ASPET Statement on the Use of Dietary Supplements and Ephedrine

The American Society for Pharmacology and Experimental Therapeutics (ASPET) supports regulations and legislation to amend the Federal Food, Drug, and Cosmetic Act that would establish labeling, advertising requirements, and restriction of sales of dietary supplements containing ephedrine and pharmacologically related stimulants.  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 believes that dietary supplements containing ephedrine alkaloids present a clear, significant, and unreasonable risk of illness, injury, or death under conditions of use recommended or suggested in the labeling of ephedrine products, or if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use.  Legislation addressing labeling, advertising, and sales of ephedrine products will help, but may not be sufficient to address a serious public health issue and will call attention to major research deficits surrounding the use of dietary supplements.  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. 

Potentially significant adverse events include death from increases in heart rate and blood pressure, stroke, acute psychoses, and heart attacks. Insomnia, heat stroke, and increased urinary retention associated with the use of ephedrine in both minors and adults have also been reported.  Although the extent of injuries and deaths associated with ephedra is not precisely known due to the acknowledged under reporting of adverse events, there is unqualified scientific agreement on the importance of exercising appropriate caution in the marketing, advertising, and sales of ephedrine containing compounds at this time.  Due to the potential health risks to consumers using these unregulated products as dietary supplements, it would be prudent to advise a ban on the production and sales of such products.  As currently marketed, these products contain a significant or unreasonable risk of illness or injury under the conditions of use recommended in the labeling or, absent conditions of use in the labeling, under ordinary conditions of use.

On the broader issue of dietary supplement regulation, 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.  The unregulated use of dietary supplements provides an additional risk magnified by the lack of analytical oversight and control in manufacturing practices.

Thus, an attempt to mandate reporting on adverse experiences on the use of dietary supplements is warranted.  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.

ASPET believes that 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. 

ASPET is a 4,700 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.