Pearson v. Dept. of Health and Human Services , 1999 U.S. App. LEXIS 464 (1999)

Is the FDA rule prohibiting the use of disclaimers, and instead outright prohibiting product labeling that is not supported by significant scientific research, an unconstitutional prior restraint...


The Court of Appeals held that the FDA practice was unconstitutional. The standard employed by the agency was not defined by the agencies rules, making it unclear to applicants what level of scientific agreement was required to support a nutritional supplement health claim. By requiring "significant agreement" the FDA prohibited claims that were debatable, or only supported by marginal scientific agreement. The supplements Pearson was attempting to label had been in the marketplace for a long time and had been proven safe. The FDA contended that the evidence, while supported by an adequate amount of research, did not present a high enough level of agreement about the truth of the claims. Pearson claimed, and the court agreed, that a disclaimer could allow the supplement to represent the degree of support the statements had from scientific literature, while expressing the FDA's lack of support for the claim. Because the FDA's process did not represent the least restrictive method of accomplishing a legitimate government restriction of a fundamental right, it was unconstitutional. The court deferred to the FDA on the precise wording of any disclaimer.

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Reference Info:Federal, D.C. Circuit, D.C. | United States

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