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HHS/FDA RIN: 0910-AB88 Publication ID: Fall 2010 
Title: Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements 
Abstract: The Food and Drug Administration published a final rule in the Federal Register of June 25, 2007 (72 FR 34752), on current good manufacturing practice (CGMP) regulations for dietary supplements. FDA also published an Interim Final Rule in the same Federal Register (72 FR 34959) that provided a procedure for requesting an exemption from the final rule requirement that the manufacturer conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. This IFR allows for submission to, and review by, FDA of an alternative to the required 100 percent identity testing of components that are dietary ingredients, provided certain conditions are met. This IFR also establishes a requirement for retention of records relating to the FDA's response to an exemption request. 
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: Private Sector 
CFR Citation: 21 CFR 111   
Legal Authority: 21 USC 321    21 USC 342    21 USC 343    21 USC 371    21 USC 374    21 USC 381    21 USC 393    42 USC 264   
Legal Deadline:  None
Timetable:
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 Rule  06/25/2007  72 FR 34752   
Interim Final Rule  06/25/2007  72 FR 34959   
Interim Final Rule Comment Period End  10/24/2007    
Final Action  To Be Determined    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: No 
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:
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:240 402-2784
Fax:240-402-2657
Email: linda.kahl@fda.hhs.gov