2.2: Industry Consumer Information

Enhance the FDA's efforts to help ensure that industry communications to consumers and health care providers are truthful and not misleading, provide information about product risks and benefits, and appropriately convey the degree of scientific uncertainty associated with such product messages.

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A well-informed public is one of the best weapons against some of the biggest public health threats facing the country. Better information means that consumers can make better choices. And some of the most important health choices that people make are about the foods they choose to eat. Our choices about our diets are choices about our health. Those choices should be based on the best and latest scientific information. One of the FDA's most important public health tasks is to help ensure that Americans can rely on that information to make smart decisions about food. To make these smart decisions, people need good, clear information about the nutritional value of their foods. They also need to be protected from misleading information, from "snake oil" claims that create false hopes and can get in the way of improving their health. The Task Force on Consumer Health Information for Better Nutrition was charged, among other things, with developing a system for the FDA to help consumers get more accurate information about the health consequences of their food choices. The FDA believes that this process for making science-based health claims, when combined with the agency's strong enforcement work, will help people choose healthier products. More effective enforcement of the law against companies that make false or misleading health claims also means that consumers can rely on the science-based information on the label. The health claims that the FDA believes are highest priority to go through this enhanced FDA-regulated process are the ones where the evidence seems quite good already--not definitively settled, but good enough that many expert organizations believe people should know about it in making their diet choices. The claims that the agency intends to review for possible inclusion on food labels in the months ahead include: Consuming 5 to 9 servings of fruits and vegetables a day may reduce your risk of cancer and other chronic illnesses Substituting foods that are high in unsaturated fats for foods high in saturated or trans fats (vegetable oils instead of solid fats) may reduce your risk of heart disease A diet that features foods high in omega-3 fatty acids, or that substitutes tree nuts instead of proteins high in saturated fats, may reduce your risk of heart disease In order to create an environment for good information, the agency is committed to aggressively pursuing those who make false and misleading claims. In 2002, the FDA inspected more than 80 dietary supplement firms, several of which voluntarily corrected identified violations. In February 2003, the FDA seized dietary supplements from a firm in Florida in light of illegal claims that the products would treat a variety of medical conditions, including prevention of cancer and treatment of arthritis. More recently, the FDA worked with the FTC in May 2003 to crack down on Internet marketers of products claimed to protect against, treat, and even cure Severe Acute Respiratory Syndrome (SARS). Direct-to-Consumer (DTC) advertising has become an important source of patient information about prescription drugs. Research demonstrates that these ads can have a positive impact on patient/physician communications. For such advertising to best inform consumers, it must effectively communicate not just the potential benefits of the advertised prescription drug, but also potential risks, such as those associated with drug interactions and the specific health condition of the individual considering taking the drug Highlights for Objective 2 Develop draft guidance on a scientific evidence-based rating system for qualified health claims for conventional foods and supplements. Expand efforts, in conjunction with the Federal Trade Commission (FTC), to take action against unsubstantiated claims on dietary supplements through warning letters, seizures, and/or injunctions against misbranded products. Develop guidance for industry on the content of the "brief summary" for direct-to-consumer advertising.

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Indicator:1

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