![]() ![]() On August 8, 2003, Kraft Foods submitted a notification (the "Kraft notification") containing the following proposed claim: "Diets rich in whole grain foods and other plant foods, and low in saturated fat and cholesterol, may help reduce the risk of heart disease." The 120-day period from the date of submission of the Kraft notification is December 9, 2003. ![]() The claim may be made after 120 days from the date of submission of the notification until such time as FDA issues a regulation: (1) prohibiting or modifying the claim or (2) finding that the requirements of the Act have not been met, or a district court in an enforcement proceeding has determined that the requirements for making such a claim have not been met. The notification must be submitted to FDA at least 120 days before the food is introduced into interstate commerce. ยง 343(r)(3)(C)) of the Federal Food, Drug, and Cosmetic Act (Act), a manufacturer may submit to the Food and Drug Administration (FDA) a notification of a health claim based on an authoritative statement from an appropriate scientific body of the United States Government or the National Academy of Sciences (NAS) or any of its subdivisions. ![]() Back to FDA Modernization Act (FDAMA) Claims ![]()
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