GET READY FOR THE VITAMIN POLICE

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