2005D-0337 Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque
FDA Comment Number : EC2
Submitter : Mr. Rob Gerlach Date & Time: 11/17/2005 01:11:53
Organization : Mr. Rob Gerlach
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
To Whom it may concern:

I'm not sure to which specific products (not just class of product) this proposal applies or whether it seeks to restrict availability of specific products, but if it covers flouride rinses such as Colgate Fluorigard, I see no reason why this kind of product should be restriced to behind-the- counter when I, as a consumer, am intelligent enough to specifically seek and use said product for the prevention of dental caries, being aware that typical preventative measures are inadequate in my case. I am obviously able to read the label regarding issues that may occur from use of such product and act accordingly in a mature and consistent manner.

To presume that I am incapable of doing so, or that I need some kind of permission to use such products, is both insulting and ridiculous.

Those that are unable to engage in such a simple task such as finding a product that suits their needs and reading its labelling for pertinent information is probably either illiterate (and for which I should not have to suffer) or mentally incompetent, in which case said person would (or should) be under the supervision of mental illness advocate.

The job of Government is not to protect citizens from themselves, but to protect them from affecting eachother negatively -- and of course, for the national defense. At least this is what the Constitution of the United States says..

Many thanks for your attention and consideration,

-Rob