Hydroxycut Yanked By FDA

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Reports of critical liver problems and one death have prompted the FDA to pull 14 popular Hydroxycut items from the shelves. Government health officials urged body builders and dieters to immediately stop ingesting their favorite product and return it to the place of purchase.

Touted as derived from natural ingredients, the Canadian made supplement is favored by those hoping to shed pounds and body builders desiring improved muscle tone and definition. Readily available in grocery stores and pharmacies, at least nine million packages were sold in the U.S. last year, according to the FDA.

Dr. Linda Katz of the agency’s food and nutrition division said they have received 23 reports of serious liver problems including jaundice (yellowing of the skin or whites of the eyes), elevated liver enzymes, liver failure, a transplant, and one patient waitlisted for a new liver. Also, a 19-year-old boy died in 2007 but his death was not reported to the FDA until March of this year.

Other documented health concerns include cardiovascular disorders, seizures, and rhabdomyolysis, which is a type of muscle damage. The condition often precedes other grave health issues such as kidney failure.

Surprisingly, the FDA says the liver injuries did not appear to be the result of overdose but then…. their information came from the involved patients. All claimed they adhered to the recommended dosage on the Hydroxycut bottle.

The agency adamantly urged users to seek medical attention if they experience any of the following conditions: jaundice, nausea, vomiting, light-colored stools, brown urine, excessive fatigue, weakness, itching, loss of appetite, and abdominal pain.

Although Hydroxycut Cleanse and Hoodia products are not affected, Iovate Health Sciences Inc., of Oakville, Ontario, has agreed to recall the following:

~Hydroxycut Regular Rapid Release Caplets
~Hydroxycut Caffeine-Free Rapid Release Caplets
~Hydroxycut Hardcore Liquid Caplets
~Hydroxycut Max Liquid Caplets
~Hydroxycut Regular Drink Packets
~Hydroxycut Hardcore Drink Packets (Ignition Stix)
~Hydroxycut Caffeine-Free Drink Packets
~Hydroxycut Max Drink Packets
~Hydroxycut Liquid Shots
~Hydroxycut Hardcore RTD (Ready-to-Drink)
~Hydroxycut Max Aqua Shed
~Hydroxycut Carb Control
~Hydroxycut Natural
~Hydroxycut 24

The company stated on their May 1 website that the recall was voluntary. “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 abundance of caution and because consumer safety is our top priority, we are voluntarily recalling these Hydroxycut-branded products,” the statement said.

As always, this is a situation of consumer beware. Our government does not regulate dietary supplements as rigidly as medications. Appalling, manufacturers need not prove to the FDA that their products are effective or safe before greedily tossing them out to a quick-fix public. Regulators claim to monitor aftermarket reports for indications of potential problems and recently, companies have been under pressure and tightened requirements to alert the FDA when this occurs.

Dr.Katz lamented, “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.” Also, the agency heavily relies on voluntary information to detect a red flag situation. Many times, cases are never reported.

Based on available information, health officials said they cannot determine which Hydroxycut ingredients or proprietary blends are the toxic culprits, probably because the product formulation has changed several times. But last month a medical journal report speculated that one ingredient…a tropical fruit derivative, hydroxycitric acid, could possibly cause liver damage.

Once again, the FDA is stumped. They said they could not ascertain which other factors, such as length of use, dosage, combining with other supplements or drugs, or one’s health condition could affect the risk of using Hydroxycut.

Healthy diet and exercise anyone?