April 4, 2003 - FDA's proposed new ephedra labeling standards.

ATTACHMENT 1
FDA'S CURRENT PROPOSED LABELING FOR EPHEDRINE ALKALOID PRODUCTS

PRIMARY WARNING LABEL
WARNING:
Contains ephedrine alkaloids. Heart attack, stroke, seizure, and death have been reported after consumption of ephedrine alkaloids. Not for pregnant or breast-feeding women or persons under 18. Risk of injury can increase with does or if used during strenuous exercise or with other products containing stimulants (including caffeine). Do not use with certain medications or if you have certain health conditions. Stop use and contact a doctor if side effects occur. See more information ....



SECONDARY WARNING LABEL

This product contains ephedrine alkaloids, which can have potentially dangerous effects on the heart and central nervous system.
Do not use with:
   a monoamine oxidase inhibitor (MAOI) or 2 weeks after stopping a MAOI drug;
   certain drugs for depression, psychiatric, or emotional conditions;
   drugs for Parkinson's disease;
   drugs for obesity or weight control;
   methyldopa
Contact a doctor before using this product if you have or ever had:
   heart disease, high blood pressure, thyroid disease, seizure, diabetes, depression, other mental, emotional or behavioral conditions, glaucoma, or difficulty urinating due to prostate enlargement.
Stop use and contact a doctor immediately if these side-effects occur:
   dizziness, sever headache, rapid and/or irregular heartbeat, chest pain, shortness of breath, nausea, loss of consciousness, or changes in emotions or behavior (such as depression, hallucinations or severe mood swings).
Your risks of serious side-effects from this product can increase:
   with increase dose, frequency, or duration of use;
   if you take it with other dietary supplements containing ephedrine alkaloids (such as ephedra, ma huang, sida cordfolia);
   if you take it with additional products containing stimulants, such as caffeinated beverages and foods (including dietary supplements containing guarana, kola nut, mate, yohimbine/yohimbe, citrus aurantium);
   if you take it with medications containing synephrine, phenylephrine, ephedrine, pseudoephedrine, or phenylporpanolamine;
   if you use it before or during strenuous exercise.