On September 11, 2015, the U.S. Food and Drug Administration (FDA or the agency) released draft guidance, “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods- Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11” (draft guidance). The Food Marketing Institute (FMI) appreciates the opportunity to respond to FDA’s request for comments on the draft guidance intended for covered establishments subject to the nutrition labeling requirements under the Federal Food, Drug and Cosmetic Act (FD&C Act) and the implementing regulations. These requirements include the menu labeling provisions of section 403(q)(5)(H) and the final rule on nutrition labeling of standard menu items in restaurants and similar retail food establishments published on December 1, 2014.1 The draft guidance attempts to provide additional information on the nutrition labeling that is required for foods sold in covered establishments that are subject to FDA’s Final Menu Labeling Rule (final rule).

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