Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -586

Accepted - Volume 307

Comment Record
Commentor Ms. Karen George Date/Time 2003-03-24 19:25:04
Organization Millennium2Health
Category Company

Comments for FDA General
Questions
1. General Comments I own, along with my partner, a natural health company in Signal Hill California. We distribute tested formulas of herbal supplements with proper instructions as to how to take them. We don't have any products with ephedra in them. We appreciate how the passage of the Dietary Supplement Health and Education Act of 1994 improved consumer access to dietary supplements and information about them,while increasing consumer protection against unsafe products and false and misleading claims. I am concerned that FDA has only just begun to initiate aggressive enforcement actions under DSHEA, yet is calling for suggestions for increased legislative authority in order to better regulate the supplement industry. Shouldn't you first give these recent efforts a chance to work, and perhaps even implement good manufacturing practices for supplements, before calling for new laws? Simply put, I believe the agency can regulate ephedra without dismantling DSHEA. It is also my understanding that DSHEA increased FDA's enforcement powers and that FDA can seize a dietary supplement if it presents an unreasonable or significant risk of illness or injury. Furthermore,the government can stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard. The former FDA commissioner, Dr. Jane Henney, has even stated before Congress that she believes that DSHEA provides FDA with the necessary legal authority to protect the public health. I agree with Dr. Henney,strongly support DSHEA, and do not think any additional legislative authority is necessary.




EC -586