1. Saldanha, Leila G. PhD, RD

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In November 2005, findings on consumers' reactions to health claims were presented at a daylong Food and Drug Administration (FDA) public meeting. The meeting highlighted some of the many complexities that the Agency and manufacturers of conventional foods and dietary supplements face with the existing health and nutrition claims system. As highlighted in the article by FDA's Dr Kathleen Ellwood in this issue, the current mosaic of claims that can be made on food and dietary supplement labels evolved over the years as a result of several Congressional and legal decisions. The Nutrition Labeling and Education Act (NLEA) of 1990 (Public Law 101-538) was the first legislation permitting health claims on foods, and it was also the most conservative. The NLEA permitted health claims only if there was evidence to support the claim, if there was significant scientific agreement (SSA) among qualified experts, and if the claim was not misleading.


Congress expanded the variety of claims that can be made on food and dietary supplement labels through passage of the Dietary Supplement Health Education Act in 1994 and the FDA Modernization Act in 1997. The Dietary Supplement Health Education Act permits statements of nutritional support, commonly referred to as structure/function claims, and the FDA Modernization Act permits health claims based on an authoritative statement by a scientific body.


The NLEA SSA standard was overturned through court decisions in 1999 and 2002, ruling that it was overly restrictive in light of first amendment. See case laws Pearson v Shalala (164 F.3d 650,656 [DC Cir 1999]) and Whitaker v Thompson (248 F. Supp.2d 1 [DDC 2002]). The court ruled in favor of the defendants by permitting health claims that did not meet the SSA requirement, as long as the statements were truthful and not misleading when appropriately qualified to indicate the level of scientific support for the claim. These types of claims are now referred to as qualified health claims, whereas the NLEA claims that meet the SSA standard are referred to as unqualified health claims.


The research findings presented at the November 2005 FDA public meeting focused on whether consumers were able to differentiate among the different types of claims (ie, unqualified health claims, qualified health claims, and structure/function claims). Also discussed was how these claims could be structured so that they are not misleading to consumers. The findings revealed a wide range of conclusions on how the public perceives each type of claim both independently and relative to other claims using only words and with graphic images. The studies were controlled for consumers' prior knowledge of the nutrient and health condition that was the subject of the claim in the analysis of results. Nevertheless, consumers preferred simpler straightforward language, such as that used in structure/function claims. Knowledge of the nutrient and relevance of the health condition to the consumer affected the responses. Although graphics were helpful, the letter grades were often confused with the overall quality of the product. The research findings presented in November focused on consumer perceptions about the certainty of the science underlying health claims and not the truthfulness or scientific accuracy of the claims.


On the issue of scientific accuracy, the 2002 Institute of Medicine report Evolution of Evidence for Selected Nutrient and Disease Relationships summarizes findings from a review by an Institute of Medicine expert panel of the scientific evidence for the 10 diet and health relationships identified in the NLEA to determine the validity of the conclusions reached about these relationships more than a decade later. The 10 relationships were calcium and osteoporosis, dietary fiber and cancer, dietary fiber and heart disease, dietary fat and heart disease, dietary fat and cancer, sodium and high blood pressure, zinc and immune function in the elderly, omega-3 fatty acids and heart disease, antioxidant vitamins and cancer, and folate and neural tube defects. Key findings presented in the Institute of Medicine report included the following: (1) Confidence in nutrient-disease relationships can change, often in an unexpected direction; (2) No pattern of evidence clearly predicts change in the confidence of relationships, particularly those initially deemed uncertain or promising; (3) Large randomized trials have the greatest effect in changing the level of confidence in a nutrient-disease relationship. The findings in the Institute of Medicine report are not surprising; as with consumer perceptions, scientific evidence supporting health claims also evolves as new scientific findings on diet and health become publicly available.


The challenge now for the FDA is to decide how best to fit the different types of health and nutrition claims into one system, see Figure 1. Also, given the fact that science is constantly evolving, the FDA must find a way of periodically reviewing the scientific evidence to ensure that the scientific accuracy of approved claims remains current. One recommendation made by participants at the November 2005 meeting was for the FDA to include qualifying language, such as "very strong science suggests," in the NLEA health claims so consumers could recognize the difference between unqualified and qualified health claims. Also, the FDA could adopt the Federal Trade Commission's truth-in-advertising guidelines more explicitly. These guidelines state that all statements must be truthful and not misleading before dissemination and that companies must have adequate substantiation on file for all objective product claims. However, given the constraints of the various Acts and court decisions, the FDA may be unable to do this.

Figure 1 - Click to enlarge in new windowFigure 1. Nutrition and health claims.

The challenge for manufacturers is determining not only which type of claim is most effective in communicating the benefits of their product to consumers but also the costs and timeframe that are involved in delivering that claim to the market. The NLEA health claims are not very appealing to consumers because they contain qualifying language that reflects the state of the science about the nutrient-disease relationship. They are, however, the most definitive statements to date about the relationship of a food substance to a disease or health-related condition. They must also meet the highest scientific standard, that is, SSA among qualified experts, and are the most rigorous from a regulatory perspective. Under the NLEA, companies must petition the FDA to consider new health claims through rule making. Qualified health claims also require FDA premarket approval but currently do not go through the rule-making process. The FDA instead issues letters of enforcement discretion stating how it intends to implement these claims. On the other hand, the straightforward language in structure/function claims is appealing to consumers. These claims do not require FDA premarket approval. Companies must simply notify the FDA within 30 days of making the claim and have scientific substantiation on file to support structure/function claims. The FDA has drafted guidance to industry on substantiation of these claims that is publicly available on its Web site.


So what can nutrition practioners do while the FDA and manufacturers work out a suitable system for making unqualified health claims, qualified health claims, and structure/function claims to ensure that these claims are scientifically accurate and not misleading to consumers? Practioners should know the different types of claims and the requirements for making these claims. The FDA and Federal Trade Commission Web sites are good sources for this information. Companies should be in a position to provide publicly available information that they use to substantiate claims, as they are required to have these on file.