Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -237

Accepted - Volume 4

Comment Record
Commentor Mr. Gary Webb Date/Time 2002-07-28 11:11:54
Organization Mr. Gary Webb
Category Individual

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? Even though I am Canadian, I am concerned about the proposed changes to DSHEA. The US and Canada are great countries and we value our freedoms immensely. Many other countries look to us as examples of promoters for personal freedoms. This freedom includes the human right to choose for ourselves what dietary supplements to take for the overall sustained health and well being for our bodies. Your laws and regulations affect us Canadians as well. I believe it is the mandate of the FDA to make sure that the supplements are safe and effective for the overall good of the US citizens. Clinical trials and case studies have overwhelmingly proven that supplementation enhances the well being of many people. It has been known from the beginning of time that we require unadulterated nutrition for our bodies. Please, do not let a select minority tamper with that freedom. Please, do not let greed influence your decision regarding DSHEA. Please, when casting your vote, think of the overall health benefits of the citizens. Terrorism is one way of taking away the freedom from the people. A more subtle way to limit that freedom is to take it away from it's own citizens by changing the laws in order to please a strong lobbying group -- namely, the drug companies.

EC -237