Discover your next big idea at PACK EXPO Las Vegas this September
Experience a breakthrough in packaging & processing and transform your business with solutions from 2,300 suppliers spanning all industries.
REGISTER NOW & SAVE

Court criticizes FDA on rejected claims

The Court of Appeals for the D.C. Circuit, considered the most influential court of appeals on regulatory matters, essentially rejected FDA's high-handed approach to denying health claims deemed lacking "significant scientific agreement." It faulted the agency for failing to define "significant scientific agreement" and for refusing even to consider allowing manufacturers to make some label claims as long as they're mitigated by an FDA-approved disclaimer statement.

The case concerned FDA's outright rejection of four health claims proposed by manufacturers of dietary supplements based on what FDA said was the lack of significant scientific agreement. The scientific support for the claims was inconclusive, but the agency refused a proposal that the health claims be accompanied by a disclaimer saying FDA had found the evidence inconclusive. The court's decision left plenty of room for FDA to again reject the health claims, but it will have to explain why support for the claims does not reach the threshold of significant scientific agreement and clarify why disclaimers cannot clear up potential consumer confusion. FDA may either ask for a rehearing from the court or a review by the Supreme Court.

2024 PACK EXPO Innovations Reports
Exclusive access: Packaging World editor-curated reports revealing PACK EXPO's most groundbreaking technologies across food, healthcare, and machinery sectors. Each report features truly innovative solutions selected from hundreds of exhibitors by our expert team. Transform your operations with just one click.
Access Now
2024 PACK EXPO Innovations Reports
Coding, Marking, and Labeling Innovations Report
Explore our editor-curated report featuring cutting-edge coding, labeling, and RFID innovations from PACK EXPO 2024. Discover high-speed digital printing, sustainable label materials, automated labeling systems, and advanced traceability solutions that are transforming packaging operations across industries.
Access Report
Coding, Marking, and Labeling Innovations Report