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In 2003, the US Food and Drug Administration (FDA) began authorizing qualified health claims for conventional foods. Although the FDA had developed generic qualifying language for these claims, the language had not yet been tested with consumers. We conducted shopping mall intercept research among a random sample of 408 adults. The research tested consumer preference, understanding and believability, and impact on nut consumption of 4 variations of the 'B' level qualified health claim for nuts and heart disease. The FDA generic language was used as the control. The results show that one of the alternatives was ranked significantly higher than the FDA generic claim for clarity and understandability but was similar in all other categories, including the scientific uncertainty associated with the claim. This research demonstrates that it is possible to meet FDA's standards for truthful and not misleading health claims using consumer-friendly language.

The US Food and Drug Administration (FDA) authorizes health claims for use on food labels so that consumers can make smart, healthy choices about the foods they buy and consume in the context of their total daily diets. A health claim describes the relationship between a specific food or food component and reduced risk of a disease or health-related condition.1 Historically, FDA regulations specified that no diet-disease relationship could be discussed in labeling unless the FDA had determined, based on the totality of publicly available scientific data, that there was 'significant scientific agreement' among qualified experts that the claim was valid.2 As a result of this high standard, only about a dozen unqualified health claims have been authorized:

In fact, according to a recent survey, a mere 4.4% of food products sold in the United States carry any type of health claim on their packages.3

The FDA established interim procedures for qualified health claims for conventional foods, in the hope that consumers would benefit from more diet and health information on food labels. Qualified health claims differ from unqualified health claims because they must be accompanied by a statement that explains the level of scientific certainty. Qualified health claims are now being used when the evidence is not well-enough established to meet the significant scientific agreement standard but the 'weight of the scientific evidence' supports the proposed claim and can be stated in a language that does not mislead consumers. 'Qualifying' language is included as part of the claim to indicate that the evidence supporting the claim is still emerging.4

In 2003, the FDA issued interim procedures for qualified health claims in the labeling of conventional food and dietary supplements. The agency stated that it would continue to authorize 1 level of claims that had no qualifying statements (category A, or unqualified claims; the highest claim that could be made representing significant scientific agreement) while using its enforcement discretion for 3 levels of qualified claims: category B would represent a good to moderate level of scientific agreement; category C, a low level of scientific agreement; and category D, a very low level of scientific agreement. Some called this scheme a report card-like proposal. An example of generic qualifying language that might be appropriate for each of these claims is shown in Table 1 .

In March 2005, the International Food Information Council (IFIC) released data from its qualified health claims consumer research project. According to the research, 'Consumers had difficulty sorting out the strength of the scientific evidence associated with four distinct claim levels, regardless of the claim type.' This may be indicative of consumer desire for simpler language regarding the associations between food and health.5 Previous research on health claims has shown that, in general, shorter claims are more effective than long claims.6

In 1998, the Federal Trade Commission released findings from a study that examined consumer interpretations of food, nutrition and health claims in advertising. The findings suggested that it was possible to communicate limitations in the level of scientific support for diet-disease relationships that have not yet attained significant scientific agreement. It could not be determined, however, whether the relatively low level of scientific certainty that the respondents attached to all of the tested ads reflected an inherent skepticism of health claims in advertising in general or of the 2 tested subject areas and products in particular.7 The Federal Trade Commission conducted subsequent research on this topic, and although the data require further analysis, preliminary findings are broadly consistent with the 1998 results.8 Recent consumer research conducted by FDA 9 suggests that consumers have difficulty correctly ranking qualified health claims by their level of scientific certainty, using the generic qualifying language, unless a letter 'grade' is assigned to the claims. However, the IFIC research noted above 5 found that such 'grades' are problematic because consumers tend to apply them to factors unrelated to the claim, such as product quality or safety. Additional research is needed to resolve these issues.

In August 2002, the International Tree Nut Council Nutrition Research and Education Foundation (INC NREF) submitted a petition to the FDA requesting an unqualified health claim for nuts (both peanuts and tree nuts) and heart disease, which read, 'Diets containing one ounce of nuts per day can reduce your risk of heart disease.' More than 30 studies pertaining to most nuts consumed in the United States have shown that including such foods in the diet can favorably affect serum lipids and thereby reduce the risk of heart disease. Moreover, this evidence suggests that substituting a handful of nuts per day in place of other snacks or saturated fat-containing protein foods in the typical American diet could have a significant benefit to public health. The FDA reviewed the INC NREF petition and responded in March 2003 with a proposed qualified health claim for nuts and reduced risk of heart disease using its generic qualifying language: 'Nuts [including name of specific nut], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. FDA evaluated the data and determined that, although there is scientific evidence supporting the claim, the evidence is not conclusive. See nutrition information for total fat and saturated fat content.'10

However, because consumer research on qualified health claim language was not available, INC NREF conducted a shopping mall intercept study using the Federal Trade Commission research as a model. The study tested the FDA-proposed 'generic' qualifying language for a 'B' level qualified health claim, as well as 4 variations with respect to nuts and the reduced risk of heart disease. The objectives of this study were (1) to test the clarity of the FDA generic claim language compared with 4 alternate claims; (2) to determine how well each of these claims communicated the desired message; and (3) how well each of the claims communicated its scientific uncertainty.

Four alternative claims were developed to compare against FDA's generic qualifying language (see Table 2 ). These claims were designed to reflect the 'weight of the scientific evidence' standard, as described in FDA's notice, 'Guidance for Industry: Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements: Availability.'11

Four hundred eight interviews were conducted among a demographically balanced sample of adults during May and June 2003 in shopping malls in 16 geographically dispersed locations in the United States. The respondents were not specifically selected to be primary grocery shoppers because INC NREF was also concerned about eating behavior and did not want to be exclusionary.

Personal interviews were conducted with a random sample of the population after consumers were randomly intercepted and then screened to meet the predetermined demographic criteria. The demographic profile of the sample was weighted to represent the US population for sex, age (ages ranged 21-70 years, with a mean age of 41.2 years), region of the country, marital status, employment, education, household size, ethnicity, and income.

The survey consisted of 5 questions assessing comprehension of the claims and 9 questions on demographic characteristics. Each respondent was exposed to 3 claims-the claim using FDA's generic language plus 2 of the alternatives to limit interviewee fatigue. The respondents rated each claim on a 5-point scale for clarity, believability, scientific certainty (how sure the experts are that nuts help reduce the risk of heart disease), and their likelihood to buy/eat more nuts. The order of exposure to the claims and the specific combination viewed were rotated so that all claims had an equal chance of being in the first, second, and third position to avoid an order of presentation bias. During analysis, data were weighted to ensure that those exposed to each claim had similar profiles with respect to their demographics and also their use of nuts.

Table 3 shows the percentage of respondents who rated the claims with the highest rating ('5' on the 5-point scale) and with the top 2 ratings ('4' or '5' on this scale). All of the claims received high scores on believability.

The alternative claims entitled 'Uncertainty Remains' and 'Data Limited' received significantly higher scores ( P < .04) for believability that nuts reduce the risk of heart disease compared with the other tested claims. The 'Data Limited' qualifying language was also ranked significantly higher (38%, 'much more likely to buy/eat more nuts'; P < .04) than all other claims with respect to increased purchase intent.

The 'Evidence Suggests' qualifying language was ranked significantly higher ( P < .02) than FDA's generic language for clarity/understandability but was similar in all other categories, including the scientific uncertainty associated with the claim that nuts reduce the risk of heart disease. As in the Federal Trade Commission study of 1998, the 'Evidence Suggests' language demonstrated that it is possible to communicate clear and understandable information on the role of nuts in reducing the risk of coronary heart disease without misleading consumers on the degree of scientific uncertainty that still exists.8 Therefore, in July 2003, the FDA authorized the claim, 'Scientific evidence suggests but does not prove that eating 1.5 ounces per day of most nuts as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease,' as one of the first category B qualified health claims to be authorized under the new guidelines.12

Because of their saturated fat content, only certain nuts are eligible to use the claim: almonds, hazelnuts, certain mixed nuts, peanuts, pecans, pignolia pine nuts, pistachios, and walnuts. The claim applies to whole or chopped nuts that are raw, blanched, roasted, salted, and/or lightly coated and/or flavored. Nut-containing products that contain at least 11 g of nuts per serving and are low in saturated fat and cholesterol may also use the claim.

Nutrition professionals can use qualified health claims to help educate consumers about the important role that food and nutrition play in overall health, the differences in the strength of the evidence for beneficial effects of different foods and constituents, and the need for portion control. Without a specific mention of serving size, 36% of those who viewed the claims assumed that nuts should be eaten daily, and 42% thought nuts should be consumed several times per week. When it came to portion size, the amounts believed to be healthful covered a very wide range, from a handful (1-2 oz) up to 1/2 to 1 cup of nuts! The final FDA-approved qualified health claim recommends consumption of 1.5 oz of nuts per day.10 Because most consumers do not think in terms of ounces when it comes to portion size, materials were developed to help translate 1.5 oz into 1/3 cup of nuts using various visuals. These materials are available for free on the INC NREF Web site at http://www.nuthealth.org .

Health claim regulations continue to evolve, and more consumer research is needed to fully understand how consumers comprehend and interpret qualifying language for the different levels of claims. Nevertheless, the INC NREF research shows that FDA's standards for truthful and not misleading qualified health claims can be met with consumer-friendly language.

This study was funded by the INC NREF, a nonprofit organization that represents 9 tree nuts: almonds, Brazils, cashews, hazelnuts, macadamias, pecans, pine nuts, pistachios, and walnuts. INC NREF worked with Protocol Research Solutions, formerly CLT Research, located in New York, NY.

1. US Food and Drug Administration. Claims That Can Be Made for Conventional Foods and Dietary Supplements . Rockville, Md: US Food and Drug Administration; September 2003:1-4. [Context Link]

2. US Code of Federal Regulations. Health Claims: General Requirements (21 CFR 101.14). [Context Link]

3. LeGault L, Brandt MB, McCabe N, Adler C, Brown A-M, Brecher S. 2000-2001 Food label and package survey: an update on prevalence of nutrition labeling and claims on processed, packaged foods. J Am Diet Assoc . 2004;104:952-958. [Context Link]

4. US Food and Drug Administration. FDA's Implementation of 'Qualified Health Claims': Questions and Answers . Rockville, Md: US Food and Drug Administration; August 27, 2003:1-7. [Context Link]

5. International Food Information Council Foundation. Qualified Health Claims Consumer Research Project Summary. Washington, DC: International Food Information Council Foundation; March 2005. Available at: http://ific.org . Accessed August 3, 2005. [Context Link]

6. Geiger CJ. Health claims: history, current regulatory status, and consumer research. J Am Diet Assoc . 1998;98:1312-1322. [Context Link]

7. Federal Trade Commission. FTC Releases the Food Copy Test Results . Washington, DC: Federal Trade Commission; November 18, 1998:1-2. [Context Link]

8. Comments of the Staff of the Bureau of Consumer Protection, the Bureau of Economics, and the Office of Policy Planning of the Federal Trade Commission. In the Matter of Food Labeling: Health Claims; Dietary Guidance (Docket No. 2003-0496). January 26, 2004. [Context Link]

9. Derby BM, Levy AS. Working Paper. Effects of Strength of Science Disclaimers on the Communication Impacts of Health Claims. Washington, DC: US Food and Drug Administration; September 2005. Available at: http://www.fda.gov/OHRMS/dockets/dockets/03N0496/03N-0496-rpt0001.pdf . Accessed March 6, 2006. J Am Diet Assoc .1998;98:1312-1322. [Context Link]

10. International Tree Nut Council Nutrition Research and Education Foundation. Authorization of a Health Claim for Nuts and Coronary Heart Disease . Health Claim Petition (Docket No. 02P-0505). August 27, 2002. [Context Link]

11. US Food and Drug Administration. Guidance for industry: qualified health claims in the labeling of conventional foods and dietary supplements: availability. Fed Reg. December 20, 2002;67:78002. [Context Link]

12. US Food and Drug Administration. Qualified Health Claims: Letter of Enforcement Discretion-Nuts and Coronary Heart Disease . Rockville, Md: US Food and Drug Administration; July 14, 2003:1-4. [Context Link]

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