Pruning the FDA

Overzealous regulation keeps important health information from reaching the public

Alexander Volokh
National Review, August 11, 1997

That a man suffering from constipation should drink prune juice is a truth so fixed in people's minds that there is only one place where people are still unsure of it: Rockville, Maryland, home of the Food and Drug Administration. However well known the effects of prune juice may be to the public and the scientific community, the FDA does not allow prune-juice manufacturers to print "This product may relieve constipation" on their labels. Manufacturers who do so face civil and criminal penalties.

At least the ban on prune-juice claims does not hurt many people. Other FDA prohibitions are more harmful. Low-dose aspirin consumption, for example, can sharply reduce the risk of a heart attack. A million and a half Americans have heart attacks every year, and over half a million die; an estimated 100,000 could be saved if aspirin manufacturers were permitted to publicize their product's protective effects. However, although researchers have been documenting the benefits of low-dose aspirin since the mid 1970s, it was not until 1997 that the FDA said it might allow manufacturers to tell health professionals the good news. Even then, the agency said it would continue to ban the information from ads aimed at consumers -- although [Bayer], maker of Bayer aspirin, recently began to flout this policy in TV commercials, so far without prompting an enforcement action by the FDA. 1

Durk Pearson and Sandy Shaw are scientists who have been studying the aging process and designing nutrient supplements since 1968. In 1982 their Life Extension: A Practical Scientific Approach, a technical tome of more than eight hundred pages, sold a million and a half copies, staying on the New York Times best-seller list for ten months. Flabbergasted by the public's interest, Pearson and Shaw realized that the main barriers to improving health through diet supplements had changed since 1968, when the problem was a lack of scientific knowledge. By 1982, the beneficial effects of many nutrients -- including beta carotene, vitamin C, and vitamin E -- had been well established; the main barrier had become the FDA's interference with the marketing of products based on such information.

The FDA permits certain health-related statements for dietary supplements, but these generally involve classic deficiency diseases (such as scurvy) or vaguely link a nutrient with a body structure or function without citing specific diseases (e.g., "This vitamin could improve the functioning of the body's natural health system"). The agency allows health claims only if they are backed by "significant scientific agreement." The problem is that no one knows what that means. The 1994 Nutritional Labeling and Education Act required the FDA to establish a procedure for identifying "significant scientific agreement," but so far the agency has refused to define the phrase.

If you walk into a health-food store today, you can look at the shelves and not be able to distinguish one from another, because any manufacturer who makes a health claim could be prosecuted. Fruits and vegetables high in anti-oxidant vitamins, fiber, or omega-3 fatty acids can legally bear a claim about their role in preventing cancer or heart disease, but dietary supplements with the same ingredients can not. If a product is man-made and carries a therapeutic claim, it becomes, in regulatory terms, a "drug," and getting a claim about a drug approved can take years and cost as much as $300 million -- which no one is going to spend on a widely available, unpatentable product such as prune juice or aspirin.

Frustrated by this situation, Pearson and Shaw decided to challenge the FDA in court. In 1994, together with the Preventive Medical Association, Citizens for Health, and the National Health Federation, they sued the agency, charging that its censorship of truthful health claims violates the First Amendment as well as the Nutritional Labeling and Education Act. "The FDA has one of the last great prior restraints on speech in the Western world," says Jonathan Emord, the Washington attorney handling the suit. "They prohibit ab initio any therapeutic claim made in association with a food, drug, or dietary supplement, regardless of whether it's true or not -- unless the party has obtained FDA approval of the claim." Given the Supreme Court's traditional suspicion of prior restraint, Pearson argues, "the FDA is very vulnerable to a First Amendment attack. The main reason we sued the FDA was not to prove that vitamin E can be a useful supplement to take, but to restore the First Amendment's control over what the FDA is doing. If we have to go about it one substance at a time, that's a staggering amount of money and a staggering period of time, and an awful lot of dead bodies in between."

Since 1942, the Supreme Court has said that "commercial speech," which would include the claims regulated by the FDA, does not merit full First Amendment protection. But in recent years the Court has taken an increasingly dim view of restrictions on commercial speech. In the 1995 case Coors v. Rubin, for example, the Court overturned a federal prohibition of alcohol-content statements on containers of beer. The following year, in 44 Liquormart v. Rhode Island, it found that a state ban on the advertisement of liquor prices also violated the First Amendment. "If Liquormart and Coors stand for any proposition, it's that there can be no absolute ban on truthful, non-misleading speech," says Emord. "Yet that's exactly what the FDA's prior restraint does. They impose the restriction on speech absolutely, and then require the industry to selectively prove the truth of their claims to the FDA's satisfaction."

Pearson and Shaw's lawsuit is pending before Judge Gladys Kessler in the U.S. District Court for the District of Columbia. But the suit may already have helped loosen FDA policy. For years, studies suggested that women of childbearing age who took 400 micrograms of folic acid daily could reduce their babies' risk of neural-tube birth defects by as much as 40 per cent. In the 1980s, the U.S. Public Health Service, which oversees the FDA, even issued public advisories recommending that dosage. Yet until last year, the FDA took the position that no dietary supplement could carry any scientific information associating consumption of folic acid with a reduction in the risk of neural-tube defects. Each year that the FDA prohibited communication of this information on labels, about 2,500 preventable neural-tube defects occurred. In 1996, after Pearson and Shaw filed their suit, the FDA reversed its position, even though no new scientific information on the subject had appeared. "The only logical explanation for the reversal," says Emord, "is that the FDA felt the political pressure."

Given the FDA's traditional inflexibility, even this small victory for free speech and free choice calls for a toast. Break out the prune juice.

Alexander Volokh is a policy analyst at the Reason Public Policy Institute in Los Angeles.