Regulation for dummies.

• Author: Pearson, Durk
• Position: Letters - Letter to the Editor

We were very disappointed by Todd Seavey's review of Protecting America's Health ("Regulation for Dummies" April).

Since it's impossible to detail all of our disagreements in a short letter, we would like to focus on one particular point: The Food and Drug Administration (PDA) is causing far more harm to the health of Americans than it is preventing. It has cost the lives of more than 1 million Americans since 1994 by prohibiting the inclusion in labels and in labeling (literature that accompanies a product at the point of sale) that omega-3 fatty acids can reduce the risk of a sudden-death heart attack by 50 percent to 80 percent. At least 150,000 Americans each year were thus prevented from saving their lives with safe, inexpensive fish oil supplements. One million dead because of FDA censorship of truthful health information on one dietary supplement is a severe harm to the public health, far more than those killed by 19th-century patent medicines.

In 1994 the two of us filed suit against the FDA for violating the First Amendment by prohibiting the inclusion of truthful information concerning four health claims. In 1999 a federal appeals court ruled in our favor, and the FDA declined to appeal to the Supreme Court. Thus this decision, Pearson v. Shalala, is the law of the land. Yet for the next two years (until we sued and won again), the FDA continued to prohibit the inclusion of truthful information on the heart- and life-protecting effects of omega-3 fatty acids. In 2001, seven years after our initial suit was filed, the FDA agreed to allow a "qualified" health claim.

The purported 19th-century "free for all" is usually the fallback position of those who approve of FDA controls on foods, dietary supplements, medical devices, and drugs. It is the unrecognized costs, however, such as the FDA'S unconstitutional prohibition of truthful information on foods and dietary supplements, that reveal an FDA that does far more harm than good.

Our recommendation is that the FDA be transformed...