| Comment Record|
Mr. James Bernstein ||
2003-04-04 11:55:17 |
Amer Soc for Pharmacology & Experimental Therapeu |
| Comments for FDA General |
1. General Comments
April 4, 2003
RE: FDA Docket No. 95N-0304
Dietary Supplements Containing Ephedrine Alkaloids:
The American Society for Pharmacology and Experimental Therapeutics (ASPET) supports legislation to amend the Federal Food, Drug, and Cosmetic Act that would establish labeling and advertising requirements for dietary supplements containing ephedrine and prohibit sales of ephedrine supplements to individuals under age 18. ASPET also supports legislation requiring manufacturers of dietary supplements to register with the Food and Drug Administration any reports on adverse experiences with the use of these supplements.
ASPET believes that dietary supplements containing ephedrine alkaloids do present a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, 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 to address a serious public health issue and 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.
Potential adverse events, such as insomnia, increases in heart rate and blood pressure, and increased urinary retention associated with the use of ephedrine in both minors and adults have been reported. Although the extent of these adverse effects is controversial, there is unqualified scientific agreement on the importance of exercising appropriate caution in the use of ephedrine containing compounds at this time, as this legislation affords.
On the broader issue of dietary supplement regulation, many U.S. consumers mistakenly believe that herbal products and dietary supplements are regulated by the FDA and 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 chronic disease processes.
ASPET believes that appropriate legislation is needed to help to explicitly raise important public health concerns from the unregulated use of products whose efficacy may be unproven and whose manufacturing standards are unregulated.
ASPET is a 4,500 member scientific society whose members conduct basic and clinical pharmacological research in academia, industry and the government. Our members research efforts help develop new medicines and therapeutic agents to fight old, new, and re-emerging diseases.