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HHS/FDA RIN: 0910-AB66 Publication ID: Fall 2003 
Title: Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims 
Abstract: Section 403(q) of the Federal Food, Drug, and Cosmetic Act, which was added by the Nutrition Labeling and Education Act of 1990 (NLEA), requires that the label or labeling of food products bear nutrition information. Among other things, section 403(q) of the Act authorizes the Food and Drug Administration (FDA) to add or delete nutrients that are to be declared on the labels or labeling of food products by regulation if it finds such action necessary to assist consumers in maintaining healthy dietary practices. FDA issued final regulations implementing NLEA in 1993. FDA subsequently received a citizen petition requesting that FDA amend its regulations on food labeling to require that the amount of trans fatty acids be listed in the nutrition label and be limited wherever saturated fat limits are placed on nutrient content claims, health claims, or disqualifying levels and disclosure levels. In response to this petition and based on new evidence, FDA proposed the actions requested in the petition on November 17, 1999 (64 FR 62746). In addition, FDA proposed to define the claim "trans fat free." 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: Yes  Unfunded Mandates: Private Sector 
CFR Citation: 21 CFR 101   
Legal Authority: 21 USC 321    21 USC 331    21 USC 342    21 USC 343    21 USC 348    21 USC 371    ...   
Legal Deadline:  None
Action Date FR Cite
NPRM  11/17/1999  64 FR 62746   
NPRM Comment Period Reopened  12/05/2000  65 FR 75887   
NPRM Comment Period End  01/19/2001    
NPRM Comment Period Reopened  11/15/2002    
NPRM Comment Period End  12/16/2002    
Final Rule  07/11/2003  68 FR 41434   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Local, State, Tribal 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: No 
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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