FDA Announces Crackdown On Chelation Therapy

By Pushor Mitchell LLP
Categories: Blog

The Washington Post (10/15, Stein) reports that on Oct. 14, officials from the Food and Drug Administration "announced a crackdown on" chelation, "a controversial therapy widely hawked on the Internet and elsewhere as an alternative treatment for conditions such as autism, Alzheimer’s disease and Parkinson’s disease by ‘cleansing’ the body." In fact, the FDA "said it has sent warning letters to several companies notifying them that the substances they sell without a prescription for…’chelation’ are ‘unapproved drugs and devices,’ which makes them illegal." 

The Chicago Tribune (10/15, Tsouderos) reports that the chemicals used in chelation, "which help remove metals from the body, are potent drugs that carry serious risks, including kidney damage, dehydration, and even death, said FDA Medical Officer Dr. Charles Lee." 

In a separate but related piece, the Chicago Tribune (10/15, Tsouderos) notes that the FDA letters "come a year after a Chicago Tribune investigation found chelation treatment is popular among parents of children with autism, even though the therapy is…based on a disproven hypothesis that children with the disorder are actually suffering heavy metal poisoning." In fact, "in 2008, the National Institutes of Health halted a controversial government-funded study of chelation before a single child with autism was treated" after investigators "had found that rats without lead poisoning showed signs of cognitive damage after being treated with a chelator."

Reuters (10/15, Steenhuysen) reports that the FDA sent letters to nutritionist Dr. Rhonda Henry, as well as to World Health Products LLC; Evenbetternow LLC; Hormonal Health LLC; Cardio Renew Inc; Artery Health Institute LLC; Maxam Nutraceutics/Maxam Laboratories; and Longevity Plus. 

The AP (10/14, Perrone) reported that the agency’s "warning letters call on each company to immediately stop marketing and selling their products or face legal action." The products in question are freely available online and "come in a variety of forms, including sprays, capsules and drops."
 
For more, see the article in the Washington Post ; Washington Post (10/15, Stein)