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HHS/FDA RIN: 0910-AF22 Publication ID: Fall 2015 
Title: Food Labeling: Revision of the Nutrition and Supplement Facts Labels 
Abstract:

FDA is amending the labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. The rule would modernize the nutrition information found on the Nutrition Facts label, as well as the format and appearance of the label. On July 27, 2015, FDA issued a supplemental notice of proposed rulemaking accepting comments on limited additional provisions until October 13, 2015. Also on July 27, 2015, FDA reopened the comment period on the proposed rule as to specific documents until September 25, 2015. 

 
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 
CFR Citation: 21 CFR 101.9    21 CFR 101.36   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 343    21 U.S.C. 371   
Legal Deadline:  None

Statement of Need:

Almost all of the regulations for the nutrition labeling of foods and dietary supplements have not been amended since mandatory nutrition labeling was first required in 1993. New scientific evidence and consumer research has become available since 1993 that can be used to update the content and appearance of information on the Nutrition Facts and Supplement Facts labels.  Consumers can use the updated information to select foods that will assist them to maintain healthy dietary practices.

Summary of the Legal Basis:

FDA's legal basis derives from sections 201, 403, and 701(a) of the Federal Food, Drug, and Cosmetic Act.

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, when finalized, so that the economic burden to industry can be minimized.

Anticipated Costs and Benefits:

This rule will affect all foods that are currently required to bear nutrition labeling. It will have a significant cost to industry because all food labels will have to be updated. Much of the information currently provided on the Nutrition Facts and Supplement Facts labels is based on old reference values and scientific information. The changes would provide more current information to assist consumers in constructing a healthful diet. The potential economic benefit from the final rule stems from the improvement in diet among the U.S. population. Diet is a significant factor in the reduction in risk of chronic diseases such as coronary heart disease, certain types of cancer, stroke, diabetes, and obesity.

Risks:

If information on the Nutrition Facts and Supplement Facts label is not updated, reference values that serve as the basis for the percent daily value will continue to be based on old scientific evidence, and consumers could believe that they are consuming an appropriate amount of nutrients when, in fact, they are not. In addition, consumers would not be able to determine the amount of specific nutrients in a food product because mandatory declaration of those nutrients is not currently required. Furthermore, consumers may overlook information on the label because it is not displayed prominently on the label. Changes to the reference values, nutrients declared on the label, and changes to the format and appearance of the label would reduce the risk of consumers not having information necessary to assist them in maintaining healthy dietary practices. 

Timetable:
Action Date FR Cite
ANPRM  07/11/2003  68 FR 41507   
ANPRM Comment Period End  10/09/2003    
Second ANPRM  04/04/2005  70 FR 17008   
Second ANPRM Comment Period End  06/20/2005 
Third ANPRM  11/02/2007  72 FR 62149   
Third ANPRM Comment Period End  01/31/2008 
NPRM  03/03/2014  79 FR 11879   
NPRM Comment Period End  06/02/2014 
Reopening of Comment Period as to Specific Documents  07/27/2015  80 FR 44302   
NPRM Comment Period End as to Specific Documents  09/25/2015 
Supplemental NPRM to Solicit Comment on Limited Additional Provisions  07/27/2015  80 FR 44303   
Supplemental NPRM to Solicit Comment on Limited Additional Provisions Comment Period End  10/13/2015 
Administrative Docket Update; Extension of Comment Period  09/10/2015  80 FR 54446   
Administrative Docket Update; Comment Period End  10/13/2015 
NPRM Reopening of Comment Period for Certain Documents  10/20/2015  80 FR 63477   
NPRM Reopening of Comment Period for Certain Documents Comment Period End  10/23/2015 
Final Action  03/00/2016 
Additional Information: Includes Retrospective Review under E.O. 13563.
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, Local 
Small Entities Affected: Businesses, Governmental Jurisdictions  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:
Blakeley Fitzpatrick
Interdisciplinary Scientist
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition, HFS-830, 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:240 402-5429
Email: nutritionprogramstaff@fda.hhs.gov

 
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