hydroxycut-recalled-malaysia

Following is an article that was published back in May 2009. In Malaysia, Hydroxycut is current distributed by GNC.

By Lorraine Heller, 04-May-2009
The US Food and Drug Administration (FDA) has initiated a massive recall of a top-selling American weight loss supplement brand, after a series of adverse event reports indicated that the products could be linked to serious liver damage.

The Hydroxycut products, which sold over nine million units in 2008 alone, were voluntarily recalled on Friday by their manufacturer Iovate Health Sciences.

FDA issued an advisory on Friday morning, warning consumers to immediately stop using the products, which are sold nationwide under the Iovate and MuscleTech brand names. The 14 products included in the recall are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss.

The agency said it was taking this action after receiving 23 reports of serious health problems related to liver damage. One death was reported, as well as six patients diagnosed with serious liver disease and two requiring liver transplant. Other health problems reported included seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

FDA said it has not as yet determined which specific ingredients are associated with the adverse events.

However, Dr Vasilios Frankos, director of the Division of Dietary Supplement Programs at FDA’s CFSAN, said that as part of the agency’s investigations into the ingredients at fault, it could be looking at other products on the market that contain the same ingredients.

“We’re investigating and that’s really all we can say at this point,” he told journalists in a press conference.

AERs

The safety issue was identified by an adverse event reporting (AER) system, which is designed to allow FDA to monitor for signals of safety concerns related to dietary supplement products.

AERs have been subject to much tighter regulations since the end of 2007, when the Dietary Supplement and Nonprescription Drug Consumer Protection Act came into effect. This stipulates that any serious adverse events reported to a manufacturer must be sent on to FDA within 15 days. FDA can inspect both serious and non serious adverse event reports for six years after receiving them.

In the current case, the agency said it had first started receiving adverse event reports around 2000, when the products originally contained the weight loss ingredient ephedra, which was later banned. More adverse event reports came through after the products’ reformulation in 2004.

The death associated with the products, which occurred in 2007 and involved a 19 year old man, was not reported to the agency until the end of March 2009. FDA said this time lag was “not really that unusual” as the incident had occurred before the mandatory reporting requirements were implemented.

Ingredients?

The 14 products in question contain a variety of ingredients and herbal extracts, and FDA said it has not yet determined which ingredients or dosages are related to the risks reported.

“It’s actually not accurate to say ‘ingredients’ because what we have are propriety blends of ingredients and the amount of each component of that blend varies from product to product (…) It’s very hard to draw a specific individual ingredient determination when you have a product like that,” said Dr Frankos.

Linda Katz, interim chief medical officer at FDA’s CFSAN added: “What we do know is that the reaction is idiosyncratic, which is part of the concern that we have and why we want to get the information out rather quickly to make sure that we do not expose consumers to undue risk.”

Idiosyncratic reactions are ones that do not appear to have a dose-response relationship, or ones for which there are no specific risk factors, she explained. “Most of the individuals in which we’ve had AERs had normal liver functions and were otherwise healthy individuals.”

Susan Cruzan from FDA’s Office of Public Affairs told NutraIngredients-USA.com that the agency “is looking at the ingredients and will continue to review and evaluate them”.

She added that there was no evidence that unacceptably high levels of an ingredient were present in the product due to a manufacturing error, a risk factor that is specifically addressed by new supplement GMP regulations.

Weight loss

The dietary supplement weight loss category is one of the industry’s most vulnerable areas. As well as being a major focus for regulators due to an abundance of misleadingly marketed products, or products containing undeclared drugs, the sector is also suffering from internal inconsistency.

Its strongest ingredient, ephedra, was banned in 2004 after it was found to be associated with severe health risks, including death. Since then, there have been no undisputed category leaders.

“If we were to be asked ‘what are you best players in the weight loss game’, we wouldn’t have an answer. In the past we would have said ephedra, or hoodia, but now we simply don’t have a unified response. That is tactically and commercially unacceptable. For a category this size, it’s astonishing. Our strategy must be to get a unified response,” said Loren Israelsen, executive director of trade group United Natural Products Alliance (UNPA) at an industry seminar last year.

Ingredients currently used in weight loss supplements include: bitter orange, chromium, guar gum, hoodia, garcinia, Conjugated Linolenic Acid (CLA), pyruvate and chitosan. Nutrition Business Journal, values the US weight loss supplements market at $1.7bn.

Kevin Zahri

I am a US certified personal trainer and nutritionist with over 12 years experience. Over the years, I have published over 10 books, written for Men's Health, other fitness and lifestyle magazines, hosted TV shows and appeared on various TV shows, programs and magazines. I am also an avid corporate wellness speaker and web entrepreneur.

More about me here or follow me on Facebook or Twitter.

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  • bob

    Hi Kev!!

    Saya pernah ambil Nutrex Research punyer diet pills.Called Lipo-6…It works and I’ve consumed bout 3 bottles(Normal size) which I order frm US. But the side effect is susah nak tido dgn nyenyak(frequent nightmare) coz it contains hig percentage of caffeine and bila saya ambil dgn coffee, I felt a lil’ bit dizzy…I got a slight hypertension problem. is it healthy for me to continue?

  • Lipo 6 atau mana2 stimulant based fat burner tidak digalakkan guna 6 jam sebelum tidur. Ia juga tidak digalakkan untuk sesiapa yg ada hypertension atau apa2 condition yg boleh lead to heart attack.
    hope this helps

  • shah

    hi kev,
    i hendak bertanye, adakah product dari nutrex research such as lipo 6, lipo 6 black product yg sesuai di gunakan for weight loss…adakah ianya sme dengan product Hydroxycut from muscltech yang di katakan tidak elok dan boleh menyebabkn kematian…please reply me as soon as possible..

  • bob

    now I’m more on to the natural way of loosing my weight.no more supplement or diet pills…cardio + muscle building + balanced/healthy diets = lifetime result!!!Shaun T hip hop abs DVD really helps me out with calorie intake less than 1800/day. I’m shaving off 8kg in just a month!!!trick the body by consume bout 1.5 to 2 litres of water everyday so it gonna flush the stored water out in just a week(for those who have the ‘gumuk air’ problem).coz your body will store and kept water when you don’t drink enough. it helps to cleanse the colon system too.

  • I found kevinzahri.com very informative. The article is professionally written and I feel like the author knows the subject very well. kevinzahri.com keep it that way.

  • kayte

    hi kevin,
    saya dah ambil bermacam-macam pill diet seperti sibutramine (reductil) xenical saya hanya ambil for short term saja coz ada side effect from this medicine macam sibutramine it will cause my high blood pressure . is there any other alternative way that i can get my desire weight . tetapi sampai sekarang saya tak boleh dapat berat badan yang ideal tinggi 159cm berat 53kg ideal weight is 48 kg

  • GlotteTed
    yb5f
    Scorttoulpill
    Bwbd

  • @ kayte

    sibutramin, xenical ialah medicine untuk obesiti, manakala Lipo-6 tu semua ialah supplements.
    Supplements bermaksud penambahan dari apa yg tiada, apa yg saudara/saudari kene ada ialah proper diet n training, barulah gunakan supplements

    Chow

  • ccdev

    Bro,

    after reading this, i am kiasu about the protein powder that i was thinking about trying. it may be a different product to the diet stuff but still not sure what they put in it (BCAAs, HydroWhey Hydrolyzed Whey Peptides??). I’m a newbie and just want to check with you the ‘urban legend’ that if a person takes protein powder and dont work out, may be bad for the liver. also, how do i know there is no ill effects like that Hydroxycut stuff that the dieters took, the FDA recall only after so long in the market. hope you can share your thoughts.

    having said that, i am trying to find the article that you wrote about the ON whey protein, good for lactose intolerant. Also, you mention somewhere (but i cannot find anymore the article) that the chocolate taste is really good, is it? Lastly, instead of trying to add carb to my diet, is the carb from the weight powder enough for light workout?

    thanks, man.

  • ccdev

    oh yeah, this article too about whey protein and kidney stone. any truth?

    “I used whey protein for about 3 years. I am an amateur bodybuilder so that is why i used it. It did absolutely nothing for me except give me a kidney stone which the doctor said was due to one of the amino acids in it.

    It is a good supplement for a meal or a large snack but will not make you gain much. And don’t take too much or you may get a kidney stone.”

  • Hook

    Hi Kevin and all,

    I wanna hear your all opinion about;

    1) GNC Total Lean
    2) GNC L-Carnitine

    Please do let me know, ok. I just took two tablets of 1) and one of 2 before dinner and I’m still awake now at 5 in the morning, typing this message.

    Would the above help you in weight loss?

    Any side effects or damage to your body like what Hydroxycut did to your liver?

    Thanks and cheers :)