新 聞 及 資 訊
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| The United States: FDA issues warnings to marketers of unapproved ‘chelation’ products |
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The U.S. Food and Drug Administration (FDA) warned eight companies that their over-the-counter (OTC) chelation products are unapproved drugs and devices and that it is a violation of federal law to make unproven claims about these products. There are no FDA-approved OTC chelation products.
The companies that received the warning letters claim that their products treat a range of diseases by removing toxic metals from the body. Some also claim to treat autism spectrum disorder, cardiovascular diseases, Parkinson’s disease, Alzheimer’s disease, macular degeneration, and other serious conditions. The drug products involved have not been evaluated by the FDA for treatment of these diseases.
The agency advises consumers to avoid non-prescription products offered for chelation or detoxification. The only FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as lead poisoning and iron overload.
The FDA issued warning letters to the following companies:
• 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 Chelate (H-870)
Please refer to the following website in FDA for details:
http://www.fda.gov/NewsEvents/Newsroom/../ucm229320.htm
In Hong Kong, the above products are not registered.
Ends/Friday, October 15, 2010
Issued at HKT 14:30
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