From: Mark Brudnak [mbrudnak@wi.rr.com] Sent: Friday, April 04, 2003 9:50 AM To: fdadockets@oc.fda.gov Subject: Dockets Management Branch (HFA-305) April 3, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Dear Sir/Madam, I own/work for a health food store/dietary supplement company in Grafton, USA, 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. Sincerely, Mark Brudnak -- Mark A. Brudnak Vice President Technology MAK Wood, Inc. makwood@earthlink.net MAK Wood, Inc. 1235 Dakota Dr. Units E-F Grafton, WI 53024-9429 U.S.A. Phone: 262-387-1200 Fax: 262-387-1400 Confidentiality Notice: This electronic message transmission contains information from MAK Wood, Inc., which may be confidential or protected. If you are not the intended recipient, be aware that any disclosure, copying, distribution, or use of the content of this information is prohibited. This material is MAK Wood Confidential. If you have received this communication in error, please notify MAK Wood Inc., immediately by email and delete the original. All material is copyrighted by MAK Wood, Inc unless otherwise indicated and is considered MAK Wood confidential. Thank you