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Executive Summary
Qualified health claims arising from the landmark 1999 Pearson v. Shalala ruling (U.S. App. Lexis 464) were predicted to be in widespread use, either filling an important consumer information void or misleading the masses. Yet, the results from the current content analysis, which examines more than 1200 instances in which qualified health claims could have been made, reveal that these claims are relatively uncommon on product packages. Indeed, only 4.6% of the packages used a qualified health claim. Almost twice as many (9.4%) of the packages used the consumer-equivalent structure–function claim. The most common health-related claims were nutrient content claims (26.4%) and structure–function claims that were unrelated to the allowed qualified or unqualified health claims (28%).

The findings suggest that the efforts of various constituencies advocating either for or against the use of qualified health claims have borne little fruit. The manufacturers tend not to use even the qualified health claims that they have petitioned the Food and Drug Administration (FDA) to use but rather have chosen to communicate information through consumer-equivalent structure–function claims and an abundance of structure–function claims for which little scientific evidence exists. In addition, research on consumer understanding of unqualified health claims, qualified health claims, and structure–function claims implies that consumers do not perceive differences between these claims in a way that aligns with FDA’s distinction. The Pearson decision did not open the floodgates of information from emerging science, and the Dietary Supplement Health Education Act (DSHEA [Public Law No. 103-417. 108 Stat. 4325]) has presented the opportunity for marketers to legally make untested statements through structure–function claims. This latter pattern is likely to continue unless the DSHEA is modified. Rather than continue to devote resources to petitioning, testing, and approving qualified health claims, both manufacturers and the FDA may want to expend their limited resources on other, more fruitful endeavors that have recently received much public attention: food safety, obesity-reduction programs, drug efficacy, and pharmaceutical risk communication.

Biography
Paula Fitzgerald Bone is Nathan Haddad Professor of Business Administration in the College of Business & Economics at West Virginia University. She is currently engaged in work studying fats education among at-risk consumers, health care reform, consumer financial literacy, and China’s recently introduced nutrition labeling regulations. Her publications focus on labeling in the food, supplement, over-the-counter drug, and pharmaceutical drug markets.

Karen Russo France is Associate Professor of Marketing in the College of Business & Economics at West Virginia University. She continues to work in the area of labeling in the food and supplement industry and has extended her work internationally to studying labeling in China and the Chinese consumer’s perceptions of package labels.

Journal of Public Policy & Marketing, Volume 28, Number 2, Fall 2009
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