Abstract

In the US, the Food and Drug Administration (FDA) has oversight for qualified health claims (QHCs). These claims emerged as the result of a legal dispute about commercial speech rights on dietary supplements and food products. The initial court ruling allowed manufacturers to include diet–disease information on packaging, when supporting evidence does not meet the traditional threshold of Significant Scientific Agreement. QHCs communicate about a potential health benefit of the consumption of a food or supplement, and due to their nature, are required to specify the balance of evidence behind the diet–disease relationships. As a result, the language contained in QHCs is complex, making them difficult for consumers to understand. The language has been further complicated by a continuing series of court challenges about how scientific evidence is described in QHCs. To understand the evolution of QHC language, we review the progression of court rulings surrounding qualified health claims and subsequent regulations by the FDA. This analysis provides a case study of the challenging task of effective science communication within a dynamic food litigation and policy environment.

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