Pearson Vs Shalala Summary

In Pearson v. Shalala, when appellant tried to validate the health claims as per the procedure for evaluating the validity of health claims for the dietary supplements (21 CFR section 101.7), the FDA denied to include the four health claims on the labels for the dietary supplements marketed by Mr. Pearson and Mr. Shaw11. The FDA deemed that the claims lack the significant scientific agreement standard because the evidence provided for approval includes the research that examines the relationship between consumption of foods containing the components of dietary supplements and the risk of the diseases. On that basis, the FDA determined that the specific effect of the dietary supplement components could not be determined with certainty11. Along with that, the government disputed that the appellants proposed health claims could create confusion among the consumers11. In response to this, the appellant argued that their First Amendment rights have been impaired as under Administrative Procedure Act because the FDA was required to provide

Shalala, the FDA (defendant) did not authorize the appellants to include the four claims on the label of the dietary supplements with the reasoning that the scientific evidence is not enough to meet the requirements of significant scientific agreement11. In response to this, the appellant argued that the FDA never explained the term significant or on what basis the FDA measures the significant evidence and thus violated their constitutional rights under First Amendment by not providing an explanation with reasoning for rejecting the appellants proposed health claims11. Also, the appellants argued that under Administrative Procedure Act the FDA is obliged to articulate a standard good deal more concrete than the undefined “significant scientific agreement”11. Therefore, the court hold that the FDA’s interpretation regarding the four claims is invalid as the FDA did not provide a valid definition of scientific