June 19, 2002
Free market can regulate herbal supplements
Some herbal dietary supplements, such as those containing ephedra, have been killing people and leaving many others with severe disabilities from stroke. Yet botanicals are virtually exempt from FDA oversight. Henry Miller, a Hoover Institution senior research fellow and former official with the Food and Drug Administration, makes the case in USA Today that it would be a disaster for the industry to wait until political and public outrage compels the FDA to step in. Rather, the industry should move to a voluntary system of oversight and private certification. This would inform and protect consumers and avoid the hugely expensive and time-consuming FDA approval process.
And for more from Henry Miller on how FDA regulations costs lives, read this piece in the Washington Times. Its conclusion:
The bottom line is that regulators make decisions defensively — in other words, to avoid approvals of harmful products at any cost — so they tend to delay or reject new products of all sorts, from fat substitutes to vaccines and painkillers. That's bad for public health and for consumers' freedom to choose. Americans are, literally, dying for better regulation.Excerpts from Miller's USA Today piece:
A public health disaster seems inevitable. Historically, society overreacts to such occurrences. Congress would likely reclassify botanicals as drugs in response to the ensuing public outcry.
That would be calamitous for supplement manufacturers: Development, testing and FDA marketing approval of the average new drug takes 12 to 15 years and costs upward of $800 million. Reclassifying botanicals as drugs would effectively spell the demise of the goose that is laying multibillion-dollar eggs, and the end of consumers' access to a wide array of non-traditional medicines.
A better option would be voluntary oversight by an independent, non-governmental regulator modeled on the Nationally Recognized Testing Laboratories. The prototype of these facilities is Underwriters Laboratories: a non-profit group that for a fee uses hundreds of standards to certify a wide spectrum of products, many with inherent potential hazards.
Such voluntary oversight would be advantageous to all involved. Manufacturers who choose to participate could bolster their claims that they make premium products. Most importantly, certification would offer consumers assurance of a minimal level of safety, and it would retain the widest selection of herbal therapies.
This regulatory model would move us closer to a truly free market: consumers making independent, informed choices among a wide variety of competing products. Without it, we can't make rational decisions -- and we may take unnecessary risks.