October 14th, 2010
06:41 PM ET

OTC chelation products are not FDA approved, agency warns

The Food and Drug Administration is cracking down on companies who advertise over-the-counter (OTC) chelation products to treat a range of diseases.  The agency warned eight companies to stop marketing these products because they are not approved and violate federal law.

Chelation  is a recognized therapy for lead, iron and other heavy metal poisonings.  "These products are not meant to be marketed over the counter at all," Dr. Michael Levy, the FDA's director of New Drugs and Labeling Compliance said. "The only FDA approved products are marketed by prescription and under the guidance of a physician."

Companies that don't comply could have their products seized or face criminal sanctions.

OTC chelation products, often sold over the Internet, claim to treat a number of diseases including autism, heart disease, Parkinson's and Alzheimer's.

Chelation therapy, even when done under medical supervision can be very dangerous.  When these products are used improperly they can cause serious harm including dehydration, kidney failure and death. The agency says while some of these products are marketed as dietary supplements, they are unapproved drugs and dangerously misleading.  Any chelation therapy that is marketed over the counter is suspect, they said.

It's been widely reported that many parents of children with autism give their kids these drugs thinking it will reverse their autism by removing any mercury that's in their body from vaccines.  Levy says, "none of the chelation products are approved for autism."  He adds "we do not have evidence right now that they are safe and effective for that use."

The FDA says they are not even sure what's in some of these products, but internet marketing has increased.  They come in a range of forms including capsules, liquid drops, sprays, suppositories, even clay baths.  The agency is warning consumers to avoid all non-prescription chelation products.

soundoff (20 Responses)
  1. ginger Blymyer

    I always wanted to try chelation and when we moved to Mexico I did. I figured at age 72 I had lots of bad stuff in my system. I took ten intravenous treatments. But then I got weaker and weaker and contracted Coxsackie Virus and almost died, I was on my back for 8 weeks, lost 25 pounds and have never regained my energy. My immune system seemed to have been compromised and the virus took hold. I have had a problem with my eye also. So I don't know if the chelation took out all the good stuff along with the bad. The doctor did not give me intravenous vitamins so did not replenish. Now I would never recommend ti.

    October 14, 2010 at 19:27 | Report abuse | Reply
    • Angela

      Thanks for the information Ginger. I have also wanted to try and your comments may have saved my health. I wish you the best of luck for improving.

      October 14, 2010 at 20:30 | Report abuse |
  2. Janet

    The FDA is a joke. The will not crack down on the Diabetes and Obesity Drug makers who make 50 billion a year!

    1.Why? The FDA get kickbacks$$ and so do the doctor$$
    2.The drug comapnies get a recall after the billions have been pocketed!
    3. The FDA knows this AND supports the drugmakers!!

    A filmmaker has been reversing diabetes and Obesity in now 10 countries worldwide WITHOUT MEDICATIONS and the drug companies do not promote this

    see here http://spirithappy.wordpress.com

    October 14, 2010 at 20:05 | Report abuse | Reply
    • thor

      Well it's a good thing you are smarter than all the doctors of this world. Where would we be wothout people like you selling pills to cure popular diseases. Want to reverse diabetes, stop being a fatty.

      October 14, 2010 at 20:48 | Report abuse |
    • akay

      This gets reported as "not approved" as if that should mean something. Who cares what some muckety-muck in DC approves of?

      If you look at what's actually being said, they are claiming that these OTC chelation products are ineffective and dangerous, and that hits a lot closer to home.

      If the government takes action against worthless quack remedies with dangerous ingredients, isn't that what we pay the government to do?

      October 16, 2010 at 16:57 | Report abuse |
  3. thor

    What I'm hearing is that when your kid has autism you might aswell try to fix it yourself with some pills from the internet. I'm mean what's the worst that can happen? They get more autistic? Who cares about side effects ,they're ruined anyway, If I can't fix the Autism then they are no good to me.

    October 14, 2010 at 20:53 | Report abuse | Reply
    • Daws

      It's not mild pills, it's a serious treatment that can severely affect your health and should not be misused like this, I wish the FDA went further and disallowed it from such frivolous use altogether. It's like, lets just let them have chemo too, it should be alright since what's the harm, they can't get more autistic. As long as we slap a warning label on it, should be fine >.<

      January 6, 2011 at 07:32 | Report abuse |
  4. Meredith

    Chelation therapy is dangerous without medical supervision. Ginger, did you ever do a urine test before treatment? In doctor supervised chelation therapy, the first step is to take a dose of the medicine, and the perform a urine test to see if the toxic metals you have released from your tissues are exiting the body. Some people do not eliminate them properly, and by attempting chelation therapy they are letting these heavy metals travel around the body again to do more damage. It can be a helpful treatment for many things, but only under a physicians care.

    October 15, 2010 at 07:06 | Report abuse | Reply
  5. Ron

    The chelation therapy everyone has posted about so far is all administered by an intravenous infusion (IV), which are at minimum in the 2-3 gram range in dosage. The OTC chelation the FDA is "warning" everyone about is generally 1 gram or less and is not dangerous as long as you take a mineral supplement to offset the good minerals which may have been chelated and drink plenty of water. I have been intimately involved in the OTC chelation industry for over a decade on the suppository side, there have been millions of suppositories sold without any incident of hospitalization. Some people are more sensitive than others and must take a lower dose, but in all the time I have worked in this field, I have never heard of an instance where authorities were called in to investigate because someones life was in danger. IV chelation is generally is given a maximum of three times over a two week period because it is so harsh and the doses are so high and it unquestionably requires a doctor's supervision, but with the OTC doses being so low, a person was able to get benefit at a vastly lower cost and without the need to be monitored by a physician. I find it ironic the FDA is so concerned with keeping people "safe" when OTC chelation has such a huge track record of no incidents, yet drugs they approve like Avandia, Crestor, Cymbalta, Fosamax and Lipitor are WAY more dangerous and have actually CAUSED death, yet are fast tracked by FDA for approval. I guess what it really comes down to is money, not safety.

    October 15, 2010 at 07:55 | Report abuse | Reply
    • akay

      The thing is, any drug is safe at extremely low doses because if you don't take enough, it doesn't do anything.

      The main strike against chelation therapy is that it's worthless for many of the diseases the quacks sell it for, so any risk is unjustified, even if that risk is minor.

      October 16, 2010 at 16:35 | Report abuse |
  6. Chris

    What is wrong with a having a simple warning label ? Why ban something that works. You can smoke yourself to death with a warning label. Yet When it comes to natural remedies that defy the drug companies. Your a criminal for using it or selling it. How many drugs have been recalled after families have suffered do to death or maiming from use of these approved poisins ? Hiding natural cures for enlarged prostate from the public is crimminal.

    October 15, 2010 at 08:20 | Report abuse | Reply
  7. AL

    When the government starts putting warning labels on our food and water sources due to the use of pesticides, insecticides and herbicides that cause most of the badness today then I will take to heart their suggestion that homoepathic chelation should be halted.

    October 15, 2010 at 12:49 | Report abuse | Reply
  8. Q

    Homeopathic chelation? Sciency sounding magic for the gullible and conspiracy theorists. Why do the natural remedy folks believe a $50/bottle herbal supplement to cure their child's autism or treat their cancer is the product of benevolence rather than a profit motive? The profit motive is universal, however, the demonstration of efficacy most certainly doesn't reside in the natural remedy community. Like the religious faithful, they prefer belief and anecdote over demonstrable mechanism and statistically significant results. Besides, science/disease is complicated, whereas fixing every ailment with your diet returns control and peace of mind to the individual in a scary stochastic world. The same pseudo-self empowerment that drives the religious to believe belief itself will let them let live forever.

    October 15, 2010 at 13:53 | Report abuse | Reply
  9. Daws

    If only they had some teeth and just banned them from use by anyone than a licensed physician. The quack uses they come up with can kill.

    January 6, 2011 at 07:26 | Report abuse | Reply
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