government with responsibility for public health protection or nutrition research such claims may be used 120 days after a health claim notification has been submitted to FDA, unless the agency has informed the notifier that the notification does not include all the required information and 3) as described in FDA’s guidance entitled Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements, the agency reviews petitions for qualified health claims where the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation. There are three ways in which FDA exercises its oversight in determining which health claims may be used on a label or in labeling for a conventional food or dietary supplement: 1) the 1990 Nutrition Labeling and Education Act (NLEA) provides for FDA to issue regulations authorizing health claims for foods and dietary supplements after reviewing and evaluating the scientific evidence, either in response to a health claim petition or on its own initiative 2) the 1997 Food and Drug Administration Modernization Act (FDAMA) provides for health claims based on an authoritative statement of the National Academy of Sciences or a scientific body of the U.S. Health claims describe a relationship between a food substance (a food, food component, or dietary supplement ingredient), and reduced risk of a disease or health-related condition. Among the claims that can be used on food and dietary supplement labels are three categories of claims that are defined by statute and/or FDA regulations: health claims, nutrient content claims, and structure/function claims.
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