Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1335

Accepted - Volume 326

Comment Record
Commentor Mr. Ben Peck Date/Time 2003-04-04 09:59:22
Organization Public Citizen
Category Consumer Group

Comments for FDA General
Questions
1. General Comments Docket No. 95N-0304 On behalf of the consumers our organizations represent, we strongly urge that ephedra containing dietary supplements be banned by the FDA. Merely putting a warning label, any warning label, on these products will not adequately protect the public. The evidence of the danger posed by these products is unequivocal. The FDA has in its possession more than 100 reports of death related to the use of Ephedra-containing products. Given evidence of serious adverse events even among people taking the recommended dose of these products (I), the legal standard for a ban of ephedra under the Dietary Supplement Health and Safety Act (DSHEA) of unreasonable risk of harm when used at the recommended dose, has clearly been met. Merely adding a warning label to these products instead of banning them virtually guarantees additional deaths and permanently disabling injuries to unsuspecting users. The proposed label warns consumers against taking more than the recommended dose or consuming ephedra-containing products before or during strenuous exercise. Unfortunately, the available evidence indicates that observing these warnings will not keep the public safe. Many of the adverse events experienced by consumers have occurred in people who are not strenuously exercising and who are using recommended doses. Please act in the interest of the public, not in the interests of ephedra-makers and ban these dangerous products before you have to confront families of new victims who will be killed or permanently disabled if you fail to exercise your legal authority for a ban. Sincerely, The Children’s Foundation Families USA Gray Panthers National Priorities Project National Women’s Health Network Public Citizen ____________ I. Samenuk D, et al. Adverse cardiovascular events temporally associated with Ma Huang, an herbal source of ephedra. Mayo Clin Proc, 2002;77:12-16.




EC -1335