By Henderson, David R.
Reason , Vol. 35, No. 11
Ephedrine--Adverse and Side Effects
Pharmaceutical Industry--Laws, Regulations and Rules
Pharmaceutical Industry--Product Defects and Recalls
United States. Food and Drug Administration--Powers and duties
United States. Food and Drug Administration--Laws, regulations and rules
The Food and Drug Administration's (FDA's) recent bah on dietary supplements containing ephedra shows just how dysfunctional government regulation of drugs and dietary supplements is. Ephedra, according to the FDA, is a naturally occurring substance derived from a Chinese herb. Ephedrine, the main active ingredient of ephedra, has been used for centuries to treat respiratory symptoms and is also used to aid weight loss, enhance sports performance, and increase energy.
Why the ban? The FDA claims that dietary supplements containing ephedra pose "an unreasonable risk" for the consumer. The FDA states in its press release that it reviewed "a seminal report by the RAND Corporation." But in the fine print, you read that, of 16,000 adverse events RAND studied, there were two deaths, four heart attacks, nine strokes, one seizure, and tire psychiatric cases. RAND said these events "may indicate a safety problem but do not prove that ephedra caused the adverse event" (emphasis added). Even Naderite Sidney Wolfe, a self-proclaimed consumer advocate, claims only 155 ephedra-related deaths over a decade.
Interestingly, many users of such dietary supplements rushed to stock up on their supplies before the bah begins. They judged, apparently, that the benefits were worth the risks. To the FDA, though, their judgment does not count. And therein lies the problem.
The same problem arises with the FDA's requirement that drug companies test for safety and efficacy before being allowed to sell a drug. …