FDA Chelation Warnings Reflect Growth In Bogus OTCs, Supplements
This article was originally published in The Tan Sheet
Executive Summary
FDA says its Oct. 14 warnings about unapproved autism treatment claims for chelation products marketed as OTCs or dietary supplements reflect a growing problem of fraud in consumer health care product marketing
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FDA says its Oct. 14 warnings about unapproved autism treatment claims for chelation products marketed as OTCs or dietary supplements reflect a growing problem of fraud in consumer health care product marketing. FDA sent chelation warning 1 letters to World Health Products of Draper, Utah, Carson City; Nev.-based Hormonal Health, San Bernardino; Calif.-based Evenbetternow; Maxam Nutraceutics/Maxam Laboratories of Hood River, Ore.; Cardio Renew in Apple Valley, Minn.; New York firm Artery Health Institute; Longevity Plus in Payson, Ariz.; and Dr. Rhonda Henry of Dayton, Nev. The firms marketed chelation products as OTCs or supplements and several also sold unapproved screening tests purported to detect the presence of heavy metals in urine, the agency said. Michael Levy, director of Center for Drug Evaluation and Research's Division of New Drugs and Labeling Compliance, said the agency acted because "we have noted an increase in the availability and prominence of these products on the Internet." In a same-day media briefing, Levy emphasized FDA is enforcing against chelation products sold directly to consumers, either as OTCs or supplements, and is not addressing possible off-label use of Rx chelation drugs, including for autism treatment. The unapproved drugs "represent the wide variety of products that are available over the counter to consumers now," he said. DNDLC's medical officer Charles Lee said FDA suspects that adverse events linked to chelation OTCs or supplements are under-reported. "The companies really have no incentive to submit reports and certainly there's a lot of under-reporting in the over-the-counter setting anyway," Lee said. Consumers using the unapproved products have little guidance on what to expect, he said. "A lot of these are labeled in such a way to imply that they are not associated with adverse events. So, if something happens somewhere down the line, maybe not in the immediate few minutes but maybe the next day, parents may not make the association between the two," Lee said. Autism Treatment Not Among Rx Indications No chelation therapy is approved OTC and no autism treatment claim is approved for a dietary supplement product. Nor is autism treatment an approved indication for Rx chelation drugs, which are used for treating conditions such as lead poisoning and iron intoxication. FDA has not approved any at-home screening devices for detecting heavy metals in urine. "Any chelation therapy that is marketed over the counter is suspect," Levy said, pointing out that none of the firms submitted new drug applications for an OTC product. "These products do not have proven safety and efficacy," he said. "OTC chelation products are dangerously misleading because they target patients and caregivers of patients that have serious conditions with limited treatment options." Autism treatment claims for chelation products are not the only unapproved claims targeted for potentially vulnerable consumers, Autism Speaks researcher Daniel Coury said. Coury, director of the organization's Autism Treatment Network, noted chelation products also make unsubstantiated claims for treating conditions including Alzheimer's and Parkinson's diseases and rheumatoid arthritis. When traditional, approved treatments do not work, caregivers for children with autism, like consumers with other conditions, look for other options. "Parents of children with autism have been looking at alternative treatments for a long time," Coury said. However, data from Autism Treatment Network's database show less than 5 percent of participating families have tried chelation therapy, he added. Other data sources show the number may be as high as 10 percent. "It's not the great majority of families," he said. Safety issues associated with the products, which can alter the levels of substances in the blood, include dehydration, kidney failure and death. Lee said use of unapproved chelation products also could delay consumers from receiving tested and approved treatments for their conditions. Further, any chelation therapy includes risks. "The risks of using the approved products undoubtedly would be similar if you used it for autism as it would be for the actual approved indications. All of the products are prescription and are to be used under the supervision of a physician," Lee said. Ongoing Enforcement Expands The seven warning letters follow FDA's June 2010 warning letter about CTI Science's OSR#1 supplement, which the Kentucky firm promotes for relief of oxidative stress but which had become known as an autism treatment. OSR#1 is not a chelation product, but contains benzoate and cystamine (2 (Also see "Supplements Used For Autism Do Not Need Overt Claims To Draw Scrutiny" - Pink Sheet, 5 Jul, 2010.)). One of the firms targeted in the Oct. 14 letters, Maxam, stated in a press release earlier in 2010 that "many parents of autistic children" suspect a link between the condition and toxic accumulation. The firm's website, at the time, promoted its PCA-Rx supplement as an "alternative to traditional chelation therapy." Coury said while there are "not a lot of data" to support theories linking autism to toxic metals, researchers and families of children with autism hold out hope that chelation or another as-yet unapproved treatment will work. "We would like to see any treatment that would improve the health and care of children with autism," he said. - Malcolm Spicer ( 3 [email protected] ) |