Health Professionals

EEC Expert Panel Consensus Statement

1. Available information does not demonstrate an association between the use of dietary supplements containing ephedrine alkaloids and serious adverse events when used according to Industry recommendation for ephedra product. This recommendation includes: (a) a serving limit of not more than 25 mg of total ephedrine alkaloids, (b) a limit on daily consumption of not more than 100 mg of total ephedrine alkaloids, and (c) appropriate warnings consistent with other available over-the-counter ephedrine alkaloid products.
   
   
2. All labeling of dietary supplements containing ephedrine alkaloids should contain appropriate directions and warnings for the public as adopted by Industry and similar to those approved for over-the-counter ephedrine alkaloid products.
   
   
3. The available information derived from studies of ephedrine and caffeine and dietary supplements containing ephedrine alkaloids supports the concept that dietary supplements containing ephedrine alkaloids may be useful in weight management.
   
   
4. Given the absence of data demonstrating an association between ephedra dietary supplements and serious adverse events, the presence or absence of a "susceptible population" cannot be determined. However, severe overdosing can lead to serious adverse events, and minor and/or very rare idiosyncratic reactions may occur (e.g., skin rashes, allergic reactions) with use at recommended serving sizes, as they can with any ingested food.
   
   
5. The pathology data available do not show any pattern consistent with ephedrine alkaloid- containing dietary supplements as a cause of death. An independent, multidisciplinary panel should be assembled to perform a clinical, pathological review of all deaths reported to FDA.
   
   
6. In order to provide a more comprehensive scientific database, the National Institutes of Health, Department of Health and Human Services, and industry should work together to consider further controlled studies to address unresolved issues.
   
   
7. Preparations that contain ephedrine alkaloids and are marketed without responsible label instructions and serving size limitations or are marketed with claims of achieving an altered state of consciousness or euphoria (including so called "street drug alternatives") should be prohibited because they promote excessive use and abuse.

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