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Court Finds FDA Rejection of Truthful Health Claims Unconstitutional

On January 15, 1999 a U.S. Court of Appeals rejected a Food and Drug Administration attempt to prohibit the use of truthful, scientific health claims on the label of dietary supplements. The FDA's grounds for rejecting these four claims were found to be in violation of free speech protection and too vague to satisfy legal requirements. This ruling is the result of a law suit brought by manufacturers Durk Pearson and Sandy Shaw in 1994 against the FDA for rejecting four product labels submitted for preapproval.

In the United States, it is legal for the label of a dietary supplement to contain "structure/function" claims: a statement that a supplement enhances the structure or function of the human body. No FDA approval is required. However, in order to make a "health claim" (saying that the supplement has an effect upon a disease), the producer must obtain preapproval of this claim from the FDA.

In defending its rejection of the Pearson and Shaw product labels, the FDA argued that it is allowed to protect consumers by suppressing scientific information that it believes is too misleading for consumers to understand, even with appropriate disclaimers. The court ruled, however, that truthful advertising related to lawful activities is protected by the First Amendment and that when information might be misleading, the preferred solution is to provide more information, not less, to the consumer.

The court also found that the FDA's justification for rejecting these claims -- that they "lack significant scientific agreement" -- is too vague. The court ordered the FDA to reconsider the four health claims in question, and to define what it means by "significant scientific agreement."

While the FDA's exact response is yet to be seen, this decision reinforces some basic freedoms of both producers and consumers. It sets the stage for allowing producers to divulge fuller information about the health benefits of their products. Consumers therefore have greater access to the scientific evidence that supports -- or negates -- those health claims. In the long run, this decision empowers consumers to take charge of their own health


Court finds FDA rejection of truthful health claims unconstitutional: Read our indepth report based on the published court decision.



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(c) Copyright 1999-2003 Dietary Supplement Quality Initiative. For permission to reprint, please contact our editor.