foods must be supported by scientific evidence as outlined in the guidance document, Guidance for Industry and FDA: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements (CFSAN, 2003). In addition, the FDA is conducting further consumer studies to make sure the language used in claims is well understood by consumers (FDA, 2004b).

In the interim period, the FDA will prioritize health claims for review based on the potential significance of the product’s health impact on a serious or life-threatening illness, and the strength of evidence in support of the claim. The health claims that will be evaluated first include the benefits of eating foods high in omega-3 fatty acids, including certain fatty fish like ocean salmon, tuna, and mackerel, for reducing the risk of heart disease.

Country of Origin and Other Labeling The 2002 Supplemental Appropriations Act amended the Agricultural Marketing Act of 1946 to require retailers to inform consumers of the country of origin of wild and farm-raised fish and shellfish. This information can be conveyed by label, stamp, mark, placard, or other clear and visible sign on the product, package, display, holding unit, or bin containing the seafood at the final point of consumption. Food service establishments are exempt, as are processed products.

Box 6-1 describes an unresolved issue over which governmental sector has the authority to control the consumer’s access to certain information

BOX 6-1

Challenge to California’s Proposition 65

In 2005, the Food and Drug Administration claimed that California’s action was a violation of federal law. On March 8, 2006, the House passed HR 4167, the National Uniformity for Food Act, which amends the Federal Food, Drug, and Cosmetic Act to “provide for uniform food safety warning notification requirements” and to supersede state legislation and practices on food-warning labels, including Proposition 65. At the writing of this report, the Act had not passed the Senate. An amendment to the Act included a clause to exclude mercury warnings: “Nothing in this Act or the amendments made by this Act shall have any effect upon a State law, regulation, proposition or other action that establishes a notification requirement regarding the presence or potential effects of mercury in fish and shellfish.”


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