FDA issued warning letters to eight companies noting certain products they are selling for chelation are unapproved drugs and devices, marketed in violation of federal law. The agency also released a consumer advisory, updating its Consumer Update website with details about the warning letters and urging consumers to avoid non-prescription products for chelation. In its warning letters, FDA noted the various products claim to treat a range of diseases—including serious conditions such as autism, Alzheimer’s disease and cardiovascular diseases—by removing toxic metals from the body. However, there are no approved over-the-counter chelation products; the use of such products can pose serious safety issues including dehydration and kidney failure.
Warning letters were issued to the following companies: Artery Health Institute LLC, Cardio Renew Inc., Dr. Rhonda Henry, Evenbetternow LLC, Hormonal Health LLC, Longevity Plus, Maxam Nutraceutics/Maxam Laboratories and World Health Products LLC.