hydroxycut Liquid Shots

* Hydroxycut Hardcore RTDs (Ready-to-Drink)

* Hydroxycut Max Aqua Shed

* Hydroxycut 24

* Hydroxycut Carb Control

* Hydroxycut Natural

[Lamborghinilova]

Was there any information about why?

Or is there likely to be?

and thanks.

[blairandkelly]

FDA Recalls Hydroxycut After Reports of Liver Damage

WASHINGTON — 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 Food and Drug Administration said the maker of 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 liver failure. One received a transplant and another was placed on a list to await a new liver.

There was no immediate comment from the U.S. distributor of the diet pill, Iovate Health Sciences, headquartered near Buffalo, N.Y. Made by a Canadian company, Hydroxycut is used by people trying to shed pounds and by body builders to sharpen their muscles.

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.

Katz said it has taken so long to get a handle on the Hydroxycut problem because the cases of liver damage 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 of the products has changed several times. A medical journal report last month raised questions about one ingredient, hydroxycitric acid, derived from a tropical fruit. The article said it could potentially damage the liver.

[blairandkelly]

either kick the shit to the kerb or at least take milk thistle

[teamfatboy]

Was there any information about why?

Or is there likely to be?

and thanks.

There's a little more here

There was nothing on Bodybuilding.com, Flexonline or T-Nation when I checked, but the story broke late on a US Friday night, so when the US wakes up I'd imagine the boards will be full of it. Of course, advertising revenues may stop some commercial websites from talking-up the recall....

[GHOSTN]

discussion on bodybuilding.com

http://forum.bodybuilding.com/showthrea ... =116029971

[BIGKIWI]

Just saw this very interesting

[Optimass]

Wow ... I wonder how or if this will affect other manufacturers?

[Gym rat]

Wow I wonder how this will affext the reatailers who sell hydroxycut?? I also thought that was very intreasting.

[GreekAdonis]

Got to remember that the US version of Hydroxycut and the NZ version are different formulas.

[musclenz]

Just some more scare mongering by the FDA. They don't know what if any ingredient in Hydroxycut has caused the so called liver damage & one death in 9 million sales can hardly be described as significant. They have no idea how people are administering the dose or any control over what else they are using, probably taking 150mg DRol & 100mg Dbol with it! The FDA want control over the huge supplement industry in the US. Hydroxcut is a great product & works very well. They got rid of ephedrine what next.

[teamfatboy]

MuscleNZ's points are on the money - in my view there's too little known as yet. Were those afflicted otherwise in good health? Were they following the directions on the bottle or were they thinking "One's good, two's better?" Were they thinking "It's over-the-counter, its too weak to do any good?"

Remembering that this is the US, home of the class-action lawsuit (where a law firm drums up business against a manufacturer to mount a case on a no-win, no-fee basis.

Even so, the FDA's caution is not the worst they could have done...I think I'd read that a caution like that does not oblige the manufacturer to recall the products.

However, a prudent the manufacturer would cover their ass by the recall, to avoid litigation - nothing crimps profits like being sued!

[startinfromscratch]

gee take this stuff off the shelves quick, theyre far more dangerous to society than ciggys and alcohol :doh:

[Bee]

Got to remember that the US version of Hydroxycut and the NZ version are different formulas.

They are the same formulas thats why its getting pulled in Nz and Oz. The product was shit as n weight loss formula anyway, all it did was over stimulate the CNS, so it felt like you had a bit more energy. Because you felt more alert. Anyway only my views

[Bee]

Just some more scare mongering by the FDA. They don't know what if any ingredient in Hydroxycut has caused the so called liver damage & one death in 9 million sales can hardly be described as significant. They have no idea how people are administering the dose or any control over what else they are using, probably taking 150mg DRol & 100mg Dbol with it! The FDA want control over the huge supplement industry in the US. Hydroxcut is a great product & works very well. They got rid of ephedrine what next.

Just playing Devils advocate "would your response be the same if you where affected or someone in your family or a close friend?" The point is that some companies does not do their research well enough, and the put out products that are sub par and make people think they work and that they will benefit from the use of these products.

[musclenz]

Just some more scare mongering by the FDA. They don't know what if any ingredient in Hydroxycut has caused the so called liver damage & one death in 9 million sales can hardly be described as significant. They have no idea how people are administering the dose or any control over what else they are using, probably taking 150mg DRol & 100mg Dbol with it! The FDA want control over the huge supplement industry in the US. Hydroxcut is a great product & works very well. They got rid of ephedrine what next.

Just playing Devils advocate "would your response be the same if you where affected or someone in your family or a close friend?" The point is that some companies does not do their research well enough, and the put out products that are sub par and make people think they work and that they will benefit from the use of these products.

This has got nothing to do with a product that is "sub par" or "unresearched". Its about an FDA finding that now rates an excellent & well supported fat loss product as hepatotoxic. It has been speculated that this is indeed associated with the Yohombi addition in the "Hardcore" version & its well known adverse reactions with certain classes of anti depressant and other drugs. While these are rare it certainly would not be unheard of.

The difficulty stems from Yohimbine being a fairly potent Monoamine Oxidase Inhibitor (MAOI). Nearly all modern anti depressants and a wide range of other drugs are strongly contra indicated for consumption within at least two weeks of consuming a MAOI. Combining certain drugs e.g prozac (fluoxetine) or ecstasy (MDMA) with a MAOI is well known to be extremely dangerous.

Its often what people stack with these type of products that can be the problem. Surely a supplement company cannot be responsible for every possible contravention of each drug or herbal compound.

[GreekAdonis]

Got to remember that the US version of Hydroxycut and the NZ version are different formulas.

They are the same formulas thats why its getting pulled in Nz and Oz. The product was shit as n weight loss formula anyway, all it did was over stimulate the CNS, so it felt like you had a bit more energy. Because you felt more alert. Anyway only my views

The NZ version doesnt have the Yohimbine in it.

[musclenz]

Got to remember that the US version of Hydroxycut and the NZ version are different formulas.

They are the same formulas thats why its getting pulled in Nz and Oz. The product was shit as n weight loss formula anyway, all it did was over stimulate the CNS, so it felt like you had a bit more energy. Because you felt more alert. Anyway only my views

The NZ version doesnt have the Yohimbine in it.

The FDA is ruling on the US version. Thats what I use :wink: There are other possible hepatotoxic ingredients such as Chromium, Green Tea extract and Hydroxycitric Acid.

[vracula]

shiz i have half a bottle left,anyone want it for fr..............yeah right!