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HHS/FDA RIN: 0910-AC50 Publication ID: Fall 2004 
Title: Food Labeling: Trans Fatty Acids in Nutrition Labeling: Consumer Research To Consider Nutrient Content and Health Claims and Possible Footnote or Disclosure Statements 
Abstract: The Food and Drug Administration issued an advance noitce of proposed rulemaking on July 11, 2003 (68 FR 41507), to solicit information and data that potentially could be used to establish new nutrient content claims about trans fatty acids; to establish qualifying criteria for trans fat in current nutrient content claims for saturated fat and cholesterol, lean and extra lean claims, and health claims that contain a message about cholesterol-raising lipids; and, in addition, to establish disclosure and disqualifying criteria to help consumers make heart-healthy food choices. The agency also requested comments on whether it should consider statements about trans fat, either alone or in combination with saturated fat and cholesterol, as a footnote in the Nutrition Facts panel or as a disclosure statement in conjunction with claims to enhance consumers' understanding about such cholesterol-raising lipids and how to use the information to make healthy food choices. Information and data obtained from comments and from consumer studies that will be conducted by FDA also may be used to help draft a proposed rule that would establish criteria for certain nutrient content or health claims or require the use of a footnote, or other labeling approach, about one or more cholesterol-raising lipids in the Nutrition Facts panel to assist consumers in maintaining healthy dietary practices. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 101   
Legal Authority: 21 USC 321    21 USC 343    21 USC 371   
Legal Deadline:  None
Action Date FR Cite
ANPRM  07/11/2003  68 FR 41507   
ANPRM Comment Period End  10/09/2003    
ANPRM Comment Period Reopened for 45 days  03/01/2004  69 FR 9559   
ANPRM Comment Period Extended for Additional 60 days  04/19/2004  69 FR 20838   
ANPRM Comment Period End  06/18/2004    
NPRM  To Be Determined    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Federalism: No 
Included in the Regulatory Plan: No 
Related RINs: Related to 0910-AB66 
Agency Contact:
Julie Moss
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
(HFS-832), Center for Food Safety and Applied Nutrition (HFS-830), 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:301 436-2373
Fax:301 436-2639

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