2004N-0454 - Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
FDA Comment Number : EC26
Submitter : Mr. Eric Schuetz Date & Time: 11/09/2004 04:11:22
Organization : Maryland Poison Center
State Government
Category :
Issue Areas/Comments
The DSHEA of 1994 has been a nightmare for those of us in the Poison Center community. Callers to the poison center frequently want to identify tablets or capsules that they have, and if there are no identifying marks, then the answer to their query is that it is one of two things: a "dietary supplement" because they are not required to use identifying markings, or an illicit "drug of abuse." While I am sure the motives behind the DSHEA were altruistic, in reality all that it did was open a pandora's box of quackery that has not been witnessed in this country for almost a hundred years, resulting in hundreds or even thousands of "fly-by-night" companies that produce some sort of a remedy for a short period of time, then sell out their business to a larger company or close their operations altogether, thus there is no way to ensure good manufacturing practices, purity or quality, safety or efficacy. In short, a mess. Donald Fehr, the head of the major league baseball players' union, when threatened by the Senate to "clean up" baseball's "supplement" problem, replied that it was the Senate that started it all with the DSHEA. I agree. Please do whatever you can to reverse the DSHEA.