From: fonorow@internetwks.com Sent: Friday, April 04, 2003 9:32 AM To: fdadockets@oc.fda.gov Cc: vice.president@whitehouse.gov Subject: DSHEA/Request for Comment on Ephedra Lebel Rules Fri Apr 4 08:19:03 CST 2003 Dockets Management Branch Food & Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Dear Sir/Madam, We understand that the FDA is soliciting public comment on its power to regulate labeling of dietary supplements. First I support the current DSHEA (1994) act that separated life giving nutrients from dangerous drugs. I am happy to read that the FDA is (finally) implementing court decisions that will better inform the consumer about health benefits (as well as risks) on labels. The FDA must strive to act in the general public interest, because its actions can have a severe impact (positive or negative) on special interests, such as large pharmaceutical firms which find it hard to compete with "cheap" nutritional products designed to prevent disease. So long as your actions are in the general public interest, the public at large will be supportive. But while certain Herbs may cross the line between nutrient and drug, such as Ephedra, in general, the problem is not with life giving nutrients. The problem is with inherently toxic prescription drugs. For example, we have been unable to find a case of a single death from an overdose of a vitamin in the medical literature. Several thousand die every year from aspirin and NSAIDS overdose. Until the recent Ephedra publicity, and we are still not certain there is document proof the Ephedra - by itself - causes a problem, it is the only Herb we know of that has been linked to fatalities. Consider the following, directly under FDA control and supervision: Recent conservative estimates in the Journal of the American Medical Association place drug errors as the third leading cause of death in the United States (JAMA, April 15, 1998. pg 1200). This surprising statistic does not stand alone: According to the Chicago Tribune (July, 2002), more than 80,000 people die needlessly of infections in U.S. hospitals. According to the U.S Federal Drug Administration (FDA) web site, common analgesics, for example, Non Steroidal Anti-Inflamatory Drugs (NSAIDS), are the leading cause of liver failure and kill 15,000 Americans and injure perhaps 2 million every year. These examples, and there are many others, illustrate the illness that results directly from health care treatments, providers, or companies in related business. This is where the problem lies, already under FDA supervision, not dietary suplements that happen to compete with prescription drugs. Owen Fonorow Vitamin C Foundation 2880 Sun Valley Road Lisle, IL 60532 (630) 416-1438 fonorow@foxvalley.net www.VitaminCFoundation.org