This case challenged the FDA’s decision to override Congress by allowing food companies to claim that a food helps to prevent a disease, where the claim is not supported by the statutory standard “significant scientific agreement.”
The FDA announced in July 2003 that it would allow food companies to make health claims even when the evidence is too weak or inconclusive to meet the statutory standard. The FDA announced that it would even permit claims where the weight of the evidence suggests that the claim is likely false, as long as the claim is qualified by a disclaimer. Moreover, the FDA stated that, when considering a “qualified claim,” it would not follow the notice-and-comment rulemaking procedure that Congress required as a prerequisite for allowing a health claim for food. CSPI and Public Citizen filed suit to challenge the FDA’s regulatory regime. The district court, however, dismissed the suit as not “ripe” for review.