The Consumer Health Information for Better Nutrition Initiative has as its central focus improving the public availability and consumer understanding of up-to-date scientific evidence on how dietary choices can affect health. A better-informed public, supported by effective, science-based regulation of health information, would be expected to make better nutritional choices. Such regulation would also encourage food and dietary supplement producers to compete in ways that better protect the public from disease risks. As part of this Initiative, the FDA Task Force on Consumer Health Information for Better Nutrition (the Task Force) was created.

We believe the work of this Task Force provides an effective framework for the agency and the food and dietary supplement industry to use, to provide more and better information to consumers about the health and nutritional benefits of their products. The Task Force believes that significant public health benefits will result when consumers have access to, and use, more and better information to aid them in their purchases -- information that goes beyond just price, convenience, and taste, but also includes science-based health factors. Armed with more scientific information about the likely health benefits of the foods and dietary supplements they purchase, consumers can make a tangible difference in their own long-term health, by lowering their risk of numerous chronic diseases. With millions of citizens making use of such information for their own health benefit, a great deal will be gained when this type of information is provided in food labeling.

Task Force activities are an important step in realizing this broader potential of food and dietary supplement labeling. Yet, it is only a first step. We support serious steps to permit information on food labeling in the form of health claims and dietary guidance that consumers can use now. For example, we are aware that there is data available on the potential positive impact on health of consuming foods high in omega-3 fatty acids. Such a claim should be one of the first to be reviewed under the approach put forward by this Task Force. In addition, general dietary advice and guidance that addresses ways consumers can reduce the risk of cancer - for example, by consuming five-to-nine fruits or vegetables each day - should be an immediate focus of the agency, to encourage and make available in the labeling of more food products. These are just two examples of opportunities available. Over time, we expect the process to become even more effective.

On December 18, 2002, Commissioner of Food and Drugs, Mark B. McClellan, M.D., Ph.D., announced a major new initiative to make available more and better information about foods and dietary supplements, to help American consumers prevent diseases and improve their health by making sound dietary decisions. The Consumer Health Information for Better Nutrition Initiative is designed to foster two complementary goals concerning the labeling of food and dietary supplements:

1. to encourage makers of conventional foods and dietary supplements to make accurate, up-to-date, science-based claims about the health benefits of their products; and
2. to help eliminate bogus labeling claims by pursuing marketers of human dietary supplements and others who make false or misleading claims about the health benefits or other effects of their products.

Through these objectives, the agency seeks to help consumers improve their understanding of how their dietary choices may influence their health, to promote competition among product developers to find better ways to improve health through better diets, and ultimately to prevent serious and life-threatening diseases via better dietary choices. As the Health and Human Services Secretary said, "By putting credible, science-based information in the hands of consumers, we hope to foster competition based on the real nutritional value of foods rather than on portion size or spurious and unreliable claims. Such labeling can help empower consumers to make smart, healthy choices about the foods that they buy and consume."

The future of nutrition and diet/disease relationships is evolving rapidly. Science is exploring opportunities for improving the health consequences of nutrition. The goals of this exploration include a better understanding of the impact of general dietary patterns for the US population as a whole, and specific understanding of how an individual's genetic makeup interacts with food and the environment. This latter field (nutritional metabolomics) strives to increase the ability to "design" foods and diets for individuals in order to maximize health.

The Consumer Health Information for Better Nutrition Initiative is at the forefront of this evolution. It is designed to encourage the kind of marketplace where healthy foods can compete readily among all foods available. In addition, the Initiative’s mission is to foster research and better understanding about diet and health, protect consumers, and help consumers protect themselves from misleading claims -- claims by producers of foods and dietary supplements about health benefits not supported by science.

The agency is aware that there are many opportunities to improve public health beyond those traditionally associated with the product approval and enforcement activities of the FDA. These opportunities have much to do with assisting the public in making wise dietary choices that benefit long-term health. When the FDA's mission is understood to include this role, a number of strategies become evident. For example, challenging the industry to channel competitive energies into disseminating health information in food labeling and promoting food products on the basis of nutritional value, as well as taste, price, and amount. The agency may also pursue consumer information options in collaboration with other federal agencies, health researchers, and stakeholders as more information about substance/diet relationships becomes available. Thus, this report represents only a first step in a larger, far reaching program to improve public health.

Health messages on product labels that may influence consumer knowledge, and hence dietary choices, fall into three major categories. Agency policies on all three may have important consequences for consumer behavior.

First, "health claims" have a different definition and regulatory provisions compared to other types of claim statements on conventional foods and dietary supplements. Health claims are specifically about the relationship between a substance and a disease, and they are reviewed and authorized by the FDA. An example of a health claim related to the disease osteoporosis is: Calcium may reduce the risk of osteoporosis.

Second, "structure/function" claims are also allowed on foods, but make no reference to disease. Instead, they highlight how the food substance works within or supports the body. An example of a structure/function claim would be: Calcium helps build strong bones. These structure/function statements are not pre-reviewed by the FDA but must be truthful and substantiated and not misleading. Though the statutory standards for structure/function claims differ from health claims, they too may affect consumer behavior, and thus assuring their accuracy is another important element for effective regulation of product claims for consumers.

Finally, truthful and non-misleading general "dietary guidance" statements can also be made on food labels without FDA review. These statements, unlike health claims which target a specific substance and a certain disease, focus instead on general dietary patterns, practices, and recommendations that promote health and encourage better nutrition. An example would be the "5-a-Day" program from the National Cancer Institute (NCI), which encourages the consumption of fruits and vegetables for better health.

The Task Force recommends that the FDA use an evidence-based ranking system for health claims on food labels (including conventional food and dietary supplements).

Health claims are voluntary statements on food labels that were authorized by the 1990 Nutrition Labeling and Education Act (NLEA). They are intended to assist consumers in understanding the relationship between a substance in a conventional food or dietary supplement and its ability to reduce the risk of contracting a disease in healthy populations. They were put in place by Congress so that food manufacturers could voluntarily, by the use of labeling, let consumers know about important beneficial food components that had the ability to reduce disease risk when integrated into the total daily diet. Health claims are not drug claims, which by law focus on diagnosing, treating, curing, or mitigating disease. Rather, health claims address the reduction of risk as part of a total diet. There is more evidence than ever that dietary choices have major impacts on population health. For example, researchers have indicated that changes in diet could lead to a significant reduction in chronic diseases such as heart disease.

In establishing the standard for health claims on labels, the FDA decided to use the same standard for dietary supplements and conventional foods; regulations for health claims apply equally to both. This decision was motivated by public health considerations; all consumers eat conventional foods and most use dietary supplements, so inconsistent standards would lead to consumer confusion and biased consumption choices. The FDA authorizes health claims when they determine, based on all publicly available scientific evidence, that there is significant scientific agreement (SSA) among experts qualified by scientific training and experience that the claim is supported by such evidence.

Dietary factors and sedentary lifestyles contribute substantially to the burden of preventable illnesses and premature deaths in the United States. Indeed, dietary factors are associated with 4 of the 10 leading causes of death: coronary heart disease, some types of cancer, stroke, and type 2 diabetes. For example, high blood cholesterol is a major risk factor for coronary heart disease that can be modified by diet and other factors. Lifestyle changes that prevent or lower high blood cholesterol include eating a diet low in saturated fat and cholesterol, increasing physical activity, and reducing excess weight. Fat intake in the United States as a proportion of total calories is lower than it was many years ago, but most people still eat too much saturated fat.

There is evidence of a public health gap in knowledge and behavior with respect to substance/disease relationships. A Sloan State-of-the-Industry Report showed consumers have no problems holding dichotomous attitudes about the pleasures of food and its power to influence their health. As more shoppers acknowledge indulging their cravings, more also admit that what they eat can have a major effect on how healthy they feel.

A Food Marketing Institute survey indicated an increasing percentage of consumers who recognize the importance of eating healthfully and are interested in trying foods that may improve their health. 86% agree or strongly agree that "in most cases, eating healthfully is a better way to manage illness than medications”. 54% said they are very interested in trying health-promoting foods. 51% want products designed to help them with high blood pressure and diabetes; 50% with allergies; 49% with weight control; 41% with osteoporosis; 40% with arthritis, and 40% (women) with problems involving women's hormones. Despite these encouraging findings, other results from the same survey indicate that the percentage of consumers who acknowledge unhealthy eating behaviors is also increasing. 72% of shoppers agree or strongly agree with the statement, "I eat foods I enjoy, even if they're not good for me”. 34% agree or strongly agree with the statement, "I eat whatever I want and don't think much about how it affects my health”.

There is growing concern about obesity and appropriate health messages to address this public health issue. Overweight persons are at increased risk for several chronic diseases. In recent decades, there have been a number of U.S. efforts aimed at reducing obesity. However, these have not halted the alarming “obese increase” trend. For example, in 1999, an estimated 61% of U.S. adults were overweight or obese, with nearly twice as many overweight children and almost three times as many overweight adolescents as there were in 1980. The consequences of the obesity epidemic have manifested in premature death and disability, increased health care costs, lost productivity, and social stigmatization. Approximately 300,000 deaths a year in the U.S. are associated with overweight and obesity, with an estimated cost of $117 billion in 2000. Thus, finding more effective ways to improve understanding and behavior is an urgent health priority.

Although the scientific evidence in a number of substance/disease relationships does not, or might not, meet the standard of SSA, there is considerable evidence of a relationship between dietary choices and health and, in turn, a need to better inform consumers. For example, the following relationship, which may not meet the SSA standard, may be said to be based on somewhat settled science and therefore would be important information for consumers: Foods high in omega-3 fatty acids decrease the risk of heart disease. Even if only some of these apparently likely relationships are borne out in subsequent studies, greater consumer awareness of these relationships and changes in diet as a result would be expected to lead to significant public health benefits.

In addition, there is the opportunity to expand health messages beyond qualified health claims to dietary guidance. An example of such a dietary guidance statement from the NCI is: "Diets rich in fruits and vegetables may reduce the risk of some types of cancer and other chronic diseases." This dietary guidance highlights a general category of foods and provides a valuable reminder about food choices. Also, an increasingly important message for consumers is to substitute foods that decrease the risk of disease for those that do not, in order to build better diets. For instance, the booklet "Dietary Guidelines for Americans" provides an important substitution health message about fats and heart disease: "Substituting vegetable oils for solid fats may reduce your risk of heart disease."

The Task Force discussed above came from the need for a regulatory framework to implement qualified health claims in light of major scientific, public health, and legal developments during recent years -- as well as the need for scientific criteria to address the basis for qualified health claims, and a better understanding of the nature of non-misleading claims on food labels. The Task Force was given approximately six months to complete its work, focusing primarily on the issue of qualified health claims. However, its discussions were enriched by considerations of promoting partnerships with sister public health agencies and others, with the goal of improving the quality and impact of possible claims and labeling statements on conventional human foods and dietary supplements.

Throughout the years, the federal government has worked to provide information to consumers about healthy eating patterns and wise food choices. Such advice originated with the Basic Four, and has progressed through today's Dietary Guidelines for Americans and the Food Guide Pyramid. We expect that, over time, scientists will better understand these diet/health relationships. As this happens, consumer actions based on this information should be encouraged and promoted by use of the food label.

www.fda.gov -- The official FDA (Food and Drug Administration) website.

www.mypyramid.gov – The My Pyramid site can help you choose the foods and amounts that are right for you. Get a quick estimate of what and how much you need to eat, based on information you enter for age, sex, and activity level. For a detailed assessment of your food intake and physical activity level, click on MyPyramid Tracker. Get advice to help you make smart choices from every food group. Find your balance between food and physical activity, and get the most nutrition out of your calories.