2: Empowering Consumers: Improving Health Through Better Information

Enable consumers to make smarter decisions by getting them better information to weigh the benefits and risks of FDA-regulated products.

Other Information:

For all that the FDA can accomplish through efforts to improve enforcement and regulatory protections for the public--as well as to help encourage the development of safer, more effective, and affordable food and medical technologies--people, through their own choices, can have an even greater impact on improving their health. For example, in 2000, total costs of obesity were calculated to be $117 billion ($61 billion direct and $56 billion indirect). As the prevalence of obesity continues to rise, the long-term health and economic consequences of obesity will be astounding. Lack of physical activity and poor nutrition account for approximately 300,000 deaths each year, making these risk factors second only to tobacco use in causes of preventable death. It has been estimated that up to 48 percent of English-speaking patients in the United States lack functional health literacy--the ability of an individual to understand, access, and use health-related information and services.12 U.S. Surgeon General Richard H. Carmona recently recognized low health literacy as a widespread problem affecting public health preparedness, addressing health care disparities, and disease prevention. Combined with the increasing incidence of many health problems, such as diabetes and obesity, this is a serious public health problem. Clearly, making sure that health information available to consumers is clear, informative, and effective in helping them to improve their health is more important than ever. And the importance of protecting consumers from misleading information is greater than ever as well. From encouraging better guidance to patients in pharmacy labels, to giving clearer guidance on communicating risk and benefit information in direct-to-consumer advertising, to launching new enforcement initiatives against dietary supplement manufacturers who make health claims without scientific foundation, the FDA is undertaking major new efforts to help consumers make better-informed decisions about how to use their health care dollars. The FDA accomplishes this important task in a number of ways. First, the FDA takes steps to ensure that information provided by a product's sponsors is accurate and that it communicates information consumers need to know in order to safely use a product. Second, the FDA itself communicates directly with the public and through health care providers concerning risks and benefits of regulated products. The scope of this communications responsibility is especially significant when it comes to food, as the FDA regulates some 75 percent of all foods consumed here, and given the current national epidemic of obesity and the related consequences, such as heart disease and diabetes. The FDA knows that consumers want the best information available about each of the products they use. And consumer research has demonstrated that more and better information helps consumers make smarter and better-informed decisions. A recent study by the Federal Trade Commission on peoples' interpretation of food nutrition and health claims in advertising found that people are able to accurately interpret these kinds of qualified claims, even in cases where there are limitations in scientific support, so long as the specific disclosures are clear and accurate. Recent innovations, such as the new label on over-the-counter (OTC) drugs (Figure 2) and direct-to-consumer (DTC) advertising, have had positive effects on consumer health decision-making. For example, consumer research conducted in developing the OTC drug label showed that the new label would increase consumers' confidence in their ability to use the information on the label and better enable them to make correct product-use decisions. Yet the FDA also knows that information can at times be confusing to some consumers, and too much information can provide a cacophony of data that can obscure the most important facts. Obviously, scientific accuracy is a key element of effective communication for consumers. Some other factors that affect the value of written medical information include, for example, the vocabulary and grammar used, the size of the typeface, and patient-related factors having to do with the patient's literacy. Consider the situation with the nutrition information on food products. Since 1993 consumers have been able to use the Nutrition Facts panel on food packages to help decide what foods to purchase. These labels were developed with the intent of enhancing the ability of Americans to make healthy diet choices. However, data on the health of Americans, particularly the growing problem of obesity, suggest that we are making dietary and other lifestyle choices that adversely affect our health despite access to this information (see below). Obesity and Nutrition-Related Illness in the United States The World Health Organization considers obesity one of the top five health problems in the developed world, including the United States. Almost 65 percent of U.S. adults were overweight (BMI = 25) in 1999–2000. Obesity is associated with type 2 diabetes, cardiovascular disease, hypertension17,18 and some cancers. There was a 10-fold increase in incidence of type 2 diabetes among children between 1982 and 1994. Obesity is estimated to account for 5.5 to 7.8 percent of all health care expenditures. The FDA's strategic plan calls for the agency to improve its knowledge about effective communications to consumers and health care providers throughout all of its major activities, including drugs, medical devices, and food products. The agency's current and future communication strategies for conveying risk, as well as the promotional activities of FDA sponsors, will be scientifically evaluated for their effectiveness in reaching target audiences and conveying information that is accurate and not misleading. The agency will be seeking out communications experts in academia, other government agencies, and industry to assist in these efforts. Other key strategies include: Taking steps to improve the FDA's processes for reviewing industry communications to consumers and health care providers Enhancing the FDA's processes for reviewing message content and delivery Ensuring that critical health messages are being delivered in ways that meet the health needs of targeted groups, including the underserved and at-risk.

Objective(s):

2.1: Consumer Communications Infrastructure

2.2: Industry Consumer Information

2.3: Health Benefits-Risk Information

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