law as a specific food or component of food) and a disease or health-related condition. Some of the criteria for health claims are dependent on reference values for nutrition labeling because a food must meet the criteria for a certain nutrient content level based on the DV in order to be eligible for the health claim. For example, the food needs to contain, without fortification, 10 percent or more of the DV for at least one of six nutrients (dietary supplements excepted): vitamin A, vitamin C, iron, calcium, protein, and fiber.

The wording of health claims is carefully delineated by FDA and requires that the relationship between the food component and the risk of a disease or health-related condition is stated in a way that does not imply direct causation. FDA has approved 14 health claims that may be used on packaging, and new claims may be added to the list. (For more information on current claims, see CFSAN, 2003a.)

Health claims must be authorized by FDA prior to their use in food labeling. There are several methods for obtaining authorization. First, FDA reviews scientific evidence supporting a proposed health claim in response to a health claim petition. When FDA finds that the evidence satisfies the significant scientific agreement validity standard prescribed under NLEA, the agency issues a regulation authorizing use of the health claim. Second, under the Food and Drug Administration Modernization Act of 1997 (P.L. 105-115), if a scientific body of the U.S. government or the National Academies has published an authoritative statement about the relationship between a nutrient and a disease or health-related condition, that statement may serve as the basis for authorizing the use of a health claim. In such a situation, a manufacturer submits to FDA a notification of its intent to use a health claim based on the authoritative statement. Barring an objection by FDA, claims based on authoritative statements become authorized 120 days after submission of the notification. Third, when FDA’s evaluation of scientific evidence supporting a petitioned health claim concludes that the available evidence does not meet the significant scientific agreement standard, but that there is some credible evidence in support of the health claim, FDA will consider permitting a “qualified” health claim that includes appropriate qualifying language to explain the level of scientific proof that the claim is truthful. In approving a qualified health claim, FDA issues a letter stating that it will consider its “exercise of enforcement discretion” in permitting a qualified claim under prescribed conditions although the health claim has not been authorized by a regulation. FDA first considered permitting the use of qualified health claims for dietary supplements and conventional

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