As part of its continuing initiative to provide Americans with the information they need to make nutritional choices about foods and dietary supplements, FDA recently launched an initiative to help consumers obtain accurate, up-to-date and science-based information about the health consequences of these products. FDA’s Task Force on Consumer Health Information for Better Nutrition developed a process to review such claims. The process will rely on expertise from the Agency for Healthcare Quality Research and other governmental agencies, coupled with enhanced consumer studies to review health claims before they appear on food labeling. The Consumer Health Information for Better Nutrition Initiative has as its central focus the twin goals of making available better, easily understood, up-to-date scientific information about how dietary choices can affect health, as well as encouraging companies to compete based on health and nutrition consequences, in addition to such non-health related features of products like taste and ease of preparation. According to FDA, a better informed public—aided by science-based health information—would be able to choose foods that are more nutritious, potentially addressing such urgent public health problems as the rise in obesity and overweight.

Highlighted in FDA’s report were key areas where the agency intends to focus its efforts on providing better nutrition information and health messages to consumers. These key areas highlight:

• The benefits of eating at least several servings a week of foods high in omega 3 fatty acids, including certain oily fish like ocean salmon, tuna and mackerel, for reducing the risk of heart disease;
• The benefits of eating five to nine servings a day of fruits and vegetables for reducing the risk of some cancers and other chronic illnesses;
• The benefits of replacing solid fats that are high in saturated and trans fats with vegetable oils containing unsaturated fats for reducing the risk of heart disease; and
• The benefits of substituting nuts for other sources of saturated fat-containing protein to help reduce the risk of heart disease.

The task force, made up of government experts on health information and nutrition from FDA, the FTC and the National Institutes of Health, proposed a two-phase plan to improve consumer understanding of health consequences of their dietary choices. FDA will complete, and encourage other research groups to complete, a consumer studies research agenda designed to improve its understanding of the most effective way to present scientifically-based, truthful and non-misleading information to consumers, as well as identifying the kinds of information known to be misleading. In the second phase of the task force’s plan, the agency intends to develop regulations based on further public comment, further research studies and FDA’s experience in phase one, along with encouraging manufacturers to provide better science-based information about the health consequences of dietary choices.

FDA has also taken the following steps to help develop better information for consumers about the health consequences of dietary choices. These include:

• FDA has refocused its Applied Nutrition programs in its Center for Food Safety and Applied Nutrition, to provide additional resources for, and senior involvement in, the Consumer Health Information for Better Nutrition Initiative.
• FDA has established new policy expert positions in the Office of the Commissioner on Nutrition, risk management and risk communication to assist in these applied nutrition activities.
• FDA is establishing closer ties between its dietary supplement program and the experts in its drug program who have extensive professional knowledge of the medical risk factors for various diseases.
• FDA is enhancing its enforcement activities related to misleading claims about heath benefits of products, particularly dietary supplements, that are not supported by scientific evidence.
• FDA has recently developed an Interagency Agreement with the Agency for Healthcare Research and Quality so that its Evidence-based Practice Centers can augment FDA’s internal capabilities to review the research literature on particular health claims about dietary products. FDA will also explore contracting with outside independent experts on particular issues, much as the agency already does to augment its review expertise in many medical product areas.
• FDA has enhanced its food advisory committee activities and expertise in the area of nutrition and health information.

With all of these enhancements, FDA has devoted additional efforts to improve health information. Because any qualified health claim that appears on a product label must be reviewed in advance by FDA to assure scientific accuracy and non-misleading presentation to consumers, FDA may not be able to take rapid action on all health claims submitted to the agency. Thus, initially, FDA will focus on reviewing qualified health claims in areas where, among other things, the scientific evidence is good but the health information is not being communicated on product labels to consumers. In general, FDA will use such a “priority setting” approach to achieve the most impact on public health in the most economical way.

To support the objectives of the task force and to further its recommendations, FDA has made available two final guidance documents via the Federal Register. The first, entitled “Guidance: Interim Evidence-based Ranking System for Scientific Data,” describes a process for systematically evaluating and ranking the scientific evidence for a qualified health claim. This ranking system will categorize the quality and strength of the scientific evidence—for example, through the equivalent of a “B,” “C” or “D” grading system—for every proposed qualified health claim. Until FDA has completed the research agenda it is proposing, it will consider the use of standardized qualifying language for each qualified health claim it reviews. FDA is conducting further consumer research to make sure that the language used is easily and accurately interpreted by consumers.

The highest grade, “A” or the equivalent, means that there is significant scientific agreement (SSA) about the health claim. In other words, the evidence supporting the claim is derived from well-designed studies conducted in a manner consistent with generally recognized procedures and principles. Such a claim requires no disclaimer and is therefore referred to as an unqualified health claim. A current example of a Grade “A” health claim is one relating calcium to a reduced risk of osteoporosis. Under the new system, the grade of “B” would be assigned to those petitions for which there is good scientific evidence supporting the claim, but for which the evidence is not enitrely conclusive. Grades of “C” would apply to claims for which the evidence is limited and inconclusive. The fourth level, “D,” would be given to claims with little scientific evidence to support them. Health claims graded “B,” “C” or “D” are referred to as qualified health claims because they require a disclaimer or other qualifying language to ensure that they do not mislead consumers.

The second guidance document, “Guidance: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements,” explains how applicants can seek a qualified health claim for their food or dietary supplement during the first phase of this initiative. It also describes how FDA will set priorities for reviewing qualified health claims petitions, so that the agency focuses on reviewing claims most likely to have important public health benefits.

The agency began applying these interim guidances for health claim petitions submitted on or after September 1st.