Dietary Supplements Containing Ephedrine Alkaloids
A multidisciplinary panel of experts met on July 27, 2000, to review and assess the scientific information relevant to dietary supplements containing ephedrine alkaloids. A list of the members of the panel is attached, including biographical sketches.
Prior to the July 27 meeting, each panel member reviewed the health assessments that the Food and Drug Administration (FDA) released on April 3, 2000, including health assessments prepared by outside consultants to FDA. The panel also reviewed the relevant published literature, and reviewed the adverse event reports (AERs) that FDA released on April 3, as well as the AERs that FDA released in 1997. The literature review included the published literature on the incidence of heart attacks, strokes and seizures in the general population of non-ephedra users, including young adults. Finally, at the July 27 meeting, the panel reviewed unpublished data on the effectiveness of ephedra products in weight management.
The consensus conclusions of the panel are as follows:
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 the American Herbal Products Association (AHPA) trade recommendation for ephedra products. 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 (see attached).
2. All labeling of dietary supplements containing ephedrine alkaloids should contain appropriate directions and warnings for the public as adopted by AHPA (see #1) 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.
- Dietary Supplement Industry Calls On FDA To Adopt National Standards On Ephedra
- Similar to Over-the-Counter Products, There is No Association Between Reported Adverse Events and Ephedra When Consumed as Directed
- Response to Consumer Reports Article about Sports Dietary Supplements Ephedra