Hydroxycut NEWS

**Steven Klippstein** · 04.05.2009, 00:00

http://www.fda.gov/consumer/updates/...cut050109.html

http://www.youtube.com/watch?v=xKxgdmDTv7U

http://www.youtube.com/watch?v=z2qJaA1gjP4

Warning on Hydroxycut Products

Serious Health Risks
Recalled Products

The U.S. Food and Drug Administration (FDA) is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.

Hydroxycut products are dietary supplements that are marketed for weight loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.

Serious Health Risks
FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA.

Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.

Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

FDA urges consumers to stop using Hydroxycut products in order to avoid any undue risk, says Linda Katz, M.D., interim chief medical officer of FDA's Center for Food Safety and Applied Nutrition. "Adverse events are rare, but exist," Katz says. "Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products.

Recalled Products
The list of products being recalled by Iovate currently includes:

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
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
Although FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and Hoodia products are not affected by the recall.

Consumers who have these products are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.

Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

Online: www.fda.gov/MedWatch/report.htm
Regular Mail: Use FDA postage paid form 3500 found at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 800-FDA-0178
Phone: 800-FDA-1088

FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

For More Information
FDA's Web Page on Hydroxycut Products
www.fda.gov/oc/opacom/hottopics/hydroxycut/

FDA 101: Dietary Supplements
www.fda.gov/consumer/updates/supplements080408.html

Date Posted: May 1, 2009

I saw this on the news in a NY taxi tv. My opinion is the whole MuscleTech brand is a scam..All the money goes into false marketing. The crappiest most ineffective products I have ever used and over priced at that. I asked this question before, but do you not think about how bodybuilders we look up to promote such products? I bet you they also rarely use them...Jay, Dexter, Darrem ...on the other hand they need to make a living so you basically have a money issue vs. an ethical issue?

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 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 liver failure. 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 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 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 liver 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 dietary supplements, 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."

#1 selling fatburner in the USA...(or at least somewhere in the top), so let's see how many law suits come out of this.

Also like to see if this allegation is in proportion of the big media attention it's getting now.
Epehdrine (where the hell is Adipokinetix

) got a bad reputation because some people dropped, but those allegations were not justified and it appeared those same people took some other stuff with it causing an accumulated effect or they had a condition or they took big amounts of it.

Hydroxycut has been around for years, sold millions etc etc, so I wonder if this an after effect from the old batch or something from the new "advanced" formulas and which ingredient is the main perp for this?

I'm NOT trying to defend MuscleTech (at all), and never advise people to take their products because of price:effectiveness ratio, but I'll take a "let's wait and see" approach on this.

I see that dpsnutrition where I order my supps took them from their website already.
BB.com still has them for sale, but I'm sure later today they too should have adjusted their website.

http://www.youtube.com/watch?v=mpnQR...layer_embedded