Text of Senator Charles Schumer's Letter to Mark B. McClellan Commissioner of the Food and Drug Administration
May 7, 2003
The Honorable Mark B. McClellan
Commissioner of the Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dear Dr. McClellan:
Thank you for your April 23 response to my March 3 letter to you about ephedra and ephedra copycats.
While I appreciate your response about the actions the FDA has taken with regard to ephedra and ephedrine alkaloids, I remain concerned about ephedra copycats. As consumers become more aware of the danger of using ephedra, they will switch to other products that work the same way, have similar physiological effects, and pose the same risks. I write today to ask about the status of the study I requested in March about whether the public faces similar risks from ephedra-like substances as they do from ephedra itself.
Even without the Administration banning ephedra, there has been a sharp decline in use of this dietary supplement and a sharp increase in the use of alternative products. General Nutrition Centers (GNC) - the nation's largest retailer of nutritional supplements - reported that their sales of ephedra products were down $88 million for this year. Last week, GNC announced that they will no longer sell ephedra products at all.
At the same time, however, we have seen a sharp increase in the sales of ephedra copycats. Most of these products are "thermogenic" dietary supplements that - like ephedra products - claim to increase your energy and burn fat by increasing your metabolism. Like ephedra, these products work by stimulating the heart and nervous system, which can raise blood pressure.
For example, Cytodine Technologies, the company that produced the ephedra supplement Xenadrine associated with Baltimore Oriole Steve Bechler's death, has replaced that product with an ephedra-free product, Xenadrine-EFX. This product is already advertised as "America's #1 Diet Supplement." Like the original Xenadrine, Xenadrine-EFX is thermogenic and (according to an article in Journal of the American College of Nutrition cited by Cytodine) even outperforms ephedra products.
Overall, I have identified over 30 products now being sold as "ephedra-free" alternatives to products containing ephedra. These products include:
Andro Trybulen from Schwartz Labs
Anorex Z from Klein-Becker USA
BetaBlast Ephedra-Free from Experimental and Applied Sciences, Inc.
BetaLean® Ephedra-Free from Experimental and Applied Sciences, Inc.
Deluxe Burners from Eclipse 2000
Deluxe Thermogenix from Eclipse 2000
Energy Rush Ephedra Free Formula from General Nutrition Corporation
Ephedra-Free Lipo 6 from Nutrex
Extreme Diet FX from Met-RX
Fast N' Thin Fat Burner Energy Enhancing Formula from Dymatize Enterprized
Herbalife Dieting Optimum Program Ephedra Free from Herbalife Inc.
Herballife Thermojetics Weight Loss Ultimate Ephedra Free from Herbalife Inc.
Hydroxycut Ephedra Free from Muscletech Research and Development
Metabolic Thyrolean from Prolab Nutrition
NoPhedra Thermogenic Weight Loss from Absolute Nutrition
Nutramerican Trim Spa from Nutramerica
Optiburn Ephedra Free from Slimsense
ReForm from Scitec Nutrition
Simply Cut Epehdra-Free from Experimental and Applied Sciences, Inc
Stacker 2 Ephedra Free from NVE Pharmaceuticals
Systems Six from Irwin Naturals
Takeoff Hi-Energy Fat-Burner - Ephedra Free from Maximum Health Performance Inc.
Thermadrene XP from Sportpharma
Thermojetics® Green Ephedra Free from Herbalife
Thermo-Lean Ephedra Free from BBS Body Building Supplements
Thermo-Stat from ISS Research
Thyroburn from Sportpharma
Thyrodene Ephedra Free from Maximum Health Performance
Thyrogenic Ephedra Free from Maximum Health Performance
Thyrox T-3 Radical Metabolic Booster from Absolute Nutrition
Total Lean Ephedra-free from the General Nutrition Corporation
Xenadrine EFX Ephedrine Free from Cytodine Technologies
Zantrex-3 No Ephedrine from Zoller Laboratories / Basic Research LLC
I ask that you expedite the study of ephedra copycats so we can learn as soon as possible if the products people use to replace ephedra are not as dangerous as ephedra itself. 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.
Thank you for your attention to this matter.
Sincerely,
Charles E. Schumer
United States Senator