To Tell the Truth

Challenging FDA censorship

If you sell nutritional supplements in the United States and you want to tell consumers about the benefits of your product, you have to get permission from the Food and Drug Administration. There are thousands of true statements you could make about the health effects of nutrients, but the FDA has approved only two: that calcium helps prevent osteoporosis, and that folic acid reduces the risk of neural-tube birth defects. Both claims were approved years after they were widely accepted by the scientific community.

In the nine years it took the FDA to approve the calcium claim and the three years it took to approve the folic acid claim, thousands of people suffered from osteoporosis and thousands of babies were born with neural-tube defects. Durk Pearson and Sandy Shaw, who design dietary supplements and license manufacturers to produce them, note that many of these cases might have been prevented by information the FDA blocked. Alarmed by the harmful and potentially deadly consequences of the FDA's labeling restrictions, Pearson and Shaw are challenging the agency's censorship in federal court.

Pearson and Shaw want to label their products with truthful statements based upon substantial scientific evidence, such as:

• "Consumption of antioxidant vitamins in the amounts contained in this product may reduce the risk of certain kinds of cancers."

• "Consumption of 25 to 35 grams per day of dietary fiber may reduce the risk of colorectal cancer."

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

Despite the cautious phrasing, the FDA considers such statements misleading, since the evidence supporting these associations is not conclusive (as Pearson and Shaw concede). The agency requires "significant scientific agreement" before approving a health claim, a standard it defines "on a case-by-case basis."

Represented by Washington, D.C., attorney Jonathan Emord, Pearson and Shaw argue that the FDA's rules amount to prior restraint and violate the commercial speech doctrine. They add that the restrictions are in any case too broad, since they apply not only to labeling in the narrow sense but also to books, scientific articles, or summaries of research displayed or distributed near dietary supplements (in a health food store, for example). They charge that the lack of a clear standard for approving health claims violates both the Fifth Amendment's Due Process Clause and the Nutrition Labeling and Education Act of 1990.

Pearson and Shaw first filed their suit in the U.S. Court of Appeals for the Ninth Circuit, which decided it did not have jurisdiction. Commenting that the "petition is far from frivolous," it referred the case to the U.S. District Court in Washington, D.C., which is scheduled to hear oral arguments on April 30.