Unsupported Claims

There are thousands of true statements that could be made about the health benefits of nutritional supplements, but the Food and Drug Administration has approved only two: Manufacturers are allowed to tell you that calcium helps prevent osteoporosis and that folic acid reduces the risk of neural-tube birth defects.

Both of these claims were approved years after they were widely accepted by scientists. In the nine years that it took the FDA to approve the calcium claim and the three years that it took to approve the folic acid claim, thousands of people suffered from osteoporosis and thousands of babies were born with neural-tube defects.

There's no telling how many of these cases might have been prevented by information the FDA blocked. Likewise, we will never know exactly how much death and disability can be attributed to the agency's ongoing prohibition of other health claims.

As libertarians, Durk Pearson and Sandy Shaw were disturbed by these hidden costs. And as designers of dietary supplements, they had a professional interest in freer communication with their customers. They decided to challenge the FDA's censorship in federal court.

So far this story sounds like yet another quixotic battle with bureaucracy. What makes this case different is that Pearson and Shaw actually won.

In a little-noticed decision handed down in January, the U.S. Court of Appeals for the District of Columbia Circuit rejected the FDA's policy of squelching virtually every attempt to inform customers about the value of dietary supplements in preventing disease. The three-judge panel unanimously ordered the agency to reconsider its decisions barring Pearson and Shaw from using four proposed health claims.

Far from the boasts of snake oil salesmen, Pearson and Shaw's claims were cautiously phrased and based on substantial scientific evidence:

1) "Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers."

2) "Consumption of fiber may reduce the risk of colorectal cancer."

3) "Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease."

4) ".8 mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form."

The FDA rejected all four statements, asserting a lack of "significant scientific agreement," a phrase it uses a lot but has never defined. The appeals court concluded that the FDA's failure to set forth a clear standard for its decisions resulted in "arbitrary and capricious action," a violation of the Administrative Procedure Act.

"To refuse to define the criteria it is applying is equivalent to simply saying no without an explanation," the court said. "It must be possible for the regulated class to perceive the principles which are guiding agency action."

The judges went further. Even if the meaning of "significant scientific agreement" were clear, they said, the FDA could be violating the First Amendment by insisting on this test.

The court noted that Pearson and Shaw had offered to include disclaimers on their labels (for example, "The FDA has determined that the evidence supporting this claim is inconclusive") to allay the agency's concern that consumers might be misled. The FDA rejected this alternative but characteristically failed to justify its position, beyond declaring that the claims were "inherently misleading"--an incantation that did not impress the court.

During oral arguments, one judge asked the FDA's attorney whether a statement about omega-3 fatty acids by the Department of Health and Human Services, the FDA's parent agency, would be "inherently misleading" on a label. She said yes.

"Why is it inherently deceptive in the label, and not in the brochure?" the judge wanted to know. "I've got to tell you," said another member of the panel, "I walk to the grocery store all the time…I just don't get the impression that people are absolutely terrorized when they approach a dietary supplement."

In its opinion, the court said the government seemed to be arguing "that health claims lacking 'significant scientific agreement' are inherently misleading because they have such an awesome impact on consumers as to make it virtually impossible for them to exercise any judgment at the point of sale. It would be as if the consumers were asked to buy something while hypnotized, and therefore they are bound to be misled. We think this contention is almost frivolous."

Showing appropriate skepticism, the judges seemed to think that American consumers are capable of doing likewise.