Moreover, with some large retailers selling higher-potency formulations, and more consumers taking large doses for long periods, safety problems are likely to increase, and a public health calamity seems inevitable. But even absent a high-profile, lethal incident, we are certain to have more people suffering from overdosing or underdosing of critical drugs.
The beginnings of our highly risk-averse federal system of drug regulation date to 1938, when Congress responded to the contamination of an antibiotic by a toxic chemical called diethylene glycol, which killed more than 100 people. If a similar problem were to occur with botanicals, Congress would likely change their regulatory classification from "food supplements" to "drugs" in response to the ensuing outcry. The development, testing and FDA marketing approval of the typical new drug take 12 to 15 years and cost upward of $1 billion. Reclassifying botanicals as drugs would effectively spell the demise of the multibillion-dollar industry and the end of consumers' access to a wide array of nontraditional medicines.
