FDA Warns Marketers of Unapproved ‘Chelation’ Drugs

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.

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.

FDA compliance expert Deborah Autor says the companies are preying on people made vulnerable because of serious illness.

“These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options,” says Autor.

In letters dated Oct. 14, FDA warns the companies that they are facing possible legal action if they continue to make unsubstantiated claims. The firms that received the letters (along with the chelation products they market) 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 Chelate (H-870)

FDA says consumers should avoid non-prescription 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.

The products come in a number of forms, including sprays, suppositories, capsules, liquid drops, and clay baths.

Overall, FDA says there’s been an increase in the number of nonprescription, chelation products that claim to cleanse the body of toxic chemicals and heavy metals. Although some of the products are marketed on the Internet as dietary supplements, by law they’re unapproved drugs and devices because they claim to treat, mitigate, prevent, or diagnose disease.

This article appears on FDA’s Consumer Update page4, which features the latest on all FDA-regulated products.

Posted: October 14, 2010

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PCA-Rx Maxam Labs F.D.A. a true Takedown Letter

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Awaken Nutrition – Have you ordered from Awaken Nutrition?

Better yet have you ordered from Maxam Labs ?

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm229184.htm

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A fundraising event has been held in Abbots Langley to raise money for Brooke Cornwell

Residents across Abbots Langley turned out in force yesterday evening in order to raise money for a five-year-old suffering from a rare blood disease.

Villagers were busy buying jewellery, scented candles and bubble bath from stalls inside the Swan Pub in College Road, while sizzling sausages were sold on an outside barbecue – all in order to raise money for Brooke Cornwell.

Brooke, of Breakspeare Close, Watford, suffers from Diamond Blackfan Anaemia, a disorder which means her bone marrow cannot produce enough red blood cells to carry oxygen around her body.

As a result she needs to have blood transfusions every three weeks and iron chelation therapy – to rid her body of excess iron caused by the transfusions.

Charitable duo Mandie Collingbourne, 31, and Kerri Chapman, 27, organised the event in order to send Brooke to Camp Sunshine in Maine, America, so that she can meet and interact with similar children, as well as see a specialist.

Mrs Chapman, of Jersey Farm, St Albans, said: “As a mother-of-two, when I heard about what Brooke has been through, I felt moved to help.

“She’s such a remarkable little girl, so, so brave. Mandie and I really wanted to help so we decided to hold this fundraiser in Abbots Langley so that she could go to Camp Sunshine.

“If we raise anything extra that will go towards paying for whatever else Brooke needs.

“The community has really come together to show their support, it’s very touching how people pull together when needed.

“We hope that we can make a difference to little Brooke’s life.”

A number of local businesses as well as store Costco donated items including toasters, kettles and Waterford crystal sets all of which were raffled off.

Brooke’s mother, Amber Cornwell, 29, said: “I can’t believe what Mandi and Kerri have done for us – it’s just amazing, the pair of them, they are amazing.

“We applied to the camp in Maine a couple of months ago and we’ve just found out Brooke has been offered a place – all we need to do now is raise a couple of thousand so that me, my husband and Brooke can fly over to America.

“Lots of people have turned out to support us – we couldn’t be more grateful.”

Villagers helped raise £2,004 for Brooke.

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http://www.watfordobserver.co.uk

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Indonesia – Poultry seminar

DSM Nutritional Products Indonesia conducted a seminar entitled “DSM Poultry Forum: Updating Global Trend in Poultry Industry” in Jakarta on 12 May 2010.

The seminar was divided into 3 sessions of presentation. Before the presentation and as welcoming speech, Suaedi Sunanto, Sales Manager DSM Indonesia, introduced the company and spoke of its commitment to animal nutrition and health.

The first session was presented by Dr. Kelli H. Jones, Assistant Clinical Professor of Avian Medicine Poultry Research and Diagnostic Laboratory, College of Veterinary Medicine, Mississippi State University. Her presentation’s was entitle is “A Global Perspective on Current Health Issues in the Poultry Industry”. Focusing on Asia, Dr. Jones said that current animal health issues in Asia include IBV (Infectious Bronchitis Virus), leg problems (Rickets, Tibial Dyschondroplasia and Vertebral Osteoarthritis), CRD (Chronic Respiratory Disease), Coccidiosis, Salmonella, AI (Avian Influenza), Adenovirus (Inclusion Body Hepatitis), and tumors (Marek’s disease).
The second session was presented by Dr. Jose Maria Hernandez, Global Business Manager Poultry, DSM Nutritional Products – Switzerland, entitled “Food Chain Partnership: the DSM Experience”. Dr. Hernandez explained that main goal of food chain partnership is to ensure food safety and quality to consumers, but it depends on each stakeholder in the food chain. Based on DSM’s research to European consumers, he added that nowadays consumers are not sure about the safety of food they are eating and the companies and brands behind. “Consumers want information on how food is produced in order to regain their trust. That’s why, work with media and NGOs is important in gaining much power,” Dr. Hernandez said.
The last session was presented by Dr. Roselina Angel, Assistant Professor of Department of Animal & Avian Sciences, University of Maryland. Dr. Angel’s presentation is about amino acid digestibility in sorghum, kafirin in sorghum, phytic acid & phytin, and phosphor’s chelation. She also informed that she has been working together with an animal nutritionist from Indonesia to study palm kernel meal for one of alternative animal feedstuffs.
 

Source: newsroom – meattradenewsdaily

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Awaken Nutrition, Generation Rescue Partners in Autism Therapy

Awaken Nutrition has been “picked up” – endorsed, that is – by Jenny McCarthy’s company, Generation Rescue, which has been a giant in autism therapy and research and nutritional products. Generation Rescue and Awaken Nutrition alike are both working hard helping those with special nutritional needs in conjunction with neuro-behavioral disorders.

Awaken Nutrition’s specially-formulated line of nutritional supplements allow those with special neurological and nutritional needs to receive the proper dietary balance for optimum health. Pairing up with Generation Rescue means that Awaken Nutrition will, of course, be able to reach many more children and adults with its specifically formulated line of supplement products. Products such as the gluten and casein-free Liquid Calcium Formula, the Colon and Liver Detox duo, and the chelation therapy spray for eliminating heavy metal toxicity and mercury toxicity are forerunners in promising nutritional hope where gimmicky diets and fly-by-night “cures” have failed those in need of alternative therapy.

Join Awaken Nutrition and Generation Rescue’s quest for healthy children and healthy lives!

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Video on Oral Chelation Profiles EDTA’s Efficacy

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Chelation Therapy Gets Latest “Official” Endorsement

Earlier this week, the Associated Press reported that Tom Insel, the director of the National Institute of Mental Health (NIMH), supports testing the effectiveness of chelation therapy on children to see if it can be proved safe and effective. The autism blogosphere lit up, and advocates of chelation therapy were elated. But as with all things concerning autism, alas, the story is far more complicated than it seems.

The chelation study was first approved by NIMH in 2006. In February 2007, a study showed that giving chelation to rats who weren’t suffering from heavy-metal poisoning caused permanent cognitive impairment. Whoa. That sent NIMH back to more risk-benefit analysis. It filed an application with the Food and Drug Administration to study chelation as an investigational new drug (an IND, in FDA-speak). And keep in mind that the dynamic of testing chelation on rats involves differing variables than on human beings. The findings are not “definitive” at all.

The knowledge gleaned from the study will be limited, since only 120 children are to be enrolled.  Half will get a chelating agent for 12 weeks and the other half, a placebo. The children’s blood mercury levels and autism symptoms will be monitored along the way. That’s too few subjects to get a clear sense of whether or not chelation works, though it’s better than what we’ve got now.

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A Brief History of Chelation

Chelating agents were introduced into medicine as a result of the use of poison gas in World War I. The first widely used chelating agent, the organic dithiol compound dimercaprol (also named British Anti-Lewisite or BAL), was used as an antidote to the arsenic-based poison gas, Lewisite. The sulphur atoms in BAL’s mercaptan groups strongly bond to the arsenic in Lewisite, forming a water-soluble compound that entered the bloodstream, allowing it to be removed from the body by the kidneys and liver. BAL had severe side-effects, such as nephrotoxicity and hypertension.

Following World War II, a large number of Navy personnel suffered from lead poisoning as a result of their jobs repainting the hulls of ships. The medical use of EDTA as a lead chelating agent was introduced. Unlike BAL, it is a synthetic amino acid and contains no mercaptans. EDTA side effects were not considered as severe as BAL.

In the 1960s, BAL was modified into DMSA, a related dithiol with far fewer side effects. DMSA quickly replaced both BAL and EDTA, becoming the US standard of care for the treatment of lead, arsenic, and mercury poisoning, which it remains today.

Research in the former Soviet Union led to the introduction of DMPS, another dithiol, as a mercury-chelating agent. The Soviets also introduced ALA, which is transformed by the body into the dithiol dihydrolipoic acid, a mercury- and arsenic-chelating agent. DMPS has experimental status in the US FDA, while ALA is a common nutritional supplement.

Since the 1970s, iron chelation therapy has been used as an alternative to regular phlebotomy to treat excess iron stores in people with haemochromatosis. It is also at the forefront of clinical autism treatment.

Other chelating agents have been discovered. They all function by making several chemical bonds with metal ions, thus rendering them much less chemically reactive. The resulting complex is water-soluble, allowing it to enter the bloodstream and be excreted harmlessly.

Calcium-disodium EDTA chelation is approved by the U.S. Food and Drug Administration (FDA) for treating lead poisoning and heavy metal toxicity.

In 1998, the U.S. Federal Trade Commission (FTC) pursued the American College for Advancement in Medicine (ACAM), an organization that promotes “complementary, alternative and integrative medicine” over their advertising of EDTA chelation therapy, with claims including “Chelation therapy is a safe, effective and relatively inexpensive treatment to restore blood flow in victims of atherosclerosis without surgery.” The FTC found that “scientific studies do not prove that EDTA chelation therapy is an effective treatment for atherosclerosis.”, and that the statements by the ACAM were false. In 1999, the ACAM agreed to stop misrepresenting chelation therapy as effective in treating heart disease, avoiding legal proceedings.

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