Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -301

Accepted - Volume 307

Comment Record
Commentor Ms. Sandra Stauch Date/Time 2003-03-17 13:23:16
Organization Nature's Life
Category Dietary Supplement Industry

Comments for FDA General
Questions
1. General Comments This letter is in response to the request, on Page 6 of the FR notice, that: “Furthermore, FDA seeks comments on what additional legislative authorities, if any, would be necessary or appropriate for FDA to address this issue most effectively”. While I support your current enforcement efforts regarding ephedra products, I am concerned that FDA is requesting comments to increase its authority for all dietary supplements. FDA should first give its newly aggressive enforcement policies a chance to remove unsafe products from consumer sale before requesting comments for new legislative authority. In addition, publishing the long delayed proposed regulations on Good Manufacturing Practices (GMPs) for dietary supplements would greatly reduce the chance of an unsafe dietary supplement reaching consumers. I believe the FDA can regulate ephedra, and any other ponteially unsafe dietary supplement, without any additional legislative authority, and specifically without any changes to DSHEA. DSHEA actually increases FDA’s enforcement powers: FDA can seize any dietary supplement that presents an unreasonable or significant risk of illness or injury (e.g. unsafe). FDA can immediately stop the sale of any particular or an entire class of, dietary supplements if they pose an imminent public health hazard. Both the current commissioner, Dr. Mark McClelland, and the former FDA commissioner, Dr. Jane Henney, testified to Congress that DSHEA provides FDA with the necessary legal authority to protect public health against unsafe dietary supplements. I agree with Drs. McClelland and Henney, strongly support DSHEA as is, and do not think any additional legislative authority is necessary for the FDA to protect consumers from potentially unsafe dietary supplements. FDA does not need additional legislative authority, it needs to exercise its ample authority already granted by DSHEA. I am an informed citizen and work for a company selling dietary supplements. My customers and I appreciate the Dietary Supplement Health and Education Act of 1994 (DSHEA) improved consumer access to dietary supplement products and information, while increasing consumer protection against unsafe products, and false and misleading claims.




EC -301