Chelation is a process whereby metals are removed from the body using a drug, a chemical which binds to the metals and allows them to be excreted. Because of the incorrect notion that autism is caused by mercury or is a “novel” form of mercury poisoning, chelation is one of the more common alternative medical therapies applied to autistics.
The FDA has recently issued a warning to many of those who market unapproved chelators. Two articles appear on the FDA website today:
FDA Tightens Reins on Unapproved ‘Chelation’ Drugs
and a press release
FDA issues warnings to marketers of unapproved ‘chelation’ products.
They have also issued a printer-friendly pdf: FDA chelation warning pdf
From that pdf:
Federal regulators are warning eight companies to stop selling so called ‘chelation’ products that claim to treat a range of disorders from autism to Alzheimer’s disease by removing toxic metals from the body.
The Food and Drug Administration (FDA) says the companies have not proven their products are safe and effective in treating autism spectrum disorder, cardiovascular disease, macular degeneration, Parkinson’s disease or any other serious illness. Some of the companies also claim their products can detect the presence of heavy metals in the body in an attempt to justify the need for chelation therapy.
The groups that have been warned are:
• World Health Products, LLC: Detoxamin
Oral, Detoxamin Suppositories, and the
Metal Detector test kit
• Hormonal Health, LLC and World Health
Products, LLC: Kelatox Suppositories,
and the METALDETECTOR Instant Toxic
Metals Test
• Evenbetternow, LLC: Kids Chelat Heavy
Metal Chelator, Bio-Chelat Heavy Metal
Chelator, Behavior Balance DMG Liquid,
AlkaLife Alkaline Drops, NutriBiotic
Grapefruit Seed Extract, Natur-Leaf,
Kids Clear Detoxifying Clay Baths, EBN
Detoxifying Bentonite Clay, and the
Heavy Metal Screen Test
• Maxam Nutraceutics/Maxam Laboratories:
PCA-Rx, PC3x, AFX, AD-Rx, AN-Rx,
Anavone, AV-Rx, BioGuard, BSAID, CF-Rx,
CreOcell, Dermatotropin, Endotropin,
GTF-Rx, IM-Rx, Keto-Plex, Natural Passion,
NG-Rx, NX-Rx, OR-Rx, Oxy-Charge,
PN-Rx, Ultra-AV, Ultra Pure Yohimbe, and
the Heavy Metal Screening Test
• Cardio Renew, Inc: CardioRenew and
CardioRestore
• Artery Health Institute, LLC: Advanced
Formula EDTA Oral Chelation
• Longevity Plus: Beyond Chelation
Improved, EndoKinase, Viral Defense,
Wobenzym-N
• Dr. Rhonda Henry: Cardio
I wonder how the FDA chose these groups for the first round of warnings. I also wonder if/when there will be more warning letters.
Also from the FDA pdf:
FDA says consumers should avoid nonprescription products offered for chelation or detoxification. FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as the treatment of lead poisoning and iron overload. The agency says even the prescription medications carry significant risks, and they should only be used with medical supervision.
I don’t know why the FDA has taken so long to step in and take action. Chelation has been going on for years, and has never had a sound basis in science or even a good rationalization for the treatment of autism.
Trine Tsuderous has an article on the Los Angeles Times website, FDA warns about treatments for autism, heart disease.
Left Brain Right Brain 
Now will Doctor’s Data, Inc sue the FDA?
@DNB: that made me LOL. Thanks!
Age of Autism (probably Kim Stagliano) used twitter to claim:
I am not surprised that they are worried about this action. I am also not surprised that they stick to the failed story about mercury poisoning being related to mercury.
It’s time to catch up to the present, a time when the mercury hypothesis is dead.
Do we have health freedom in America? I guess not…the FDA is here to protect us, oh I’m so glad! Not! The FDA is at it again, removing competition for mainstream drug and western medicine surgery procedures.
If I want to try chelation for something, then that is my right and freedom. I don’t need a fraudulent, corporate controlled FDA to tell me what is safe or not. Look it up people, prescription drug overdoses and hospital mistakes is the 3rd leading cause of death in America.
When will we wake up and stop letting the FDA remove our health freedoms? When?
This is ludicrous. The FDA is not addressing personal liberty, rather in light of personal liberty, they’re addressing the marketers, saying that they have to establish what is safe and effective for specific treatments before selling it to consumers.
As for limiting competition, I suppose the FDA does have that effect – they have established rules for the marketplace that don’t necessarily favor those who for whatever reason don’t think those rules should apply to them or their product/procedure.
Fred Winters:
So you were also angry that Frances Kelsey blocked the sale of thalidomide in the USA? Are you angry that the FDA requested that Fen-Phen be withdrawn from the market?
Or is it only your own pet drugs and medical procedures?
I suspect Fred Winters has some Chelation therapy he wants to flog.