2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC90
Submitter : Mr. John Pantermuehl Date & Time: 12/07/2005 06:12:40
Organization : Mr. John Pantermuehl
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
FDA should mandate that drug companies provide clinical proof of chemical imbalance before allowing claims to be made that these drugs correct chemical imbalance.

If this is not forthcoming, advertisements of drugs to correct a condition that has not been proven to exist should explicitly state this.