FDA launches its Consumer Health Information For Better Nutrition Initiative. (Top of the News).

In late December last year FDA commissioner Mark McClellan said that the agency would issue guidance for providing more and better health information for consumers through its Consumer Health Information For Better Nutrition Initiative. As such, FDA will now recognize that qualified health claims can be permitted for conventional foods as well as for dietary supplements. Currently, there are three qualified health claims that are permitted for dietary supplements, including folic acid and neural tube defects, omega 3 fatty acids and coronary heart disease and B vitamins and coronary heart disease. In addition, food manufacturers will now be able to petition the FDA to use claims already approved for dietary supplements. This new consumer health information initiative comprises three related actions. (1) Issuing guidance on qualified health claims for conventional foods and dietary supplements. FDA currently permits such claims for dietary supplements under certain circumstances but not for conventional foods. To meet the criteria for making a new, qualified claim on a conventional food, the manufacturer would need to provide a credible body of scientific data supporting the claim. The company would need to demonstrate, based on a fair review by scientific experts of the totality of information available, that the "weight of scientific evidence" supports the proposed claim. All qualified health claims will require review by FDA before they may be used on the food label. (2) Strengthening enforcement of dietary supplement rules. FDA is emphasizing its commitment to carrying out the intent of Congress in the Dietary Supplement Health and Education Act (DSHEA) of 1994 by outlining its enforcement strategy against false or misleading claims about dietary supplements. (3) Establishing an FDA Task Force on Consumer Health Information for Better Nutrition. This task force will develop a framework to help consumers obtain accurate, up-to-date and science-based information about conventional foods and dietary supplements. This includes the development of additional scientific guidance on how the "weight of the evidence" standard will be applied, as well as the development of regulations that will give these principles the force and the effect of law. The task force will be chaired by FDA deputy commissioner Lester Crawford, D.V.M., and the vice chair will be Joseph Levitt, director of FDA's Center for Food Safety and Applied Nutrition (CFSAN). In addition to other FDA staff, the task force will rely on expertise from various government agencies, consulting with other government experts in the fields of health information and nutrition, as appropriate. Within the next six months, the task force hopes to identify procedures for implementing the initiative, as well as determining the organizational staffing needs necessary for the timely review of health claim petitions and to develop a consumer studies research agenda designed to best present scientifically-based information to consumers in a truthful and non-misleading way, and to identify the kinds of information known to be misleading to consumers. The task force will hold monthly meetings--the first of which was held in February--to seek public input.