Get Ready for the Vitamin Police
By Richard E. Ralston
March 10, 2004
The Food and Drug Administration (FDA) is now seeking to expand
its considerable powers into the regulation of vitamins and
nutritional supplements.
The FDA has evidently discovered that Americans, after centuries
of experience doing so, cannot now be counted on to take vitamins or
dietary supplements without poisoning or killing themselves. The FDA
is concerned that we have not been getting their approval first.
Perhaps a disclaimer is in order here: We should all use informed
and discriminating judgment before gulping down a tonic that claims
effortless weight loss—while turning us into Don Juans who will live
forever. But we should not be less cautious if the bottle bears an
FDA seal of approval.
If some consumers recklessly disregard such caution, no Federal
agency can help them. But this is America. If consumer health is
destroyed by the willful malfeasance of a vitamin manufacturer,
whole armies of trial lawyers stand ready to help put those firms
out of business.
Assuming that many of these products do enhance the health
of Americans, we will become less healthy when the FDA starts
regulating them. If the FDA record on approving prescription drugs
is any indication, the approval process for vitamins will require an
expensive research and application process lasting years. This
usually costs a minimum of $100,000, and will result in many
products coming off the market.
The FDA does not just ask for research proving that something
works. They often require that the manufacturer prove a
negative—that it will not or cannot do harm. That makes the whole
evaluation process very arbitrary. I used to buy artificial
sweeteners in Germany that had been banned in the United States; for
some reason they did not cause cancer in Germany. In the United
States research showed that when extremely large doses were injected
into rats, the rats developed tumors. The injections were a standard
research technique used to simulate the effect of consuming the
sweeteners for many years. Of course the same quantity of sugar
injected into rats would have killed them instantly, but perhaps the
FDA did not feel it was in the position to ban sugar. Now that
might have saved millions of lives, but there was a complication:
this is still a free country.
One of the reasons that the FDA uses to justify regulation is the
need to control the dose of each product. They state (correctly)
that people have sometimes unwisely taken too much of vitamins such
as A or C. But what can the FDA do about it? What is to stop you
from taking two or more pills? If we follow this line of reasoning,
we should immediately remove aspirin from the store shelves.
Some representatives of the pharmaceutical industry support these
FDA proposals. They may want these supplements to run the same
nightmare gauntlet of obtaining FDA approval that they do. That is
disgusting, but it casts some light on a wider issue.
What if a Federal Vitamin Administration (FVA) had been created
during the New Deal in the 1930’s, and was now employing tens of
thousands of people regulating vitamins? Anyone proposing its
elimination, or even a bit of deregulation would be attacked for
putting our health at risk.
Today the FDA adds billions of dollars to the cost of drugs. The
FDA often needlessly delays the availability of new drugs for years.
With all of those employees spending billions of dollars—and
requiring pharmaceutical companies to do the same, they probably
have prevented some accidents. But at what cost? The first principle
of medicine is “do no harm.” What is the cost to our health of
keeping many drugs off the market, and adding greatly to the cost of
the drugs that survive?
Americans should not be asking what vast new areas of our lives
require FDA regulation. We need to be asking how much less the FDA
should be doing.
Richard E. Ralston is Executive Director of Americans for Free Choice in Medicine.
Copyright © 2004 Americans for Free Choice in Medicine. All rights reserved.
For reprint permission, contact AFCM.
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