From: Normalane@aol.com
Sent: Tuesday, July 30, 2002 7:05 PM
To: fdadockets@oc.fda.gov
Subject: Docket 02N-0209 
Dear FDA Representative

I wanted to resond to the Docket Management Comment Form questions that are related to this docket but the comment sections were impossible for the lay person to be able to understand exactly what was being asked.  Most comment sections had not one question but as many as seven questions to comment on.  A person would have to do research and write a report of up to several pages for each "Comment."

I believe this is an insult to the American people to be given a comments request form with this type format.  

If the words "Consumption of antioxidant vitamins in the amounts contained in this product may reduce the risk of certain cancer" were to appear on a dietary supplement label with no disclaimer from the FDA, who would it hurt?  It is almost impossible to imagine how anyone would suffer a threat to his/her health from such a claim or from the absence of an FDA disclaimer.

Consumers have the responsibility to be diligent about educating themselves when they chose any pharmaceutical or dietary supplement.  The FDA has overstepped its regulatory bounds by enforcing misguided disclaimers.  

The FDA's mandate is to evaluate the safety and effectiveness of pharmaceuticals, foods, cosmetics etc.  not to require labels on dietary supplements to carry an unnecessary disclaimer.  The health of the citizens is not protected, but it protects the giant drug companies who stand to lose millions when more consumers choose to improve their health with supplements and reduce their need for high priced pharmaceuticals.

I am in favor of the FDA being placed in the position where it has to deregulate dietary supplements.

Thank you.

Norma Chudleigh