Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -409

Accepted - Volume 307

Comment Record
Commentor Mr. Neil Levin Date/Time 2003-03-20 13:22:44
Organization The Fruitful Yield, Inc.
Category Health Professional

Comments for FDA General
Questions
1. General Comments Recent reports on the herb Ephedra show that people need to be careful about what they use. It needs to be carefully labeled, and may cause side effects at high doses. I welcome proposed warning labels. But critics are wrong about dietary supplements being unregulated, under-regulated, or deadly. Ephedra has been attacked, but the FDA rightly hasn't prohibited its use because itís far safer than drugs if used according to labeling guidelines. Speculations that Ephedra caused athlete deaths havenít been sustained by toxicological evidence. Ephedra eases breathing and saves more lives than it may endanger, having proven safe over billions of doses. A Rand survey of consumer complaints remains unconfirmed by medical tests. Published studies are persuasive evidence of Ephedra's safety and effectiveness, if following label cautions. Foolish legislators may now seek to ban Ephedra. Then dieters will use more dangerous products, obesity will cause more chronic diseases and deaths, and asthmatics will suffer. Public health will suffer. The health food industry and responsible health professionals strongly support the use of warning labels to prevent adults from abusing Ephedra. We carry many Ephedra-free alternatives for those who seek to further minimize their risk. There is absolutely no opposition to the use of warning labels on ephedra products. Weíre just against an unreasonable ban.




EC -409