RAND also identified "four myocardial infarctions, nine cerebrovascular accidents, one seizure, and three psychiatric cases" that fell into the same category. Even in such cases, the FDA concedes, the reports "may indicate a safety problem but do not prove that ephedra caused the adverse event. . . . Other unmeasured factors may have contributed, and such serious adverse events are likely to happen (albeit at very low rates) among the millions of users of ephedra anyway."
With an estimated 12 million to 17 million Americans taking something like 3 billion doses of ephedra products a year, FDA Administrator Mark McClellan admits, "serious adverse events from ephedra appear to be infrequent." That point is underlined by data from the federal government's Drug Abuse Warning Network (DAWN), which indicate that two deaths, or even 100, over a decade would not make ephedra stand out on a list of drugs mentioned by medical examiners.
In 1999, the last year for which nationwide totals were reported by drug, DAWN counted 811 mentions for Valium, 641 for Benadryl, 427 for Tylenol, 305 for Prozac, and 104 for aspirin. No drug is completely safe, but ephedra seems considerably safer than many popular over-the-counter remedies and prescription drugs.
The ephedra industry is vulnerable partly because it depends on a loophole in federal law that allows "dietary supplements," including "herbs," to be sold without the FDA approval required for pharmaceuticals. Hence manufacturers have to pretend their product is not a drug. This legalistic maneuver gives consumers a bit more freedom to self-medicate, but it also raises unreasonable expectations about safety.
The dietary supplement route is not the only way for a psychoactive substance to escape regulation as a drug. Coffee is considered a food, for example, even though it contains caffeine. Indeed, the manufacturer of NoDoz, which is considered a drug, reassures consumers by telling them the caffeine pill is "safe as coffee."
It's too bad for the ephedra industry that "Mormon tea," an ephedra brew that Mormons used to drink instead of beverages containing caffeine, never really caught on.