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| Government
and Public Affairs ASPET REVISED POSITION STATEMENT ON DIETARY SUPPLEMENTS JUNE 1, 2004 The American Society for Pharmacology and Experimental Therapeutics (ASPET) supports re-evaluation of regulations and legislation that currently excludes dietary supplements from regulation under the Federal Food, Drug, and Cosmetic Act. ASPET believes it is timely to establish labeling, advertising requirements, and restriction of sales of dietary supplements that may prove harmful to consumers. ASPET also supports regulation and legislation requiring manufacturers of dietary supplements to promptly inform the Food and Drug Administration of any reports of adverse experiences with the use of these supplements. ASPET commends the April 2004 FDA rule prohibiting the sales of dietary supplements containing ephedrine alkaloids. The FDA rule underscores the potential for abuse of other unregulated substances, including those containing anabolic steroids or other products containing potent pharmacologic agents that may result in adverse reactions or death of consumers, including significant numbers of the juvenile population. The available scientific evidence suggests strongly that the unregulated marketing and use of some dietary supplement products may present a significant and unreasonable risk of illness, injury, or even death under ordinary conditions of use or even when used as recommended or suggested in the labeling of these products. Legislation addressing truth in labeling, advertising, and sales of these products will help, but may not alone be sufficient to address this serious public health issue. In addition, legislation requiring the reporting of adverse experiences with the use of these supplements will assist in the identification of issues involving the chemistry, manufacturing, and control of these products. Surveys confirm that the majority of U.S. consumers mistakenly believe that herbal products and dietary supplements are regulated by the FDA and have been scientifically proven to be safe and effective, and to contain the ingredients and their amounts stated in product packaging. The unregulated use of dietary supplements provides an additional risk magnified by the lack of analytical oversight and control in manufacturing practices. Sound pharmacological studies are needed to help determine the potential for interactions among herbal products, dietary supplements, and prescription drugs as well as adverse effects on chronic disease processes. Some dietary supplements and botanical products exhibit drug-like properties because they contain drugs, even though they are natural products. Genuine, effective regulatory and legislative action is needed to help to remedy an important public health problem created by the unregulated use of products whose efficacy is unproven and whose manufacturing standards are unregulated. It is the position of ASPET that a congressional review of the 1994 Dietary Supplement Health and Education Act (DSHEA) is timely and warranted. ASPET is a 4,800 member scientific society whose members conduct basic and clinical pharmacological research in academia, industry and the government. Our members research efforts help to develop new medicines and therapeutic agents to fight existing and emerging diseases. |