FDA's CONSUMER HEALTH INFORMATION FOR BETTER NUTRITION INITIATIVE
On December 18, 2002, the Food and Drug Administration (FDA) announced a new initiative to encourage the flow of high-quality, science-based information regarding the health benefits of conventional foods and dietary supplements to consumers. Individual dietary choices are important in preventing disease and improving the public's health. Enhancing the availability of high-quality health information to help consumers make sound dietary decisions is a top priority of the agency.
The goal of the Consumer Health Information for Better Nutrition initiative is to facilitate the flow of information to consumers concerning the role of sound dietary practices in achieving and maintaining good health, while assuring that this information complies with legal requirements that it be truthful, non-misleading, and based on sufficient scientific evidence. FDA intends to achieve this goal through measures to encourage truthful and non-misleading claims for conventional foods and dietary supplements. Any such food claims will require review must be reviewed by FDA before they may be used on the food label. In the dietary supplement area, in which FDA's statutory authority involves postmarket monitoring, FDA is undertaking aggressive, comprehensive enforcement and oversight.
Background
FDA recognizes two subcategories of food: conventional food and dietary supplements. Historically, conventional foods have been consumed for their sensory appeal (smell, taste, aroma) and nutritional value. Increasingly, as a result of better science and innovative food products, foods can be used to achieve health benefits beyond basic nutrition. Dietary supplements, too, are used by consumers with the goal of achieving particular health benefits.
In 1994, Congress enacted the Dietary Supplement Health and Education Act (DSHEA). Under DSHEA, dietary supplements do not need pre-market approval from FDA. But a firm is responsible for ensuring that its product is safe and that any claims about it are substantiated by adequate evidence to show that they are not false or misleading. Marketers of dietary supplements may make certain claims about the health benefits of their products, including descriptions of the supplement's effects on the structure or a function of the body (e.g., "helps support cartilage and joint function"). In addition, dietary supplements may be marketed with qualified health claims as a consequence of litigation against FDA. Neither DSHEA nor litigation has changed the well-established principle that a dietary supplement is subject to regulation by FDA as a drug if it is promoted to treat, prevent, or cure a disease or condition.
The legislative and litigation activity have contributed to an uncertain regulatory environment for health claims for foods. For example, FDA has previously taken the position that a judicial decision authorizing qualified health claims for dietary supplements did not equally authorize such claims for conventional foods. Consequently, claims of health benefits for conventional foods that are based on scientific evidence are not being made. At the same time, FDA has become increasingly concerned by the proliferation of unsubstantiated and misleading claims being made by certain unscrupulous dietary supplement marketers. FDA wants a "marketplace of ideas" relating to health information for foods, with truthful and non-misleading, scientifically based information available to consumers.
FDA believes that a market in which food marketers compete based on scientifically substantiated, truthful health claims will yield substantial benefits to the public health. FDA for many years has authorized the use of simple claims concerning the presence of a particular nutrient in a food (e.g., "good source of calcium"). Research demonstrates, though, that consumers are more likely to respond to information concerning the health benefits of consuming particular conventional foods and dietary supplements if the information identifies, with specificity, the health benefit associated with the product. Provided these messages are presented in a manner that accurately conveys the degree of supporting scientific evidence, evidence on consumer behavior developed by the FTC and other experts indicates that these messages help consumers in selecting foods that are likely to contribute to overall health. In the aggregate, even though some scientific evidence will undoubtedly be refined by further studies, decisions by individual consumers that are based on accurate scientific information about the likely benefits of food choices will improve public health.
Objectives
FDA's Consumer Health Information Initiative is intended to achieve the following complementary objectives:
Elements of the Initiative
To achieve the twin objectives of discouraging false or misleading claims while encouraging the flow of accurate health information about conventional foods and dietary supplements, FDA is taking the following actions:
1. Guidance on Qualified Health Claims for Conventional Foods and Dietary Supplements
FDA announced the publication of a guidance document describing the circumstances in which the agency will decline to take enforcement action against conventional foods and dietary supplements marketed with qualified health claims. Such claims can now be made for dietary supplement manufacturers, but FDA has until now contended that such claims could not be made for conventional foods. Under the guidance, claims will continue to be subject to preapproval by FDA and must meet a scientific "weight of the evidence" standard. This guidance will also make clear FDA's conviction that consumers are partners in their own health care, and that the perspective FDA adopts in considering whether food claims are misleading is the "reasonable consumer" standard. This is the same standard that has long been employed effectively by the Federal Trade Commission (FTC).
2. Strong Enforcement of Dietary Supplement Rules
FDA presented a report on its enforcement of DSHEA, reaffirming FDA's commitment to effective implementation of Congress's intent to ensure that claims to consumers are truthful and not misleading. Reflecting this commitment, the agency recently announced a major seizure of a dietary supplement product making unsubstantiated herpes and flu treatment claims.
3. FDA Task Force on Consumer Health Information for Better NutritionFDA announced the formation of a Task Force on improving consumer health information, to help consumers make nutrition decisions based on the latest and best scientific evidence. Within six months, the Task Force is to report on a framework to facilitate consumer access to accurate, scientifically-based information on conventional food and dietary supplements. Specifically, the charge of the Task Force includes the following elements:
Commissioner McClellan has asked Deputy Commissioner Lester Crawford, D.V.M., Ph.D., to serve as the Chair of the Task Force, and has asked Joseph Levitt, Director of Center for Food Safety and Applied Nutrition (CFSAN), assist Dr. Crawford as Vice Chair.
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