Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1234

Accepted - Volume 326

Comment Record
Commentor Ms. Maria Solomon Date/Time 2003-04-02 18:34:00
Organization Natrol
Category Dietary Supplement Industry

Comments for FDA General
Questions
1. General Comments I strongly support the need for stricter regulations on Ephedrine Alkaloids. There is so much misuse by the consumer of the dietary supplements containing the Ephedrine Alkaloids. Some dietary supplement companies avoid informing the general consumer of the danger that if the product is not taken as instructed it may not lead to a personís well being but may do more harm than if not used constructively and as directed. Thereís no reason why it shouldnít be sold as dietary supplement but you may want to regulate by restricting the sale to physicians only. This may properly monitor the publicís intake, but even the licensed practitioner monitoring will not avoid an overdose of the product. Even with proper education of ephedrine the public does not care and consecutively some over-indulge on the use of ephedrine. This product needs more clarification, for the dietary supplement industry and consumers, levels of ephedrine alkaloids that can be used per serving, daily use limits, and limitations on duration of use. Many, many people are unaware of the serious health risk. Most reported adverse events have occurred in healthy young to middle-aged adults who used the products for weight control or increased energy. With proper label instructions and warnings, consumers can be educated on how to use the product safely.




EC -1234