Hydroxycut, FDA, and “Diet Supplements”

Hydroxycut, produced by Iovate Health Sciences of Oakville, Ontario, is the latest diet supplement that has been volunarily recalled at the urging of the US FDA.

In all, the Food and Drug Administration said it had received 23 reports of significant adverse health effects in people who used Hydroxycut, including one person who required a liver transplant. Other complications included heart problems and a kind of muscle damage that could lead to kidney failure, the agency said.

Wondering what the difference is between “diet supplements” and “drugs”?  From the FDA:

 One thing dietary supplements are not is drugs. A drug, which sometimes can be derived from plants used as traditional medicines, is an article that, among other things, is intended to diagnose, cure, mitigate, treat, or prevent diseases. Before marketing, drugs must undergo clinical studies to determine their effectiveness, safety, possible interactions with other substances, and appropriate dosages, and FDA must review these data and authorize the drugs’ use before they are marketed. FDA does not authorize or test dietary supplements.

Another way of thinking of it is that diet supplement is meant to be something like a vitamin or mineral; to prevent a deficiency, say.  It is not meant to cure or treat a disease.   This may sound like a fine line, and it is – it’s a legal distinction that was drawn so that vitamins or glucosamine pills do not have to go through the FDA drug approval process, even though in some cases (St John’s Wort) they may have similar effects.  

This distinction makes it possible to get weight-loss supplements onto the market without having to pass the standard of efficiency required for weight-loss drugs (which, really, ain’t all that much anyway – 5% more weight loss than a placebo).  They’re tested by the companies producing them, yes, but that will vary from company to company.   This is a good fact to keep in mind!  The FDA is empowered to act if it receives reports of harm from a supplement that is already for sale, but do you want to be one of the people who is harmed? 

I am not saying to never take supplements. I take supplements myself – vitamins B12, D, and occasionally E (keeps my skin less dry).  I also take fish oil capsules.  I buy from companies that have been around a while.   The big doses are the B12 and D, which I have been diagnosed deficient in and which I have regular follow-up tests to make sure I’m getting not-too-much not-too-little.  

I also assume that if something sounds too good to be true, it probably is.



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8 responses to “Hydroxycut, FDA, and “Diet Supplements””

  1. Bree Avatar

    The only dietary supplement I take is a daily iron pill, because I’m severely anemic and I’m a carrier of sickle cell anemia. I probably could benefit from B12 too, but my doctors were more concerned about my iron levels. The pills also help to keep me from getting fatigue and random aches associated with iron deficiency.

    As for weight loss and diet pills, I’ll pass, thanks.

  2. peggynature Avatar

    I just wanted to link to an interesting 2002 FTC report about diet product advertising trends, where they concluded: “The use of false or misleading claims in weight-loss advertising is rampant.” (And this admission is coming from authors who still apparently believe in the “obesity epidemic,” etc.)

    I think it’s really telling that, although issues like this come up time and time again, where some sketchy diet product (whether FDA-approved or not) is advertised, it turns out to be harmful for people. And yet it seems like the industry hasn’t changed at all, nor have their advertising tactics.

    One might be tempted to conclude that someone stands to make a lot of profit by continuing to let this stuff slide.

  3. Ruth Avatar

    I used to stare longlingly at the shelves full of weight loss supplements in the pharmacy and wish I could afford them so I’d be skinny again. Then I read Linda Bacon’s Health at Every Size and woke up to the fact that I’d much rather be healthy and heavy than skinny and dependent on drugs and supplements to keep me that way. Reading warnings like this just reinforce that I made the right choice.

  4. Carolyn Avatar

    The thing is – you are not allowed to patent or trademark a natural element (plant, vitamin etc). Since most supplements are made from these – the FDA ignores them because there isn’t money behind these like there is in pharmaceuticals (you can patent and trademark the hell out of chemicals!)

    So really, we (the consumer) are getting screwed over because big government only follows the trail of big money. And it’s very telling that many of these plants have the same affects that pharmaceuticals have without some of the dangerous side affects – yet they are being ignored and even called “snake oil”.

    If you are interested in the diet / supplement industry – watch the documentary Bigger Faster Stronger. It is available free online and its fascinating.

    1. living400lbs Avatar

      I agree the “natural elements” are not considered to be worth the expense of FDA approval – but most of the weight loss (and “increase sexual energy” and “cure dementia” and other such dreck) is enticing to those with little scruples….

      I’m not sure this is about “big government not caring about the little people” though. The government generally doesn’t make it illegal for normal people to shoot their own feet, either….

      1. Regina530 Avatar

        This reminded me of a woman in the town I used to live in (Muncie, IN) who got drunk and shot herself in the foot with a shotgun because she had a painful corn. I believe she got charged with some kind of misdemeanor with a firearm, though. So maybe it IS illegal to shoot onself in the foot?

        ps…this story even made it to Jay Leno’s monologue, as well as all the radio stations, national news, and local.

    2. Kaylee Avatar

      Actually, you cannot “trademark” a chemical composition. You can trademark the name ( “Asprin”, “alli”, etc.), which is indefinitely renewable, but you can only *patent* the actual chemical composition, which lasts 20 years, and then you start to see all of the generic brands hit the market.

  5. wriggles Avatar

    The use of false or misleading claims in weight-loss advertising is rampant’

    Sounds like pointless redundancy, how can you tell?

    The premise of so-called ‘fat burning’, is itself based on the fallacy of calorie wasting as a weight-loss solution.

    Anyway, the issue here is the damage caused by this product.

    It seems increasingly clear that whenever ‘calorie wasting’ gets into pill form, it’s either ineffective or destructive, usually both. And time and time again it causes the same kind of damage that accompany worst case ‘obesity’ scenarios.

    That cannot be a coincidence.

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