The FDA issued a media release and held a
press conference on over-the-counter
chelating products. A recording of the press
conference was made available this afternoon
(recording available at 800-839-7073). FDA
issued warning letters to 8 companies
promoting over-the-counter nutritional
supplements for chelation therapy (HERE).
Chelation is a method of removing heavy
metals from the body. The FDA warning has no
bearing on prescription chelation drugs
which are used under the supervision of
medical professionals.
In its press conference, the FDA implied that chelation products were being used by parents of children with autism without a doctor's supervision, but on questioning by reporters, FDA representatives were unable to back up the claim with any evidence of use of OTC chelation products by autism parents or of their use without medical supervision. The FDA asserted that the OTC products being promoted were dangerous and could lead to kidney damage, dehydration and death. On questioning by reporters, the FDA admitted that it had received no reports of adverse reactions to the products or to chelation in general, other than 1 death 5 years ago which was due to a medical error and in which a prescription drug was used. The FDA suggested that the reason it had received no reports on side effects was because parents and patients were unable to make the connection between the product and any harmful effects, yet they had no studies to support this claim. The FDA also admitted that its action was prompted by "the prominence of the products on the internet" and was not due to any safety issues. The FDA, when pressed further, stated that the warnings were based on marketing practices and not on any safety reports. The FDA asserts that any product with a health claim must be proven safe and effective, and the companies promoting these products had not conducted the necessary clinical trials.
SafeMinds agrees with the FDA that products being promoted as drugs and biologics should have thorough and unbiased assessments for safety and that parents should work with their healthcare professionals when considering health interventions. SafeMinds feels that FDA has tried to cast autism parents in a negative light without any supporting evidence, by implying that autism parents were giving their children dangerous products without medical oversight. Only on questioning by the media did the FDA have to back off from its wild claims. SafeMinds feels the FDA owes the autism community an apology.
In its press conference, the FDA implied that chelation products were being used by parents of children with autism without a doctor's supervision, but on questioning by reporters, FDA representatives were unable to back up the claim with any evidence of use of OTC chelation products by autism parents or of their use without medical supervision. The FDA asserted that the OTC products being promoted were dangerous and could lead to kidney damage, dehydration and death. On questioning by reporters, the FDA admitted that it had received no reports of adverse reactions to the products or to chelation in general, other than 1 death 5 years ago which was due to a medical error and in which a prescription drug was used. The FDA suggested that the reason it had received no reports on side effects was because parents and patients were unable to make the connection between the product and any harmful effects, yet they had no studies to support this claim. The FDA also admitted that its action was prompted by "the prominence of the products on the internet" and was not due to any safety issues. The FDA, when pressed further, stated that the warnings were based on marketing practices and not on any safety reports. The FDA asserts that any product with a health claim must be proven safe and effective, and the companies promoting these products had not conducted the necessary clinical trials.
SafeMinds agrees with the FDA that products being promoted as drugs and biologics should have thorough and unbiased assessments for safety and that parents should work with their healthcare professionals when considering health interventions. SafeMinds feels that FDA has tried to cast autism parents in a negative light without any supporting evidence, by implying that autism parents were giving their children dangerous products without medical oversight. Only on questioning by the media did the FDA have to back off from its wild claims. SafeMinds feels the FDA owes the autism community an apology.