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HHS/FDA RIN: 0910-AF22 Publication ID: Fall 2011 
Title: Food Labeling; Revision of the Nutrition and Supplement Facts Labels 
Abstract: In the Federal Register of July 11, 2003 (68 FR 41507), FDA published an ANPRM (the 2003 ANPRM) to solicit information and data on trans fat labeling and claims made about trans fats. Comments received to the 2003 ANPRM that pertain to the labeling of trans fat will be addressed in this proposed rule. In addition, the Agency published an ANPRM on the prominence of calories on the food label on April 4, 2005 (the 2005 ANPRM) (70 FR 17008), and an ANPRM on the revision of reference values and mandatory nutrients on November 2, 2007 (the 2007 ANPRM) (72 FR 62149). The Agency also intends to address the comments received to the 2005 and 2007 ANPRM's in this proposed rule. FDA is proposing to amend labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. Mandatory nutrition labeling of food was first required in 1993. Much of the information found on the Nutrition Facts label has not been updated since that time. If finalized, this rule will modernize the nutrition information found on the Nutrition Facts label, as well as the format and appearance of the label. Among the changes proposed, the Agency intends to: 1) Provide updated Daily Reference values (DRVs) and Reference Daily Intake values (RDIs) that are based on the latest scientific evidence from consensus reports, such as the Institute of Medicine Dietary Reference Intakes; 2) provide DRVs and RDIs, as well as requirements for foods purported to be for children under 4 years of age and pregnant or lactating women; and 3) make changes to the mandatory declaration of specific nutrients. The Agency is also considering revisions to the format and appearance of the Nutrition Facts label and the Supplement Facts label, including the prominence of calories on the label. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: Yes  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 101.9    21 CFR 101.36   
Legal Authority: 21 USC 321    21 USC 343    21 USC 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
ANPRM  07/11/2003  68 FR 41507   
ANPRM Comment Period End  10/09/2003    
ANPRM  04/04/2005  70 FR 17008   
ANPRM Comment Period End  06/20/2005    
ANPRM  11/02/2007  72 FR 62149   
ANPRM Comment Period End  01/31/2008    
NPRM  12/00/2012    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, Local 
Small Entities Affected: Businesses, Governmental Jurisdictions  Federalism: Yes 
Included in the Regulatory Plan: No 
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