Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -251

Accepted - Volume 4

Comment Record
Commentor Ms. K. Holland Wemple Date/Time 2002-07-29 08:44:12
Organization Mannatech
Category Dietary Supplement Industry

Comments for FDA General
Questions
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? July 29, 2002 Dear Friends, I would like to echo Tish Onsager's position, which follows: In 1994 the DESHEA, Dietary Education Health & Education Act, states: Consumers should be empowered to make choices about preventative health care programs based on data from scientific studies of health benefits related to particular dietary supplements... In 1943 a court case stated that FDA's purpose should be: ....to protect the public, the vast multitude which includes the ignorant, the unthinking and the credulous who, when making a purchase, do not stop to analyze. Personally, I'd like to see that the FDA's agency be changed to FNDA, Food, Nutraceuticals, & Drug Administration. Once a Nutraceutical passes the stringent requirements to be classified as a Nutraceutical, people should be empowered to research Nutraceuticals since they are any non-toxic food component that has scientifically proven health benefits, including disease treatment or prevention. Thank you very much, K. Holland Wemple Charlottesville, Virginia (434) 979-9166




EC -251