Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1269

Accepted - Volume 326

Comment Record
Commentor Mrs. Nancy Polsue Date/Time 2003-04-03 11:05:40
Organization Peach Basket
Category Dietary Supplement Industry

Comments for FDA General
Questions
1. General Comments I manage a health food store in Fredericksburg, Texas and have been in the natural products industry for several years. Both my customers and I 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. Please, do not let the fact that some people have abused a particular herbal supplement be the reason destroying the progress made by DSHEA. I personally use supplements and have found them more helpful with fewer side effects than any of the medications that have been prescribed to me. Many of my customers have said the same thing. Unfortunately, there will always be those who abuse products, prescription or herbal. Let's not harm the many in an effort to stop the abusers - they will only find something else anyway.




EC -1269