Proponents' View 

(Before the FDA ban)

The Ephedra Education Council, a group made up almost entirely of ephedra manufacturers, claimed that ephedra is safe when taken in accordance with the American Herbal Products Association's recommended serving limits, warnings, and precautions. These recommendations include the following:

• Do not take more than 25 mg ephedrine alkaloids per serving and not more than 100 mg per day.
  
• Consult a health care professional before consuming an Ephedra-containing dietary supplement if you have heart disease, thyroid disease, diabetes, high blood pressure, depression or other psychiatric condition, glaucoma, difficulty in urinating, prostate enlargement, or seizure disorder, if you are using a monoamine oxidase inhibitor or any other prescription drug, or you are using an over-the-counter drug containing ephedrine, pseudoephedrine or phenylpropanolamine (ingredients found in certain allergy, asthma, cough/cold and weight control products).
  
• Do not use Ephedra products if you are under the age of 18. Do not use Ephedra products if you are pregnant or nursing.
  
• Discontinue use and call a health care professional immediately if you experience rapid heartbeat, dizziness, severe headache, shortness of breath, or other similar symptoms.
  
• Exceeding recommended serving will not improve results and may result in serious adverse health effects.

The Ephedra Education Council Expert Panel, consisting of medical and scientific experts from a variety of relevant disciplines, met in regard to a request of information on ephedra from the U.S. Department of Health and Human Services. The panel's conclusions, based on a review of the current literature and the FDA's adverse event reports, are as follows:

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.