Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -574

Accepted - Volume 307

Comment Record
Commentor Mr. Karl Riedel Date/Time 2003-03-24 14:12:39
Organization Nature's Life
Category Dietary Supplement Industry

Comments for FDA General
1. General Comments 7180 Lampson Avenue, Garden Grove, CA 92841-3914 USA TEL: (714) 379-6500 • (800) 854-6837 • Fax (714) 379-6501 / March 05, 2002 Dockets Management Branch (HFA-305) Food and Drug Administration (FDA) 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 RE: Proposed regulations on Dietary Supplements Containing Ephedrine Alkaloids. I am an informed citizen, and work for a company selling dietary supplements. My customers and I appreciate that the Dietary Supplement Health and Education Act of 1994 (DSHEA) improved consumer access to dietary supplements products and information, while increasing consumer protection against unsafe products, and false and misleading claims. I also appreciate, and applaud, that FDA has recently been taking more aggressive enforcement actions against unsafe supplements, but I am concerned that 9 years after the passage of DSHEA, and 6 years after the final labeling regulations, FDA deferred such aggressive regulatory enforcement for so long. This letter is responding 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 very 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 even 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. Although we have never sold ephedra products, I believe the agency can adequately regulate ephedra, or any other potentially unsafe dietary supplement, without any additional legislative authority, and specifically without any changes to DSHEA. DSHEA actually increased 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 furthermore 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 the public health against unsafe dietary supplements. FDA does not need additional legislative authority, it just needs to exercise its ample authority already granted by DSHEA. 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 consumer from potentially unsafe dietary supplements. Regards & Health, Karl Riedel Cc: Senators Feinstein and Boxer, Congresswoman Sanchez

EC -574