EXPERT PANEL CONSENSUS STATEMENT

A multidisciplinary panel of experts, sponsored by the Ephedra Education Council, 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 Finally, at the July 27 meeting, the panel reviewed unpublished data on the effectiveness of ephedra products in weight management.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.

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Ephedra Trade Recommendation
of The American Herbal Products Association
January, 2000

The By-Laws of the American Herbal Products Association (AHPA), as revised in January, 1998, define "Obligations of Membership" to include "adherence to all policies and business practices as outlined in the Code of Ethics." The Code of Ethics, as amended in February, 1997, establishes a procedure whereby "The Board of Trustees may issue a trade recommendation which becomes an amendment to the Code." Any recommendation of the Board is thus automatically considered as a revision to the Code, requiring compliance from all members in good standing. The current recommendation for Ephedra is listed here.

Ephedra (adopted March, 1994; revised January, 2000)

AHPA recommends the following criteria for marketing of dietary supplement products containing ephedrine alkaloids:

Labeling

1. The label of the goods should bear an adequate cautionary statement, which shall at a minimum include the following language, or comparable language:

Not intended for use by anyone under the age of 18. Do not use this product if you are pregnant or nursing. Consult a health care professional before using this product if you have heart disease, thyroid disease, diabetes, high blood pressure, psychiatric condition, difficulty in urinating, prostate enlargement, or seizure disorder, if you are using a monoamine oxidase inhibitor (MAOI) 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).

Exceeding recommended serving will not improve results and may cause serious adverse health effects.

Discontinue use and call a health care professional immediately if you experience rapid heartbeat, dizziness, severe headache, shortness of breath, or other similar symptoms.

2. The product label shall list the amount of ephedrine alkaloids per serving.

Serving Limits

Products are not to contain in excess of 25mg of total ephedrine alkaloids per serving; usage instructions should limit daily consumption to 100mg of total ephedrine alkaloids.

Herbs of Commerce Conformity

Label identification must be in conformity with the standard common name listed in Herbs of Commerce.

Synthetic Ingredients

Neither finished consumer goods nor raw materials used in their manufacture are to contain any synthetically derived ephedrine alkaloids or their salts (e.g., ephedrine sulfate; pseudoephedrine hydrochloride; phenylpropanolamine hydrochloride).

Marketing

No claims shall be made that the product may be useful to achieve an altered state of consciousness, euphoria, or as a "legal" alternative for an illicit drug.