Get ready for the vitamin police

By Richard Ralston
web posted March 15, 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 www.afcm.org © Copyright 2004
Americans for Free Choice in Medicine All rights reserved.

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