Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -57

Accepted - Volume 1

Comment Record
Commentor Mr. robert hoffman Date/Time 2002-05-29 11:32:41
Organization Mr. robert hoffman
Category Health Professional

Comments for FDA General
1. Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements? What must an administrative record contain to sustain such a position? In particular, could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? Does anything turn on whether the speech is made to learned intermediaries or to consumers? What is the evidentiary basis of such a distinction? no, the speech requirements of natural health supplements are not different then drugs, yet in that statement lyes the rub, understanding them to be alike is not a true statement. The fact that they treat the patient is fact, but the approach varies greatly. Also a natural approach to supporting health through natural substances woven into an exsisting health care system is a viable alternative to escalating drug costs, short and long term. Along with the patient becoming proactive, theraby also assisting in cost reduction. As an acupuncture physician it is my interest to enrich patients with information that will then engage them in a process of healing, therefore we can and must be more willing to allow citizens the right to choose a method of treatment vs. dictating to them what is not allowed or not given an option by the way a label is lead to disempower them.

EC -57