Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -613

Accepted - Volume 307

Comment Record
Commentor Ms. Dorena Rode Date/Time 2003-03-25 14:06:23
Organization UCDavis
Category Academic

Comments for FDA General
Questions
1. General Comments The intent of the proposed rule should be to limit consumer risk when consuming concentrated ephedrine alkaloids. I believe that products that contain crude herbs only should be exempt. Alternatively, products that fall below an action level (maybe <3 mg/daily dose) of ephedrine alkaloids should be exempt. I am particularily concerned with Sida cordifolia products that contain small amounts of the herb in conjunction with other herbs and are used to support healthy circulation (verified with clinical trials -one currently in process at Univeristy of California San Francisco for its effect on peripheral artery disease) A warning as proposed on such a product would be misleading and could harm the public by leading them away from a herbal blend which might actually be beneficial.




EC -613