Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1248

Accepted - Volume 326

Comment Record
Commentor Mr. John Pirog Date/Time 2003-04-02 22:11:42
Organization Northwestern Health Science University
Category Academic

Comments for FDA General
Questions
1. General Comments There is little that ephedrine can do that pseudoephedrine cannot do; in fact, both alkoloids are contained in Ephedra species. Both ephedrine and pseudoephedrine are sympathomimetic; both increase metabolism, both can raise blood pressure, both have the same fundamental risks. If ephedra is taken off the market, or if severe warnings are mandated on the label, manufacturers can easily--with minor adjustments to the label --substitute pseudoephedrine, which is already approved for over-the-counter sale by the FDA. And then what? Will the FDA ban all products containing pseudoephedrine? A more rational approach is to create the same labeling and quality assurance requirements for ephedrine products as those already mandated for pseudophedrine. If this is not done, if the FDA continues in its present course, then it will be creating an arbitrary and unscientific double standard for the industry, while leaving a large loophole for purveyors of questionable weight loss products.




EC -1248