Regarding the FDA and Chelation Products

[Guest guest]

The recent flurry of activity on chelation products was likely prompted

by last week's FDA warning letters to 8 makers of over-the-counter

supplements being marketed as chelating agents to remove heavy metals.

The warnings are not related to prescription chelators like

Succimer/DMSA or DMPS. All the products given warning letters were

labeled as containing EDTA. SafeMinds issued a statement on the FDA

press conference, below. Links to 2 news articles are given below as

well. The FDA action was prompted solely on the basis of marketing

claims; the FDA has zero reports of adverse reactions from these products.

http://www.webmd.com/news/20101014/no-otc-chelation-fda-warns

http://www.aolnews.com/surge-desk/article/chelation-treatment-for-autism-is-blas\

ted-by-fda/19675554

SafeMinds Statement on FDA Warning on OTC Chelation Products

October 14, 2010. The FDA issued a media release this morning 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

(http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm228685.htm).

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.