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HHS/FDA RIN: 0910-AF23 Publication ID: Fall 2015 
Title: Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCs 
Abstract:

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.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: Private Sector 
EO 13771 Designation: uncollected 
CFR Citation: 21 CFR 101.9    21 CFR 101.12   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 343    21 U.S.C. 371    Pub. L. 101-535, sec 2(b)(1)(A)   
Legal Deadline:  None

Statement of Need:

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.

Summary of the Legal Basis:

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.

Alternatives:

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.

Anticipated Costs and Benefits:

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.

Risks:

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.

Timetable:
Action Date FR Cite
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 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: Yes 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes 
Agency Contact:
Cherisa Henderson
Nutritionist
Department of Health and Human Services
Food and Drug Administration
HFS-830, 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:240 402-5429
Fax:301 436-1191
Email: nutritionprogramstaff@fda.hhs.gov