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Old 05-01-2009, 12:18 PM   #1
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Default OT: Hydroxycut recalled by FDA

Normally, I'd stick this in the weight loss thread, but it may not get proper exposure.

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FDA announces recall of popular diet pill
Hydroxycut linked to reports of liver damage, other health problems
BREAKING NEWS
The Associated Press
updated 11:00 a.m. MT, Fri., May 1, 2009
WASHINGTON - U.S. government health officials warned dieters and body builders Friday to immediately stop using Hydroxycut, a widely sold Canadian-made 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, New York. 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.




© 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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Old 05-01-2009, 12:29 PM   #2
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I did not realize the FDA does not review diet "pills"...
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Old 05-01-2009, 12:34 PM   #3
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Better off just going on a EC stack fi you want to lose some pounds. I know that ephedra is "banned" but its still available and the "side effects" are nothing compared to the other diet pills.
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Old 05-01-2009, 03:41 PM   #4
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You wanna know how to lose weight...exercise at least 3 times a week and a healthy diet!! Don't eat anything around 3 hours before you go to bed. Thats how you lose weight in a nut shell!!
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Old 05-01-2009, 03:45 PM   #5
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Originally Posted by DenverBroncosJM View Post
Better off just going on a EC stack fi you want to lose some pounds. I know that ephedra is "banned" but its still available and the "side effects" are nothing compared to the other diet pills.
Ephedra was great stuff, but unfortunately some people cannot follow directions printed on a bottle, which causes them trouble (in this case, death) and then the kneejerk reactions follow suit (banned). I tried Hydroxycut a couple of years ago and it didn't work for me. Dexatrim is the only stuff I've taken since the banning of ephedra that I can honestly say worked when combined with a decent diet and exercise.
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Old 05-01-2009, 03:56 PM   #6
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Last edited by Kaylore; 05-01-2009 at 06:05 PM..
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Old 05-01-2009, 04:20 PM   #7
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Originally Posted by LonghornBronco View Post
I did not realize the FDA does not review diet "pills"...
Anything classified as a supplement is not FDA reviewed unless there are reports and cases where it is confirmed to have caused serious harm.

You are better off downing a few painkillers every morning than taking a lot of the supplements out there, with a pain killer you know to the nanogram what you are getting, with a supplement it is anyones guess and may vary from package to package.
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Old 05-01-2009, 04:20 PM   #8
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I did not realize the FDA does not review diet "pills"...
The FDA doesn't review/approve any dietary supplments. Until this year, they also did no inspections of supplement manufacturing facilities, unless there was a problem of some kind.

Starting this year (inspections to begin this fall), they will start enforcing GMP (good manufacturing principles) that includes procedures to 'prove' or validate that what is claimed to be on the label is in the product.

It is a highly unregulated industry.
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Old 05-01-2009, 04:36 PM   #9
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They should have to test and approve all of them. It's ridiculous and unsafe. It would never fly in Europe. That movie "Bigger, Faster, Stronger" tried to make the point that this was allowed because the manufacturers made big campaign donations to the people in power, particularly Utah Senator Orrin Hatch who created a bill in the early 90s effectively making this law.
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Old 05-01-2009, 04:42 PM   #10
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They should have to test and approve all of them. It's ridiculous and unsafe. It would never fly in Europe. That movie "Bigger, Faster, Stronger" tried to make the point that this was allowed because the manufacturers made big campaign donations to the people in power, particularly Utah Senator Orrin Hatch who created a bill in the early 90s effectively making this law.
They don't test and approve supplements in Europe either. Even in countries that have stricter regulations, it is purely based on 'what is printed on the label' not testing to confirm what is on the label is in the bottle. Again, like in the US, that changes when there is concern of a contamination or other problem, but nothing beyond that.
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Old 05-01-2009, 05:21 PM   #11
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The FDA is a joke and probably harms way more people than it helps. The supplement industry, as unregulated as it is, is an overwhelmingly safe industry. As soon as the FDA gets it's hands on it, the only people that will be hurt will be the consumer. Let people decide for themselves what they want to put in their body.
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Old 05-01-2009, 05:46 PM   #12
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Quote:
Originally Posted by Hogan11 View Post
Ephedra was great stuff, but unfortunately some people cannot follow directions printed on a bottle, which causes them trouble (in this case, death) and then the kneejerk reactions follow suit (banned). I tried Hydroxycut a couple of years ago and it didn't work for me. Dexatrim is the only stuff I've taken since the banning of ephedra that I can honestly say worked when combined with a decent diet and exercise.
Hmmmmmmmmmmmm...
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Old 05-01-2009, 06:04 PM   #13
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Originally Posted by Deuce View Post
The FDA is a joke and probably harms way more people than it helps. The supplement industry, as unregulated as it is, is an overwhelmingly safe industry. As soon as the FDA gets it's hands on it, the only people that will be hurt will be the consumer. Let people decide for themselves what they want to put in their body.
Actually, it's all over the board. It might not be an 'unsafe' industry, although there certainly have been cases of that, but it is also an industry where you can't assume what is on the label is in the bottle. There are a lot of 'garage manufacturers' out there.

Having said that, like with most things the government does, the GMP's the FDA has implemented are ridiculous.

By their own estimate, 50% or more of supplement manufacturers will go out of business, since they will have no way to meet the over the top regulations.
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Old 05-01-2009, 06:15 PM   #14
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Hmmmmmmmmmmmm...
Sometimes an appatite surpressant is necessary to achieve your goal, especially if you plateau.
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Old 05-01-2009, 06:21 PM   #15
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Part of the problem is americans tend to be extreme. We all set extremely high goals, often based on aesethetics put forth in the media. Ultimately the most important thing is good health but so many of these supplements do more to jeopardize than promote that.
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Old 05-01-2009, 06:36 PM   #16
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I just told a friend who's pretty much dependent to this stuff that it got recalled. Dude already lost a ton of weight and he was just using it because he had no energy without it. Strange side affect, we'd be standing around and the idiot would just throw up out of nowhere. Only guy I know who throws up before he starts drinking. Anyways, I told him to quit the junk and to stop being a moron.
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Old 05-01-2009, 06:54 PM   #17
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Originally Posted by tnedator View Post
Actually, it's all over the board. It might not be an 'unsafe' industry, although there certainly have been cases of that, but it is also an industry where you can't assume what is on the label is in the bottle. There are a lot of 'garage manufacturers' out there.

Having said that, like with most things the government does, the GMP's the FDA has implemented are ridiculous.

By their own estimate, 50% or more of supplement manufacturers will go out of business, since they will have no way to meet the over the top regulations.
You hear about "FDA approved" drugs killing people all the time, that have to be taken off the shelves. So you have the FDA slowing progress and hurting consumers and they still approve drugs that are unsafe. The point is, you are never going to be 100% safe 100% of the time. So you have to ask yourself if the regulations are causing problems that are actually worse than the problems they are trying to solve.

The FDA is inherently anti consumer. The nature of the situation dictates that be overly cautious, at the expense of the patient. If they approve a drug that is harmful, everybody will soon know about it and point to the FDA. But if they simply don't approve a drug, even if the possibility of somebody being harmed is extremely slim and the benefits are potentially huge, nobody will know because it never gets released. So they release very few drugs and only the very safest ones. And yet harmful ones are still released. It's pointless. It takes the power away from the patient and doctor (where it belongs) and puts it in the hands of a bureaucrat in Washington whose only interest is his own.
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Old 05-01-2009, 07:28 PM   #18
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On a completely unrelated subject, but ironic. The new NFLPA rep, D. Smith is a partner at one of the largest/best firms that represents companies in dealings with the FDA. Just ironic in that we are on a football forum talking about the FDA.
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Old 05-01-2009, 07:34 PM   #19
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Quote:
Originally Posted by Hogan11 View Post
Sometimes an appatite surpressant is necessary to achieve your goal, especially if you plateau.
Thats basically all they put in the stuff...they try to make you think you can lose 50-100lbs just by taking these supplements and its not true!!
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Old 05-01-2009, 07:35 PM   #20
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Quote:
Originally Posted by Hogan11 View Post
Ephedra was great stuff, but unfortunately some people cannot follow directions printed on a bottle, which causes them trouble (in this case, death) and then the kneejerk reactions follow suit (banned). I tried Hydroxycut a couple of years ago and it didn't work for me. Dexatrim is the only stuff I've taken since the banning of ephedra that I can honestly say worked when combined with a decent diet and exercise.
Pretty much true. Folks that followed the instructions were fine. It was the people popping 3 to 4 pills and then working out like crazy that screwed it all up.
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Old 05-01-2009, 08:27 PM   #21
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Originally Posted by maher_tyler View Post
You wanna know how to lose weight...exercise at least 3 times a week and a healthy diet!! Don't eat anything around 3 hours before you go to bed. Thats how you lose weight in a nut shell!!
It's not quite that simple.

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Originally Posted by Hogan11 View Post
Ephedra was great stuff, but unfortunately some people cannot follow directions printed on a bottle, which causes them trouble (in this case, death) and then the kneejerk reactions follow suit (banned). I tried Hydroxycut a couple of years ago and it didn't work for me. Dexatrim is the only stuff I've taken since the banning of ephedra that I can honestly say worked when combined with a decent diet and exercise.
+1. I loved Ephedra.
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Old 05-01-2009, 08:45 PM   #22
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It's not quite that simple.



+1. I loved Ephedra.
If your serious about losing weight it is. Your not gonna lose more than 10lbs by just taking a pill. If you ever read the directions it tells you to drink a glass of water with it before you eat...hmmmm wonder why...if you drink water before you eat your stomach is more full..they trick you into thinking your losing weight because of the stupid pill. If you lost weight by taking pills and it had been proven the FDA would approve it!!
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Old 05-01-2009, 08:52 PM   #23
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Originally Posted by maher_tyler View Post
If your serious about losing weight it is. Your not gonna lose more than 10lbs by just taking a pill. If you ever read the directions it tells you to drink a glass of water with it before you eat...hmmmm wonder why...if you drink water before you eat your stomach is more full..they trick you into thinking your losing weight because of the stupid pill. If you lost weight by taking pills and it had been proven the FDA would approve it!!
Sorry man, it just don't work like that. Lots of people try that 3 days of exercise and "healthy" diet and get no where, mainly because they aren't doing the right exercises and/or the diet is not conducive to losing weight. Trust me, I struggled with this same problem after I suffered injuries in high school football and then again when I had the staph infections in 2007.

I never could lose weight with ease until I met a few people who had been in even worse situations. They had been on a modified version of the low carb diet, and since I've gone on that and supplemented it with lots of weight training, I've lost weight again with ease.

As far as Ephedra goes, it's thermogenic properties have been well known for decades and it IS a proven supplement for losing weight. An ECA stack is very effective at increasing metabolism, increasing energy and surpressing appetite.
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Old 05-01-2009, 09:13 PM   #24
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Sorry man, it just don't work like that. Lots of people try that 3 days of exercise and "healthy" diet and get no where, mainly because they aren't doing the right exercises and/or the diet is not conducive to losing weight. Trust me, I struggled with this same problem after I suffered injuries in high school football and then again when I had the staph infections in 2007.

I never could lose weight with ease until I met a few people who had been in even worse situations. They had been on a modified version of the low carb diet, and since I've gone on that and supplemented it with lots of weight training, I've lost weight again with ease.

As far as Ephedra goes, it's thermogenic properties have been well known for decades and it IS a proven supplement for losing weight. An ECA stack is very effective at increasing metabolism, increasing energy and surpressing appetite.
Yea but what are the side effects...i bet high blood presure is one of them. Your not gonna lose a lot of weight if your not eatting correct serving sizes..thats where a lot of people get lost. They're fallowing they're diet, eatting salads etc. but have a heaping plate with all sorts of dressing and what not all over it. I also think people get impatient and expect immeadiate results..it takes a lot of time to lose weight. Also, breakfast should be the biggest meal and all other meals should progressively get smaller. It's definitely a lot of work!!
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Old 05-01-2009, 10:04 PM   #25
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Yea but what are the side effects...i bet high blood presure is one of them.
The rise in blood pressure is very slight and only temporary. Ephedra opens up airways but constricts blood vessels a small amount. I tested my BP a few times when taking it and saw almost no increase.

Ephedra is safe, provided you follow the rules when taking it.

Quote:
Your not gonna lose a lot of weight if your not eatting correct serving sizes..thats where a lot of people get lost. They're fallowing they're diet, eatting salads etc. but have a heaping plate with all sorts of dressing and what not all over it.
While that's all true, weight loss is a combination of many factors, and making just one misstep can throw off the whole process.

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I also think people get impatient and expect immediate results..it takes a lot of time to lose weight.
The diet I'm on helped a friend of mine lose 100lbs of body fat in under a year.

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Also, breakfast should be the biggest meal and all other meals should progressively get smaller. It's definitely a lot of work!!
Breakfast is an important meal, but I don't make it any larger than the rest of my meals.
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