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HHS/FDA RIN: 0910-AB88 Publication ID: Spring 2007 
Title: Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements 
Abstract: The Food and Drug Administration proposed in the Federal Register of March 13, 2003 (68 FR 12158), current good manufacturing practice (CGMP) regulations for dietary ingredients and dietary supplements. The proposed rule was published to establish the minimum CGMPs necessary to ensure that, if firms engage in activities related to manufacturing, packaging, or holding dietary ingredients or dietary supplements, they do so in a manner that will not adulterate and misbrand such dietary ingredients or dietary supplements. FDA also proposed to require manufacturers to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements. The proposed rule also responds to concerns that such regulations are necessary to ensure that consumers are provided with dietary supplement products which have not been adulterated as a result of manufacturing, packing, or holding; e.g., which have the identity and provide the quantity of dietary ingredients declared in labeling. 
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 111   
Legal Authority: 21 USC 321    21 USC 342    21 USC 343    21 USC 348    21 USC 371    21 USC 374    21 USC 381    21 USC 393    42 USC 264   
Legal Deadline:  None
Action Date FR Cite
ANPRM  02/06/1997  62 FR 5700   
ANPRM Comment Period End  06/06/1997    
NPRM  03/13/2003  68 FR 12157   
NPRM Comment Period End  08/11/2003    
Final Action  12/00/2007    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: Yes 
Agency Contact:
Linda Kahl
Senior Policy Analyst
Department of Health and Human Services
Food and Drug Administration
HFS-206, Center for Food Safety and Applied Nutrition (HFS-024), 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:301 436-2784
Fax:301 436-2657

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