0910-AF23 201510 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCs

FDA is amending its labeling regulations for foods to provide updated Reference Amounts Customarily Consumed (RACCs) for certain food categories. This rule would provide consumers with nutrition information based on the amount of food that is customarily consumed, which would assist consumers in maintaining healthy dietary practices. In addition to updating certain RACCs, FDA is also amending the definition of single-serving containers; amending the label serving size for breath mints; and providing for dual-column labeling, which would provide nutrition information per serving and per container or unit, as applicable, under certain circumstances.

]]> Economically Significant Previously Published in The Unified Agenda Final Rule Stage Yes Private Sector 21 CFR 101.9 21 CFR 101.12 21 U.S.C. 321 21 U.S.C. 343 21 U.S.C. 371 Pub. L. 101-535, sec 2(b)(1)(A) Yes

The regulations for serving sizes for the nutrition labeling of foods have not been amended since mandatory nutrition labeling was first promulgated in 1993. New scientific evidence, consumption data, and consumer research has become available since 1993 that can be used to update the serving size information on Nutrition Facts labels to reflect the amount of food customarily consumed. This could allow consumers to use the serving size information more effectively by giving them information to help them select foods that will promote maintenance of healthy dietary practices.

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FDA's legal basis is derived from sections 201, 403 and 701(a) of the Federal Food, Drug and Cosmetic Act and section 2(b)(1) of the Nutrition Labeling and Education Act of 1990.

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The Agency will consider different options for the amount of time that manufacturers have to come into compliance with the requirements of this regulation, so that the economic burden to industry can be minimized. The Agency also intends to publish this regulation simultaneously with other regulations requiring changes to Nutrition Fact labels to ease the economic burden on manufacturers.

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This rule will affect most foods that are currently required to bear nutrition labeling. It will have a significant cost to industry because food labels on all affected foods will have to be updated. These changes would provide more current information to assist consumers in constructing a healthful diet.

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If the RACCs are not updated, RACCs that serve as the basis for serving sizes will continue to be based on old consumption data. These updates to the RACCs will be based, in part, on current nationwide consumption data. Without these updates, consumers will not have current information to assist them in constructing a healthy diet.

]]> ANPRM 04/04/2005 70 FR 17010 ANPRM Comment Period End 06/20/2005 NPRM/Comment Period Extended 03/03/2014 79 FR 11989 NPRM Comment Period End 06/02/2014 NPRM Comment Period Extended 05/27/2014 79 FR 29699 NPRM Comment Period End 08/01/2014 Final Action 03/00/2016 Yes Businesses Federal State Yes No Yes Yes Cherisa Henderson Nutritionist 0910 Food and Drug Administration FDA 240 402-5429 301 436-1191 nutritionprogramstaff@fda.hhs.gov HFS-830, 5100 Paint Branch Parkway, College Park MD 20740