Consumer Health Digest #10-41
Your Weekly Update of News and Reviews
October 14, 2010
Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., with help from William M. London, Ed.D., M.P.H. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making.
FDA attacks "oral chelation" marketing. The FDA has warned eight companies that their over-the-counter (OTC) chelation products are unapproved drugs and that making unproven claims about them is illegal. The companies have been claiming 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. Four of the companies also sell unapproved screening test kits that they claim will detect the presence of heavy metals in urine and thus justify the need for chelation therapy. The companies and their products are:
- Artery Health Institute, LLC: Advanced Formula EDTA Oral Chelation
- Cardio Renew, Inc.: CardioRenew and CardioRestore
- 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
- Rhonda Henry: Cardio Chelate (H-870)
- Hormonal Health, LLC: Kelatox Suppositories, METALDETECTOR Instant Toxic Metals Test
- Longevity Plus: Beyond Chelation Improved, EndoKinase, Viral Defense, Wobenzym-N
- 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, Heavy Metal Screening Test
- World Health Products: Detoxamin Oral, Detoxamin Suppositories, Metal Detector test kit
The FDA has noted an increase in "chelation therapy" products marketed on the Internet that claim to cleanse the body of toxic chemicals and heavy metals. The products come in various dosage forms, including transmucosal sprays, suppositories, capsules, liquid drops, and clay baths. Although some are marketed as "dietary supplements," they are unapproved drugs because they are claimed to treat, mitigate, prevent, or diagnose disease. The FDA advises consumers to avoid all nonprescription products offered for chelation or detoxification. The only FDA-approved chelating agents are available by prescription only and have limited use.
The warning letters state that failure to promptly correct the violations could subject the companies to legal action that includes seizure and injunction.
FDA curbs black salve marketers. Toby McAdam and Greta Armstrong, doing business as Risingsun Health and The Center for Complementary and Alternative Health (TCCAH, Inc) of Livingston, Montana, have signed a consent decree that will permanently enjoin them from illegally marketing unapproved new drugs and adulterated or misbranded dietary supplement. The agreement settles a complaint that the defendants were marketing more than 40 such products. The complaint indicates that, beginning in 2006, the FDA had repeatedly warned the defendants to stop marketing illegally and that the defendants had repeatedly promised to do so but did not. Several of the products were escharotic skin salves (commonly referred to as "black salves)" that contain bloodroot and other caustic substances. Other products included oils and capsules claimed to be therapies for breast cancer, asthma, anemia, epilepsy, and other serious diseases. Corrosive salves are not safe for use against skin cancers because (a) they can indiscriminately burn whatever the tissue they encounter and (b) it is not possible to be certain whether cancer remains under the skin where it can continue to grow without immediate detection. [Barrett S. Don't use corrosive cancer salves (escharotics). Quackwatch, Oct 14, 2010]
Vaccine critic "Dr. Bob" Sears blasted again. Rahul K. Parikh, M.D., has looked closely the irresponsible advice given by "Dr. Bob" Sears in his book, The Vaccine Book." The book's centerpiece is "Dr. Bob's Alternative Schedule," which spreads vaccines over 21 visits instead of the standard 13. Parikh notes that Sears repeatedly uses "soft science, circular logic, rumors, and outright falsehoods" and that his book is "nothing more than an anti-vaccine book blanketed in a soft, sympathetic and homespun style." [Parikh RK. Face-off with the bestselling vaccine guru. Salon.com, Oct 13, 2010] Last year, in a stinging editorial, Paul Offit, M.D. and a colleague pointed out that Sears's schedule is dangerous because it significantly increases the time during which children are susceptible to vaccine-preventable diseases. [Offit P, Moser CA. The problem with Dr Bob's alternative vaccine schedule. Pediatrics, Jan 2009]
Classic health survey report posted. The full text of A Study of Health Practices and Opinions has been posted to the Consumer Health Sourcebook Web site. The FDA-sponsored survey, published in 1972, investigated questionable and fallacious health beliefs and why people are susceptible to them. The covered areas include vitamin pills, other dietary supplements, weight-reduction practices, cancer-related practices, arthritis-related practices, laxatives, self-diagnosis, self-medication for common ailments, types of practitioners used, and general health-related attitudes and opinions. It is the largest survey of its type ever conducted.
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