Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -430

Accepted - Volume 307

Comment Record
Commentor Mr. Brian Putchio Date/Time 2003-03-20 15:49:11
Organization NUTRI-BODIES
Category Dietary Supplement Industry

Comments for FDA General
Questions
1. General Comments It has come to my attention that a bill (H.R. 207) has been introduced that aims to classify a wide variety of nutritional supplements as controlled substances. As a consumer of nutritional supplement products, I am gravely concerned about the consequences of this bill. This bill represents an abuse of the legislative system, and a blatant misuse of the controlled substance act. How can the government vote to overnight make criminal the possession of substances which have been used for years by millions of people without any evidence for adverse health effects? How can the government agree to allow the attorney general to classify compounds as controlled substances without determining the existence of any appropriate toxicological or pharmacological activity? The controlled substance act was certainly not enacted with the intention that it may be used as a political tool. Please, I urge you to read this bill closely. This bill is so overbroad it covers products that have absolutely nothing to do with muscle growth!! These products are very popular with mature adults interested in life-extension and anti-aging. These include DHEA, 7-keto DHEA and pregnenolone. These dietary supplements are backed up by peer reviewed studies demonstrating a wide array of health benefits. If this bill is passed, these products will be reclassified as dangerous controlled substances. Don't let that happen!! Please, let the legitimate and established government procedures be used to deal with these products. For example, the DEA is currently examining certain specific steroid precursors to determine whether these particular compounds should be scheduled. The DEA should be allowed and required to complete its investigation. The established administrative procedures will determine which if any steroid precursors fit the criteria for controlled substance status. Moreover, there are other administrative avenues by which harmful products may be banned. The FDA has the authority to take action against dangerous products. This bill circumvents the proper lawful procedures, and without any evidence of legitimate public health concerns or dangers to American adults. It seeks to deal a staggering blow to nutritional supplement freedom and to the Dietary Supplements Health and Education Act (DSHEA), one of the most popularly supported pieces of legislation in American history. This bill goes far beyond its publically promoted intention and if allowed to pass it will affect the lives of a very substantial population of mature and health conscious individuals. Please consider these facts and vote AGAINST HR 207. With due respect, Brian Putchio




EC -430