Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1212

Accepted - Volume 326

Comment Record
Commentor Mr. David Bunting Date/Time 2003-04-02 12:55:14
Organization Herb Pharm, Inc.
Category Dietary Supplement Industry

Comments for FDA General
1. General Comments Traditional-style ephedra products often deliver reduced amounts of ephedrine alkaloids compared to other types of ephedra products, based on maximum labeled usage instructions. Risk from ephedra products delivering a total daily intake of 10 mg or less ephedrine alkaloids has not been adequately demonstrated. Our product, along with many others, currently carries a suitable warning on the secondary panel of the label, sufficient to protect the consumer. Many of these traditional-style extracts are packaged in containers with a maximum label size of 1.75 x 3.75 inches (6.56 square inches) and cannot accommodate the proposed warning. Furthermore, a front panel warning for any type of ephedra product is excessive in relation to other product categories such as OTC drugs where a hazard to public health has been clearly demonstrated. We therefore make two requests regarding these types of products on Docket No. 95N-0304. 1. We request that ephedra products not be required to carry a front panel warning, which constitutes excessive labeling. If FDA finds that such a label warning is necessary, we request that traditional-style products delivering a daily total of 10 mg or less ephedrine alkaloids be exempt from any front panel warning requirement. 2. We request that products delivering a daily total of 10 mg or less ephedrine alkaloids and that carry the properly displayed ephedra warning recommended by the American Herbal Products Association (AHPA) be considered safely and legally labeled.

EC -1212