Letter to Commissioner Mark B. McClellan, Food and Drug Administration
February 1, 2004
The Honorable Mark B. McClellan
Commissioner of the Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dear Dr. McClellan:
I was pleased to learn that you announced last week that your agency has stepped up scrutiny of Bitter Orange (citrus aurantium or synephrine), usnic acid and aristolochic acid. As you noted in your speech at the University of Mississippi, consumers are now using Bitter Orange as an ephedra replacement. In New York, use of Bitter Orange is a growing problem - my office completed a survey of merchants in the New York metropolitan area this week and found 15 different Bitter Orange products for sale.
While I appreciate your efforts to address this problem, I am concerned that the process will take too long. It took over eight years for the Food and Drug Administration to move from studying ehpedra and ephedrine to actually banning it. As you undoubtedly are aware, scientists say that Bitter Orange works like ephedra does, by increasing blood pressure and constricting blood vessels. I am concerned that if we wait too long before banning Bitter Orange, we will start to see horrible affects including heart failure and death, just like we did with ephedra.
I therefore respectfully request that the Food and Drug Administration ban Bitter Orange / citrus aurantium / synephrine immediately. We must move now to ensure that people do not replace ephedra with products that are as dangerous as ephedra itself. And because ephedra products were marketed to teens and their replacements appear to be particularly popular among teen athletes, I also respectfully request that you target teen populations with information campaigns about ephedra copycats and urge parents to watch out for their teens using ephedra replacement products like Bitter Orange.
As people switch from ephedra to alternatives that make similar promises and work in similar ways, we must act now to prevent similarly tragic and widespread consequences. I only hope that we learned something from our experience with ephedra. Bitter Orange use is skyrocketing, and we shouldn't wait for years-or for deaths-to act.
Thank you for your prompt attention to this matter.
Sincerely,
Charles E. Schumer
United States Senator