Finds FDA Rejection of Truthful Health Claims Unconstitutional
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.
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.
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.
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
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.