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HHS/FDA RIN: 0910-AB88 Publication ID: Spring 2008 
Title: Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and 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. The final rule (the CGMP rule) was published to establish the minimum CGMPs necessary to ensure that, if firms engage in activities related to manufacturing, packaging, labeling, or holding dietary supplements, they do so in a manner that will ensure the quality of the dietary supplements i.e., to ensure that the dietary supplement consistently meets the established specifications for identity, purity, strength, and composition, and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act. FDA also published an interim final rule (IFR) in the June 25, 2007 Federal Register (72 FR 34959) that sets forth a procedure for requesting an exemption from the requirement in the final rule described above 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: 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
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 Action  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  06/00/2008   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
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:301 436-2784
Fax:301 436-2657
Email: linda.kahl@fda.hhs.gov

 
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