Application of Epidemiological Data for Decision Making: Health Claims

The Nutrition Labeling and Education Act (NLEA), which amended the Federal Food, Drug, and Cosmetic Act in 1990, authorized the use of health claims that are based on significant scientific agreement in food labeling. In 1994, the Dietary Supplement Health and Education Act (DSHEA) defined dietary supplements and created a legal framework for use of claims that is similar to the regulation of foods. Health claims describe the relationship between a substance (food or food component) and reduction of the risk of a disease or health-related condition; they are not intended as claims to cure, treat, mitigate, or prevent disease, which are considered drug claims. Since the enactment of the NLEA, the FDA has developed a process to evaluate scientific evidence in support of health claims. In 1999, the FDA published Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements. As a result of a series of court cases, the agency developed a process for qualified health claims that characterizes the quality and strength of scientific evidence because these claims are not based on significant scientific agreement. Since 2003, the FDA has published several letters of enforcement discretion for qualified health claims that illustrate the agency’s approach to evaluating the scientific literature when the strength of the evidence is not consistent with significant scientific agreement. In 2007, the agency published the draft Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims that further outlined the FDA’s approach to evaluating scientific evidence for health claims. In January 2009, the final guidance was posted and replaced the 1999 guidance document as well as the interim guidance related to qualified health claims. The final guidance specifically addresses the use of observational data in the evaluation of health claims and describes the criteria used by the agency in the evaluation of such data. A copy of the guidance can be found on the FDA Web site (http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ ucm073332.htm). The guidance highlights some of the challenges that must be considered for the agency to use observational data to draw scientific conclusions on the relationship between a specific substance and disease or health-related condition for the health claim under review.