Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1034

Accepted - Volume 322

Comment Record
Commentor Mr. Tim Schinker Date/Time 2003-03-31 13:50:04
Organization Puri-Clean Enterprises
Category Dietary Supplement Industry

Comments for FDA General
Questions
1. General Comments Given the nature of our business, the proposed changes to the DSHEA would be detrimental to us. The capital needed to go through a lengthy approval process would hinder our businesses ability to meet market demand as needed. We strongly feel that such legislation is unnecessary for the following reasons: 1. The FDA currently has plenty of legislative authority to regulate supplements; so much so, that the former commissioner of the FDA stated so himself when testifying before congress. 2. The FDA also currently has the authority to seize dietary supplements that they feel pose an “unreasonable or significant risk of illness or injury.” In this aspect the FDA even has help from the Department of Health and Human Services, as they can stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard. 3. Lastly, the FDA has finally started to fully implement the law by taking action against unsubstantiated dietary supplements claims, and has also said that good manufacturing practices for supplements are imminent. You should give these efforts a chance to work. Thank you for hearing our concerns regarding this matter.




EC -1034