Academic journal article The Journal of Consumer Affairs

Policy Makers' Paradigms and Evidence from Consumer Interpretations of Dietary Supplement Labels

Academic journal article The Journal of Consumer Affairs

Policy Makers' Paradigms and Evidence from Consumer Interpretations of Dietary Supplement Labels

Article excerpt

The regulation of marketplace information regarding health and nutrition is in flux. Nowhere, perhaps, is this more evident than in the dietary supplement industry. Herein, we present an experiment that examines the two major types of claims used for dietary supplements, testing the underlying assumptions made by policy makers. Our study suggests that a direct-effects consumer decision-making model does not apply in this context; instead, consumers process label claims through various biasing filters.


   A well-informed public is one of the best weapons against some of
   the biggest public health threats facing the country. Simply put,
   better information means that consumers can make better health
   choices (FDA 2004, 1).

During 2003, the Food and Drug Administration (FDA) undertook a number of initiatives with the goal of improving consumer information that should, in turn, lead to "smarter decisions about the foods they eat" (FDA 2004, 11). Among these initiatives were interim regulations and industry guidance allowing qualified statements that describe the relationship between a particular food or supplement (e.g., walnuts or antioxidant vitamins) and a particular disease or health condition (e.g., heart disease or cancer). The FDA noted that "Recent court decisions have clarified the need to provide for health claims based on somewhat settled science rather than just on the standards of significant scientific agreement, as long as the claims do not mislead the consumers" (FDA 2003c, 1). Thus, the FDA provided interim industry guidance regarding unqualified and qualified health claims, proposing four levels of scientific certainty ranging from "significant scientific certainty" to "extremely low level of comfort" appropriate for both dietary supplements and conventional foods (FDA 2003b).

Given the above, it appears that the FDA's treatment of food claims is being influenced by changes in the regulation of dietary supplements. Indeed, the regulation of marketplace information within the supplement industry has undergone significant changes over the past few years--a situation resulting from a confluence of changes in consumer attitudes, legislative action, industry activity, and court rulings. A major catalyst for these changes occurred with the 1994 passing of the Dietary Supplement Health and Education Act (DSHEA). This legislation allows dietary supplement manufactures to use "structure function" claims, such as, "Helps promote a healthy emotional balance," on supplement package labels without premarket FDA approval, provided the legislated disclaimer is included.

While DSHEA allowed much greater freedom to dietary supplement marketers in making package claims, the FDA continued to restrict specific health claims that linked consumption of a supplement to a specific disease or health condition. This restriction, however, was successfully challenged in Pearson v. Shalala (1999). Judges concluded that the FDA's reluctance to allow health claims on dietary supplements (e.g., "Consumption of fiber may reduce the risk of colorectal cancer") when accompanied by appropriate disclaimers was "draconian" and an unnecessary restriction of free speech. This ruling sparked further changes in the manner in which health information is provided to consumers on food and supplement packages.

Thus, our purpose is to empirically examine the current information environment in the dietary supplement industry. We are guided by two paradigms regarding consumer information processing--one arising from a "direct-effects" approach to consumer decision making and the other placing product labeling in a context that considers consumer biases. We look at consumer beliefs derived from structure function claims as well as disease claims and examine how such claims are interpreted when accompanied by disclaimers. We examine product-specific beliefs in light of consumers' more abstract beliefs regarding their approach to health, the supplement industry, and the government. …

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